Quality Management System

QUALITY MANAGEMENT SYSTEM
ISO 9000
1
Defining Quality – What is quality?
What are some common definitions of

quality, which will be helpful in this
discussion.
2
QUALITY IN RELATION
WITH MANAGEMENT
SYSTEM - ISO 9000
3
Quality Definition: ISO 8406
The totality of features and

characteristics of a product or service
that bear on its ability to satisfy stated
or implied needs
4
WHAT IS ISO 9000
5
WHAT IS ISO 9000
• ISO is a ‘nickname’ to “International

Organization for Standardization”.
• An international standard more than 100
countries
• ISO is a non-governmental organization
established in 1947 by International Standard
Agency headquartered in Geneva.
• Principles are applicable to all organizations
6
WHAT IS ISO 9000
ISO 9000 is a written set of standard which

describe and define the basic
elements/clauses of the quality system
needed to ensure that an organization’s
products/or services meet or exceed
customer needs and expectations
7
Principles of ISO 9000
- ISO 9000 is a standard for a quality system, not product.
- ISO 9000 is based on documentation and is premised on the

following:-
- Document what you do;
- Do what your document;
- Prove it and improve it
- ISO 9000 emphasises prevention.
- ISO 9000 is a universal standard; the focus is on what

needs to be done and not on how it is to be carried out
8
WHY QUALITY SYSTEM - ISO 9000
• to satisfy customers through a quality

product
• to gain self confidence – we get what
we planned
• to achieve competitiveness in both the
local and overseas markets.
• as a blueprint for efforts to improve
the quality system of the organization.
9
ADVANTAGES OF ISO 9000
IMPLEMENTATION
10
WHAT IS IT INTENDED FOR?
This International Standard specifies quality

system requirements for use where
organization’s capability to design and supply
conforming product needs to be
demonstrated.
The requirements specified are aimed

primarily at achieving customer satisfaction
by preventing nonconformity at all stages
from design through to servicing
11
BENEFITS OF ISO 9000 IMPLEMENTATION
For the company:-
- Well defined organization and

responsibilities,
i.e., minimize grey areas and possible
resources wastage.
- Standardize practice and establishment

of proper communication channel, i.e.
maximize productivity and
communication efficiency.
12
BENEFITS OF ISO 9000 IMPLEMENTATION
For the company:-
- A greater degree of internal control.
- Ultimately, increase profitability and

market share, improve competitive position.
For the customer:-
- Increase satisfaction and growth in

confidence.
13
Eight Quality Management Principles
• Customer - focused organization
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier
relationship
14
DOCUMENTING THE SYSTEM
15
Quality Management System
Documentation
The organization shall establish, document,
implement and maintain a quality management
system and continually improve its effectiveness in
accordance with the requirements of this
International Standard.
(Clause 4.1, ISO 9001:2000)
• Documentation is a set of documents, for example specifications

and records.
• Document is information (meaningful data) and its supporting
medium.
• Quality management system is a management system to direct and
control an organization with regard to quality.
• Quality manual is the document specifying the quality
management system of an organization.
16
DOCUMENTATION PYRAMID
LOW
QUALITY/ POLICY LEVEL 1
MANUAL
OPERATION
PROCEDURES LEVEL 2
DETAIL
WORK
INSTRUCTIONS LEVEL 3
FORMS,
LABEL, LEVEL 4
RECORDS,
HIGH
ETC. A B C D E
Purchasing Production Personnel Quality Stores
Department Department Department Control
17
LEVEL 1: QUALITY MANUAL
The quality manual as a highest level

document at the peak of a pyramid
outlining the quality system and acting as
a directory for the documents and
procedures below. It will outline the
company’s policy and commitment to
quality.
18
WHY NEED QUALITY MANUAL?
1. Communicating the organization’s quality policy,
procedures and requirements;
2. Describing and implementing an effective quality
system;
3. Providing improved control of practices and facilitating
assurance activities;
4. Providing the documented bases for auditing the
quality system;
5. Providing continuity of the quality system and its
requirements during changing circumstances;
6. Training personnel;
7. Presenting quality system for external purposes;
8. Demonstrating compliance of the quality system with
quality requirements
19
Quality Policy
Clause 5.3
The overall quality intentions and

direction of an organization related to
quality, as formally expressed by top
management
20
LEVEL 2: OPERATION PROCEDURE
A second tier set of departmental

procedures detail how that commitment is
applied to the company operations and lay
down procedures for the management to
control the system
21
PROCEDURES DEVELOPMENT
1. Review current practice

2. Analyse current practice
3. Develop a draft procedure
4. Release draft for comment
5. Review comments
6. Revise and issue procedure for acceptance
7. Obtain approval
8. Issue for use
9. Implement
10. Monitor and Review
22
SUGGESTED FORMAT
1. PURPOSE
2. APPLICATION/SCOPE
3. REFERENCE DOCUMENT
4. DEFINITION
5. RESPONSIBILITY
6. QUALIFICATION OR TRAINING
7. PROCEDURE
8. RECORD
9. ATTACHMENT
23
LEVEL 3: WORK INSTRUCTIONS
This third tier of work

instructions details the day-to-
day operating instructions to
provide control of quality and
being applied in the manner laid
down in operation procedures.
24
Work Instructions
The written and /or spoken direction given with regard to
what is to be done, including the information given in
training.
What is to be done?
How it should be done?
Who should do it?
When it should be done?
Supplies, services & equipment to be used
Criteria to be satisfied
Balance between instructions & training
Usually departmental, or specific to product
Frequently changed
In details
25
LEVEL 4: SUPPORTING DOCUMENTS
Relates to all the forms, documents,

records, labels, tickets, job cards, purchase
orders, goods inwards notes, registers,
logs, etc. that are used to support the levels
above.
26
SUPPORT DOCUMENTATION
1. QUALITY PLAN
3. CODES OF PRACTICE
4. USER MANUAL
5. TECHNICAL DOCUMENTATION
27
28
29

Quality Management System

Uploaded by

Copyright:

Available Formats

Quality Management System

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Quality Management System

Uploaded by

Copyright:

Available Formats

QUALITY MANAGEMENT SYSTEM

What are some common definitions of

The totality of features and

• ISO is a ‘nickname’ to “International

ISO 9000 is a written set of standard which

- ISO 9000 is based on documentation and is premised on the

- ISO 9000 emphasises prevention.

- ISO 9000 is a universal standard; the focus is on what

• to satisfy customers through a quality

This International Standard specifies quality

The requirements specified are aimed

For the company:-

- Well defined organization and

- Standardize practice and establishment

For the company:-

- A greater degree of internal control.

- Ultimately, increase profitability and

For the customer:-

- Increase satisfaction and growth in

• Documentation is a set of documents, for example specifications

The quality manual as a highest level

The overall quality intentions and

A second tier set of departmental

1. Review current practice

This third tier of work

Relates to all the forms, documents,

You might also like