Quality Management System

Total Quality Management
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Charantimath
17
Quality Management System
Trade depends on Quality
- W. Edwards Deming

Total Quality ManagementCharantimath
Learning Objectives
After studying this chapter, you should be able to:
 Explain Quality Management Systems (QMS)
 Identify the development of ISO 9000 QMS
 Understand the requirements of ISO 9001 QMS
 Identify the steps to certification under ISO 9001:2008 QMS
 Describe the benefits of ISO certification

Development of ISO 9000 Standards
 ISO 9000 standards were issued in 1987
 The revised and improved version were published in the year 2000
 ISO 9001:2008 was released in the year 2008, does not introduce
new requirements, it clarifies the existing requirements of ISO
9001:2000

Quality System Standards
Standard Title Scope
ISO
9000-2005
Quality Management
Systems-Fundamentals
and vocabulary
Provides fundamentals of quality management system
and specifies quality management terms and
definitions.
ISO
9001-2008
Quality Management
Systems-
Requirements
Specifies requirements for a quality management
system where an organization needs to
demonstrate its capability to meet customer
requirements for product and / or services and
assessment of that capability by internal and
external parties
ISO
9004:2009
Managing for the sustained
success of an
organization – A
quality management
approach
Provides guidance for the continual improvement of
an organisation’s overall performance,
efficiency and effectiveness based on a
process based approach. It focuses on meeting
the needs and expectations of customers and
other relevant parties, over the long term, and
in a balanced way.

Quality Management Principles
 Customer focus
 Leadership
 Involvement of people
 Process approach
 System approach to management
 Continual improvement
 Factual approach to decision making
 Mutually beneficial supplier relationship

Quality Management System Model
Input
Customer
Requirements
Continual
improvement
Measurement, Analysis and Improvement
(Clause 8)
Management
Responsibility (Clause 5)
Product Realization
(Clause 7)
Resources Management
(Clause 6)
(Clause 4)
Output
Product/Service
Customer
Satisfaction

ISO 9001:2008
 Basic Clauses (1 to 3)
 Main Clauses (4 to 8)

Basic Clauses
Clause No. Contents
1 Scope
1.1 General
1.2 Application
2 Normative reference
3 Terms and Definitions

4. Quality Management Systems
 4.1 General Requirements
 4.2 Documentation Requirements

Documentation Requirements
Quality Objectives
Quality Manual
Procedure
Work Instructions
Records
Policy
Quality

5. Management Responsibility
 5.1 – Management Commitment
 5.2 – Customer Focus
 5.3 – Quality Policy
 5.4 – Planning
 5.5 – Responsibility, Authority, Communication
 5.6 – Management Review

6. Resource Management
 6.1 – Provision of Resources
 6.2 – Human Resources
 6.3 – Infrastructure
 6.4 – Work Environment

7. Product Realisation
 7.1 – Planning of product realisation
 7.2 – Customer related process
 7.3 – Design and Development
 7.4 – Purchasing
 7.5 – Production and Service Provision
 7.6 – Control of Monitoring and Measuring Equipment

8. Measurement, Analysis and Improvement
 8.1 – General
 8.2 – Monitoring and Measurement
 8.3 – Control of Non-conforming product
 8.4 – Analysis of Data
 8.5 – Improvement

Certification Bodies
 ABS Group Inc.
 Banner Pharmacaps India Pvt. Ltd
 Bureau Veritas Quality International (BVQI)
 International Certifications Services (Asia) Pvt. Ltd (ICS)
 KPMG Quality Registrar India
 Lloyd’s Register Quality Assurance
 T?v India Pvt. Ltd
 T?v S?ddeutschland India

Steps to Certification
Sr.No
.
Activities Generally responsible
1 Management Commitment CEO / Board of Directors
2 Formation of core group (In Large, multi division,
multi location companies)
CEO
3 Quality policy CEO
4 Appointment of Management representative (MR) CEO
5 Train MR Training agency
6 Awareness program for all employees M.R. / Dept. Head / Consultant
7 Set Quality Objectives for the company and for all the
functional areas
MR, CEO and
all departmental heads
8 Prepare a list of documentation and procedure for
writing procedures
M.R.
9 Form implementation team (generally of all
department heads) and delegate writing
documentation
CEO / MR
10 Mapping the existing Processes / Writing exiting
procedure / Work methods / Instructions /
Checklists
Dept. Heads/
key personnel

Sr.No
.
11 Comparison with applicable ISO 9001 standards and
identify gaps
Dept. Head/MR/Consultant
12 Writing additional procedures/work instructions to
fill gaps
Department Heads
13 Apex quality manual MR/guidance from consultant
14 Compile linkages among procedure MR
15 Regular review of progress MR with core group
16 Check adequacy for certification with respect to the
standard
MR, Departmental heads
17 Identify certification agency MR (Consultant if required)
18 Request for certification, submit quality manual for
review/fees
MR

Sr.No
.
19 Training programmed for Internal Quality audits
(IQA)
MR, Consultant (By qualified lead assessor)
20 First internal audit including adequacy audit MR and IQ auditors, consultant, if required
21 First management review meeting (MRM) CEO, MR, Dept. heads and internal quality
uditors
22 Take planned corrective and preventive actions All departmental heads and MR
23 Second IQA MR and IQ auditors
24 Second MRM CEO, MR, Dept. heads and internal quality
auditors
25 Follow up or compliance audit to check completion
of corrective actions effectively
MR, consultant, internal quality auditors
26 Preliminary Assessment
(Generally optional, but a recommended practice)
Accredited Certification Agency
27 Final Assessment for certification Accredited Certification Agency

Benefits of ISO Certification
External Benefits:
 The logos will increase the stature of the company in the marketplace
and help to enlarge the customer base
 It will satisfy the larger businesses that the company operates and will
result in fewer customer audits needing to be carried out to confirm the
on-going commitment to getting it right the first time
 It will reduce one of the hurdles to entering an approved supplier list
run by a potential customer
 ISO 9001 is an international standard and it will open international
doors and not just those locally
 The quality manuals can be used as a sales and marketing tool. It will
both describe the company’s commitment to standards and customer
requirements as well as promote the company to new customers

Benefits of ISO Certification
Internal Benefits:
 A properly implemented system reduces production errors and leads to a reduction in
the necessary rectification work in the long term
 The reduced rectification work coupled with a maintained list of suppliers and sub-
contractors leads to reduced warranty work as the product becomes more reliable
 The implementation will give the company a one-off opportunity to fully assess its
management systems to ensure they are efficient and effective. It will give the staff
the opportunity to assist with the production of the system.
 The regular internal views required will make the company look hard at itself to
ensure there are fewer areas where errors could occur
 Staff will be better aware of their responsibilities and the need to satisfy customers
 In certain areas the introduction of a suitable system could suggest to an insurance
company that there is a reduced problem with regards to negligence and lead to
reduced insurance premiums
 It will provide an improvement in communications both internally and to customers
 It provides an opportunity for the management to introduce procedures and other
requirements it has been trying to introduce for a long time.

Quality Management System

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