ISO 9000 Implementation

1. ISO 9000Implementation Imran Hussain

2. ISO 9000: 1994 Clauses • Management Responsibility • Quality System • Contract Review • Design Control • Document Control • Purchasing • Purchaser Supplied Product • Product Identification and Traceability • Process Control • Inspection and Testing

3. ISO 9000: 1994 Clauses • Inspection Measuring and Test Equipment • Inspection and Test Status • Control of Non-Conforming Product • Corrective Action • Handling, Storage, Packaging and Delivery • Quality Records • Internal Quality Audits • Training • Servicing • Statistical Techniques

4. ISO 9000:2000 Clauses • Quality Management System • Resource Management • Product or Service Realization • Management Responsibility • Measurement, Analysis and Improvement

5. ISO 9000: 2000Quality Management System

6. Quality Management SystemDocumentation Standard ISO 9000 Quality Manual Policy Statement, Commitment, Organisation, Responsibilities LEVEL 1 Quality System Procedures Company Practices, Interfaces LEVEL 2 Work Instructions Written Instructions to Control Tasks LEVEL 3 Forms Quality Records LEVEL 4 Sales Design Purchasing Manufacturing Accounts Personnel After Sales

7. Why have a Quality Policy?

8. Need for Quality Policy • All organizations have in mind some principles, beliefs which are their broad guides to managerial conduct • These guides rest on a philosophical and ethical base • They concern important issues and are intended to have a long life, i.e. to act as a stabilizer • Such principles and beliefs are referred to as a Quality Policy

9. Need for Quality Policy • When organizations grow, there are different managers working under which various employees are working • Things need to be defined at that stage as things start becoming ambiguous • As the unwelcome incidents accumulate, there arises a growing urge to think through, write out, and publish quality policies to serve as guides to managerial action

10. Advantages of Policies • It provides insiders and outsiders with a new, superior form of predictability, i.e. a written guide to managerial action • It forces the organization to think about quality problems to a depth never before achieved. “before you write it down, you must think it out” • It establishes legitimacy and can be communicated in an authoritative, uniform manner • It permits practices to be audited against that policy

11. Disadvantages of Policies • Major disadvantage is work involved • Some managers think that written policies tend to restrict innovation and to narrow the range of action available to adapt to changing conditions

12. Corporate Quality Policies • As a company grows, it becomes evident that no one set of quality policies can fit all company activities • This problem is solved by creating several levels of quality policy out of which one is corporate policy which usually consists of • The purpose of writing and publishing quality policies • A brief statement of corporate intent • The minimal actions to be taken by the company divisions with respect to quality • Interdivisional relationships concerning quality • Relationship of quality policies to other company policies

13. Corporate Quality Policies • A delegation of authority to subordinate company organization units to establish subsidiary quality policies appropriate to their needs • Summary statement • It is the policy of the company to provide products and services of a quality that meet the initial and continuing needs and expectations of customers in relation to the price paid and to the nature of competitive offerings, and in doing so, to be the leader in product quality reputation

14. Corporate Quality Policies • Importance of quality • Leadership in quality has top priority • Quality shall be given equal priority to costs and delivery • Quality competitiveness • Equal or exceed competitive quality • Be of the highest quality • Customer relations • Provide customer satisfaction • Meet customer perception of good quality

15. Corporate Quality Policies • Internal Customers • We regard the receivers of our work results as “customers” whose needs are important to understand and satisfy • Work Force Involvement • Our policy is to foster a spirit of pride among employees regarding the company’s quality performance • Quality improvement • Resources will be allocated primarily to the prevention of defects and corrective action will be focused on rot-cause identification and elimination

16. Divisional Quality Policies • The same design shall be used in all factories making a specific product. • Quality of design shall be used in all factories making a specific product

17. Quality Policies for Functional Areas • Many of the policies are prepared to provide guidance to managers in specific functional departments such as product development, manufacturing and marketing • New product introduction • Design reviews shall be conducted with customer, market and regulatory bodies in order to ensure the compliance of the design for quality • Suppliers • We seek to establish long-term, open relations with our suppliers

18. Quality Policies for Functional Areas • Manufacturing • Manufacturing process capability must be verified during the product development cycle • Production • Involvement and a spirit of pride will be fostered among employees by encouraging ideas and resolutions regarding the company’s quality performance • Customer service • Service operations shall be conducted so as to minimize customers’ shutdowns

19. Quality Objectives • An objective is an aimed-at-target– an achievement toward which effort is extended. • Quality objective is an aimed-at-quality target • Quality objectives should be quantifiable in nature (measurable) - SMART

20. Objectives vs. Policies

21. Objectives vs. Standards

22. Implementing ISO 9000:2000 • Awareness Training • Establish a Team • Establish ISO 9000 Status • Prepare Action Plan • Track Action Plan • Present Status of Action Plan • ISO 9000 Readiness Assessment • Contact Registrar (Certification Body) • Official ISO 9000 Audit • Continuous Improvement • Celebrate!

23. ISO 9000:2000 Clauses • Quality Management System • Resource Management • Product or Service Realization • Management Responsibility • Measurement, Analysis and Improvement

24. Quality Management System (QMS) • Concerned with the documentation and management of the QMS • Sub-clauses: • Quality Manual • Control of documents • Control of records

25. Management Responsibility • Concerned with the responsibility of management in the implementation of the quality system • Sub-clauses: • Management commitment • Customer focus • Quality policy • Planning • Responsibility, authority, and communication • Management review

26. Resource Management • Concerned with the provision of resources needed to implement the QMS • Sub-clauses: • Provision of resources • Human resources • Infrastructure • Work environment

27. Product or Service Realization • Concerned with the provision of processes to implement the product or service • Sub-clauses: • Planning of product realization • Customer related processes • Customer requirements • Customer communication • Design and development • Control of changes • Purchasing process • Production and service provision • Validation of processes • Identification and traceability • Customer property • Preservation of product • Control of measuring and monitoring devices

28. Measurement, Analysis and Improvement • Concerned with the establishment of a measurement program to measure QMS performance and to identify problems • Sub-clauses: • Measurement of customer satisfaction • Internal audits • Measurement and monitoring of processes • Measurement and monitoring of product • Control of nonconformity • Analysis of data • Continual improvement • Corrective action • Preventive action

29. References • Software Quality Management and ISO 9001, by Michael Jenner, Ch. 1, 2 • A Practical Approach to Software Quality, by Gerard O’Regan, Ch. 3