Presented By : Prasad Kadu

Sections covered
 What is ISO ?
 Genesis of ISO
 Family of ISO
 What is ISO 9001 ?
 8 Quality Management Principles
 8 Clauses of ISO 9001
 Why is ISO required ?
 Advantages of ISO 9001
 Misconceptions of ISO 9001
 How to get ISO certification ?
 Documentation required for ISO 9001 certification
What is ISO ?
 It stands for international Organization for Standard.
 ISO story began in 1946 at an Institute of Civil Engineers , where 65 delegates
from 25 countries met to form an international body.
 ISO 9000 was first published in 1987. It was based on the BS 5750 series of
standards from BSI that were proposed to ISO in 1979.

 However, its history can be traced back to 1959 for the publication of the
United States Department of Defense MIL-Q-9858 standard .

 MIL-Q-9858 was revised into the NATO AQAP series of standards in 1969,
which again were revised into the BS 5179 series of guidance standards
published in 1974, and finally revised into the BS 5750 series of requirements
standards in 1979 before being submitted to ISO.

 HQ at Geneva Switzerland and has members of 164 countries 3368 technical

bodies as of today.
What is ISO ?
 The name ISO came from ‘ isos ’ in Greek meaning
Equal (Standardization).
 It is the worlds largest developer of International
Standards covering specifications for products ,
services and good practices (CGMP).
 Has helped in breaking barriers to international trade
through global consensus.
 Bureau of Indian Standards (BIS)
Founders of the ISO at London
1946
Family of ISO
 Many standards of ISO are there like
1. ISO 9000 : Quality Management
2. ISO 14000 : Environmental Management
3. ISO 50001 : Energy Management
4. ISO 22000 : Food safety Management
5. ISO 26000 : Social Responsibility
6. ISO 27001 : Information Security
ISO 9000 family
 ISO 9001:2008 - sets out the requirements of a quality
management system
 ISO 9000:2005 - covers the basic concepts and
language
 ISO 9004:2009 - focuses on how to make a quality
management system more efficient and effective
 ISO 19011:2011 - sets out guidance on internal and
external audits of quality management systems.
ISO 9001…… Quality Management
 ISO 9001 : 1988 …… Quality Assurance
 ISO 9001 : 1994 …… Quality Assurance
 ISO 9001 : 2000 …… Quality Assurance and Customer
satisfaction
 ISO 9001 : 2008 …… Quality Management System
 ISO 9001 : 2015 …… Sustainable Development
ISO 9001…. QMS
 Lays down the requirements for Quality Management
Systems (QMS)
 Definition of QMS :
The process of Management of the System of an
organization , with regard to its Quality related
activities, for meeting and enhancing customer
satisfaction and also taking care of all other interested
parties such as the legislative and regulatory bodies,
shareholders, suppliers, and the employees.
8 Quality Management Principles
1. Customer focused organization
Organizations depend on their customers and therefore should
understand current and future customer needs, should meet customer
requirements and strive to exceed customer expectations
2. Leadership
Leaders establish unity of purpose and direction. They should create
and maintain the internal environment in which people can become
fully involved in achieving the organization's objectives
3. Involvement of people
People at all levels are the essence of an organization and their full
involvement enables their abilities to be used for the organization's
benefit.
4. Process approach
A desired result is achieved more efficiently when activities and
related resources are managed as a process.
8 Quality Management Principles
5. System approach to management
Identifying, understanding and managing a system of interrelated
processes as a system contributes to the organization's effectiveness
and efficiency in achieving its objectives.
6. Continual improvement
Continual improvement of the organization's overall performance
should be a permanent objective of the organization.
7. Factual approach to decision making
Effective decisions are based on the analysis of data and information.
8. Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a mutually
beneficial relationship enhances the ability of both to create value.
Clauses of ISO 9001
 Clauses 1 , 2 and 3 :
Tell us about the introduction , terms and definitions
related to ISO.
They also tell us about the concepts and principles
used in the standards along with the guidance on the
QMS scope.
 The remaining five clauses numbering 4 through 8
provide the control requirements that a QMS must
implement.
Clauses of ISO 9001
 Clause 4 - Quality Management System - sets requirements to
identify, plan, document, operate and control QMS
processes and to continually improve QMS effectiveness.

 Clause 5 - Management Responsibility - sets requirements

for top management to demonstrate its leadership and
commitment to develop, implement and continually improve the
QMS.

 Clause 6 - Resource Management - sets requirements to

determine, provide and control the various resources needed to
operate and manage QMS processes; to continually improve
QMS effectiveness; and to enhance customer satisfaction by
meeting customer requirements.
Clauses of ISO 9001
 Clause 7 - Product Realization - sets requirements to plan,
operate and control the specific QMS processes that determine,
design, produce and deliver an organization’s product and
services.
 Clause 8- Measurement, Analysis and Improvement - sets
requirements to plan, measure, analyze and improve processes
that demonstrate product and QMS conformity and continually
improve QMS effectiveness.

The overall objective of your QMS must be to enhance customer

satisfaction by meeting their requirements. This objective can be
achieved by using the ISO 9001 requirements to control your
QMS processes and by continually improving QMS effectiveness.
Why is ISO required ?
 Fulfill customer requirements.
 Keep up with the competition.
 Gain a market advantage.
 Provide a better framework for development and
growth.
 Improve image.
 Gain publicity and build confidence.
 Comply with export market requirements.
 Create a system identifying and defining
requirements.
Advantages of ISO 9000
 Improved their levels of customer satisfaction and
loyalty.
 Boosted their operational performance.
 Acquired new customers and retained existing clients.
 Achieved cost savings.
 Improved communications, morale and job
satisfaction of the employees.
 The certificate can be used as a marketing tool.
Misconceptions about ISO 9001
 Set poor standards and get certified.
 An already recognized organization does not need to prove its
excellence in quality.
 An organization with a good existing QMS process does not
need certification.
 Certification is expensive for small scale organizations.
 Results in a lot of unnecessary paperwork.
 All job descriptions must be documented and peoples
competence must be evaluated for them.
 All outdated documents must be removed from the place of use.
 Everyone in the organization must be able to repeat the quality
policy verbatim.
How to get ISO certification
 Organizations willing to achieve ISO certification shall follow steps mentioned
below
Step 1: Decide ISO certification to be obtained.

Step 2: Review advantages of ISO certification.

Step 3: Contact ISO certification consultants if requirements of

ISO system is not known.

Step 4: Review existing work practices being followed in the

company and identify gaps against requirements
mentioned in ISO standards

Step 5: Prepare action plan describing work to be done to fulfill

requirements of ISO standard
Cont…..
Step 6: Give trainings to all employees of organization about
ISO requirements.

Step 7: Complete necessary documentation like manual,

procedures preparations.

Step 8: Follow defined ISO system in routine and overcome

difficulties in following same.

Step 9: Conduct internal audit

Step 10: Contact ISO certification agencies and finalize 3 year

contract with them.
Cont…..
Step 11: After ensuring adequate preparations for audit,
call certification agency for stage 1 audit.

Step 12: Close non conformities given by certification agencies

during stage 1 audit.

Step 13: Call certification agency for stage 2 ( final ) certification

audit.

Step 14: Close non conformities given by certification agency during

stage 2 certification audit.

Step 15: Receive ISO certificate after 4-6 weeks of successful

completion of stage 2 certification audit

Step 16: Use ISO logo as per recommendation of certification agency.

Documentation required for ISO
9001:2008 certification
 Documented statements of a quality policy and quality
objectives.
 A quality manual .
 Documented procedures required by this International
Standard
 Documents needed by the organization to ensure the
effective planning, operation and control of its
processes.
 The size of organization and type of activities.
 The complexity of processes and their interactions.
 The competence of personnel.
Documentation required for ISO
9001:2008 certification
 Certificate of Incorporation.
 VAT , CST , TIN and Service certificates.
 Organizational Hierarchy information.
 Customer appraisal certificates.
 Information about the financial worth of the company.
 Information about the owners.
 Documents related to Safety precautions and
measures observed by the organization.
ISO 9001:2008 implementation
guidelines…..2000  2008
 The key focuses of the ISO 9001:2008 amendment were to
enhance the clarity of ISO 9001:2000 and to enhance its
compatibility with ISO 14001:2004.
 Certification to ISO 9001:2008 is not an “upgrade”, and
organizations that are certified to ISO 9001:2000 should be
afforded the same status as those who have already received
a new certificate to ISO 9001:2008
 No new requirements but users of the former version will
need to take into consideration whether the clarifications
introduced have an impact on their current interpretation
of ISO 9001:2000, as changes may be necessary to their
QMS.
Translation from 2000  2008
The changes incorporated in this ISO 9001:2008 edition were
classified in terms of impact into the following categories:
 No changes or minimum changes on user documents, including
records .
 No changes or minimum changes to existing processes of the
organization.
 No additional training required or minimal training required .
 No effects on current certifications .

The benefits identified for the ISO 9001:2008 edition fall into the
following categories:
 Provides clarity.
 Increases compatibility with ISO 14001.
 Maintains consistency with ISO 9000 family of standards.
 Improves translatability.
The next version of ISO 9001……
The ISO 9001:2015

A meeting in Bilbao, Spain, in June 2012, was held for

the revision of ISO 9001 and a draft was developed,
with a draft design specification and project plan.
What is intended to achieve….
What the draft says.....
According to the draft design specification, the revised standard should
(among other things) :
 Provide a stable core set of requirements for the next 10 years or more.
 Remain generic, and relevant to all sizes and types of organization operating in
any sector.
 Maintain the current focus on effective process management to produce
desired outcomes.
 Take account of changes in quality management systems practices and
technology since the last major revision in 2000.
 Reflect changes in the increasingly complex, demanding and dynamic
environments in which organizations operate.
 Apply Annex SL of the ISO Directives to enhance compatibility and alignment
with other ISO management system standards.
 Facilitate effective organizational implementation and effective conformity
assessment by first, second and third parties.
 Use simplified language and writing styles to aid understanding and consistent
interpretations of its requirements.