UNDERSTANDING A QUALITY

MANAGEMENT SYSTEM BASED

ON ISO 9001:2000 STANDARDS
Presented By
QUALITY ASSURANCE UNIT
INTERNATIONAL ISLAMIC UNIVERSITY MALAYSIA
 PRESENTATION OUTLINE
1) DEFINITION OF ISO

2) DEVELOPMENT OF A QUALITY
MANAGEMENT SYSTEM

3) ISO 9001:2000 STANDARD

REQUIREMENTS

4) DOCUMENTATION STRUCTURES
WHAT IS ISO?
 International Organization for
Standardization.

 A set of standards for quality

management and quality assurance
systems developed by the International
Standard Organization.
WHAT IS ISO 9000?
 They provide a framework for quality system
development in all types of industries
including service organizations.

 It is just purely a management system that

will help us to run our business in a more
organized and systematic manner which will
lead to a more consistent in quality of the
service that we deliver to our customers.
ISO STANDARDS
Currently, there are 4 quality standards:
1) ISO 9001:2000 (QMS – Requirements)
2) ISO 9000:2000 (QMS – Fundamentals and
Vocabulary)
3) ISO 9004:2000 (QMS – Guidelines for
Performance Improvements)
4) ISO 19011:2003 (QMS – Guidelines for Quality
and/or Environmental Management Systems
Auditing)
ISO STANDARDS
For us, there is only one standard applicable for the
certification
ISO 9001:2000

1) Based on “process – model”.

2) Less emphasis on documented procedures.
3) Core processes covered under :
a) Quality management system
b) Management responsibility
c) Resource management ISO 9001:2000
d) Product realization Clauses
e) Measurement, analysis
and improvement
What should be focused under
ISO 9001:2000?
- Customer satisfaction
(Both external & internal)
- Improving processes
- Continuous activity
- Preventive measure
- Elimination of a problem
 Teaching and Learning

INPUT PROCESS OUTPUT

Students Teaching & Learning Graduates

Customer Feedback
Students/Alumni/Industries
 Research and Publication

INPUT PROCESS OUTPUT

Researchers Research & - Research Work
Publication - Book/Journal

Customer Feedback
Public
 Model of a Process- based Quality
Management System
I
I Clause 4.0
S n
n QUALITY MANAGEMENT SYSTEM t
CONTINUAL IMPROVEMENT a
t e
t
e R r
i
r e e
Management s
e q s
Responsibility f
s u t
a
t i Clause 5.0 c e
e r Measurement, d
Resource t
d e Analysis,
Management i
m Improvement p
o
p e a
a Clause 6.0 Clause 8.0 n
n r
r t t
t Product y
y Input (and/or service) Product
Output
realization
Clause 7.0
PROCESS PEOPLE
Clause 7.0 Clause 5.0
Clause 8.0 Clause 6.0

DOCUMENTS
Clause 4.0
 QUALITY
MANAGEMENT SYSTEMS

A management system to direct and

control an organization with regard to
quality

Clause 3.2.3, ISO 9000:2000

QUALITY MANAGEMENT SYSTEM
REQUIREMENTS
CLAUSE 1.0 - SCOPE
1.1 General
1.2 Application

CLAUSE 2.0 – NORMATIVE REFERENCE

CLAUSE 3.0 – TERM AND DEFINITIONS

QUALITY MANAGEMENT SYSTEM REQUIREMENTS
– Cont.
CLAUSE 4.0 - QUALITY MANAGEMENT SYSTEM
4.1 General Requirements
Establish, document, implement, maintain a QMS and
continually improve its effectiveness.

4.2 Documentation Requirements

(a) Documented statements of a quality policy &
quality objectives
(b) A quality manual
(c) Documented procedures & quality records required
by this international standard
(d) Document needed by organization to ensure
effective planning, operation and control

4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Records
QUALITY MANAGEMENT SYSTEM REQUIREMENTS
– Cont.
6 Documented Procedures
(Required by the Standard)

 Control of Documents

 Control of Records

 Internal Audit

 Control of Nonconforming Product

 Corrective Action

 Preventive Action
QUALITY MANAGEMENT SYSTEM REQUIREMENTS –
Cont.
CLAUSE 5.0 – MANAGEMENT RESPONSIBILITY

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Planning
5.4.1 Quality Objectives
5.4.2 QMS Planning

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility & Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 Management Review
5.6.1 General
5.6.2 Review Inputs
5.6.3 Review Outputs
QUALITY MANAGEMENT SYSTEM REQUIREMENTS
– Cont.
CLAUSE 6.0 - RESOURCE
MANAGEMENT

6.1 Provision of Resources

 The organization shall determine &
provide the resources - human
resources, facilities & work environment,
needed:

 To implement and maintain

the QMS and continually
improve its effectiveness

 To enhance customer
satisfaction by meeting TIMELINESS!!!!!….
customer requirements
QUALITY MANAGEMENT SYSTEM REQUIREMENTS
– Cont.

6.2 Human Resources

6.2.1 General
6.2.2 Competence,
Awareness &
Training
6.3 Infrastructure
6.4 Work Environment
QUALITY MANAGEMENT SYSTEM REQUIREMENTS
– Cont.
CLAUSE 7.0 - PRODUCT REALIZATION

7.1 Planning of Product Realization

7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to Product
7.2.2 Review of Requirements Related to Product
7.2.3 Customer Communication
7.3 Design and Development
7.3.1 Design and Development Planning
7.3.2 Design and Development Inputs
7.3.3 Design and Development Output
7.3.4 Design and Development Review
7.3.5 Design and Development Verification
7.3.6 Design and Development Validation
7.3.7 Control of Design & Development Changes
QUALITY MANAGEMENT SYSTEM REQUIREMENTS
– Cont.
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product

7.5 Production and Service Provision

7.5.1 Control of Production & Service Provision
7.5.2 Validation of Processes for Production & Service
Provision
7.5.3 Identification and Trace-ability
7.5.4 Customer Property
7.5.5 Preservation of Product

7.6 Control of Monitoring and Measuring Devices

QUALITY MANAGEMENT SYSTEM
REQUIREMENTS – Cont.
CLAUSE 8.0 - MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1 General

8.2 Measuring and Monitoring

8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring & Measurement of Processes
8.2.4 Monitoring & Measurement of Product
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
Quality Manual (policy, objectives)

Documented Procedures
(Instructions, Diagrams etc.)

External Documents
(Standards, Guidelines,
Regulations etc.)

Forms/Records
EXAMPLE : SCOPE - RESEARCH AND
PUBLICATION

QUALITY MANUAL
Consists of :
1) Information of the Organization

2) Quality Policy

3) Quality Objectives

4) Explanation of the ISO 9000 clauses

relating to the scope/processes
QUALITY SYSTEM PROCEDURES

1. Core processes : have a large impact on the strategic

goals of an organization (critical to customer satisfaction)

2. Support processes : critical to the operation of an

organization, but do not add direct value to the services.

3. 6 Mandatory Procedures : required by the ISO9001:2000

Standard.
 Control of Documents
 Control of Records
 Internal Audit
 Control of Nonconforming Product
 Corrective Action
 Preventive Action
SUPPORTING DOCUMENTS

1) Work Instructions
2) University’s Policies and Regulations
3) Government Circulars
4) Other Supporting Documents related to
the Quality System Implementation
ORGANIZATION
 Clear direction (Establishment of Quality Policy &
Quality Objectives).
 More efficient and effective operations.
(Establishment of MANUAL OF WORK
PROCEDURES).
 Is driven by measurable objectives at all relevant
functions (results oriented – all levels of staff are
aware of what is expected from them through
QUALITY OBJECTIVES).
 Minimize non-conformity cost (All staff have clear
responsibilities and clear & systematic work
procedures).
STAFF/EMPLOYEE
 Have clear job responsibilities and authority, and ways
of doing things. (Establishment of Manual of Work
Procedures).
 Increase interaction and teamwork. (Commitment from
Top Management and staff at all levels).

CUSTOMER
 Feel more confident and assured.

 Complaints by customers will b handled properly

through the establishment of Customer Complaints
Procedure.

IMPROVEMENT EFFORTS
 Recognizing and acknowledging improvements
(Analysis of Data, Quality Objectives, Complaints, etc.)
AUDIT STAGES
Quality System Documentation
ADEQUACY AUDIT Audit (Audit Documents)

Audit on behalf of the organization itself

INTERNAL AUDIT for internal purposes to check on the
conformity of the processes

COMPLIANCE AUDIT Quality System Implementation Audit

CERTIFICATION

SURVEILLANCE AUDIT Yearly audit

Audit conducted on the 3rd year of

RE-ASSESSMENT AUDIT
certification
Any Questions???

Thank you