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ISO 9001:2000

The 1994 version of ISO 9000 series has given way to the ISO 9000:2000 series of standards and guidelines. The new
series was released on 15th December 2000. The ISO 9001:2000 standard for Quality Management Systems (QMS) is
the most significant of the ISO 9000:2000 series. Organisations that are already certified to one of the ISO 9000:1994
standards need to switch over to the ISO 9001:2000 standard before 15th December 2003, to remain ISO certified.

Understanding > Introduction

Quality improvement has to be ongoing. This feature characterises the development in quality standards too. The 1994
version of ISO 9000 series has given way to the ISO 9000:2000 series of standards and guidelines. The new series was
released on 15th December 2000. The ISO 9001:2000 standard for Quality Management Systems (QMS) is the most
significant of the ISO 9000:2000 series.
We have already dwelt extensively on the 1994 version ISO 9000 standards. In this module we introduce the universally
applicable ISO 9001:2000 standards.
How different is it from the previous ISO 9000:1994 standard?
The ISO 9001:2000 standard is simplified and is applicable across a larger cross-section of industry. The requirements
specified are generic and apply to both product and service oriented organisations. We now look at the changes that have
been incorporated in it.
1. Integration of standards:
The ISO 9000: 1994 version had three standards
• ISO 9001 – Quality model for design, development, production, installation and servicing.
• ISO 9002 – Quality model for production, installation and servicing.
• ISO 9003 – Quality model for Final Inspection and Testing.
Depending on the business they were in organisations got certified to either ISO 9001 or ISO 9002 or ISO 9003. The
presence of multiple models was actually confusing to understand or implement. Hence, the new ISO 9000:2000 series
integrated all the models under a single ISO 9001:2000 standard.
With the advent of ISO 9001:2000, all ISO 9000 certified organisations will now have a single QMS certification.
Organisations only need to follow the requirements relevant to their area of business and exclude others. Organisations
that are already certified to one of the ISO 9000:1994 standards need to switch over to the ISO 9001:2000 standard
before 15th December 2003.
2. Reduction in clauses:
The 20 clauses prescribed in the 1994 version, caused various problems to the organisation. First, there was an apparent
discontinuity in the flow of the clauses. Second, the clauses did not reflect the way business was done. Hence, though the
organisations demonstrated compliance to the 20 clauses, their presentation differed from the operational practice.
The new standard has brought down the 20 clauses to five broad and comprehensive ones. These are:
Clause 4: Quality Management System.
Clause 5: Management Responsibility.
Clause 6: Resource Management.
Clause 7: Product Realisation.
Clause 8: Measurement, Analysis and Improvement.
3. Meeting customer requirements:
The key objective of ISO 9001:2000 QMS is customer satisfaction. Organisation needs to evaluate customer needs and
expectations and ensure that the entire workforce is aware of them. Customer needs should be the basis for defining
targets for improvement within the organisation. Focus on customer communication can help in understanding the
customer.
4. Adopting the “process” approach:
The five clauses of the ISO 9001:2000 standard clearly emphasise on the “process” approach. They focus on:
1. Identifying and conforming to customer needs.
2. Value addition to the customer by the processes.
3. Process evaluation based on performance and effectiveness.
4. Constantly enhancing the system based on objective evaluation of process.
5. The role of management:
In the new standard, management role has been widened and reinforced. Top management personnel need not take part
in the everyday operation of the QMS. They however need to frame the quality policy and quality objectives, perform
assessments, ensure adequacy of resources and focus efforts on meeting customer and regulatory requirements. In spite
of the reservations regarding management role in quality system, it is usually considered to be the foundation for a
successful QMS.
6. Continual enhancement of quality system:
This feature was also a part of the previous standard (1994) but reflected only in a few clauses such as corrective and
preventive action, and auditing. But the new standard views continual improvement as an important aspect of QMS
implementation. It also requires organisations to regularly check, evaluate, redefine, and communicate quality targets.

7. Ongoing information gathering and evaluation:


The new QMS emphasises the need for an ongoing process of information gathering and analysis. The organisation should
continually analyse information regarding customers, products, processes, and suppliers.
8. Reduced rigidity helps customised documentation:
The less rigid nature of the standard has given more freedom for organisations to present their documentation. Apart from
the quality manual, documentation is specifically required for only six basic areas – control of documents, control of quality
records, internal audits, control of nonconforming product, corrective action and preventive action.
This does not mean that the organisation neglects the documentation of other areas. Rather the organisation should
identify and document all processes and procedures that will ensure an effective QMS. The organisation must consider
various factors such as organisation size, the nature of its processes, the difficulty and interdependency of processes and
the skill of personnel before documentation.
9. Different Perspectives:
The 2000 version has shifted its perspective in the following areas:
1. While the previous version viewed the final product as an outcome of many processes, the newer version views it as a
process outcome.
2. The old standard considered quality as total characteristics of a product or service for fulfilling requirements. The newer
version expresses quality as the capacity of the product to meet customer and regulatory requirements.
3. The newer version has the terms – organisation, supplier and customer instead of the old standard terms – supplier,
sub-supplier and customer respectively.
10. Exclusions:
In the previous version, organisations dealing with production, installation and servicing were registered under ISO 9002.
If there was no provision for service in the organisation, it was mentioned in the quality manual. But in the recent version
exclusions are permitted only for section 7 (product realisation) requirements, subject to the non-relevance of
requirements to the organisation. The organisation must clarify and validate the exclusions.

Continue the tour:


The Principles Behind ISO 9001:2000

Understanding > The Principles Behind ISO 9001:2000


The ISO 9001:2000 QMS standards are based on 8 principles.
These along with the advantages of applying them are listed
below:

1. Customer Focus:
Organisations depend on their customers and therefore, should
understand current and future customer needs, and strive to
exceed customer expectations. This involves
• Better response to market trends.
• Making objectives and operations customer-centric.

• Focussing energies on increasing customer satisfaction.

• Gauging customer satisfaction for further action.


2. Leadership:
Leaders establish the organisation’s direction and provide unity
of purpose. They should create and maintain an environment in
which people can become fully involved in achieving the
organisation's objectives.
Leadership:

• Promotes harmony in the organisation.

• Drives a single purpose through the organisation.

• Recognizes individual contributions.


• Makes employees responsible and accountable through
proper training and empowerment.
3. Involvement of Employees:
Employees irrespective of their position are the essence of an
organisation and organisations benefit from their involvement
and abilities. Employee involvement ensures their total
commitment towards meeting organisational objectives.
4. Process Approach:
A desired result is achieved more efficiently when related
resources and activities are managed as a process. This helps:

• Recognise important activities in the system.

• Improve important activities through effective


utilisation of resources and efficient methods.
• Make output constant, reliable, and fast.
5. System Approach to Management:
Identifying, understanding and managing interrelated processes
as a system contributes to an organisation's effectiveness and
efficiency in achieving its objectives. It

• Directs processes to achieve organisation’s objectives


and to focus on important processes.
• Develops a system to achieve objectives.
• Initiates process integration and interdependency
through a structured approach.

• Uses resources effectively depending on capabilities of


organisation
6. Continual Improvement:
Continual improvement should be a permanent objective of the
organisation. The advantage of this endeavour is that it

• Aligns activities of organisation with the organisational


plan.
• Develops a continual improvement consciousness
among the people.
• Trains people in employing tools of continual
improvement.

• Views continual improvement of the organisation as


every employee’s objective.
7. Factual Approach to Decision Making:
Effective decisions are based on the analysis of data and
information. Thereby
• Data on hand is reliable.
• Analysis of data is accurate.
• Decision-making is effective.
8. Mutually Beneficial Supplier Relationships:
An organisation and its suppliers are interdependent and a
mutually beneficial relationship enhances their ability to create
value. As a result
• Value creation potential increases.
• Clarity of communication improves.
• Resources are pooled for achieving common goals.
Continue the tour:
ISO 9001:2000 QMS Requirements

Understanding > ISO 9001:2000 QMS Requirements

Every product goes through various stages of production before


the final delivery to the customer. To support this process the
organisation needs a structured management system. This
approach requires total involvement from the top management.
A management system guides an organisation to meet customer
needs and also comply with the regulations. In addition to the
customer focus, the organisation also has responsibilities
towards its stakeholders, staff and society. Fulfilling these
responsibilities entails specific requirements of a QMS.
These requirements form the basis for the ISO 9001:2000
standards.

Clause by clause explanation of ISO 9001:2000 QMS


requirements
4. Quality Management System:
This clause outlines the requirements of a QMS.
4.1 General Requirements:
General requirements state that an organisation must implement
a continually improving QMS, meeting the requirements of the
standard.
What organisations need to do?

• Determine the processes, required by the QMS that is


applied by the organisation.
• Identify the interdependency of the processes and their
occurrence.

• Recognise the requirements and procedures for


effective process operation and control.
• Ensure availability of all resources required to operate
processes.
• Perform process checking, evaluation and review.
• Direct actions for achieving objectives.
• Continually improve on processes.
4.2 Documentation Requirements:
This section of the standard deals with the documentation of a
QMS.

4.2.1 General:
Documentation requirements for a QMS include:
• Documents for implementing a quality system.

• Documents detailing the organisation’s processes.

4.2.2 Quality Manual:


The quality manual is an important part of documentation and
deals with
• The span of the QMS.
• Exclusions if any.

• The organisation’s accepted procedures for


implementing quality system.
• Details of process interrelationships within the QMS.
4.2.3 Control of Documents:
This relates to the steps involved in document control i.e.
maintaining and managing documents. These include:
• Endorsing documents before distribution.
• Assessing and re-endorsing documents whenever
required.
• Identifying the existing revised edition of documents
including amendments if any.
• Supplying recent versions of required documents and
ensuring availability at relevant locations.
• Maintaining the legibility of documents and making
them distinguishable.
• Replacing or distinguishing obsolete editions to prevent
their accidental use.
4.2.4 Control of Records:
Records are the proof of an organisation's implementation of a
quality management system hence they need to be carefully
maintained. This section lists the requirements for managing
records starting from their creation till their disposal.
5. Management Responsibility:
The success of any QMS is in direct proportion to the role played
by the management. This clause features the management role
in a QMS.
5.1 Management Commitment:
The management should demonstrate their commitment to the
establishment and continual improvement of the QMS. They can
do this by:
• Communicating the need to meet customer, statutory
and regulatory requirements.
• Developing a quality framework addressing the above
needs.
• Setting quality objectives and providing necessary
resources.
• Performing management reviews to improve existing
systems.
5.2 Customer Focus:
This section deals with ways to achieve customer satisfaction. It
is the management’s responsibility that customer needs are
identified and consistently met, to ensure customer satisfaction.
5.3 Quality Policy:
A quality policy is essential for initiating the quality system. This
section provides a framework to the management for building
the quality policy.
The quality policy should:

• Be aligned with the overall organisational goals.

• Direct the organisation towards continual improvement


of the quality system.

• Be established across the organisation.

• Act as a guideline for the setting up and evaluating the


quality objectives.
• Be continually evaluated for relevance.
5.4 Planning:
This section highlights the management's role in defining quality
objectives and planning the quality system.
5.4.1 Quality Objectives:
The management should ascertain that quality objectives are
fixed for all the activities and functions of the organisation. The
defined quality objectives need to be measurable and aligned
with the established quality policy.
5.4.2 Quality Management System Planning:
The management should play a role in the planning of the quality
system. Planning should be directed towards achieving the basic
requirements of the standard and the QMS quality objectives.
Any changes planned to the system should be consistent with
the system.
5.5 Responsibility, Authority and Communication:
This section lists the requirements to be followed by the
management while assigning responsibility, choosing a
representative and promoting communication.
5.5.1 Responsibility and Authority:
This part of the clause states that the management must assign
responsibilities and make employees at all levels accountable in
order to involve the organisation as a whole in the endeavour for
quality.
5.5.2 Management Representative:
The section details the management representative's role.
Appointed by the top management he should:
• Monitor the processes required by the QMS.
• Update the management on the QMS's performance
and ensure continual improvement.

• Advance the cause of customer needs across the


organisation.
5.5.3 Internal Communication:
It is the management's responsibility to see that the information
relating to the QMS is communicated well through established
channels.
5.6 Management Review:
The primary objective of quality management is customer
satisfaction. Hence, there must be a continual improvement in
the QMS to achieve this goal. This section deals with the need for
conducting management reviews and specifies the requirements
they need to meet.
5.6.1 General:
This section centres on the basic requirements for improving the
QMS. The quality system is reviewed at regular intervals for
effectiveness. The review aims at identifying possibilities of
improvement and changes in the policy and objectives of the
QMS.
5.6.2 Review Input:
This section lists the aspects that the management must
consider while conducting a review.
• Audit results.
• Customer feedback.
• Conformity of product to quality.
• Process performance.
• Precautionary and remedial actions implemented.
• Results of previous management reviews.
• Factors affecting QMS.
• Suggestions for improvement.
5.6.3 Review Output:
A management review should work towards:
• QMS improvement.
• Increase in product quality on par with the customer
requirements.
• Identifying resources needed for the system.
6. Resource Management:
Every system needs specific resources for its success. The QMS
sustains itself through the following:
6.1 Provision of Resources:
Resources need to be identified and provided so as to:
• Sustain the QMS and enhance its effectiveness.

• Fulfil customer needs and increase customer


satisfaction.
6.2 Human Resources:
Manpower forms a major part of an organisation's resources.
This section addresses the requirements for managing human
resources.
6.2.1 General:
Skilled personnel need to be employed in areas of work that
have direct impact on quality.
6.2.2 Competence, Awareness and Training:
For effective utilisation of human resources:
• Establish the levels of proficiency for performing a work
that affects product quality.

• Ensure training of personnel to fulfil these


requirements.
• Regularly evaluate the measures taken to meet the
above-mentioned requirements.
• Ensure that the personnel are aware of the significance
of their role in contributing to the quality system.
• Maintain records of training, awareness programs,
qualifications and experience of personnel.
6.3 Infrastructure:
An organisation should identify and provide the necessary
infrastructure (land, building, equipments, supporting facilities)
for maintaining quality.
6.4 Work Environment:
The onus of identifying and creating the necessary work
environment for maintaining product/process quality lies on the
organisation.
7. Product Realisation:
Every product passes through the stages of planning, customer
specifications, design, purchasing, production and service,
control and monitoring. This clause lists the requirements for
each of these stages.
7.1 Planning Product Realisation:
The organisation ought to devise and establish processes
required for product development. These processes need to be in
line with the general requirements of the quality system. The
organisation has to:
• Establish suitable quality standards, processes and
documents for the product.
• Provide resources for developing the product.
• Establish required process for checking product quality.
• Maintain records to confirm that both the processes and
product meet the requirements.
7.2 Customer Related Processes:
Customer requirements shape the product. Keeping this in view
this section details the stipulations for identifying, analysing and
communicating customer requirements.
7.2.1 Determining Product Related Requirements:
This section requires that the organisation identify:
• Explicit requirements of customers.
• Implicit requirements of customers.
• Statutory and regulatory product requirements.

• Supplementary requirements established by the


organisation.
7.2.2 Review Product Related Requirements:
Product requirements should be reviewed by the organisation
before taking the responsibility to deliver. This necessitates that
• Product specifications are clear.
• Changes made to earlier product specifications are
communicated and mutually accepted.

• The organisation is capable of achieving the specified


requirements.
• Records of the review are maintained.
7.2.3 Customer Communication:
The organisation needs to identify and establish effective
methodologies for communicating to customer's information
regarding the products, contracts, orders, feedback and
complaints.
7.3 Design and Development:
Once the requirements are known, the product can proceed to
the design stage. This section categorises the design
requirements under planning, design inputs, design outputs,
design review, design verification, design validation and design
change control.

7.3.1 Design and Development Planning:


The organisation needs to define the following aspects for design
and development of a product.
• The stages of the process.
• The monitoring process at each stage.
• Design and development responsibilities.
The organisation must also put in place systems that augment
cooperation between various groups involved in the design and
development. Proper communication and delegation of
responsibilities facilitates this.
Deliverables from the planning process are readjusted to take
into account the advancements in design and development.
7.3.2 Design and Development Inputs:
The following product design inputs need to be identified and
recorded:
• Operational and performance standards.
• Statutory and legal requirements.
• Data from previous designs if any.
• Necessary design and development requirements.
7.3.3 Design and Development Outputs:
The design and development outputs are checked against the
relevant design and development inputs for conformity. The
output must:
• Meet the input criteria.
• Detail aspects such as procurement, manufacturing and
after sales service.
• List the approval criteria for product quality.
• Highlight product features vital for safe and appropriate
use.
7.3.4 Design and Development Review:
Design and development reviews have to be planned and
conducted at appropriate intervals. These reviews should ensure
that:
• The progress made in design and development meets
the proposed criteria.
• Problems are detected well in advance and suitable
action is taken.
The team conducting the review should consist of personnel
across various functions. The details of the review and actions
taken thereof should be recorded.
7.3.5 Design and Development Verification:
The outputs need to be verified to ascertain that they have met
the input requirements. The records of verification and corrective
action if any should be maintained.
7.3.6 Design and Development Validation:
The organisation should have a process of validation so that the
designed product meets the customer requirements for which it
is being made. Validation should take place before the product
gets into production mode or is delivered to the customer.
Records of validation conducted should be documented.
7.3.7 Control of Design and Development Changes:
The changes made during the design and development needs to
be recorded. They should be examined and confirmed before
being applied. A review of these reveals the impact of change on
the product.
7.4 Purchasing:
This section explains the requirements to be considered for
procuring a product from a supplier.
7.4.1 Purchasing Process:
Products procured from the supplier should match the purchase
specifications laid down. The effort made to do this should
correspond to their impact on the final products performance.
Suppliers are chosen based on their ability to conform to the
organisation’s product specifications.
Guidelines for choosing and approving suppliers should be laid
down and followed. Details of supplier appraisal conducted along
with relevant action taken also should be recorded.
7.4.2 Purchasing Information:
The details of product to be purchased need appropriate
definition, along with:
• Specifications for acceptance of products, processes,
methods and equipment.
• Proficiency of personnel to be deployed, and
• Quality system standards followed.
7.4.3 Verification of Purchased Product:
Steps, such as inspection and testing to ensure that the procured
product meets the required specifications should be followed.
If the organisation plans to verify at the supplier's location, it
must be stated in the purchase information.
7.5 Production and Service Provision:
This section deals with the organisational requirements with
respect to production and service provisions.
7.5.1 Control of Production and Service Provision:
The provision for production and service is under restricted
conditions that include
• Accessibility of data pertaining to product details.
• Accessibility of work instructions.
• Availability of appropriate equipment.
• Defined procedures for monitoring and measurement
along with necessary equipment.
• Application of steps for approval, delivery and after
delivery processes.
7.5.2 Validation of Processes and Service Provision:
The organisation should evaluate and approve the processes
where the output cannot be crosschecked before delivery. In
such cases defects surface only after the product is put to use or
a service provided. Validation helps ascertain that the process or
product meets the desired objectives.
The following factors need to be considered for validation:
• Establishing criteria for assessment and clearance of
the processes.
• Clearance of equipment and skill of personnel deployed.
• Defined procedures.
• Control of records.
• Revalidation.
7.5.3 Identification and Traceability:
The product should be clearly identified wherever possible in the
process of product realisation. The progress of the product
realisation should be determined through relevant monitoring
and measurement methods. Distinctive identity of products that
need to be traced should also be maintained and recorded.
7.5.4 Customer Property:
Customer property being used by the organisation should be
handled with care. The property must be identified, protected
and maintained properly. The customer must be immediately
notified and details recorded of any damage or loss of the
property.
7.5.5 Preservation of Product:
The organisation must maintain the quality of the product till it is
delivered to the customer. This includes stages such as storage,
packing, transportation and delivery.
7.6 Control of Monitoring and Measuring Devices:
The organisation should establish monitoring and measurement
procedures. This includes maintaining appropriate instruments
for ascertaining conformance of the product to the desired
specifications.
Where appropriate, the measuring instruments should be:
• Calibrated and details recorded.
• Fine-tuned as per requirements.
• Identifiable.
• Maintained and protected to ensure that measurements
are error free.
• Checked to prevent inadvertent changes to
measurements taken.
If the instrument does not meet the calibration specifications,
the organisation must evaluate its previous measurements.
Necessary corrective action should then be initiated. Details of
calibration and evaluations conducted should be recorded.
8. Measurement, Analysis and Improvement:
This clause focuses on the need to adhere to the continual
improvement objective of the quality system.
8.1 General:
The organisation should have in place monitoring, measurement,
analysis and improvement processes, including statistical
methods for:
• Indicating the conformance of product or service to
stipulations.
• Ensuring adherence to the QMS.
• Continually improving the QMS.
8.2 Monitoring and Measurement:
This section contains the requirements to be met for monitoring
and evaluating the quality system.
8.2.1 Customer Satisfaction:
The organisation should determine whether they are satisfying
customer requirements through regular customer feedback. It
should also devise and define ways for gathering and analysing
customer feedback.
8.2.2 Internal Audit:
Internal audits should be conducted periodically to ensure that
the QMS

• Meets the ISO 9001:2000 standards and the


organisation defined QMS requirements.
• Is well deployed and sustained.

• The organisation needs to define and document aspects


such as the basis of an audit, the area it covers, its
periodicity, the people responsible for conducting it,
and the approach adopted. It also needs to define and
document how the audit results are recorded and
utilised. The entire audit process must be unbiased and
conducted by someone external to the division or
department under audit.
8.2.3 Monitoring and Measurement of Process:
Efficient monitoring and measurement methods need to be
employed to substantiate the ability of the QMS processes to
achieve the desired goals. If the results do not conform to the
objectives outlined, appropriate corrective action must be taken.
8.2.4 Monitoring and Measurement of Product:
The product should be monitored and measured at various
stages of the product realisation to ensure conformity to defined
specifications. In case of non-conformity, the product delivery
should be stalled unless the concerned customer or authority’s
acceptance is obtained.
8.3 Control of Non-Conforming Product:
Products failing to conform to the customer requirements should
be identified and accidental use is to be prevented. The
organisation can adopt the following approaches while dealing
with such products. It should
• Take necessary steps to avert the nonconformity.
• Prevent the product from its intended use.
• Release the product for usage only with the concerned
customer or authority’s consent.
Information pertaining to such products and the corresponding
action taken should be recorded. If the action was initiated to
correct the product, necessary re-checking must be done before
approval.
If the defect is identified after the product is delivered to the
customer, then the organisation must consider appropriate
action.
8.4 Analysis of Data:
Pertinent data must be gathered and examined to ascertain the
relevance of the QMS. The areas where enhancement can be
made should also be identified with the help of the information
analysis. The data collected from monitoring and measurement
activities is one of the sources for such an analysis.
The gathered data must provide information about:
• Customer feedback.
• Meeting of established product requirements.
• The tendency of particular processes and products.
• Scope for taking pre-emptive steps.
• Contractors and suppliers performance.
8.5 Improvement:
This section lists the requirements for the continual improvement
of the QMS (Quality Management System).
8.5.1 Continual Improvement:
The effectiveness of organisations QMS must be continually
improved. Striving to meet the principles set by the quality
policy, and endeavouring to meet the quality objectives can be
one way of achieving this.
The opportunities for improvement can be determined by
evaluating audit results, analysis of data, and management
review. Improvements can be made through corrective and
preventive action, or through innovative means.
8.5.2 Corrective Action:
Appropriate corrective actions are essential for ensuring that a
non-conformance does not recur. Corrective action involves:
• Assessing the nonconformities.
• Identifying the origin of nonconformity.
• Evaluating the necessity of taking action to prevent
repetition of nonconformity.
• Identifying and applying the required action.
• Maintaining records of actions taken and consequent
results.
• Re -evaluating the corrective action implemented.
8.5.3 Preventive Action:
To avoid possibilities of non-conformance, the organisation must
take appropriate precautionary or preventive actions. The
following procedures for preventive action need to be
documented and implemented:
• Identify probable nonconformities and their origin.
• Assess the necessity of action to avert nonconformities.
• Identify and carryout the necessary actions.
• Document the actions taken and their outcomes.
• Re-evaluate the preventive actions implemented.
Planning and Implementation > Step By Step
Implementation Of ISO 9001:2000 QMS
The ISO 9001:2000 standard is focussed on accomplishing the
following objectives.
• Achieve customer satisfaction through product or
service quality.
• Develop a process based, systems approach.
• Create a culture of employee involvement and continual
improvement.

• Improve overall performance of the organisation.

• Reduce operational risk.


A few basic steps should be followed to achieve these objectives
through implementation of ISO 9001:2000 standard.

Summary of steps for implementing ISO 9001


1. Top management involvement.
2. Choosing and training a project manager.
3. The project manager prepares a project plan.
4. Setting up a steering committee.
5. Conducting gap analysis.
6. Communication, awareness and training.
7. Forming teams and assigning responsibilities.
8. Team review.
9. Review by the steering committee.
10. System implementation.
11. Internal audit.
12. Management review.
13. Pre-assessment audit.
14. Final audit.
1. Top management involvement:
Any company wide quality program needs total involvement of
the top management. The success of the ISO 9001:2000
implementation begins with the commitment of the
management. The commitment from the top management
sustains and drives the ISO 9001 implementation.
The top management must show its commitment by

• Expressing the importance of meeting customer


requirements to the organisation.
• Establishing the quality policy.
• Ensuring that the quality objectives are defined.
• Ensuring required resources are available.
• Choosing a management representative.
• Performing management reviews.
2. Choosing and training a project manager:
The first concrete step an organisation can take towards
implementing the ISO 9001:2000 QMS is to choose a project
manager. A project manager chosen should be a key player in
the organisation’s management. The top management should
appoint him and oversee the implementation of the whole
project.
He must therefore, have an in-depth knowledge of the
organisation’s working, a thorough understanding of essential
management principles and clarity about the ISO 9001
requirements.
The project manager must have an in-depth knowledge of the
ISO 9001 requirements. He should also be provided appropriate
training to enable him to determine
• The QMS implementation plan.
• QMS communication strategy·
• The resources needed.
• Training and awareness needs.
This training ensures that a skilled professional committed to
quality heads the project.
3. Preparing a project plan:
Post training, the project manager develops a project plan. The
project plan is an outline for the ISO 9001:2000 implementation.
The objective of a project plan is to define the various phases of
implementation and developing time schedules for accomplishing
them.
The start of the project could possibly be the process of gap
analysis. The gap analysis process, normally takes between 2 to
5 days. It depends on the organisation’s size, number of
auditors, auditors’ experience and existing quality system.
The immediate objective of the organisation is to get the ISO
certification at the earliest possible date. This date is influenced
by many factors. It is therefore essential for the project manager
to weigh the following when setting the time for achieving
certification.
• The closing date of the project shapes the intermediate
deadlines to be met.
• A shorter time frame for implementation consumes
more resources.

• A longer deadline may cause the organisation to lose


momentum.
It is essential to fix a tentative date based on factors driving the
organisation towards certification. Consulting with auditors can
also prove useful in this regard. Once a tentative date is fixed,
the process can be directed accordingly. The date can be
modified depending on the progress made and the speed of the
process.
4. Setting up a steering committee:
The project manager chooses a steering committee to assist him
in the planning, synchronising and resource mobilisation required
for the project. The implementation of the standard necessitates
constant review and discussion among the steering team. The
steering committee is an essential part of the QMS
implementation.
Its responsibilities include:
• Choosing team members for each procedure.
• Setting the time limit for each team.

• Determining training requirements for employees and


scheduling training programmes.
• Meeting regularly to assess progress, hold discussions
with various teams and assess the various resources
required for implementation.
• Reviewing and approving procedures.
• Assessing and selecting a registrar.
5. Conducting gap analysis:
It is essential for the organisation to establish the status of the
current quality system. A gap analysis process compares the
current quality system with the requirements of the ISO
9001:2000 standard. The result of the analysis provides
information about the gap to be abridged for various processes
of the existing system. While the above steps are all a part of
planning, the actual implementation starts only after the gap
analysis.
The project manager in consultation with the steering committee
could appoint an internal or external team to conduct the gap
analysis.
6. Communication, awareness and training:
The gap analysis will highlight the deficient processes and the
areas for improvement. The steering committee should then
determine how to fill the gap and achieve the ISO 9001:2000
requirements. An organisation wide implementation strategy is
necessary for this.
Organisation wide implementation must begin with conducting
ISO awareness programmes. These programmes communicate to
the employees what ISO 9001:2000 is all about. It also answers
why ISO 9001:2000 is being implemented, how it will affect the
objectives of the organisation and the employees, and the role
each can play.
Once the employees are aware of the ISO 9001 standard, they
must be trained to adapt to its requirements. Implementation of
the ISO 9001 standard affects the entire organisation. The
training programmes must therefore, be targeted at all the
employee categories – senior management, middle
management, supervisors and workers. The training of
employees include
• Determining the training needs for QMS specific
competencies (such as preparing quality manual,
writing directives for procedures and processes,
principles of audit).
• Imparting the required training including new
techniques for monitoring, measurement and testing
among others.
• Training personnel to manage change brought about by
the standard.
7. Forming teams and assigning responsibilities:
The steering committee then selects employees for creating
project teams. These project teams are assigned specific tasks
based on the result of gap analysis. Their main role is to upgrade
the deficient processes/ procedures and prepare documentation
to meet the ISO standard’s requirements.
The steering committee assigns responsibilities to individuals and
groups. The committee must also allocate necessary resources
and set the deadlines for completion of the tasks.
Assigning tasks:
While assigning tasks the steering committee should
• Assess the division of responsibilities to ensure that
they are evenly distributed, so that no individual or
team is heavily loaded with responsibilities.
• Identify a leader for each team. It is advisable to have
a member from the steering committee as a team
leader. This would enable the team to communicate
better with the steering committee.
Identifying required resources:
The steering committee must determine whether the teams or
members require assistance to carry out their responsibilities
during implementation of ISO standard. It must also guide the
teams and it’s members in accomplishing the entrusted tasks.
This may range from providing prepared materials to giving
special training.
Establishing time limits:
The steering committee must set the time limit for the teams to
finish the tasks. The biggest factor influencing the time limit is
the availability of resources. Hence, the steering team must
review the availability of resources and establish intermediate
deadlines with respect to it.
Time limits must be set considering the sequence of tasks. The
steering committee must be clear about the preceding and
succeeding tasks to be distributed among all the teams.
Deadlines for key activities, which form the basis for other
activities, must be set earlier.
An estimated time for completion of the project depending on
the availability of resources must also be established. The gap
analysis sheet can also be referred to determine the exact
quantity of work to be acoomplished by the teams. All these will
help in determining an approximate time required for the whole
process.
8. Team review:
A continual review is essential to determine if the
implementation project is on the right track. Normally individual
team leaders conduct these reviews. They hold team meetings to
discuss and modify processes. The meetings are based on the
results of gap analysis and the outcomes of the assigned tasks.
The team leader reviews these results to determine the team’s
progress.
The proceedings in a team review can be listed as
• Discussing the process the team is entrusted with.
• Discussing the gap analysis relevant to the team.
• Identifying the required resources by the team for
completing the tasks.
• Establishing deadlines based on the gap analysis sheet.
• Ensuring that the procedures and the processes match
and necessary modifications are made wherever
required.
• Creating and documenting a new procedure if there is
no defined procedure available.
• Listing the requirements that have not been met. An
assessment of these requirements is essential for
modifying the process.
Depending on this review, processes are modified, resources re-
allocated and deadlines reset with the approval of the steering
committee. The project team then proceeds with accomplishing
the assigned tasks.
9. Review by the steering committee:
The steering committee directs the implementation project. The
steering committee’s review is essential to determine the
applicability and effectiveness of the QMS. The review focuses on
evaluating the processes for further improvement and the
required changes to the processes to effect this improvement.
The steering committee assesses the following:
• The role of each project team and the entrusted
responsibilities.
• Whether the targets can be met.
• Whether the training needs of employees are met.
• The availability of resources as planned or is there a
need for alterations.
• Approval of the procedures and processes developed by
the team leaders.
10. System implementation:
Once all the tasks assigned to the various teams are
accomplished, the organisation is ready to implement the
system. All the modified procedures and processes are put into
effect. Implementation of the system ensures that the
requirements of the gap analysis are fulfilled.
The following are the significant characteristics of a successful
QMS.
• Top management fully supports the QMS.
• Current business processes form the core of the QMS.
• QMS documentation is easily accessible to all the
employees.
• Documentation of the QMS is concise, clear, and easy
to use and control.

• Opportunity for growth through continual improvement


is inherent in the organisation.

• Management representatives are entrusted with critical


responsibilities for managing and enhancing the QMS.
· Internal audit adds value and is an essential part of
the continual improvement objective of the system.
11. Internal audit:
Internal auditing is the first step to determine the effectiveness
of the implementation project. It is an essential part of the
continual improvement objective of the system. Hence, it is
critical to choose and train the right kind of internal auditors. The
auditors should preferably be from across various functional
areas of the organisation. This enables a better understanding of
the system during audit.
Internal audits are performed to confirm that the implemented
QMS:

• Meets the ISO 9001 requirements and the quality


objectives established by the organisation.
• Is effective and is continually being improved.
Internal audits must be continued even after the QMS has been
implemented and certified.
12. Management review:
A management review is conducted when the QMS has been
implemented and maintained for about three to six months. This
is essential for determining the continual applicability, conformity
and effectiveness of the quality system. The review involves
evaluating the need for modifications to the QMS and identifying
opportunities for improvement. The management review is
normally conducted on the basis of:
• Audit results.
• Customer feedback.
• Process performance and product compliance.
• Status of remedial and preventive actions.
• Results of past management reviews.
• Changes impacting the QMS.
• Suggestions for improvement.
13. Pre-assessment audit:
The organisation can apply for certification when there are no
noticeable non-conformities in the system. However, it would be
beneficial for the organisation to go for a pre-assessment audit
by an external/independent auditor. This will iron out small
deficiencies the organisation might have overlooked. It will also
build the confidence of the organisation for the final audit.
14. Audit by the registrar:
This is the culmination stage of the whole project. An
organisation that has implemented and tested the quality system
can apply for an audit from a certifying body. A recognised
certifying body conducts the audit.
Auditing of documents is performed first. An on-site audit of the
QMS is conducted if the documentation conforms to the
requirements of the ISO 9001 standard. If the functioning of the
QMS meets the entire ISO 9001:2000 requirements, the
organisation is recommended for certification as ISO 9001:2000
compliant. The certificate is usually valid for three years. During
this period the registrar periodically reviews the QMS to ensure
its continual improvement.
Continual Improvement:
Getting certified is not the end of the road for the ISO
9001:2000 QMS implementation in the organisation. It is just the
beginning. The organisation needs to continually identify
customer requirements and other areas for improvement. It is
this process of continual improvement that actually keeps the
ISO 9001:2000 certification from becoming obsolete.
Gap Analysis > Description

One of the first steps in implementing ISO 9001:2000 standard


Quality Management System (QMS) is to conduct a Gap analysis.
Gap analysis helps identify the gaps between the organisation’s
existing processes to the requirements of the ISO standards.
Following are the steps involved in conducting an effective Gap
analysis.
Form a Team:
Normally, organisations seek the services of an external auditing
agency for conducting a Gap Analysis. However, if the
organisation has personnel who are well versed with the ISO
standards with prior experience in conducting gap analysis, then
their services are preferred.
The team formed to conduct the Gap Analysis should preferably
comprise of personnel from different functional backgrounds. The
team size depends on how large the organisation is and the
complexities involved in the study. Duration of gap analysis
program largely depends on the depth of evaluation required and
geographical factors.
Schedule:
Scheduling initially requires a comprehensive understanding of
the objectives of the Gap Analysis program. Therefore, an
agenda incorporating these objectives is prepared.
Scheduling also involves allocating responsibilities to the team
members for the various stages of gap analysis and setting the
deadline for executing the program. Gap analysis can be
conducted either by a process based or area-based approach.
Conduct:
The conduct phase of gap analysis involves an initial assessment
of the existing QMS in order to evaluate the extent of its
conformance to the requirements. Remember that the focus
should be on what is in place rather than what needs to be in
place. Gap analysis uses some effective tools, such as
questionnaires, that would help the organisation expedite its
initial review.
Gap analysis tools can be listed as:
• Quality management system gap analysis tool.
• Management responsibility gap analysis tool.
• Resource management gap analysis tool.

• Product realisation gap analysis tool.

• Remedial gap analysis tool.


A standard template of questions fills these five sets of tools.
Answer to each of these questions could be: Yes, No, and N/A.
The questionnaire also has a column for comments and
explanations.
A Yes implies that the organisation has already met the
requirement, a No identifies a gap, while an N/A answer implies
that the question is not related to the organisation’s activities.
A No requires the team to delve deeper to identify and list items
that need to be implemented, redesigned or documented.
Questionnaires help in conducting gap analysis (vide appendix).
The team members fill the questionnaire by conducting
interviews of various process owners or key personnel in various
processes. The focus of the gap analysis is both on the processes
followed and on the documentation.
Reporting:
After conducting the analysis the audit results are abridged in
the form of a task list. Several types of tasks are detailed. These
may include processes that:
• Conform to the standard and are documented.
• Conform to standard and need to be documented.
• Do not conform to the standard and need to be
redesigned.
• Are required to be in place as per the standard.
Use task list for planning:
This involves formulating the corrective actions that need to be
taken for filling the identified gaps. The responsibility for
developing corrective action plans is assigned to select personnel
working in the relevant processes. A time limit is set for these
personnel to accomplish this task.

The Gap analysis report forms the basis for the ISO 9001:2000
QMS implementation within the organisation. It acts like a
compass to show the direction the organisation needs to move in
and the efforts and resources it should expend to become
compliant.

Continue the tour:


Gap Analysis Questionnaire
Gap Analysis > Questionnaire

N Y Comm
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4.Quality management system:

4.1 General requirements:


• Are the procedures required for
implementing ISO 9001QMS in the
entire organisation identified?
Is the order and interrelationship
between the various QMS processes
established?
• Has the basis and approach for properly
managing and controlling processes
been established?
• Have the information and resources
required for managing the
organisations procedures been
provided?
• Are these processes constantly
monitored, measured and evaluated?
• Has the organisation implemented the
required measures to realise intended
objectives and ensure continual
improvement?

4.2 Documentation requirements:


4.2.2 Quality manual:
• Does the organisation have a defined
and a documented quality manual? Is it
well maintained?
• Does the manual mention the
procedures that were documented and
maintained for QMS (Quality
Management System)?
• Does it provide details of areas
excluded, along with the reasons for
the exclusions? Are the exclusions
among those permitted by Clause 7?
• Does the manual provide a cross
reference of interrelated QMS processes
along with an explanation of kind of
interrelationship?

4.2.3 Control of Documents:


• Does the organisation have a defined
process to effectively manage and
control its QMS documents as required
by ISO 9001:2000?
• Are all the documents certified before
release by the relevant authorities?
• Are the documents regularly evaluated
and improved?
• Does the organisation replace
documents that are outdated with the
current ones?
• Does it preserve outdated documents
for later reference?
• Are the processes and responsibilities
established and maintained according
to the modification in the various types
of documents?
• Are the documents clear,
distinguishable, dated (with dates),
logically arranged, and conserved for a
defined period?
• Are the documents from outside
sources well managed and circulated?
• Is the documentation process
effectively implemented and
pertiodically evaluated? Is it
consistently followed?

4.2.4 Control of records:


• Are the records clear, distinguishable
and easily accessible?
• Is there a defined practice that is
consistently followed to assist in
managing the records pertaining to
classification, preservation and filing?
Are these practices documented?

5. Management responsibility:

5.1 Management commitment:


• Has the management ensured that all
employees are made aware of the
significance of meeting customer and
legal requirements?
• Has the organisation defined its quality
policy?
• Are the quality objectives defined?
• Does the top management conduct
periodical reviews?
• Is the top management involved in
ensuring availability of necessary
resources?

5.2 Customer focus:


• Has the top management ensured that
the customer needs are identified and
fulfilled? Is customer satisfaction the
ultimate goal behind these activities?

5.3 Quality Policy:


• Is the policy compatible with the vision
of the organisation?
• Does the policy communicate the
organisation’s intent to conform to
standards and to continual
improvement?
• Does it provide a basis for defining and
evaluating quality objectives?
• Is the policy well communicated?
• Is the policy evaluated for its
organisational relevance on a regular
basis?
5.4 Planning:

5.4.1 Quality objectives:


• Are quality objectives defined for all
products and activities the organisation
is involved in?
• Can they be measured and evaluated in
the light of the quality policy?

5.4.2 Quality management system


planning:
• Does the organisation have plans for
meeting the general requirements and
quality objectives of the QMS?
• Are the modifications that are planned
and executed, aligned to the QMS
principles?

5.5 Responsibility, Authority And


Communication:
5.5.1 Responsibility and authority:
• Is there a defined structure of roles and
responsibilities for implementing the
QMS? Is it well documented and
effectively communicated?

5.5.2 Management representative:


• Is a management representative
assigned to oversee the QMS
implementation and to update the top
management on the progress?
• Does the management representative
drive the efforts towards greater
awareness of customer needs by the
employee?

5.5.3 Internal communication:


• Has an effective communication
strategy and approach been developed
to communicate information about the
QMS within the organisation?
• Is the progress of the QMS being
communicated within the organisation?

5.6 Management review:


5.6.1 General:
• Does top management conduct periodic
QMS reviews to evaluate its relevance,
sufficiency and usefulness?

• Does the management review evaluat


the scope for continual improvement of
the QMS in its quality policy, objectives
and targets?
• Are records of management review
created and preserved?
5.6.2 Review input:
Which of the following form part of the inputs
considered for management review:
• Audit results?
• Customer feedback?
• Process performance and product
compliance?
• Evaluation of preventive and corrective
actions taken?
• New developments that may have their
influence on QMS?
• Employee Suggestions?

5.6.3 Review output:


Which of these are the outcome of
reviews?:
• Enhancement in QMS and its processes.
• Enhancement in product characteristics
for meeting customer needs.

• Better allocation of resources.

6. Resource management:
6.1 Provision of resources:
• Are the resources, necessary for
implementing and improving the QMS,
made available?
• Are resources, necessary for improving
customer satisfaction by meeting
customer needs identified and made
available?
6.2 Human resources:

6.2.1 General:
• Are activities which significantly impact
quality, handled by employees with the
right competencies and skills?

6.2.2 Competence, Awareness And


Training:
• Is there a process in place to identify
training needs of various employees
playing a part in the QMS?
• Is relevant training provided to all
employees, especially to those whose
work has a greater impact on QMS?

• Are the employees aware of:


a) The impact of their work activities in
achieving quality objectives and the
benefits of improving their individual
performances?
b) Their role and responsibility in
achieving conformance with the
requirements of its QMS?
c) The consequences of departing from
established Quality related processes?

• Are the records of employee’s


competencies and training
retained?
6.3 Infrastructure:
• Are the facilities and infrastructure,
necessary for ensuring compliance to
the process and product requirements,
identified and made available? The
infrastructure can be in terms of
workspace, tools or equipment among
others.
6.4 Work environment:
• Has the organisation identified and
created the appropriate work
environment for product and process
compliance?

7. Product realisation:

7.1 Planning of product realisation:


• Has the organisation planned and
formulated the process for product
realisation? Do these plans align with
other QMS process requirements?

• Does the planning for product


realisation include:
• Quality objectives
• Processes, documentation and
records
• Resources required by the product
• Necessary verification, validation,
monitoring, measurement and
evaluation activities
• Are the plans appropriate to the
organisation’s operations?

7.2 Customer-related processes:


7.2.1 Determination of requirements
related to product:
Are the following identified:
• Stated customer requirements.

• Implicit customer requirements.Legal


requirements.

• Organisation’s voluntarily embraced


standards.

7.2.2 Review of requirements related


to product:
• Does the organisation review the
product requirements?
• Is this review conducted before
conveying willingness to the customer
(submitting quotation, accepting an
order)?

• Does the review ascertain if:


• Product requirements
are clearly specified?
• Modifications to
product specifications, if any are
mutually accepted?
• The organisation can
deliver to requirements?
• Are the details of the review and
consequent measures taken preserved
as records?
• In cases where customer does not
specify his requirements in writing,
does the organisation clarify
requirements from customer before
making a commitment to deliver?
• Does the organisation modify the
documents of the product when the
requirements of the product are
altered? Are these altered requirements
effectively communicated to all the
concerned employees

7.2.3 Customer communication:


• Has the organisation developed proper
approaches to communicate with
customer regarding:
• Product specifications?
• Quotations, contracts and
orders?
• Customer inputs and
grievances?

7.3 Design and development:


7.3.1 Design and development
planning:
• Does the organisation plan and manage
its new product development efforts?

• Does it include:
• Identifying and classifying the
phases in the design and development
process?
• Verification, validation and
review of each phase?
• Are the interactions between the
various design and development teams
managed for better communication and
cooperation?
• Are the sought for results adapted as
the design and development advances?
7.3.2 Design and development Inputs:
• Are the product requirement inputs
properly identified and recorded?

• Do the product requirement inputs


include:
• Features and
characteristics of product?
• Legal and mandatory
requirements?
• Inputs from previous design
efforts?
• Additional inputs
required for product design and
development?
• Are the inputs reviewed for their
sufficiency, clarity and contradictions if
any?

7.3.3 Design and development


outputs:
• Are the outputs capable of being
evaluated against the design and
development inputs? Are design
outputs evaluated and approved before
being applied?

• Does the design and development


output:
• Satisfy the input requirements
for design and development?
• Give necessary information
for procuring supplies, production, and
servicing of product?
• Address the usage and safety
aspects of the product?
• Provide acceptance
specifications?
7.3.4 Design and development review:
• Does the organisation conduct reviews
at pre-defined stages of the design and
development process?

• Do these reviews:
• Analyse the potential of the
design and development efforts to
satisfy requirements?
• Determine specific issues that
need to be addressed and recommend
solutions?
• Does the review team consist of
members from different functions
influencing the design and
development?
• Are records of review preserved?

7.3.5 Design and development


verification:
• Are design and development outputs
verified against their input
requirements?
• Are the records of the verification
preserved?
7.3.6 Design and development validation:
• Is the design of the product validated
for ability to meet intended purpose?
• Whenever possible, is validation
conducted before the making or release
of the product?
7.3.7 Control of design and development
changes:
• Is there a practice to record design and
development modifications?
• Are these modifications reviewed,
verified and validated before being
applied?
• Are the details of review considered
while analysing the influence the design
and development modifications will
have on the related components and
earlier product releases?
• Are the records of review of
modifications preserved?

7.4 Purchasing:
7.4.1 Purchasing process:
• Is it ensured that the product being
purchased meets the defined
specifications?
• Are the efforts to manage a supplier
and to ensure conformity of purchases,
proportionate to the influence they
have on the final product output?

• Does the organisation have defined


criteria to choose suppliers? Does this
criteria include the supplier’s capability
to produce products complying with the
organisation’s requirements?
• Is there a process followed to assess,
reassess and choose suppliers?
• Are the records of assessments and
other related activities preserved?

7.4.2 Purchasing information:


• Does the organisation clearly detail the
products to be purchased in its
purchase information?

• Where relevant, does this purchasing


information to suppliers include:
• Specifications for acceptance
of products, processes, methods and
equipment?
• Proficiency of personnel to be
deployed?
• Quality system standards
followed?
• Does the organisation ensure
sufficiency of purchase information
before releasing them to the supplier?

7.4.3 Verification of purchased


product:
• Before receiving product from the
supplier does the organisation conduct
testing and inspection to ensure its
conformance to the defined
specifications?

• When product verification is planned at


the suppliers’ site, does the
organisation specify details of when and
how this will be conducted, and the
preparation required on the suppliers
part?

7.5 Production and service provision:


7.5.1 Control of production and
service provision:
• Does the organisation manage and
control its production and service
operations?

• Does this include ensuring:


• Accessibility of data pertaining
to the product?
• Accessibility of work
instructions?
• Availability of appropriate
equipment?
• Defined procedures for
monitoring and measurement along
with necessary equipment?
• Application of steps for
approval, delivery and after delivery
processes?

7.5.2 Validation of processes for


production and service provision:
• Does the organisation have defined
procedures to evaluate and approve the
processes where the output cannot be
crosschecked before delivery?
• Does the validation help ensure that the
processes will meet the desired
objectives?

• Are the following factors considered for


validation:
• Establishing criteria for
assessment and clearance of the
processes?
• Equipment and skill of
personnel deployed?
• Control of records?
• Revalidation?
7.5.3 Identification and traceability:
• Does the organisation clearly identity
products that need to be traced through
the different stages of the product
realisation?
• Is the progress of the product
realisation determined through relevant
monitoring and measurement methods?
• Are these details recorded?

7.5.4 Customer property:


• Does the organisation adequately
identify, protect and maintain customer
property when it is being used by the
organisation or under its control?
• In the event of any damage or
misplacement of the property, is the
customer immediately notified and
details recorded?

7.5.5 Preservation of product:


• Is the quality of the product and its
components preserved and maintained
by the organisation during all stages
such as processing, storage, packing,
transportation and delivery?
7.6 Control of monitoring and measuring
devices:
• Has the organisation established
monitoring and measurement
procedures?
• Are appropriate instruments for
checking the conformance of product
with the required specifications
maintained?

• Where appropriate, are the measuring


instruments:
• Calibrated and records
maintained?
• Fine-tuned as per
requirements?
• Identifiable?
• Maintained and protected to
ensure that measurements are error
free?
• Handled in a way so as to
prevent inadvertent change to
measurements taken?
• If the instrument does not match the
calibration specifications, does the
organisation evaluate the previous
measurements taken by it? Is
appropriate corrective action initiated
on the basis of the findings?

8. Measurement analysis and improvement

8.1 General:

• Does the organisation have in place


monitoring, measurement, analysis and
improvement processes, including
statistical methods for:
• Indicating the conformance of
product or service to stipulations?
• Ensuring adherence to the
QMS?
• Continually improving the
QMS?

8.2 Monitoring And Measurement:


8.2.1 Customer Satisfaction:
• Is there a defined process or practice
for obtaining and evaluating customer
feedback on the product or service?

8.2.2 Internal audit:


• Does the organisation have established
procedures for conducting regular QMS
audits?
• Are these audits implemented,
evaluated, and improved on a regular
basis?
• Do the QMS audits:
• Determine if the existing QMS
conforms to the ISO 9001:2000
standards?
• Determine the extent of
implementation and maintenance of the
QMS?
• Include the information of the
results of audits?
• Concentrate on the
organisation’s activities being audited
and results of previous audits?

• Does the audit procedure include:


• The scope and frequency of
audits?
• Standard auditing
methodology?
• Duties of auditors and the
parties involved, and reports of audits?

8.2.3 Monitoring and measurement


of processes:
• Are proper monitoring and
measurement methods employed to
substantiate the ability of the QMS
processes to achieve intented goals?

• do not
If the obtained results
conform to the planned
objectives, is necessary corrective
action taken?
8.2.4 Monitoring and measurement of product:
• Is the product monitored and measured
at various stages of the product
realisation to ensure conformity to
defined specifications?

• In case of non-conformity is the


product delivery put on hold until
permitted by the concerned customer
or authority?
• Are records maintained specifying who
is responsible for approving release of
the product?
8.3 Control of non-conforming product:
• Are nonconforming products identified
and prevented from being used
accidentally?

• Are the following approaches adopted


while dealing with such products:
• Taking necessary steps to get
rid of the nonconformity or
nonconforming product?
• Releasing the product for
usage, but only after acceptance from
the concerned customer or authority?
• Preventing the product from its
proposed use?
• Is the information pertaining to such
products and the corresponding action
taken recorded?
• If corrective action is taken, is
necessary re-evaluation done before
approval?
• If a defect is identified after product is
released to the customer, does the
organisation consider necessary action
in proportion to the impact of the non-
conformance?
8.4 Analysis of data:
• Is pertinent data gathered and
examined to ascertain the relevance of
the QMS?
• Are the areas for improvements
identified with the help of the
information analysis?

• Does the gathered data include:


• Customer feedback?
• Defined product
requirements?
• The inclinations of particular
processes and products?
• Scope for taking pre-emptive
steps?
• Contractors and suppliers
performance?

8.5 Improvement:
8.5.1 Continual improvement:
• Does the organisation strive for
continual improvement?Does it use the
quality policy, quality objectives, audit
results, analysis of data, corrective and
preventive actions, and management
review for this purpose?
8.5.2 Corrective and preventive action:
• Is appropriate corrective actions taken
to ensure that a non-conformance does
not recur?

• Does the corrective action involve:


• Assessing the nonconformity?
• Identifying the origin of
nonconformity?
• Evaluating the necessity of
taking action to prevent repetition of
nonconformity?
• Identifying and applying the
required action?
• Maintaining records of actions
taken and consequent results?
• Re -evaluating the corrective
action implemented?
• Are appropriate precautionary or
preventive actions taken to avoid the
possibilities of non-conformance?

• Are the following procedures for


preventive action implemented and
documented:
• Identifying probable
nonconformities and their origin?
• Assessing the necessity of
action to avert nonconformities?
• Identifying and carrying out
the necessary actions?
• Keeping records of actions
taken and their outcome?Re-evaluating
the preventive actions implemented?

Documentation > ISO 9001:2000 Documentation

The documentation requirements for ISO 9001:2000 have been


simplified considerably compared to the ISO 9000:1994. This
was essential to enable organisations to customise
documentation to match their day-to-day processes.

Objectives of documentation:
The ISO 9001:2000 documentation system mirrors the
processes of the organisation and its conformity with the QMS
requirements. It is built around the following objectives:

1. Facilitate Information flow:


A documentation system acts as a means of communication. It
is structured based on various factors such as the business the
organisation is in, the processes followed, the existing
communication system in the organisation, and the
organisational culture.

2. Provide proof of conformity:


A documentation system establishes proof of the organisation’s
conforming to the QMS standard requirements and achieving
the defined objectives.

3. Provide future reference:


A documentation system records the organisation’s procedures
and processes in conformance to the QMS requirements. This
helps in standardising processes across the organisation. It
would also be helpful for future reference. (For example, a new
recruit can refer to the documentation for instructions on a
specific process.)

Steps involved in documentation:


Documentation plays an important role in all the stages of the
ISO 9001: 2000 implementation.Guidelines for developing ISO
9001:2000 documentation in organisations:

1. Conducting gap analysis:


Before developing the documentation it is essential to identify
the status of the organisation with respect to the ISO 9001
requirements. Gap analysis accurately distinguishes between
the existing status of the organisation and the ISO 9001
requirements.
ISO 9001:2000 explicitly necessitates the following elements to
be documented:
• 4.2.3 Control of documents.
• 4.2.4 Control of records.
• 8.2.2 Internal audit.
• 8.3 Control of nonconforming product.
• 8.5.2 Corrective action.
• 8.5.3 Preventive action.

These documented procedures need to be reviewed, revised


and maintained in agreement with the requirements of clause
4.2.3. (Control of documents)

These apart there are other documents though not explicitly


required by the ISO 9001:2000 standard that can help an
organisation improve its QMS performance. Some of these are:
• Process maps, process flow charts and/or process
descriptions.

• Organisation charts.

• Specifications.
• Work and/or test instructions.
• Documents containing internal communications.
• Production schedules.
• Approved supplier lists.
• Test and inspection plans.
• Quality plans.

Gap analysis should consider all the existing documents in the


organisation, relevant to the ISO 9001 requirements. It should
also identify areas where additional documentation is required.
This information can serve as a basis for building the QMS
documentation.

2. Arranging the information:


The final audit and certification is carried out against the
processes the organisation lays down in the documentation
system. This makes the details in the documentation system
extremely critical.

Hence, the ISO 9001 QMS documentation needs to be


systematically planned, organised and developed. Planning
should take into consideration the organisation’s working
system and quality objectives.

The following need consideration while planning for


documentation:

• The document plan must focus on different areas such


as objective of the document, organisation resources,
and target audience.
• Model for developing the documentation system.
• Distribution and control of documents.
• Inputs from experts and workers directly involved in
areas being documented.

3. Writing the documentation:


Once the framework is ready, the next task is creating the
actual documentation. The framework of the documentation
system is generally viewed as a pyramid structure. This can be
divided into four levels.

Level 1 – Quality Manual:


A quality manual outlines the organisation’s QMS. It contains
the quality policy and details the products, processes and other
QMS procedures adopted by the organisation. It also provides
the interrelationship between the various QMS processes and
cross references the other documents related to the QMS. It
thus acts as a source of information for employees and
customers.

Level 2 – Procedures:
Procedural level documents deal with the documentation of
processes the organisation follows to meet the QMS
requirements. The documentation of procedures can be carried
out by
• Writing down the existing processes.
• Performing a gap analysis.
• Modifying the processes and documentation to bridge
the gap.

Level 3 – Work Instruction:


As the name states these documents contain instructions for
performing various activities and processes. They include general
work instructions for operating processes and for testing
methods.

Level 4 – Forms and records:


Records are documents that are used for detailing the results
achieved. They are also proof of the organisation’s
implementation of processes that have met the requirements.

Forms are used for recording basic information. A few examples


are checklists used for auditing purpose and forms used for
recording information related to specific processes.

Media for documentation:


Documentation can be created and stored both in electronic or
paper format. Apart from written content, documentation can
also include :
• Photos.
• Drawings, diagrams and sketches.
• Audiotapes and videotapes.
• Product samples and defect sample.
• Paint swatches for colour matching.
• Checklists.
• Flow diagrams.
• Blank-forms.

Many organisations document their

processes around ISO 9001. Alternatively,

documentation can be structured around

the processes implemented by the

organisation. Since the employees are

already familiar with the existing processes,

it would be easier for them to adapt to the

system.

4. Conducting peer review:


Once the drafts of the documentation are ready, the senior and
middle management level participate in a peer review. The group
includes all the key people involved and closely related to the
processes. Peer reviews are conducted to plug any discrepancies
in the documentation system. If enough preparation and
research has been done, two or three peer reviews are sufficient
to take the documentation to the next stage.
5. Imparting ISO 9001 training:
Everyone in the organisation may not be able to read the whole
documentation. However, employees can be given an overview of
the new quality system prior to the audit process. Training
sessions on the importance of ISO 9001 documentation and
application in the new quality system would also be beneficial.
Such sessions will help in better QMS implementation and
smoother audits, as the employees will have a greater
understanding of the documentation system.

6. Planning for assessment:


The QMS assessment is performed through internal audits.
Depending on the availability, the organisation can have a group
of lead auditors. Otherwise, the quality manager can be the lead
auditor and train a team for performing internal audits. An
auditor needs to identify the non-conformities and provide
remedial action. Less number of nonconformities implies scope
for quicker registration.
External auditing is done by a group of auditors from an
accredited certifying agency. These auditors carry out an in-
depth evaluation of the quality system on two fronts. First, they
check if the documentation maintained by the organisation
matches the requirements of the ISO 9001:2000 QMS standard.
Then they check if the organisation is actually following
everything as documented. If compliant, they recommend ISO
9001 certification.
This certification formally declares an organisation as ISO 9001
compliant. IISO certification involves employee compliance with
the documented system. Hence, a well-planned and executed
document system is the basis for ISO 9001 standard conformity.
An impeccable documentation ensures ISO 9001 registration. But
sustaining the acquired standard calls for implementing the
continual improvement aspect of the QMS. Continual
improvement results from periodic review and corresponding
document control.

Continue the tour:


Document Control
Documentation > Document control

Effective documentation calls for a document system that is


simple to use, easy to understand and helps an organisation
achieve its quality objectives. The above requirements of
effective documentation can be met by the ‘Document control’
process. Document control is hence, a vital aspect of
documentation to sustain an organisation’s quality pursuit.

Elements of document control:

Document control involves the following

elements:

1. Approving documents:
A document is valid only when if it is approved. Hence,
obtaining approval is the first step in controlling documents.
There are many ways of approving a document. Authorised
persons approve paper-based documents. Electronic
documents on the other hand are approved through a typed
name or e-mail. Yet care should be taken to prevent false
approvals that could occur due to leaked passwords.

Generally, some documents are self-declarative, that is the


titles under the approved spaces specify the authorised person.
In other cases, organisations must decide who should approve
the documents. Normally, people who bear the responsibility of
tasks described in the document are selected.

It is always better to strive for the fewest number of approvals.


For example, consider a document containing information
regarding more than one department. This document should get
the approval of all the managers who are affected by the
information contained in it. This can be time consuming.
Therefore, minimum approvals that provide buy-in for the
information in the document must be pursued.

2. Reviewing, Updating and re-approving documents:


ISO 9001:2000 standard requires an organisation to review,
update and re-approve the documents periodically to prevent
them from becoming inaccurate and outdated. If the documents
are still valid they are approved otherwise they are updated and
re-approved.

A periodic review of documents is essential


to ensure compliance with the standard. The
frequency of these reviews depends on the
organisation’s priorities. Since document
review is also a critical task, organisations
need to employ discipline to ensure it is
performed periodically.

Business triggers like introduction of new


products, equipment and processes and
real-world events such as new technologies,
affect the documentation system. In such
instances, documents must be reviewed
accordingly. Document review in these
conditions introduces a sense of urgency.

Organisations intending to implement this


method must define the business triggers
and responsibilities in the document control
procedure. It is the duty of document
administrator to monitor these business
triggers and ensure that relevant documents
are reviewed, updated and re-approved as
needed.

3. Identifying changes and revision status:


Documents must include revision changes. If a document is on
revision for the fifth time, it will track the changes that
differentiated it from the fourth version. This helps the
document approvers and users to identify the changes in the
documents easily.

To identify changes:
• Maintain change logs at the end of the document.
• List the changes on the cover sheet.
• Underline, italicise or highlight changes throughout the
document.

Revision status denotes a document’s new version, generally


indicated by a revision number, letter or date placed directly on
the document. This helps the users to check whether they
possess the latest version. (This is essential for paper-based
documents.) For electronic documents knowing revision status
is not essential because the current version is provided to all
the users automatically.

4. Making documents accessible to users:


ISO 9001:2000 specifies that the current versions of documents
must be accessible to all the users. Every user need not posses
a copy of the document. It is sufficient if one can access the
document whenever it is needed.

Some organisations distribute documents that include an


“acknowledgement of receipt” sheet signed and returned.
However ISO 9001:2000 does not require such procedures
because they will slow down the system. Organisations must
thus maintain a perfect balance between control and simplicity.

5. Making documents legible and identifiable:


An organisation must develop documents that are clear and
understandable to all the users. Suppose, a group of
employees can understand only Spanish then the documents
must be written in Spanish. Otherwise, they can develop
graphic documents (including photographs or drawings), which
can be understood by every one irrespective of language.

Every document must be provided with a title, document


number, or a unique identifier, which differentiates it from
others. Many organisations follow the ISO 9001 numbering
system to identify documents. ISO 9001 series is reviewed and
revised every 5 years along with the numbering system. A good
numbering system would be one that best suits the
organisation’s processes and operations. It should be
appropriate for the employees and not become obsolete.

6. Controlling External Documents – As per ISO: 9001:2000:


Organisations also use external documents (documents
published outside the organisation). The procedure to
determine whether an external document requires control is
similar to that of internal documents.

External documents that may require control are:

• Troubleshooting and/or calibrating manuals published


by equipment manufacturers.

• Test procedures, specifications and /or engineering


drawings published by customers or other bodies.

• Instructions, specifications and/or procedures


published by suppliers.

• Standards published by industrial organisations


applicable to that organisation.
• International standards such as ISO 9001:2000.

External documents need identifiers for controlling its


distribution. Usually, the source that published the document
takes care of the identifiers like title or document number or any
other unique identifier. The organisation merely adopts it.

Most external documents are in paper form. Controlling their


distribution is thus necessary to control the information
contained in them. A distribution list simply includes the number
of copies available at present and their location. The copies are
numbered such that they match the locations shown on the
distribution list. This makes retrieval of old copies easy.

7. Controlling obsolete documents:


As per the requirement of ISO 9001:2000 all the obsolete
documents in an organisation must be identified and prevented
from use.

But organisations often keep obsolete documents to preserve


knowledge. These are used while comparing an existing
process to the previous ones like those used some five years
ago. If an organisation wants to retain obsolete documents,
then they must be given labels like obsolete or uncontrolled to
avoid their inadvertent usage.

The simplest way to prevent use of the obsolete documents is


to just remove them from circulation. For this their exact
location must be known. Distribution lists for all paper-based
documents, external and internal will help in identifying the
location of documents.

8. Controlling forms:
Controlling forms is crucial for quality improvements. They are
very easy to control. The two common methods of controlling
forms are:

• Controlling forms as
“attachments” to documents: In
this method forms are included as the
last page of the documents that
describe their use. Approving a
document thus automatically
approves the form. The same is true
with revising and identification.

For control purposes the form is


treated like any other page in the
document. It can be reproduced if
needed, independent of the
document. The main disadvantage in
this method is that organisations
need to revise the entire document
while revising the form.

• Forms controlled individually: In


this method, forms have separate
numbers and revisions. Their approval
may be placed on the original copy or
on a master approval sheet. This
sheet indicates the latest version of
the form. As soon as the form is
revised users are informed through a
memo or e-mail or other means.
Organisations usually print forms in large numbers. Even a
small change renders them useless. When the form does not
relate closely to the activities of the organisation it should be
discarded. Organisations should hence manage their inventory
and avoid waste.

9. Document formatting:
ISO 9001 does not specify any particular format for documents.
Organisations have the liberty to select the best suitable format
for their mode of operation. Adherence to one particular type of
format is not obligatory. However, a standard format provides a
standard appearance for the documents.

Most organisations specify only the content of document


headers, and cover sheets, while others specify purpose,
scope, responsibilities, equipment, and the like. These
decisions are left to the organisation’s discretion.

The document control procedure must clearly define the style


and format of the document. A document control procedure also
defines the control of documents and helps document
development.

Document control is an important quality assurance principle


and hence leads organisations towards better quality products.
Selecting the documents to be
controlled:
Every organisation holds hoards of
documented information. Controlling all
these documents is an uphill task. Selecting
the documents to be controlled is thus
essential.
For selection it must be determined whether the document:

• Guides the production of products/services of the


organisation.

• Contains information related to inspection, verification


or testing process followed by the organisation.

• Defines customer or product requirements.

• Useful in the controlling processes.

• Useful in decision making by production personnel.

• Is useful in gathering the data required for decision-


making.

• Contains information crucial for organisation’s success.

• Contains information related to requirement from ISO


9001:2000 QMS.
If the answer is “yes” to one or more of these questions, the
document needs to be controlled.

Some documents that need to be controlled are:

• Consider an interoffice memo posted


in the fabrication department shop
floor containing functional and
packaging requirement of the product
being fabricated. This information is
necessary for decision making,
customer satisfaction and thus is
related to ISO 9001:2000.

If not controlled it could lead to


disagreement between the
information on the memo and the
information in the control
specifications. Therefore, the
organisation should either control the
memo or discard it.

• Training departments develop


videotapes on proper set up and
operation of production lines to train
newly recruited personnel and the
existing employees. They define
process control, guide the production
and thus relate to training
requirements of ISO 9001:2000.
Hence, they need to be controlled.

• Defective product samples are


displayed in a lighted glass cabinet.
They are used when quality personnel
have doubts about product criteria.
They point out the limits of various
defects that can be accepted by the
customers. Presently the display
cabinet is labelled “for reference
only”. Despite this declaration it is
necessary to control these samples as
they define customer requirements.
• Organisations employ checklists to
store the results of product
identification. The unfilled spaces in a
blank checklist depict what’s to be
inspected. Blank checklists need to be
controlled as documents and the filled
ones as records.
Tips for designing document control:

Tips for effective document control

1. Keep it concise:
Handling a lesser number of documents is always easier.
Document control process begins from the design stage itself. If
possible the organisation must insist on the authors to create
brief and versatile documents. The organisation must also
conduct periodic reviews to ensure that there is no redundancy
and unused documentation. Wherever possible similar
documents can be merged. This will keep the documentation
concise.

2. Follow a structure:
The documentation must have a structured format. The details
of the structure have been discussed in the document writing
section. This helps establish a relationship between the
different levels of documentation. It also defines the span of
control at each level.

3. Cross-link documents:
A document is not necessarily built from the scratch. It may
have to depend on other documents to fulfill its objective. It
borrows various references from other documents. These
references may not be detailed in the same document, but may
only be linked to a specific document. For e.g. an amendment
document details only the changes made to the original
document. It does not provide the entire document. It only
refers to the original document and specifies the changes.

Often, a document may need reference from an entirely


different functional area. In such cases, the document provides
a reference to the required information from a specific
document. This increases the accessibility of the required topic
and at the same time helps in decreasing redundancy.

But the disadvantage of cross-linking is obvious when a


document needs to be revised. All the references must be
carefully reviewed and updated to comply with the revised
documentation.

A few other options to cross-referencing could be


• Designing an effective numbering system for the
document.

• Having a main document displaying the relationships


between documents.

• Employing an electronic document management


system that helps in quick accessibility of documents
and manages the document relationships.

4. Review of document:

While preparing documentation it is always

advisable to take inputs from those directly

related to the process being documented.

Incorporating a review would help in

enhancing the quality of the final document.

But the approach adopted for review

depends on the organisation. It could be

each individual signing in his approval or a

group consensus after all the involved

employees giving their opinions.

Measurement and Data Analysis > Measurement, Analysis


and Improvement

When compared to the ISO 9000:1994 standard there are some


differences in the requirements for Measurement, Analysis And
Improvement. In the ISO 9001:2000 version Planning, Internal
audit, Measurement and Monitoring of processes and products,
Control of nonconformity, and Corrective and Preventive action
have been retained. At the same time Customer satisfaction,
Analysis of data, and Continual improvement are the new areas
added to the Measurement, Analysis And Improvement section.
Requirements that have been added in ISO 9001:2000
1. Customer satisfaction (Clause 8.2.1):
Customer satisfaction is the final verdict of an organisation’s
quality management system. Hence, there is a need to
constantly measure and evaluate customer satisfaction. The
organisation must have a defined procedure for acquiring
information from the customer. Customer feedback is an
important method of obtaining information. Measuring customer
satisfaction gives an organisation the exact picture of its
performance and the extent of improvement necessary.
Achieving customer satisfaction depends on:

• The organisation’s ability to learn.

• It’s relationship with the customer.


• Application of effective measurement techniques.
As most products and services are customer-specific, it pays to
have a customer-centric approach to all activities in the
organisation.
2. Analysis of data (Clause 8.4):
The measurement process is a source of data. Organisations
need to gather this data and analyse it for determining the
performance of the quality system. This helps in understanding
whether customer requirements have been met. Data analysis
also supplies information on whether the new initiatives taken,
have contributed to the improvement in the product, process and
QMS.
3. Continual Improvement (Clause 8.5.1):
The ISO 9001:2000 standard insists on continually improving the
QMS. The organisation must define the quality policy and quality
objectives to lead it on the path of continual improvement. It
must utilise information from audit results and data analysis to
effectively direct future actions. The corrective and preventive
action taken must also contribute to continual improvement.
Curt De Vries manager ISO 9000 of Polaroid declares that his
company established metrics for measuring the greatest value-
addition required by the quality system and used other
components of the quality system to support it.

Requirements that remain the same:

1. Planning (Clause 8.1):


Though measurement and improvement of the system is widely
spoken of, many organisations lack a definite plan for the
process. Organisations must clearly establish a process for
monitoring, measurement analysis and improvement. They must
also plan how they are going to implement the measurement
process and put the plan to effect. Application of statistical
techniques and other effective methods should also be
considered.
2. Internal audit (Clause 8.2.2):
Internal audit must include the audit process, roles and
responsibilities of the audit personnel and the audit results. Audit
results are significant as they are used as input for the
management review and hence form an integral part of the
continual improvement process. The audit should be based on a
process approach and involve personnel from across various
functions.
3. Measurement and monitoring of processes and
products (Clauses 8.2.3 & 8.2.4):
The measurement and monitoring of processes and products
should be clearly defined. It must also show documented
evidence that the processes and products are conforming to the
established criteria.
4. Control of nonconformity (Clause 8.3):
Organisation might face situations wherein the product does not
meet the defined specifications. In such cases they must make
every effort to prevent the use of that product. But if the non-
compliance is identified after it has been delivered, the
organisation must notify the customer and take necessary action
to offset the effect of non-compliance. In case the non-
compliance is rectified, the product should undergo re-
verification.
5. Corrective and Preventive action (Clause 8.5.2 & 8.5.3):
Corrective and preventive actions are used as a means to
achieve continual improvement. These also form inputs to the
management review of the quality system. Corrective and
preventive actions aim to prevent the occurrence of
nonconformity in the future products and processes.
Since ISO 9001:2000 is all about documentation, organisations
must use simple and easy to understand formats, for
documenting the corrective and preventive actions.
The usual approach for documenting corrective and preventive
actions consists of
• Problem definition.

• Analysing the cause of the problem.

• Defining the corrective and preventive measures.


• Implementing the corrective and preventive measures.
• Following up by verifying whether the product/process
now meets the requirement.
• Documenting the whole process.
This documentation forms the input for management review.
Barriers for implementation of Measurement, Analysis and
Improvement:
The biggest difficulty that organisations face is to analyse the
data and find significant information. All organisations may not
be well equipped to extract the right information from the
available data. Gathered data must be viewed from the point of
what it could imply, rather than what it directly states.
For e.g. while dealing with nonconformity reports, organisations
should look at –the frequency of occurrence, whether it occurs
with the same product or customer, when it occurs etc. This will
give the required information for taking preventive action.
Another possible area where organisations might find difficulty is
the continual improvement process. Most organisations do not
identify the ISO requirements as a part of their daily operations.
Measuring results only to fulfil bare minimum ISO 9001
requirements will in no way benefit the organisation. The earlier
an organisation adopts the QMS as a part of its daily operations
the faster it will progress with continual improvement.
What do auditors look for?
The main focus of auditors in the auditing process will be on
whether the organisation is following the continual improvement
philosophy. Auditors will closely examine management’s role in
adopting the continual improvement process. They evaluate if
management has utilised the quality policy, quality objectives,
audit results, and corrective and preventive actions to facilitate
continual improvement. They also inspect the management
review records for the documented actions and achievements.
For checking conformance to the analysis requirements auditors
examine how the data was gathered, the nature of the data, how
it was reported and how it was used for evaluating the
effectiveness of the quality management system.
Customer satisfaction measurement requirements are also
examined based on how the organisation has gathered
information from the customers, interpreted it and converted it
into useful information for continual improvement.
In Conclusion:
The main objective of ISO 9001:2000 is to make continual
improvement a part of an organisation. Measurement and
analysis are performed and the results are utilised for continual
improvement. ISO 9001:2000 also states that customer
satisfaction is a distinctive performance measurement feature.
ISO 9001:2000 will be very useful to organisations planning to
implement a QMS. Organisations that have trouble in
implementing these systems will also find it supportive.
Organisations that have implemented ISO 9001:1994
successfully, will find a marginal improvement in the quality
system, and a marked improvement in the restructuring of the
quality management system.
Organisations need to analyse and restructure their existing
documentation to comply with the requirements. This is the
biggest challenge, as organisations must analyse how they will
deal with the revisions.
Organisations that follow the requirements with an intention of
just obtaining a certificate will find it difficult to comply with
these requirements. Whereas those that seek value in a QMS will
find the requirements as a challenge that will open prospects for
improvement.
Organisations normally acknowledge the importance of
management review, customer satisfaction, and continual
improvement. But it is the management’s responsibility to
integrate them all to promote an outstanding quality
management system.
Tools Deployed > ISO 9001:2000 Tools
Organisations worldwide are busy implementing ISO 9001:2000.
Those that already have the ISO 9000:1994 version certification
are also preparing for the changeover/transition to the new
quality standard.
Various tools can be used by organisations during the
implementation of ISO 9001:2000 QMS.
The pertinent tools in the various stages of the implementation
process are presented.
Gap Analysis:

• Comprehensive questionnaire on gap analysis in QMS,


Management responsibility, Resource Management,
Product realisation, Corrective actions.
Quality policy establishment:

• Brainstorming Technique.

Document control:

• Fagan Document Inspection.

• Document Management System.

Customer Focus:
• Customer surveys.
• Comment cards.
• Field reports.

• Customer Satisfaction Assessment.

Planning

• PERT.

• Critical Path Analysis.

• Gantt Charts.

Awareness and Training:

• Skills Gap-Analysis Technique.

Process Control:

• Process Analysis.

• Process Capability Analysis.

• FMEA.
• Reliability Technique

Problem identification and rectification:

• Cause and Effect Diagram.

• Problem Analysis.

• Solution Effect Analysis.

Design and development of a product:

• CAD software.

• Design for Manufacturability.

• Simulation.

• Design of Experiment.

• Quality Function Deployment.

• Poka yoke.

• Loss Function Analysis.

Delegation of responsibilities:

• Arrow Diagrams.

• Flowcharts

Monitoring and Measurement:

• Control charts.

• Pareto charts.

• Histograms.

• Check sheets.

• Scatter diagrams.

Corrective and Preventive action:

• Potential Problem analysis (PPA).

• Problem Prevention plan.

Best Practices > Making the transition to ISO 9001:2000

Organisations that have been ISO 9000:1994 standard certified,


often find the transition to ISO9001: 2000 challenging. The
success stories of two organisations that have successfully made
the transition are discussed here.
Introduction:
On 15 December 2000, the revised and improved ISO
9001:2000 standard was drafted to replace the three ISO
9000:1994 standards, thereby becoming the only certification
standard of the ISO 9000 quality system.
The ISO 9001:2000 standard is completely restructured and
emphasises on continual improvement and customer focus. This
standard focuses on the systems approach i.e. identifying,
understanding and controlling interrelated activities as a system,
thereby enhancing the organisation’s efficiency in attaining its
goals.
Organisations that are already certified to one of the ISO
9000:1994 standards are busy implementing the transition to
the ISO 9001:2000 standard. This is necessary to meet the
deadline for implementing the transition to the new standard,
which is December 2003
To many organisations that have successfully incorporated the
ISO 9000:1994 standard, the transition to ISO9001: 2000 is
challenging. This revised standard emphasises on achieving
customer satisfaction that was not a priority in the earlier
standard. The challenges that organisations face include
directing the entire organisation towards a common objective
(i.e. transition to ISO 9001:2000), focusing on continual
improvement, involving people/workforce at all stages of the
transition process, and shifting from a procedure-based approach
to a process based approach.
Since the transition involves streamlining existing processes to
conform to the ISO 9001:2000 standards, it might also require a
transformation for many organisations.
While many organisations have successfully made the transition
there are a many more still finding their way. The success story
of one such organsiation is discussed below.

Successful transition to ISO 9001:2000 in Silberline Inc:


Silberline Manufacturing has successfully registered itself to the
ISO 9001:2000 standards. It manufactures aluminium pigments
and special performance materials to be used in coatings, inks,
and plastic industries.

Silberline is one of the first U.S. companies to have successfully


accomplished the changeover to ISO 9001:2000 certification.
Silberline has been ISO 9001 certified since 1998. In October
2001 it improved its Quality Management System (QMS) to the
more developed standard ISO 9001:2000.

Since the implementation of ISO 9000 standards in 1998, the


management focused on the continual improvement and
assessment of the existing quality management system. This in a
way helped Silberline to go in for a smooth transition, which
would otherwise have been difficult.

Silberline's quality assurance department was given the


responsibility of implementing and directing the requirements for
ISO 9001:2000. A selected internal audit coordinator ensured
that the internal auditing system was well organised and
effective.

Silberline gave all its employees an opportunity to participate in


the auditing process. Those employees who voluntarily desired to
become internal auditors were trained in the requisite auditing
skills. This helped the organisation to expedite its internal audit
process and also allowed the employees to get an insight into the
requirements of the ISO 9001:2000 quality management
system.

Silberline emphasised on making its employees more conversant


with the process approach (wherein the various activities are
managed and controlled as part of a process, so that they are in
accordance with the set standards).

The changeover to ISO 9001: 2000 helped Silberline to reassess


the entire quality management system that was already in place.
It found that the evaluation and measurement of customer
dissatisfaction was being effectively handled.

Silberline used Customer satisfaction information to keep track of


customer-focused activities. Customer satisfaction information
consists of data on failures in functional areas, the rate of
service-calls and analysis of the customer mind-set about the
quality of products. Customer satisfaction information also helps
the organisation enhance quality.
Silberline’s management felt that market surveys remain
ineffective unless they are structured and spread in an organised
manner. It felt that the detailed marketing research done would
help identify customer requirements that would other wise seem
to crop up suddenly.

Silberline also reviewed its internal communication system and


changed its format. Initially, two of the senior executives in
Silberline presented the annual report on the status of the QMS
to the managers. This proved ineffective since many
questions/queries posed by the managers overseeing the various
departments were not addressed.

Then Siberline came up with a unique idea. It allowed eight


employees from different departments to present a 10-minute
report on the effectiveness and efficacy of the respective quality
management system in their departments. This helped enhance
the internal communication process apart from the efficiency of
the reporting system.

No significant changes were made in the product development


except for the presentation of all the stages of the production
process in a flowchart. This flowchart is a constituent of the QMS
that is in place in Silberline and gives a clear picture of the
product development process.

Redrafting the organisation’s quality assurance manual was the


most tedious of the entire changeover process of ISO 9001:2000
implementation. Initially, Silberline tried to relate ISO
9001:1994's 20-element model to the requirements of the
ISO9001: 2000 standard by referencing one standard with the
other standard. This was confusing and tedious process.

Silberline decided to redraft the manual on the basis of the


Process approach. Process approach involves a well-structured
identification and control of the various internal processes in
order to realise the organisations business objectives. The entire
quality manual was thus rewritten.

The new quality manual was checked and circulated through out
the organisation in order to realign all the existing procedures,
quality plans and records with the new manual. Modifications
required were implemented. This enabled Silberline to develop
an effective and well-organised QMS manual that is auditor
friendly.

The changeover/transition, accomplished by a steering


committee, lasted from April 2000 to April 2001.The committee
allocated various responsibilities to different employees.
Silberline now intends to utilise the ISO 9001:2000 standard for
continual system improvement.

Some of the steps Silberline followed to implement a smooth


changeover:
• An initial review or gap analysis of the existing quality
management system was conducted.
• The transition was made in a very short duration.
• The management was committed throughout the
changeover and completely supported its employees in
carrying out their responsibilities.
• Large numbers of employees were encouraged to
participate in the changeover process.
• An Inter departmental steering committee was
developed.
• The next case study explains in detail the successful
transition to ISO 9001:2000 by Central Industrial
supply (CIS), Houston in United States of America.
Continue:
Successful transition by CIS
Best Practices > Successful transition by CIS

CIS Houston while revising and reorganising its ISO 9002


system to the requirements of the ISO 9001:2000 standard was
simultaneously restructuring its assembly and distribution units
into customer oriented business units.

Central Industrial supply (CIS) is a leading manufacturer of


electromechanical components and assemblies for popular
high-tech OEMs. It is headquartered in Grand Prairie, Texas.

CIS’s assembly and distribution complex in Houston exemplifies


how a process approach and employee participation helps an
organisation to adapt to various changes in the system.

In 2000, CIS Houston while revising and reorganising its ISO


9002 system to the requirements of the ISO 9001:2000
standard was simultaneously restructuring its assembly and
distribution units into customer oriented business units. Also for
the first time it established Enterprise Resource Planning
System (ERP). ERP provides the basis for joining together
enterprise-wide information systems. These systems link all
aspects of a company's operations including HR, financial
planning, manufacturing, and distribution, besides connecting
the organisation to its customers and suppliers.

While working at the transition, CIS Houston had to cope with


the absence of the quality manager in charge who was away
due to terminal illness during the ISO 9001:2000 audit. Despite
all these difficulties CIS Houston’s transition to ISO 9001:2000
was successfully accomplished. It was registered to the new
standard on April 20, 2001.

This restructuring of the organisational units resulted in a major


telecommunications hardware manufacturer becoming the main
customer of CIS Houston. It also helped CIS Houston retain its
key customers including a leading information technology
server manufacturer.

Some steps taken by CIS Houston to revise its quality


management system:

• Mapped/recorded the processes.

• Started with the collection of different process flows to


get a clear insight.

• Considered the ISO 9000 quality standard as a valuable


component of the organisational activities.
• Developed a robust enterprise resource planning
system. Without an ERP system in place, collecting
data would have been a difficult process and the
reliability of the results/outcomes is doubtful. The use
of ERP systems enables customers and the
management to readily access the required
information. The information in the ERP system is
updated regularly and played a vital role in revising and
reorganising the quality management system to ISO
9001:2000 standards.
CIS Houston focused on the process approach. The customer
was the priority for this organisation. Customers expect the
product they buy to function as per their requirements. CIS
Houston took utmost care not to dissatisfy the customers in this
aspect. Customers’ changing needs and expectations from the
products they buy were noted and analysed.
In CIS, Houston the product design begins with market research.
Product design converts the customer requirements into detailed
engineering and quality features, which can be called design
specifications. Design engineers in CIS Houston have basic
knowledge desired by the customers. In short, CIS adheres to a
logical and sequential series of activities needed to complete a
specific task (i.e process flow).
In CIS Houston when a new process/operation is
implemented the front-line assembly personnel determine
the method of manufacturing the product in conformance
with the customer specifications. A series of measurements
and corrective actions are performed within a process to
ensure that the output of the process conforms to the
relevant specifications. The front-line assembly personnel
continually record/map the existing processes. This ensures
that the improvements in the processes or any deviations in
terms of customer requirements are clearly indicated in the
process flow maps.
After the restructuring of the organisation into a customer
oriented business unit, the managers of all the departments
within CIS started meeting on a monthly and weekly basis.
This was done to generate ideas and discuss the red,yellow
and green light report.
The red light report signified the presence of a hindrance or a
problem in a specific activity. The yellow light cautioned the
team and the management of an impending problem. The
green light report on the contrary signified taht the
process/activity was in control and can be implemented.
These reports consisted of the output produced by the ERP
system. They also included the objectives and targets set
during the planning phase, weekly production schedules,
safety indicators, customer satisfaction indicators, the
previous week's or month's performance, and the extent of
conformance to the requirements.

At CIS corrective action is implemented in one meeting and


evaluated in the next. This enables allocation of
responsibilities to the appropriate employees. ISO 9001:2000
is being utilised by CIS, for continual system improvement.

Conclusion:
CIS, Houston attributes its successful transition to ISO
9001:2000 to the focus on customer satisfaction,
continual improvement and implementing process approach
even before the new standard was officially drafted on
December 15 th 2000. This helped them to changeover to the
new standard requirements with ease.

Continue:
Teaching - The ISO 9001:2000 Way

Best Practices > Teaching-The ISO 9001:2000


way
The following case study details how the ISO
9001:2000 quality management system can be
implemented in an university.
Introduction:
ISO 9001 standards provides a structured approach
for an organisation to define a customer oriented
quality system. It supplements TQM by viewing
quality as a controllable process and by providing a
framework for continual improvement.
The following case study details how ISO 9001 QMS was
implemented in an educational institute to ensure that its
teaching and learning processes maintain commendable
standards of quality. It explains how the ISO model helped the
institute achieve excellence in its teaching and learning
processes.

Organisation under study:


Faculty of Management and Human Resource Development
(FPPSM) in Teknologi University, Malaysia (UTM) is the case in
study on applying ISO 9001 in Teaching and learning processes

Need for QMS:


The following were the key reasons for Teknologi
University to go in for the ISO 9001:2000 QMS in
its teaching and learning process
• Graduates performance falling short of required
standards.
• Mounting competition and increasing regulations
requiring conformance of implementing the quality
system.
• The success of ISO quality concept in other sectors.

Methodology followed for implementation:


Implementation of ISO 9001:2000 QMS in other
sectors differs from that in Higher educational
institutions (HEIs). There are two areas that need
to be managed in an HEI. One is academics and the
other is administration.
Implementing ISO 9001 in administration is easier
compared to the academic sector, which demands
individual modifications to the system.
The process-based model (9001:2000) includes factors like
customer needs and customer satisfaction that guide the
university to achieve best practices in teaching and learning
processes. This was the strategy that FPPSM embarked upon to
achieve superior performance in its teaching and learning
activities.

Process-based model:
ISO 9001:2000 QMS, focuses on customer and
process approach. This model stresses the need for
identifying and comprehending the customer needs
and anticipations to make sure that the customer
requirements are satisfied. Reports of customer
satisfaction are then collected and analysed to
verify the fulfillment of their requirements.
The inherent elements of “process based model”
(customers, their requirements, product realisation,
customer satisfaction and consistent enhancement)
in the context of the present case study are
explained below:
In the educational scenario, customers normally
fall into broad categories: External and Internal.
External Customers are the parents of the students
and the organisations that provide employment to
the output of the institute (i.e graduates). Internal
Customers are the direct beneficiaries of the
education and the quality system in the institute i.e
the students.
Customer-driven best practices in teaching and
learning:
Best practices in teaching and learning using ISO
9001:2000 process based model needs to focus on
customer (external customers). This should
include:
• Identifying the needs of the customer and using it as
an input in the teaching and learning process.

• Delivery of the teaching and learning services or


processes, which refers to product realisation.
• Output from the best practices of the teaching-learning
process that fulfils the identified requirements
stipulated by the customers.

External Customer- Requirements:


Market demands were periodically accessed and
evaluated to ascertain what an external customer
wants from a graduate. Techniques such as
feedback, market analysis, and needs analysis were
used to identify the needs of the external
customers.
The marketability and the credibility of the
University lie in recogniszingthe external customer
requirements and including them in the new
curriculum design. FPPSM identified the need for
designing a comprehensive curriculum that
indicated the knowledge and the skills required by
an external customer (employers of graduates). It
recognised the need for periodical update and
consistent enhancement to maintain its relevance
with the industrial developments.
Teaching and learning process (Product
realisation):
In order to ensure that the best practices were
applied, FPPSM followed a defined procedure for
managing the 3-Ps of the university. These include
people, process, and product. The curriculum
design ascertained that the customer requirements
were successfully handled.
In addition, the other elements for achieving best
practices in the system as management practice,
management of non-conformance product were
given due consideration in designing the
curriculum.
Focus on 3P’s:
People:
People in the context of the present case study refer
to university lecturers and students who are
involved directly in the teaching-learning process.
Focus on people helped in developing innovative
capabilities among the students and cultivating
enhanced teaching capabilities in the lecturers in
their respective fields.
Flexibility was provided in the use of technology.
The staff was given the freedom to use suitable
techniques for effective student-lecturer
communication. Techniques like printed materials,
CDs, online journals, and Internet were generally
used for this purpose.
Policies were set in accordance to the teaching and
learning environment. Although no precise
instructions and rules were specified for classroom
activities, the course content and the syllabus was
prepared to be in line with the requirements of the
university and external stakeholders.
Process:
Process, involves all the teaching and learning
activities that help produce quality graduates. Thus,
the new curriculum design involved identifying
activities that had to be controlled throughout the
process.

Activities like preparation of syllabus and


examination papers that directly impact the
production of quality graduates were rigidly
controlled and inspected to ensure that the
mentioned specifications and needs were met.
Stern and detailed procedures with guidelines were
provided for such activities. For instance,
examination papers were monitored in 3 stages:
• Board of subjects level.

• Respective department level.


• Faculty level.

Flexibility was provided for activities that do not


significantly influence quality. As in academic
advisory where the decisions might change from
one advisor to another.

Product:
Graduates are the final products and the process in
this “product” involves the examination papers, the
undergraduate projects, practical training reports,
and course work materials. The University ensured
that the products i.e. graduates consistently met the
customer requirements. Non-conforming products
were returned for correction before being allowed
to move to the next stage.

Management practice:
The University implemented a power-sharing
structure that defined the roles and responsibilities
of the key personnel (such as Heads of panel,
course coordinators, and coordinators of other
teaching-learning related committees).

The various responsibilities assigned to different


personnel in the structure are:
1.Head of panels: Approving teaching and learning
methods, selecting final examination papers,
developing and deciding on course content.
2.Course co-ordinators: Selecting, validating and
recommending appropriate staff to administer key
activities.
3.Coordinators: Establishing contacts with third
parties.
Non-conformance product management:
Students were examined so they met the
requirements of the standards set. Non-
conformance products (students) were thus
returned back (students who show signs of not
meeting the required standards) to the system for
correction. However, it should be noted that this
non-conformance product did not include the final
product i.e. the graduates, rather they were the
students who are on the path of the process.
The academic advisor was assigned the
responsibility of helping the students in selecting
subjects and making them comfortable with their
workload. He also encouraged the students to seek
the guidance of the lecturers. Motivational
seminars were conducted periodically to motivate
students.
Instilling TQM (Continual Improvement):
The academic activities were periodically
evaluated for continaul improvement. This
necessitated the use of analytical/statistical tools
and indicators. Evaluating process capability
helped in process improvement, while indicators
helped to discover the need for training, and the
manner in which it should be provided.

Evaluation generated a progressive, contemporary


curriculum that took into account the key
requirements of the external customer and society.
This helped to enhance the process performance
towards accomplishing the desired standards. Thus
overall evaluation helped to increase customer
satisfaction and more significantly win the loyalty
of all stakeholders involved.
Customer Satisfaction:
External customer satisfaction:
External Customer Satisfaction was inspected and
evaluated by means of different techniques. These
include market surveys for every two years, needs
analysis during design state of the
course/curriculum, and questionnaires to gather the
opinions of the external customers.
The techniques used were based on different
criteria like:
• Knowledge in the respective field of study.

• Leadership qualities.
• Communication skills.
• Teamwork.

The suggestions and complaints made by the


external customers were examined and
incorporated into the process.
Process-focus best practices in teaching and
learning:
The process-focus best practices in teaching and
learning focuses on the internal customers
(students):
Internal customer requirements:
The internal customers (students) benefit the most
from this teaching-learning process. Hence, in
general, they are expected to know how these
processes are to be conducted effectively. The
process involves lectures, practical training, project
supervision, course work, lab work, and final
exams.
The students in the university however, were
unable to specifyhow the teaching-learning
practices should be conducted or evaluated to
increase theri effectiveness.

Internal customer satisfaction:


In spite of the student’s lack of ability to provide
necessary suggestions on the manner in which the
teaching and learning activities should be carried
out, their inputs and viewpoints on these activities
were considered valuable insights for continual
improvement of these activities. To promote this
feedback, the students in each semester were
required to answer a set of questions (OMR forms)
to gather the following information:
1.The preparation levels of the lecturers: This
addresses the use of adequate teaching/learning
materials, maintenance of materials, and utilisation
of teaching assisting equipments.
2. The way the lecturer delivers lectures:
Involves the diversity of teaching learning
processes, self-confidence, and how interesting the
lecture is.
3. Lecturer’s assessment technique: Includes the
mode of assessment, which was completely based
on their lectures.

4. Teaching organisation: Covering distribution


of course outline during first week, keeping of
schedule, on time delivery of lectures.
5. Lecturer- student relationship: Accessibility
and willingness of lecturers to listen to students’
suggestions, tolerance and the relation lecturers
maintain with the students.

This evaluation was used to identify the


performance of individual lecturers and the overall
faculty performance.

Conclusion:
Thus, the inclusion of customer requirements and
the reports of customer satisfaction in the
curriculum design enabled the university to
increase the quality of graduates (students) to meet
the needs of the industry and the external customer.
Thus best practices in case of a HEI involves:
• Evaluation of customer requirements and the
integration of those requirements in the design of
teaching and learning process.
• Inspection of quality in the final product (graduates),
examining product at every stage of the process and
the people who participate in the process.
• Top-management support to smoothen the path for
implementation of the teaching and learning processes.
• Managing resources for the effective use and continual
improvement of the quality system to accomplish
world-class standard.

Continue:
Standardising Diplomacy

Best Practices > Standardising


Diplomacy
The American Embassy at Governor Square,
London has many distinctions. It is the
largest embassy in the world. More
importantly it is the first embassy of any
nationality in the world to achieve ISO
9001:2000 certification.
The American Embassy at Grosvenor Square, London has
around 750 people working in its various departments out of
whom half are Americans. It has achieved ISO 9001:2000
certification for its administrative department, the General
Service Office (GSO).
GSO is the largest and the most diverse department within
the embassy employing over 100 employees. Catering to the
requirements of the American employees is the main job of
the GSO. The responsibilities of GSO include providing
efficient service to the Americans when they are in UK –from
transporting their luggage to looking after the repair of their
lawn movers.

The diverse roles in the department


generally include purchasing,
transportation, storekeeping and providing
various other services. Thus the department
maintains its own personnel to conduct
training sessions for plumbers, carpenters
and electricians. It also maintains its own
interior design and fine arts specialist.

Need for QMS:


Customer service is highly valued in USA.
GSO wanted to provide customers with the
same level of service that they experienced
at home and this was the main driving force
for the embassy to look to ISO 9001:2000
certification.
The American employees in the embassy
are generally on interim postings on an
average of three years. Then they either get
transferred to another post or return to the
US. Such frequent shifting makes it hard to
retain the optimum levels of performance in
services. Every individual has a unique way
of thinking and performing tasks. Therefore,
the management system had to be
streamlined to provide standardised service.

There were no defined or established


operating procedures in the Embassy.
Though most of the people were familiar
with the method of doing their job, nothing
was recorded. For instance, the embassy
had quite a lot of people in one particular
section performing the same job. However,
when they were asked to explain how they
performed their jobs each one had a
different approach. This was despite the fact
that they worked together and met
frequently.
In addition the quality assurance manager
found that considerable amount of time was
being wasted by the new staff in learning
the job(nearly a year and a half in their
short period of 3 or 4 years). Therefore a
procedure to track or establish the activities
that were being done was needed. Thus the
quality assurance manager decided to have
a structured format that would help
standardise the way things were done.
Developing the QMS:
The quality assurance manager was
assigned the responsibility of developing the
quality system. Review of the existing
procedures was done in the first phase. This
review took into consideration the
viewpoints of all the personnel in the
embassy. It not only helped in improving
employee involvement but also assisted in
developing effective and efficient
procedures. Widespread interviews were
conducted with all the groups within the
embassy to identify customer requirements
and satisfaction.
Results of this analysis were then
considered in conjunction with the
organisations detailed service standards,
the International Collective Administrative
Support Services (ICASS). ICASS is a means
by which the US government splits and
distributes the costs of common
administration support services around the
world.
ICASS was introduced in 1990s by the US
government to enhance efficiency globally.
It helps to pinpoint the services provided to
each agency, and delegate a cost and a
time limit for that service to be delivered.
The quality assurance manager was
convinced with the ability of ICASS
standards in enhancing quality. Hence,
ICASS was taken as a standard for the
embassy QMS. Every written procedure was
attached with an ICASS service reference
number. This would give a better
understanding of the procedure in terms of:
Who is meant to do the work? What is the
timescale? At what cost?
The interesting thing here is that GSO
neither aimed for ISO 9001:2000
certification nor was any pressure from
customer or external demand for
certification. They just planned to introduce
the formal ICASS standards to enhance the
level of quality in their services.
However, concerned authorities in GSO
recognised the various benefits involved in
ISO 9001:2000 certification. They realised
that there would be no extra burden for the
Embassy. They discovered that certification
would enable them to establish their defined
procedures, and assess their quality system
against an international standard.Moreover,
the concerned authorities thought that the
external auditing involved in certification
process could provide an outside
perspective on their system. Thus they
opted for ISO 9001:2000 certification.
Implementation of the ISO 9001:2000 QMS
took over a year. A total of about 50
employees were provided ISO 9001:2000
training of whom 12 have even completed
the internal auditor course.

Care was taken that the training focused on


the activities that influenced their quality
performance. A careful study was conducted
to discover the activities in GSO that could
bring about improvement and were
successfully acted upon. An ‘e-room’ was
established to monitor and enhance
the implementation of the project.
Certification:
Lloyds Register Quality Assurance (LRQA)
that was selected as the registrar to certify
the GSO’s QMS. LRQA examined the
practical application of the ISO 9001
standards the embassy was interested in.
This included property, purchasing,
transportation and facilities management
services. LRQA was quite content with the
QMS and thus awarded the American
Embassy GSO ISO 9001:2000 certification in
August 2002.
Benefits:
An immediate result of the certification
process was the improvement in the
consistency of service provided. Operational
procedures became more efficient and thus
made life easier for those on short-term
postings. More importantly, customers were
provided with the service they were familiar
with and the service they expected.

Conclusion:
GSO has opened new vistas for other
sections of the American Embassy in London
to achieve certification. The benefits
accrued, encouraged the concerned
authorities to broaden the scope of
certification for the embassy’s entire
administrative affairs section (financial
management centre, information systems
department, human resources and visitors
unit) by the summer of 2003.

This certification was the first of its kind in


an Embassy of any country. The successful
accomplishment of certification and the
benefits thereafter were carefully observed
by the embassies across the world. Similar
programs are right now underway in the
American embassies in Brussels, Warsaw
and Vienna.
Case studies > Documentation- The Genesis of a
transformation
Genesis Telecommunication transforms from ISO 9002 1994 to
ISO 9001 2000.
Genesis Telecommunication was established in 1990, in London,
Manchester and Wokingham as a supplier and maintenance
company for the telecommunication industry. Today, it is a
leading telecommunication equipment supplier to reputed
companies like Sony, Oracle, Slaughter and May.
Genesis has always been convinced of the need for a reliable
QMS. According to Genesis the ISO 9002:1994 certification
worked well for them. Genesis viewed the ISO certification as a
QMS enhancement tool that helped improving its business
performance.
Genesis was one of the pioneers to recognise the need to
transition to ISO 9001:2000 compliance. When the deadline was
announced as December 15 2003, Genesis took all the necessary
steps required to be ISO 9001:2000 compliant.
Documentation to achieve ISO compliance:
The first step was the documentation process. Genesis
Telecommunication, initially assumed that by incorporating
changes in the existing quality manual (A quality manual reveals
quality polices and objectives) prepared for the ISO 9002:1994,
they could achieve ISO 9001:2000 certification. However, the
differences in documentation required, convinced them
otherwise.
Instead of just changing their quality manual, Genesis
Telecommunication realised that it had to first implement the
main ISO 9001:2000 management principles i.e. the process
approach. This differentiated ISO 9001:2000 from ISO
9002:1994.
The process approach:
To achieve ISO 9001:2000 compliance, the documentation must
reflect a process approach to the QMS that focuses on meeting
customer requirements by improved quality.
The process approach for the QMS focuses on
• Meeting customer requirements.
• Value addition to customers.
• Achieving process improvements as desired, and
• Continual improvement of the QMS.
Since the process approach was a new principle in ISO
9001:2000, companies found it difficult to cope with it. In order
to avoid confusion, Genesis Telecommunications incorporated a
Process mapping software protocol called the Process Expert
Professional (PSP). With the help of PSP, Genesis defined its
business functionality in the form of process maps and linked it
to existing documentation.
Further, with the PSP software employees could now read and
write information from their servers. This avoided the tedium of
scanning huge printed documents.
According to Genesis, the approach to ISO 9001:2000 disproved
their prior misconception of mere enhanced documentation. The
journey towards ISO 9001:2000-compliance saw Genesis realise
the flaws in its existing systems. This helped it achieve an
international standard QMS.
Genesis believes that with the PSP, its existing electronic
mapping communication systems were eliminated. The PSP
software helped Genesis unite all its centres into one single hub
that contained vital information about its overall quality
management and business.
Encompass hidden quality systems:
The biggest challenge that Genesis faced was encompassing all
systems that were related to its QMS in some way or the other.
This required expanding its documentation to cover all such
systems.
On the path to accomplishing these objectives were many issues
such as customer preferences and product marketing.
Consequently, these were also included as a part of the quality
management initiative. This highlighted the impact of customer
preferences on Genesis’s business. Its managers worked in
harmony to drive in a high-level of customer satisfaction.
Learning and benefits:
According to Genesis, being ISO 9001:2000 compliant has vastly
improved its level of quality along with customer satisfaction.
This is because ISO 9001:2000 facilitates the inclusion of all
systems related to quality, thereby enhancing the QMS.
The benefits of a superior QMS at Genesis, is a true reflection of
the fact that ISO 9001:2000 is ‘not’ just another benchmark
entity that organisations need to flash. If the approach to ISO
9001:2000 is correct then it can help organisations iron out
major problems that impede its QMS.
Continue:
Building on Quality
Case Studies > Building on Quality

One of Building Product Design (BPD)'s polices was to ensure


high quality to its customers. Hence it decided to opt for the new
certification quite early.

Like all other industries, the construction industry also requires a


robust Quality Management System (QMS) and hence the need
for international quality standards.
Established in the early 1980s by the construction company
Willan Group, UK, Building Product Design (BPD), erstwhile
William Building Services was involved in designing and
developing roof ventilation systems. In 1991 it was ISO
9000:1994 certified.
Building product activities were classified into four distinct areas
to facilitate better market invasion, comprehensive marketing
and better understanding of customer preferences. These were:
• Roofing.
• Natural ventilation.
• Cavity trays and
• Louvre systems.
Furthermore, BPD operated with distinct company names
relevant to each area, Glidevale Limited, Passivent Ltd., Z-Led
Ltd, and Kingfisher Louvre Systems. Each of these sub-
companies had their own designers, contractors, architects, and
managers. However, with its sub-companies, BPD was operating
towards the same goal of a high quality property construction
company.
Unlike other industries, the construction industry was not too
obsessed with ISO certifications. Customer orders poured in
anyway. So, construction companies seldom attempted to reach
international standards. Nevertheless, BPD took the decision to
render its Quality management system (QMS) ISO 9001 2000
compliant.
But why?
Post ISO 9000:1994 certification in 1991, BPD saw huge
improvements in its quality and customer service. During the
1990s when the ISO 9000:1994 standards was being at BPD, its
top management was fully involved in the enhancement of its
QMS.
Hence, when the latest version of ISO was announced, BPD’s top
management had little problem in setting up programmes to
achieve ISO 9001:2000 certification. They were certain that ISO
9001:2000 would prove beneficial to their business economy.
Consequently, they set up management programs to help
employees and managers understand the requirements for ISO
9001:2000 certification.
With four operational companies, BPD had two choices. First, the
ISO 9000:1994 certified QMS be continued. Then design and
develop a new QMS for each of the four companies based on the
new ISO 9001 2000 standard the next year. The alternative was
to just revise the old QMS to suit the four companies.
BPD adopted the former approach. Once this decision was made,
along with Lloyd’s Register Quality Assurance Ltd (LRQA) their
ISO consulting agency, BPD chalked out the aims and objectives
to achieve ISO 9001:2000 compliance.
By co-ordinating with LRQA, BPD devised its QMS to suit the new
standards. Since one of BPD’s polices was to ensure high quality
to its customers, it decided to opt for the new certification quite
early.
LRQA provided a service wherein its clients could avail a service
called the Advance Compliant Statement (ACS). In short, a
company with an ACS can claim to be ISO 9000:2000 certified
on the day ISO 9001:2000 standards are officially launched,
which was on 15th December 2000.
BPD’s managers conducted a gap analysis and concluded that
they were ready for ISO 9001:2000. The LRQA
executives/auditors inspected BPD in September 2000. They
confirmed that BPD be given the ACS and awarded ISO
9001:2000 which would be valid from December 15th 2000.
Benefits:
BPD believes that ISO 9001:2000 compliance has helped them
bag many customer orders. It believes that its QMS is good
enough to provide value for money to its customers. Today, BPD
is capable of planning, designing and meeting customer
expectations to a very high degree of accuracy, thanks to its
QMS that is ISO 9001:2000 certified.
BPD believes that ISO 9001:2000 has allowed it to become more
robust internally as well. Owing to ISO 9001:2000 BPD has
standardised its departmental procedures, which account for
better work scheduling and ultimately high quality.
According to BPD ISO 9001:2000 standard is more practical,
straightforward and reflective. This along with added features
such as better customer focus, process approach and continual
improvement has the potential to be a benchmark. It measures
not only quality but also organisational performance.
Furthermore, it helps organisations identify and rectify critical
non-conformities and drive appraisals more judiciously.
Conclusion:
It is prudent to say that QMS is critical to organisational success.
Quality management systems are the main source for added
value to customers. Achieving ISO 9001 2000 compliance is
definitely the way to ensure a co-ordinated approach towards
continual improvement and business excellence.

Continue:
Albion Redesigns its QMS
Case Studies > Albion redesigns its QMS

Design was an entirely new aspect not present in the previous


QMS (ISO 9002) that Albion pursued.
Albion Design and Fabrication, the Bedfordshire based
manufacturer of display and shop-fitting products achieved ISO
9001:2000 certification in October 2002. It is one of Europe’s
leading manufacturers of display systems, queuing systems and
audio-video support equipment. This case study explains Albion’s
fundamental approach to ISO 9001 QMS. More precisely it
explains the transition pursued by Albion for changing over from
ISO 9002 to the new ISO 9001:2000 QMS.
Case under study:
Albion Design and Fabrication Company was established in 1989
at Bedfordshire, UK. The company is renowned for its rope and
rod-based hanging display systems and its comprehensive range
of support systems for audio-visual equipment. Albion has
extensive manufacturing and warehouse facilities in the UK, a
sales and logistics operation in Germany, and a worldwide
network of distribution partners. Some 72 employees work in its
Bedfordshire plant.
Background:
The company had formally defined and established practices to
ensure effective quality in the production, installation and
servicing of its products. It also had ISO 9002 QMS certification,
which was achieved in 1997. The established procedures for
production and archiving that relate to quality were robust and
strictly followed. The quality management system was
contributing value as a basic framework to the company’s long-
term quality targets.
However, in order to renovate the plant as a whole the company
opted for ISO 9001:2000 standard. In addition, the top-
management felt at that quality related procedures, confined to
assurance of quality in the products was not sufficient. They
wanted to utilise these quality related procedures for improving
their business and hence decided to implement the ISO
9001:2000 QMS.
Developing the system:
Albion Design and Fabrication plant pursued a comprehensive
and evolutionary approach to meet the requirements of ISO
9001:2000 QMS. PDCA (Plan, Do, Check, and Act) cycle
approach was the base for every aspect of the company’s
certification process. These processes included activities from
setting up of goals to the evaluation and enhancement of the
quality related procedures.
Design was an entirely new aspect not present in the previous
QMS (ISO 9002) that the company pursued. Therefore, there
were neither previous procedures to assist in the design aspect
of the QMS.
Hence, Albion identified the need to initially conduct a company
wide training program. The program aimed at making its
employees aware of the new quality system and involved them in
the new process. An external consultant was hired to train the
employees on the new ISO 9001:2000 standards.
The various steps that were followed are detailed below:
Formation of a Task-force:
The primary step taken towards the company’s changeover
programme was the formation of a six-member taskforce.
This team represented individuals from different areas of
business. As a result, a diverse range of opinions was collected.
A quality assurance manager with the help of quality assurance
co-ordinator headed the team.
Training:
The cross-functional taskforce team was then provided with
adequate training for superior understanding and better
implementation of the new QMS.
Initially, the top-management was not certain of the
organisations ability to meet the required ISO 9001:2000
standards. Unable to comprehend the system they decided to
comprehensively allocate their time for better understanding and
implementation of the ISO 9001QMS.
Thus, before undertaking the training course the top-
management went through an extensive reading program that
could keep them abreast of the new standards. A two-day
training session followed.
Training helped the taskforce team develop a structured
approach to ISO 9001:2000 standard in setting up targets and in
specifying time limits. The training session also provided a
platform for the management to explain what was expected from
the team members.

Implementation:
The taskforce team started meeting for two hours each week to
decide upon the targets, and discuss and exchange views on
quality related issues. Duration for each meeting was fixed and
the team started integrating the outcome of the meetings to
identify possible developments and changes to the quality
manual.
Depending upon the requirement, they amended the manual.
Wherever required, new pages were added and the obsolete
ones were deleted. The quality manual was subjected to periodic
revision to further examine the scope of enhancement. In this
way a basic structure was developed to assist in the
implementation of the new quality system.
Care was taken such that the new quality system included all the
quality related activities in the organisation like process
mapping, the company’s motto, its targets, vision of the quality
system, and the new policy statement. Also the revised quality
manual ensured that all the valid procedures in the old quality
manual, were retained.
In this manner the first copy of the revised manual was
completed. They endeavoured to keep the manual as simple as
possible. Complicated terminology was avoided and the manual
was made user friendly.
The task force team then identified the need for a new and
effective auditing process to demonstrate the organisations
compliance to the required standards. Hence, another in-house
training camp was conducted. This camp was aimed at imparting
skills for auditing effectively, and to demonstrate organisations
compliance to the standards.
Transitional issues:
Time had proven to be the major issue of concern for Albion in
its transition process. The top-management was very busy as
usual. However the Albion management ensured that no matter
how busy they were, they set aside time each week for the
quality system. This ensured that all the employees was
focussed, interested and involved in the quality process.
Albion found demonstrating customer satisfaction a tough task to
handle. The quality assurance department identified the
inadequacy or inability of the customer questionnaires to
efficiently perform their task. They identified the need to improve
their customer communication approach so that more customers
answered the questionnaires.
In order to solve this problem sales people, who generally have
direct contact with the customer, were asked to specifically seek
customers’ willingness to complete the questionnaire, before
faxing them. This improved the response rate.
Cost involved in the transition process was the other issue that
was thought of before starting the quality program. Albion
identified that the major cost involved was in the training
programs to be conducted, and in the hiring of the consultant. At
the same time, they discovered the importance of training and
the benefits it could bring. So it decided in favour of hiring a
consultant for providing training and guiding the company in the
transition process.
Certification:
LRQA (Lloyds Register Quality Assurance) was selected as the
external consultant to provide necessary training to develop ISO
9001 QMS as well as to certify the organisations new QMS.
The certifying agency conducted a wide inspection of the plant
and found that the new QMS completely satisfied ISO 9001:2000
standard requirements. Consequently, the plant was awarded
ISO 9001:2000 certification in October 2002. LRQA specifically
appreciated the commitment of the top-management in the
company’s certification process.
Albion’s tips for transition:
1. Commitment of the top-management.
2. Formation of a cross-functional taskforce for the
transition process.
3. Suggestion and support from external consultant/
people, aware of the standards with prior experience in
implementing the ISO 9001:2000 QMS.
Online Navigator > Understanding

1. ISO 9000:2000 – An Introduction:


This document gives an explanation of
• Why ISO changed from 9000:1994 to 9000:2000.
• Changes that are made to the 1994 version.
• The ISO 9000:2000 family members, and
• The 8 management principles involved in the ISO
9000:2000 series.
http://www.normapme.com/eLearning/From%20ISO%20900X-
1994%20to%20ISO%20900X-2000-EN.pdf
2. What is ISO 9000:2000:
This Document explains what ISO 9000:2000 is and also
provides information regarding the implementation,
improvement and certification process involved in ISO
9000:2000 QMS.
http://www.cqual.co.uk/whatisiso.html
3. A Complete Guide to Understanding and Implementing
ISO 9000:2000:
This document is a guide to the understanding and the
implementation of ISO 90001:2000 requirements.
http://www.oxebridge.com/CompleteGuidetoISOProcessApproac
hv2.pdf
4. ISO 9001:2000 Understanding:
Link to download a sample quality manual.
http://www.qualisysgroup.com/management-iso9001-case.htm
5. Interpret the Requirements:
This document provides an interpretation for the ISO 9001 2000
standard.
http://www.mapwright.com.au/Quality_Matters.html

Continue
Online links to Implementation and Documentation
Online Navigator > Implementation and Documentation

A list of online links that relate to Implementation


and Documentation in ISO 9001:2000.

Implementation:
1. What Is ISO 9000:2000 Implementation?
This document gives a comprehensive explanation of the
implementation process for the revised ISO 9001 standard.
http://www.kamtechassociates.com/iso9k1.pdf
2. An Eight Step Approach to ISO 9000 Implementation
This document provides an 8-step approach to the
implementation of ISO 9000.
http://www.caliso9000.com/page4.html
3. Tips For Implementation
Provides some tips for implementing ISO 9001 standard
effectively.
http://www.orion-
iso.com/Pub/AboutORI/NewsBankDocs/Continuous%20Improve
ment/Dcutter-Implementing%20ISO%209000%20Process.pdf
4. Common Pitfalls In The Implementation Process
This document lists out the issues organisations mostly face in
the implementation process of ISO 9000:2000.
http://www.hkbu.edu.hk/~samho/tqm/tqmex/iso.htm
5. Increasing profitability, quality and compliance with
ISO 9000
This document details the steps necessary for realising the
benefits of implementing the ISO 9001 standard
http://www.rosternetwork.com/bna/iso_9000_white_paper.htm
Documentation
1. ISO 9000:2000 Documentation - Guidance
This document provides guidance for meeting the documentation
requirements of the ISO 9001:2000 standard.
http://isotc176sc2.elysium-ltd.net/Documentation.doc
2. ISO 9000:2000 Documentation – A complete
understanding
Explains the planning necessary for the documentation process.
http://www.stc.org/intercom/PDFs/2002/200202_17-21.pdf

Continue
Online Links to Additional Reading

Online Navigator > Additional Reading

Following are some online links relating to Additional Reading in


ISO 9001:2000.

1. http://www.holeton.com/casestudies.htm This link provides


case studies of ISO 9000:2000 for different sectors of business
namely- Aerospace manufacturing, Electrical sensor
manufacturing, Energy systems, Service division and Insurance
brokerage.

2. http://clientele.epicor.com/tools/case.asp?ID=281&P - A case
study of ISO 9001 implementation by Cimworks – a Computer
integrated manufacturing products provider.

3.
http://www.staffingtoday.net/memberserv/9804ct/usingiso.html
- A case study on using ISO for technology implementation.
4.http://www.qualisysgroup.com/management-iso9001-
case.htm - This page provides downloads for the sample quality
manual, requirements of ISO 9001:2000 and some frequently
asked questions.

5. http://www.iqa.org/information/iso9k2kworkbook.html - A
guide to the adoption of ISO 9001:2000 standard.

6.
http://www.siem.gob.mx/siem2000/spyme/promcalidad/paginas
/plena04.ppt - This presentation deals with the issues related to
transition from 1994 version to the 2000 version.

7.
http://www.asq509.org/Library/ISO%209001%20at%20NASA.p
pt - A detailed power point presentation that makes a journey
into the implementation of ISO 9001 at NASA.

8.
http://www.aidic.it/italiano/congressi/esrel2001/webpapersesrel
2001/337.pdf - This document deals with the quality
improvements related to the ISO 9001 2000 standard.
9. http://www.iso.ch/iso/en/iso9000-
14000/articles/pdf/viewpoint_4-98.pdf – This document is an
argument against ISO 9000.

10. http://praxiom.com/ This site gives a clear explanation of all


the standards and the guidelines present in the ISO 9000:2000
series.

11.
http://www.borcom.bc.ca/EXBP/ISO%209001_2000_Guideline_r
ev2.0.pdf - This document starts with a summary of ISO
9000:2000 and then explains the key clauses involved in it. It
also answers some frequently asked questions on ISO 9001.
12. http://www.isoeasy.org/illustrated.pdf - This link provides an
illustrated document that explains the ISO 9001 standard in a
simple way.
Service Providers > ISO 9001:2000 Consultants

Given below is a list of ISO 90011:2000 Consulatants with a brief


on each of them as posted in their websites.
1. Advantage ISO Consulting
http://www.advantage-iso-consulting.com/
Advantage ISO consulting firm assists organisations in complying
with the ISO 9001 2000 requirements. It offers help in
developing, implementing and maintaining the quality system. It
also supports in creating the necessary documentation for ISO
certification. It also helps in conversion from ISO 9000 1994 to
ISO 9000 2000.
2.Drysdale Consulting
http://www.drysdaleconsulting.com/
Drysdale consulting provides assistance for implementing ISO
9001 2000, ISO 14001 systems. It also helps provides training,
consulting and auditing services. It assists in transition from one
system to other and also in integration of systems.
3. FY Consulting
http://www.fyconsulting.com/iso9000.html
FY Consulting offers assistance in upgrading to and complying
with the ISO 9001 2000 requirements. It also helps in complying
with the ISO 14000 requirements and provides the necessary
documentation system.
4. Jan Roovers Associates Inc
http://www.janroovers.com/
Jan Roovers Associates Inc. provides training and consulting for
ISO 9001. It also provides support in upgrading from ISO 9000
1994 to ISO 9000 2000, documenting and implementing the
system.
5. Global Tech Ltd Management Consultants
http://globaltechca.com/
Global Tech Ltd. uses a process driven approach to enable the
quality management system to comply with the ISO 9001 2000
requirements. The firm develops the system around the existing
environment of the organisation. This enables a smooth
transition of the quality system to the ISO standards.
6. Opim Consultants Inc.
http://www.terra-tech.nb.ca/
OPIM is an innovative training firm committed to providing
consulting and training services that produce short-term
measurable benefits in the industrial and services sector.
OPIM inc. has managed and completed numerous training
projects around the globe in several sectors. These sectors
include: forestry, industrial management, sciences, ISO quality
systems, manufacturing systems, operation improvement
techniques, maintenance, telecommunications and international
procurement.
7. Orion Canada Inc.
http://www.orioncanada.com
Orion Canada offers services covering various aspects of quality.
It offers assistance ranging from finding the cause of quality
problems to designing quality management systems that comply
with requirements. Services include internal audits, measuring
customer satisfaction, maintaining quality system etc.
8. Q-Pro Consulting
http://members.shaw.ca/qpro/home.html
Q-PRO consulting provides consulting services in quality
management systems, quality control, and quality audit related
to manufacturing and service sector.
9. Sigma Affliates, Ltd.
http://www.sigmafil.com/
Sigma Affiliates Ltd. is a quality consulting and training firm. It
assists organisations develop their quality system and comply
with the ISO 9001 requirements.
10. Directory Of Consultants
http://www.iso9000commerce.com/htm/consultants.htm
This site gives a complete list of consultants in the United States
and also provides a link of consultants in the international arena
who assist organisations in the ISO 9000 certification process.

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