UNDERSTANDING A QUALITY MANAGEMENT SYSTEM BASED ON ISO 9001:2000 STANDARDS

Presented By
QUALITY ASSURANCE UNIT INTERNATIONAL ISLAMIC UNIVERSITY MALAYSIA

PRESENTATION OUTLINE
1) 2)

DEFINITION OF ISO DEVELOPMENT OF A QUALITY MANAGEMENT SYSTEM ISO 9001:2000 STANDARD REQUIREMENTS DOCUMENTATION STRUCTURES

3)

4)

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) 2) 3)

Based on process model. Less emphasis on documented procedures. 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

QUALITY POLICY OF IIUM

IIUM strives towards comprehensive excellence in teaching and learning, research and publication, consultancy and student services and facilities, consistent with its vision and mission.

Teaching and Learning

INPUT
Students

PROCESS
Teaching & Learning

OUTPUT
Graduates

Customer Feedback
Students/Alumni/Industries

Research and Publication

INPUT
Researchers

PROCESS
Research & Publication

OUTPUT
- Research Work - Book/Journal

Customer Feedback
Public

Model of a Process- based Quality Management System

I n t e r e s t e d p a r t y Clause 4.0 QUALITY MANAGEMENT SYSTEM CONTINUAL IMPROVEMENT R e q u i r e m e n t Input Management Responsibility Clause 5.0 S a t i s f a c t i o n

Resource Management Clause 6.0

Measurement, Analysis, Improvement

I n t e r e s t e d p a r t y

Clause 8.0

Product (and/or service) realization

Clause 7.0

Product

Output

PROCESS
Clause 7.0 Clause 8.0

PEOPLE
Clause 5.0 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. 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 4.2.2 4.2.3 4.2.4 General Quality Manual Control of Documents Control of Records

4.2

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 5.2 5.3 5.4 Management Commitment Customer Focus Quality Policy Planning 5.4.1 5.4.2

Quality Objectives QMS Planning

5.5

Responsibility, Authority and Communication 5.5.1 Responsibility & Authority 5.5.2 Management Representative 5.5.3 Internal Communication Management Review 5.6.1 General 5.6.2 Review Inputs 5.6.3 Review Outputs

5.6

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 customer requirements

TIMELINESS!!!!!.

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
7.2

Planning of Product Realization

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 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

7.3

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 8.2 General 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 Control of Nonconforming Product Analysis of Data Improvement 8.5.1 Continual Improvement 8.5.2 Corrective Action 8.5.3 Preventive Action

8.3 8.4 8.5

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.
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

3.

SUPPORTING DOCUMENTS
1)
2) 3) 4)

Work Instructions Universitys Policies and Regulations Government Circulars 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
ADEQUACY AUDIT Quality System Documentation Audit (Audit Documents) Audit on behalf of the organization itself for internal purposes to check on the conformity of the processes Quality System Implementation Audit

INTERNAL AUDIT

COMPLIANCE AUDIT

CERTIFICATION SURVEILLANCE AUDIT RE-ASSESSMENT AUDIT Yearly audit Audit conducted on the 3rd year of certification

Any Questions???

Thank you