ISO9001

QMS
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Agenda
 What is ISO
 ISO standards
 Certification
 QMS Principles
 ISO 9000 Series (ISO 9001:2008 in detail)
 Documentation
 Auditing
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What is ISO
 International Organization for Standardization is the world's
largest developer and publisher of International
Standards.
 network of the national standards institutes of 163*
countries
 non-governmental organization
 Published more than 18,500* standards
"International Organization for Standardization" would have different

acronyms in different languages ("IOS“ in English, "OIN" in French for
Organisation internationale de normalisation), its founders decided to
give it also a short, all-purpose name. They chose "ISO", derived from
the Greek isos, meaning "equal". Whatever the country, whatever
the language, the short form of the organization's name is always ISO.
*Source: ISO website ISO in figures for the year 2010
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 ISO standards are developed by international consensus
among experts drawn from the industrial, technical or
business sectors which have expressed the need for a
particular standard.
 ISO operates no system for verifying the conformance of
organizations’ quality system with standards.
 ISO itself carries out no audits.
 ISO awards no certificates attesting to conformity with the
standards.
 There is no such thing as ‘ISO CERTIFICATION’, whether in
relation to ISO 9000 or any other standards.
 ISO has no authority to oversee the work of QMS
Certification Bodies. However, relevant ISO Guides form
basis for acceptable practice by such bodies.
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 All the standards developed by ISO are
voluntary.
 ISO has no power to enforce their
implementation.
 ISO standards are market driven.
 ISO does not regulate or legislate.
However, countries may decide to adopt
ISO standards - mainly those concerned
with health, safety or the environment -
as regulations or refer to them in
legislation, for which they provide the
technical basis.
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 ISO STANDARDS are REVIEWED PERIODICALLY to decide
whether they need confirmation, revision or withdrawal
 PURPOSE OF REVISION: ENSURING to take account of
TECHNOLOGICAL and MARKET DEVELOPMENTS.
 Certificates are issued by Certification Bodies. (In some
countries they are called ‘Registration’ Bodies) independently
of ISO, even when a particular body may be part of the
national standards organization that is an ISO member.
(Example: BIS)
 In a growing number of countries, Accreditation Bodies
are being set up (sometimes, but not always with a
government mandate) to exercise a degree of control
over the ‘ISO Certification Industry’.
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 The vast majority of ISO standards are highly
specific to a particular product, material, or
process.
 However, ISO 9001 (quality) and ISO 14001
(environment) are "generic management
system standards".
 "Generic" means that the same standard can be applied
to any organization, large or small, whatever its product
or service, in any sector of activity,
 and, whether it is a business enterprise, a public
administration, or a government department.
 ISO 9001 contains a generic set of requirements for
implementing a quality management system and ISO
14001 for an environmental management system.
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 The ISO 9000 family of standards represent an
international consensus on good management
practice.
 The ISO 9000 series of international standards
for Quality Management System has been
adopted by more than 6,10,000 organizations
in more than 175 countries.
 ISO 9000 series was FIRST PUBLISHED in 1987.
 FIRST REVISION published in 1994.
 SECOND REVISION published in 2000.
 LATEST REVISION published in 2008.
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 What is ISO 9001?
- ISO 9001 is an international standard containing
requirements for implementing a QMS in the
organization.
 ISO 9001:2008 can be applied to ALMOST ANY
ORGANIZATIONS:
- Product Manufacturers
- Service Providers.
 It is a generic standard.
 ISO 9001:2008is not specific to any product or

industry.
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 Three standards of ISO 9000:2000 series
(Published on 15 December 2000)
- ISO 9000:2005, Quality management systems
– Fundamentals and vocabulary
– Requirements (Please note ISO 9001:2008 has
been published recently)
– Managing for the sustained success of an
organization- a quality management approach

 ISO 9000:2000 ‘CORE SERIES’ now consists of
four standards:
- ISO 9000:2005
- ISO 9001:2008
- ISO 9004:2009
- ISO 19011:2002
 ISO 19011 was published in 2002.

 ISO 19011 is a standard describing the
guidelines on quality and/or environmental
management systems auditing.

 Before publication of ISO 9001:2008 – no
accredited certificates to new standard allowed
 Up to 1 year after publication – certification /
renewal to ISO 9001:2000 still permitted
 Beginning 1 year after publication, no new
certificates to ISO 9001:2000 allowed – all audits
to be conducted to ISO 9001:2008
 2 years after publication – ISO 9001:2000
certificates will no longer be valid

The ISO Survey

Certification
- Contact with certification body
- Adequacy (Documentation Audit)
- On-site Audit
- Issue of certification
- Surveillance Audit

 The revision of 2000 version standards has
been developed on the basis eight quality
management principles.
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationship

 First principle – CUSTOMER FOCUS
 An organization depends on its customers and
therefore the organization should understand
the current and future needs of its customers,
meet customer requirements, and strive to
exceed customer expectations.
 Benefits:
1. Increased business
2. Increased market share
3. Enhanced customer satisfaction
4. Repeat business

 Second principle – LEADERSHIP
 Leaders establish unity of purpose and direction of the

organization. Leaders create and maintain internal
environment for people involvement.
 Benefits:
1. Employees’ motivation towards organization’s goals and
objectives,
2. Better understanding of organization’s objectives,
3. Better communication within the organization

 Third principle – INVOLVEMENT OF PEOPLE
 People at all levels are the essence of an organization.

Without involvement of human resources, nothing can
be achieved.
 Benefits:
1. Motivation and commitment of employees.
2. Involvement of employees at all levels.
3. Innovation and creativity.
4. Employees’ participation and contribution for continual
improvement.

 Fourth principle – PROCESS APPROACH
 A desired result can be achieved more

efficiently when all related resources and
activities are managed as a process.
 Benefits:
1. Effective use of resources.
2. Lower cost.
3. Shorter cycle times.
4. Improved, consistent and desired results.

 Fifth principle – SYSTEM APPROACH TO
MANAGEMENT
 A system contains various interrelated processes.

A system approach to management can be
explained as identifying, understanding and
managing a system of interrelated processes for a
given objective.
 Benefits:
1. Integration and alignment of processes.
2. Achievement of desired results.
3. Increase in effectiveness and efficiency in the
organization.
4. Achievement of organization’s objectives.

 Sixth principle – CONTINUAL IMPROVEMENT
 Where an organization aims to enhance

customer satisfaction, the organization must
have a permanent objective of continual
improvement of the QMS.
 Benefits:
1. Performance advantage
2. Improvements
3. Alignment of improvement activities

 Seventh principle – FACTUAL APPROACH TO
DECISION MAKING
 Effective decisions can be taken if there is

analysis of data and information. Factual
approach to decision making for continual
improvement is possible through analysis of data.
 Benefits:
1. Increased ability to have decisions based on
analysis
2. Increased ability to review, challenges and
change opinions and decisions

 Eighth principle – MUTUALLY BENEFICIAL
SUPPLIER RELATIONSHIP
 An organization and its suppliers are

interdependent. A mutually beneficial
relationship between these two enhances the
ability to both to create value to each other.
 Benefits:
1. Increased ability to create value for the
organization and its suppliers
2. Optimization of resources
3. Mutually beneficial relationship leads to long
term benefits.

What is an audit?
 An audit is “A systematic, independent

and documented process for obtaining
audit evidence and evaluating it
objectively to determine the extent to
which audit criteria are fulfilled.”
 Internal audit
 Independent, objective assurance and consulting
activity
 Adds value and improves organization’s operations

How audits add value
 Identify and correct noncompliance
issues
 Identify improvement opportunities
in standards and procedures
 Value added includes:
 Improved consistency and lower
variability
 Reduced errors, rework, cycle time,
costs
 Increased productivity

Types of audit
 Classify audits by:
 Who performs the audit
 1st party – internal / self audit
 2nd party – by customer
 3rd party – by outside / for certification
 Purpose of audit
 Compliance
 Performance

Bureaucratic v/s Value added
Bureaucratic approach
What procedures do we need to write to meet
the ISO 9001:2000 QMS requirements?
Value-added approach
How can we use ISO 9001:2000 QMS to
improve our organization.

Root cause important
Don’t inquire – “Who is responsible?”
Inquire – “What caused the problem?”

“Why it happened so?”
“Is it due to inadequate training?”
“Is it due to unrealistic procedure?”
“Insufficient manpower or resources?”
“Enough time not given?”
“What may be a better way of doing things?”

 ISO 9001 is NOT A PRODUCT QUALITY LABEL or
GUARANTEE.
 When an organization has a management
system certified to an ISO 9001 standard, this
mean THAT an INDEPENDENT AUDITOR HAS
CHECKED THAT THE PROCESSES influencing the
QUALITY (ISO 9001) CONFORMS to the
RELEVANT Standard's REQUIREMENTS.

PLEASE NOTE
IF THE EXPRESSION
“SHALL”
IS USED IN THE STANDARD,
IT MAKES THAT
ELEMENT TO WHICH IT REFERS A
MANDATORY REQUIREMENT
AND
FAILURE TO OBSERVE ITS DIRECTION
RESULTS A NONCONFORMANCE.

Quick Reference to ISO 9001:2008
 Clause 4 – QUALITY MANAGEMENT SYSTEM

 4.1 – GENERAL REQUIREMENTS
 4.2 – DOCUMENTATION REQUIREMENTS
 Clause 5 – MANAGEMENT RESPONSIBILITY

 5.1 – MANAGEMENT COMMITMENT
 5.2 – CUSTOMER FOCUS
 5.3 – QUALITY POLICY
 5.4 - PLANNING

 5.5 – PLANNING, AUTHORITY AND COMMUNICATION

 5.6 – MANAGEMENT REVIEW
 Clause 6 – RESOURCE MANAGEMENT

 6.1 – PROVISION OF RESOURCES
 6.2 – HUMAN RESOURCES
 6.3 – INFRASTRUCTURE
 6.4 – WORK ENVIRONMENT

 Clause 7 – PRODUCT REALIZATION
 7.1 – PLANNING OF PRODUCT REALIZATION

 7.2 – CUSTOMER RELATED PROCESSES
 7.3 – DESIGN AND DEVELOPMENT
 7.4 – PURCHASING
 7.5 – PRODUCTION AND SERVICE PROVISION
 7.6 – CONTROL OF MONITORING AND MEASURING
DEVICES

 Clause 8 – MEASUREMENT, ANALYSIS AND

IMPROVEMENT
 8.1 – GENERAL
 8.2 – MONITORING AND MEASUREMENT
 8.3 – CONTROL OF NONCONFORMING PRODUCT
 8.4 – ANALYSIS OF DATA
 8.5 - IMPROVEMENT

Documentation:
Level A – Quality Manual – Having scope of QMS,
Details of exclusions (if any), Quality Policy,
Measurable Quality Objectives, Documented
procedures established for the QMS or their reference
- Level B – Quality System Procedures – Six
mandatory procedures
- Level C – Documents – Such as Operational
Procedures, Work Instructions, Forms, Reports etc.
for effective planning, operation and control of
processes.

Quality Policy
Top management to ensure that:
 Quality policy is appropriate to purpose of organization.

 Quality policy has commitment to comply requirements and
continually improve QMS effectiveness.
 Quality policy has framework for quality objectives and its
review.
 Quality policy is communicated and understood (within
organization).
 Quality policy is reviewed for continuing suitability.

Quality Objectives
 Responsibility – Top Management

 Purpose – To ensure measurable quality objectives
 Top management to ensure that quality objectives are

established at relevant functions and levels within the
organization.
 Quality objectives must be MESURABLE and CONSISTENT

with quality policy.

Mandatory six documented
procedures:
 4.2.3 – CONTROL OF DOCUMENTS
 The organization must have a written

procedure for document control that
ensures QMS documents are available,
legible, identifiable, and up-to-date.

QMS Requirements – Clause 4
 CONTROL OF DOCUMENTS PROCEDURE must cover:
 Reviewing and approving all documents prior to use.

 Reviewing, updating and re-approving documents as
needed.
 Keeping master document lists (or some mechanisms) to
determine who has copies of a document and what the most
current version of the document is.
 Keeping documents accessible to the people who need
them.
 Removing obsolete documents to prevent accidental use.

4.2.4 – CONTROL OF RECORDS
 All records related to QMS must be handled

according to a documented procedure.
 Records are kept as proof that activities occurred

and as evidence that can be analyzed later.

 CONTROL OF RECORDS PROCEDURE must address:
 How records are identified.
 How records are stored and protected (easy to find,
not lost or damaged).

 How records can be retrieved.
 Who’s responsible for maintaining records.
 How long different records are maintained and how
they are ultimately destroyed.

The records must remain:
readily identifiable, and
retrievable

 8.2.2 – INTERNAL AUDIT
 Purpose – To ensure that the QMS of the organization
conforms to the planned arrangements to the
requirements of the Standard and the QMS
requirements established by the organization. Also to
ensure that QMS is effectively implemented.
 The organization needs to CONDUCT INTERNAL AUDIT

AT PLNNED INTERVALS.
 An audit programme MUST BE PLANNED.

 INTERNAL AUDIT …
 Following considerations should be taken into

account:
(i) the status and importance of the processes,
(ii) areas to be audited, and
(iii) results of previous audits.
 The organization must define audit criteria, scope,

frequency and methods. Selection of auditors and
conduct of audits MUST ENSURE OBJECTIVITY AND
IMPARTIALITY of the audit process.

 INTERNAL AUDIT …
 Auditors are NOT ALLOWED TO AUDIT THEIR OWN WORK.

 The organization is required to define in a DOCUMENTED
PROCEDURE responsibilities and requirements for
planning and conducting audits, and for reporting results
and maintaining RECORDS.
 Maintenance of RECORDS of internal audit MUST.
 The management responsible for the area being audited
MUST ENSURE that actions are taken PROMPTLY to
eliminate detected nonconformities and their causes.

 8.3 – CONTROL OF NONCONFORMING PRODUCT
 Nonconformity is defined as non-fulfillment of a requirement.
Product, which does not conform to product requirements, can
be termed as nonconforming product.
 Purpose – To prevent unintended use or delivery of
nonconforming product and to establish ways of identifying and
dealing with nonconformity.
 Nonconforming product MUST BE IDENTIFIED and CONTROLLED.

 The organization must deal nonconforming product by one or
more of the following ways: (i) by taking actions to eliminated
detected nonconformity, (ii) by authorizing its use, release or
acceptance under concession by a relevant authority and where
applicable by the customer, (iii) by taking action to preclude its
original intended use or application.

 8.5.2 – CORRECTIVE ACTION
 Corrective action is an action taken to eliminate the cause of
detected nonconformity or other undesirable situation.
 Purpose – To eliminate the cause of nonconformities in order
to prevent recurrence.
 The organization MUST TAKE CORRECTIVE ACTION. Corrective

action must be appropriate to the effects of the
nonconformities encountered.
 A DOCUMENTED PROCEDURE must be established.

 8.5.3 – PREVENTIVE ACTION
 Purpose – To eliminate the cause of potential
nonconformities in order to prevent their occurrence.
 The organization MUST DETERMINE preventive action.
 Preventive action MUST BE APPROPRIATE to the effects of

potential nonconformities.
 A DOCUMENTED PROCEDURE must be established.

Step-by-step approach in implementation
Step 1 – Top management commitment

 The top management should demonstrate commitment
and determination to implement ISO 9001:2008 QMS.
 The top management should be convinced of the
implementation benefits (internal and external).
Step 2 – Appointment of MR
Step 3 – Establishing steering committee and task force
- Steering committee – responsible for overall
planning and implementation
- Task Force – responsible for preparation of
documentation

…
Step 4 – Appointing a consultant, if necessary

- Appointing a consultant may be a
worthwhile investment.
- Although it is not necessary.
Step 5 – Collect information about ISO 9000
family
- Information from websites
- Purchase of standards
- Purchase of various books, literatures,
training material etc.
Step 6 – Start ISO 9001:2008 Awareness
Programme

…
Step 7 – Prepare Action Plan
Step 8 – Training and guidance
- In-depth training on ISO 9001:2008 QMS for
steering and task force committee members
- Training to MR
- Internal Audit Training (with inputs of ISO
19011:2002 and Value Added Internal Audit)
- Statistical Tools
- Documentation

… Step 9 - Initial status survey
- To determine gaps
Step 10 – Develop your documentation
Step 11 – After issue of documentation, start
implementation as per documentation
Step 12 – Plan and conduct ‘Internal audit’
Step 13 – Conduct Management Review
Step 14 – Arrange Pre-certification Assessment
Step 15 – Go for Certification
-

Implementation in real sense …
 Implementation should be 100 percent.
A few buy certification for show. Buying certification
does not produce product conforming to the
requirement of the customer. The ultimate purpose is
continual improvement.
Big organizations can implement integrated
management systems, while organizations having
limited resources should implement management
systems standards one by one - first they should
implement QMS, then EMS, then OH&SMs and then
SR.
 The organization should also give importance to the
training and development of their people. If people
grow in knowledge, ultimate benefit will to the
organization.
Quality Council of India (QCI)
 Autonomous body
 Established by the Government of India, (Ministry of
Commerce & Industry, Department of Industrial Policy &
Promotion being the nodal Ministry)
 To establish and operate National Accreditation
Structure for conformity assessment bodies.
 Also assigned the task of monitoring and administering
the National Board for Quality promotion and oversee
effective functioning of the National Information and
enquiry services.
 Indian Industry is represented on QCI by three premier
industry associations ASSOCHAM, CII and FICCI

ACCREDITATION BODY :
INDIA
 National Accreditation Board for
Certification Bodies (NABCB)
Quality Council of India
Institution of Engineers Building, 2nd Floor,
Bahadur Shah Zafar Marg,
110 002 New Delhi
Web: www.qcin.org
NABCB is a member of:
- IAF The International Accreditation Forum, Inc.
- PAC Pacific Accreditation Cooperation

Bureau of Indian Standards
(BIS)
 BIS Bureau of Indian Standards is the
National Standards Body of India.
 BIS is a member of ISO
 Certification activity carried out by BIS has
been accredited by Raad voor Accreditatie
(RvA) of Netherlands, to carry out IS/ISO
9001:2000 certification in 23 business
sectors.

 http://iso9001-2008awareness.blogspot.com
 http://www.siteajmer.blogspot.com/

ISO9001

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QMS

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"International Organization for Standardization" would have different

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 ISO 9001:2008is not specific to any product or

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 ISO 19011 was published in 2002.

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 Leaders establish unity of purpose and direction of the

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 People at all levels are the essence of an organization.

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 A desired result can be achieved more

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 A system contains various interrelated processes.

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 Where an organization aims to enhance

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 Effective decisions can be taken if there is

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 An organization and its suppliers are

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 An audit is “A systematic, independent

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Inquire – “What caused the problem?”

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 Clause 4 – QUALITY MANAGEMENT SYSTEM

 Clause 5 – MANAGEMENT RESPONSIBILITY

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 5.5 – PLANNING, AUTHORITY AND COMMUNICATION

 Clause 6 – RESOURCE MANAGEMENT

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 Clause 7 – PRODUCT REALIZATION

 7.1 – PLANNING OF PRODUCT REALIZATION

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 Clause 8 – MEASUREMENT, ANALYSIS AND

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Top management to ensure that:

 Quality policy is appropriate to purpose of organization.

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 Responsibility – Top Management

 Top management to ensure that quality objectives are

 Quality objectives must be MESURABLE and CONSISTENT

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 The organization must have a written

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