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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.
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.
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.
4.2.1 General:
Documentation requirements for a QMS include:
• Documents for implementing a quality system.
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.
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5. Management responsibility:
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?
7. Product realisation:
• 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 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?
7.4 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?
8.1 General:
• 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?
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?
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:
• Organisation charts.
• Specifications.
• Work and/or test instructions.
• Documents containing internal communications.
• Production schedules.
• Approved supplier lists.
• Test and inspection plans.
• Quality plans.
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.
system.
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.
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.
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.
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.
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.
4. Review of document:
• Brainstorming Technique.
Document control:
Customer Focus:
• Customer surveys.
• Comment cards.
• Field reports.
Planning
• PERT.
• Gantt Charts.
Process Control:
• Process Analysis.
• FMEA.
• Reliability Technique
• Problem Analysis.
• CAD software.
• Simulation.
• Design of Experiment.
• Poka yoke.
Delegation of responsibilities:
• Arrow Diagrams.
• Flowcharts
• Control charts.
• Pareto charts.
• Histograms.
• Check sheets.
• Scatter diagrams.
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.
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
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.
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).
• Leadership qualities.
• Communication skills.
• Teamwork.
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
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.
Continue:
Albion Redesigns its QMS
Case Studies > Albion redesigns its QMS
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
Continue
Online links to Implementation and Documentation
Online Navigator > Implementation and Documentation
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
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.
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