Quality Systems

ISO 9000 Quality Management System

 What if there are no standards? Products and equipments do not fit and are incompatible When products meet our expectations, we take it for granted We only notice when they do not meet our expectations

WHAT IS ISO?
ISO stands for International Organisation for Standardisation Worlds largest developer of standards Standards make trade between countries easier and fairer Also used to safeguard consumers, and users, of products and services
3

 ISO - network of national standards institutes of 146 countries, based in Geneva ISO from Greek word, isos, meaning equal. Objective to facilitate organisation, coordination and unification of industrial standards

 Suppliers can base development on globally accepted specifications Customers have a wide choice from competition among suppliers

 ISO 9000 and ISO 14000 most widely known generic standards generic - same standards can be applied to any organisation

 ISO 9000 is concerned with quality management ISO 14000 is concerned with environmental management

 ISO 9000 was developed by ISO Technical Committee(TC) 176 - first published in 1987 Developed for use in two-party contractual situations and internal auditing Universally accepted with worldwide emphasis on quality and adoption by EC

10

 In a two-party system, supplier and customer may end-up with multiple audits This is replaced by a third party registration system Assessment and periodic surveillance audit of adequacy of suppliers quality system by a third-party - registrar

11

Most organisations found that registration leads to : Fewer on-site audits by customers Increased market share Improved quality, both internally and externally Improved product and service quality levels from suppliers Greater awareness of quality by employees A documented formal system Reduced operating cost

12

ISO 9000 series: 1994 version

1. ISO 9000 : Quality Management and Quality Assurance Standards -- Guidelines for Selection and Use.
2. ISO 9001 : Quality Systems -- Model for Quality Assurance in Design, Development, Production, Installation and Servicing. (manufacturing) 3. ISO 9002: Quality Systems -- Model for Quality Assurance in Production, Installation and Servicing. 4. ISO 9003: Quality Systems -- Model for Quality Assurance and Final Inspection and Test.

(calibration and testing)

5. ISO 9004 : Quality Management and Quality System Elements -- Guidelines.

13

ISO 9000 Series: 2000

ISO 9000: 2000 Quality Management Systems Fundamentals and Vocabulary ISO 9001: 2000 : Quality Management Systems Requirements ISO 9004: 2000 : Quality Management Systems Guidelines for Performance Improvements

14

The quality management system includes:

A quality policy- statement describes how organisation approaches quality The quality manual Must address each clause of the ISO 9000 standard. Quality objectives-Goals sought or aimed Quality procedures-Describe step-by-step what the company does to meet quality policies Forms, records and so on- provide proof of activities

15

 The original standards and1994 revision only required to have a documented, verifiable process Can comply with standards and produce poor quality product Dissatisfaction resulted in ISO 9001:2000 series.

16

Eight Principles for 2000 version

ISO 9000: 2000 version has been developed based upon 8 principles.
(1) Customer focus: To understand and satisfy customers requirements and exceed their expectations. Leadership: Establishing direction and purpose of organization and creating a supportive working environment.

(2)

17

3) Employee Involvement: Ensuring that employees at all levels of the organization take part in quality improving activities.
(4) Process approach: All work should be done using processes and these processes are to be carefully managed. System approach: Management: problems should be solved using system approach, not considering any singular part of the system.

(5)

18

(6)

Continuous improvement: Recognizing the fact that improvement is not one shot job, continuous improvement of the system of production or service should be the philosophy of the organization. Management by facts: Every move, every decision, every action in the organization must be made based upon factual data. Supplier partnership: Creating a collaborative business environment for mutual benefit and creating a win-win situation.

(7)

(8)

19

 ISO 9000:2000 revision aligns closer to quality management Measure customer satisfaction and dissatisfaction Manage a system of interrelated process
Different from document what you do requirements of earlier version

20

Implementation of ISO 9000

Top management commitment
CEO must be willing to commit resources to get ISO certification

Appoint the Management Representative

Responsible for coordinating implementation and maintenance of quality system

21

 Create awareness and exposure Appoint an Implementation Team drawn from all levels and areas Selection of scope for implementation. Top management to identify the core process Time schedule for implementation and registration of system

22

 Conduct gap analysis between existing system and requirements of ISO 9000 Documentation of quality manual, procedures and work instructions Internal audit. Identify officers who are trained to conduct audit

23

 Management Review. Review conducted in order to determine effectiveness of stated quality goals Implementation of ISO 9000
Implement after adequacy audit Adequacy audit after QMS has been fully documented

Auditing for registration - recommended certificate if compliance audit conducted and corrective actions taken

24

Eg: of ISO 9000 Consultants in Malaysia

CAI-Oxbridge (Malaysia) Sdn. Bhd. East Asia Quality Consultants QPIC Consultants Sdn. Bhd. Malaysia Institute of Quality Assurance National Productivity Corporation (NPC) QAI Sdn. Bhd.

25

Internal Audit
Checks must be made to ensure system is being followed and expected results obtained Objectives of internal audit:
Determine actual performance conforms to documented QMS Initiate corrective action in response to deficiencies

26

 Follow-up on non-compliance. Provide continued improvement in system. Cause auditee to think about process and therefore encourage possible improvements.

27

 Auditing methods
Examination of documents
Documents examined in a systematic manner, eg: check purchase order if purchases made conform to requirements

Observation of activities
Eg: observe teaching in classroom

Interviews

28

5.3 Quality policy: (eg: of audit for quality policy) The mgmt. should ensure the following regarding quality policy: It is appropriate to the purpose of the org. It includes a commitment to comply with requirements and continuously improve the effectiveness of the QMS It is communicated and understood within the organization

29

EXAMPLE

30

Specific tasks: The management will establish, document and publicize its policy, objectives and commitment to quality the management will designate a representative with authority and responsibility for implementing and maintaining the requirements of the standards

31

Management review tasks: Follow up internal audit findings, especially noncompliances ISO 9000 registrar audits Customer satisfaction survey results

Customer complaints
Adequacy of existing quality policy and objectives Adequacy of existing documented quality system

Cost of poor quality

Training needs/issues Organizational structure/ staffing
32

Auditors Questions
Who is your management representative? Where is this documented? Is there any alternative person in case of absence of the management representative? Who reviews the quality system to ensure its continued suitability and effectiveness in satisfying the requirements of ISO 9000 and the companys stated quality policy and objectives? How often does the management review the quality system? How are review findings recorded?
33

Registration
Registration bodies registered with MOF and accredited by Dept of Standards SIRIM QAS International Sdn. Bhd. Moody International Certification (M) Sdn. Bhd CI Certification Malaysia Sdn. Bhd. SGS (Malaysia) Sdn. Bhd. RWTUV (Malaysia) Sdn. Bhd.

34

 Base selection of registrar on qualification and experience, and certificate recognition Eg: SIRIM QAS accredited
Department of Standards Malaysia (DSM) United Kingdom Accreditation Service (UKAS)

35

 Certification is valid for three years Surveillance audit once in every 12 months May be suspended or revoked if system is found not to be satisfactorily maintained

36

Begin

Complete and Submit Questionnaire to Registrar

Submit Documented Quality System to Registrar for Review Make any necessary Changes to Documented Quality System

Format Assessment (Report issued at conclusion)

No Registration Recommended

Review Question From Registrar

No

Plan Pre-assessment Date (optional) Yes

Is Quote Acceptable?

Pre-assessment Visit (Report issued at Conclusion)

First Surveillance Visit

Yes Submit Application Form Plan Assessment Date Surveillance Cycles Begin
37

Issues in ISO
(i)

The major issue in ISO 9000 is document (or manual) preparation

(ii)

Analyze the trade-off between cost and benefit

(iii) ISO 9000 may be redundant in a mature total quality environment

38

Gaining a market advantage is the wrong motivation for adopting ISO 9000 ISO registration is usually applied to a unit of the company ISO registration is more popular in Europe

39

5. Management Responsibility

6. Resource Management

4. QMS Continual Improvement

8. Measurement Analysis and Improvement

Customer Satisfaction

Input Requirements

7. Product Realization

Output Product

40