IS/ISO 9004:2000-

QUALITY MANAGEMENT
SYSTEMS(QMS)

CHENCHO RINZIN
NEED FOR A QUALITY SYSTEM
 Globalization and liberalization gave a severe thrust
to Engineers and Managers to Produce products with
quality at a lower cost.
 Customer wants only good quality product at a
cheaper price.
 Only possible if the organizational resources are
properly utilized, and innovative novel ideas are
incorporated in the cost reduction.
 This is only possible if organization has got a
structured quality management system with good
monitoring feature.
DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 WHAT IS ISO.
 ISO-International Organization for Standardization.
 Founded in 1964 in Geneva, Switzerland.
 Its mandate is to promote the development of
international standards to facilitate of goods and
services.
 ISO is a global network that identifies what
international standards are required by the business,
government and society.
 Then develops them in partnership with the sectors that
will put them to use.
DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 STRUCTURE OF ISO 9000:2000

 ISO 9000:2000-QMS Fundamentals and

vocabulary.
 ISO 9001:2000-QMS Requirements
 ISO 9004:2000-QMS Guidance for performance
improvement.

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 ISO
 The purpose of an organization is to:
a) Identify and meet the needs and expectations
of its customers and other interested parties
(i.e. employees, suppliers, owners, society)
to achieve competitive advantage and to do
this in an effective and efficient manner;
b) Achieve, maintain, and improve overall
organizational performance and capabilities

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 ISO 9004:2000
 This standard provides guidance for continual
improvement and can be used for performance
improvement of an organization.
 While ISO 9001 -give quality assurance to the
manufacturing processes for products and to enhance
customer satisfaction.
 ISO 9004 takes in a broader perspective of quality
management and gives guidance for future
improvement.

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 QUALITY MANAGEMENT SYSTEMS
 Leading & operating an organization successfully
requires managing in a systematic and visible
manner.
 Success should result from implementing and
maintaining a management system that is designed
to continually improve performance by addressing
the needs of all interested parties.

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 DOCUMENTATION
 Documentation:-To ensure the quality of a product
in an organization it is necessary to document all the
activities.
 The slogan of ISO says,

“What ever you Do, document it.

Whatever you Document, Do it.
Demonstrate”.

DEPARTMENT OF MANAGEMENT
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Document Pyramid

Policy Why, What

Procedures Who,When,Where

Work Instructions How

Records Evidence
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General Documentation
Requirements

 The extent and nature of process documentation and

records should be appropriate to the organization.
 Requirements for documentation and records may
arise from:
 Contractual requirements from the customer or
other interested parties,
 Acceptance of international, national, regional and
industry sector standards,
 Statutory and regulatory requirements,
 Decision by the organization.

DEPARTMENT OF MANAGEMENT
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QUALITY MANAGEMENT PRINCIPLES

 Eight Management Principles was Set up by ISO

9000:
 Customer focused organization
 Leadership
 Involvement of people
 Process approach
 System approach to management
 Continual improvement
 Factual approach to decision making
 Mutually beneficial supplier relationships
DEPARTMENT OF MANAGEMENT
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DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
COSTS AND BENEFITS OF SETTING
UP A QMS.
1.Costs.
 Can be divided into direct and indirect
costs.
 Direct Cost includes
Hiring Consultants or External
Trainers(if Required)
Sending personals for External
Training.

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 COSTS AND BENEFITS OF SETTING
UP A QMS Cont’d
 Indirect Costs includes:-
Time spent in developing the systems
Reorganization.
External Charges.
Time spend by audits.
Corrective actions-Revision of manuals
Expenditure on processing, stationary etc..
In India the fee charged by accredited
certification bodies varies from USD 3000(for
company with 100 employees) to USD 5000(for
companies with 200 employees)
DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 FACTORS TO LOWER THE COSTS.

 Having people in the company already

conversant with QMS requirements.
 Having Documented Systems-related
activities such as work instructions,
plans etc in place.
 Using consultants only for specific
activities.

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 BENEFITS OF OBTAINING ISO
CERTIFICATION
 Internal benefits:-
 Improves customer focus and process.
 Improves management commitment and
decision making.
 Better working conditions for employees
 Employees motivations increases.
 Reduce cost of internal failures.

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 BENEFITS OF OBTAINING ISO
CERTIFICATION
 External Benefits:-
 Gain confident in customer.
 Company image.
 More Publicity
 Better objective evidence

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 IMPLEMENTATION OF QMS
1. Evaluate the organization’s need/goals
for implementing QMS.
2. Obtain information about the ISO family
3. Appoint a consultant, if necessary
4. Awareness and Training.
5. Gap analysis
6. Product Realization processes
7. Staffing

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
IMPLEMENTATION OF QMS
8. Planning a Time frame
9.Draft a quality manual
10.Carry out internal audits
11.Apply for certification
12.Conduct periodic evaluations

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
Evaluate the organization’s need/goals for
implementing QMS.

 Need may arise from repeated customer

complaints; frequent warranty returns;
high levels of works; rejection of product
or services.
 Identify the goals which you want to
achieve through QMS,such as customer
satisfaction, market share, efficiency.etc.
 Third party certification.

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
Obtain information about the ISO family

 Should have a knowledge on the

requirements of ISO’s.
 Information like Quality management
principles,FAQs,application,documentati
on requirements.

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 Appoint a consultant, if necessary

 Due to lack of adequate competence to

develop QMS.
 But its good to check his/her back
ground knowledge.
 Carry out the cost benefits analysis
 Training for the key staff

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 Awareness and Training.

 Raise awareness about QMS requirements

 Plan and provide specific Training on QMS
 How to audit compliance with QMS
 The training are provided by:-

The institute of Quality Assurance(IQA)

American society of Quality(ASQ)
International Auditor and Training Certification
Association(IATCA)

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 Gap analysis

 Evaluate gaps between the existing

quality management system and QMS
requirements of ISO 9001.
 Prepare how to bridge these gaps.
 Can be carried out by self assessment
or by external consultant.
E.G How does the organization identify
customer’s needs and expectations on a
regular basis?
DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 Product Realization processes

 The process covered by clause 7 of ISO

9001:2000 includes
 Customer related processes
 Design and development
 Purchasing
 Production and service provision
 Control of measuring and monitoring
devices.

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 Staffing

 Decide on the responsibilities of the

persons who will be involved in
developing and documenting the QMS
 Appointment of management
representative.
 Establishment of committee.

DEPARTMENT OF MANAGEMENT
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 Planning a Time frame

 Prepare complete plan to close the gaps

 Include activities to perform, resources
required.
 Clauses 4.1 and 7.1 of ISO 9001:2000
provides information that should be used
when developing the plan.

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 Draft a Quality Manual

 Include how the QMS applies to the

products,processes,locations,departments
and organization.
 Describe the interaction between the
processes of the QMS.
e.g. interaction between product realization
processes and other
mangement,measurement and
improvements.
 Draft quality policy and objectives.
DEPARTMENT OF MANAGEMENT
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 Carry out internal Audits

 Quality Audits are defined as “A systematic and

independent examination to determine whether
quality activities and related results comply with
planned arrangements and whether these
arrangements are implemented effectively and
are suitable to achieve the objectives.(ISO
8402)
 Here the trained auditors carry out one or two
internal audits during the phase of
implementation.
DEPARTMENT OF MANAGEMENT
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 Apply for certification

 After the completion of the above

step(10th step) the company decides to
obtain the certification.

DEPARTMENT OF MANAGEMENT
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 Conduct periodic evaluations

 After certification, the organization

should periodically conduct internal
audits to review the effectiveness of the
QMS.

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
 CERTIFICATION

1.How to select a certification body.

2.Preparing for assessment
3.Auditing
4.Nonconformities
5.Award the ISO 9000 certificate.
6.Surveillance audits

DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET
DEPARTMENT OF MANAGEMENT
STUDIES.PSNACET