1. Eng R. L. Nkumbwa-2010 Copperbelt University 1 ISO 9001 - 2008 Quality Management Systems

2. Eng R. L. Nkumbwa-2010 Copperbelt University 2 Agenda General Introduction Quality Management Principles Process Approach Compatibility with Other Management Systems

3. Eng R. L. Nkumbwa-2010 Copperbelt University 3 Introduction ISO recently released the latest revision: ISO 9001 – 2008. This part of the training session will cover an introduction to the ISO standard, 2008.

4. Eng R. L. Nkumbwa-2010 Copperbelt University 4 Overview ISO 9001:1994 was the last revision prior to the 2000 release and now we have the 2008 version. The standard tells a company what they have to do, but not how to do it.

5. Eng R. L. Nkumbwa-2010 Copperbelt University 5 Advantages of Becoming ISO Certified (QMS) Our customers want it Reduce expenses/variability – Optimization of costs and resources Lower costs and shorter cycle times through effective use of resources Focused and prioritized improvement opportunities Repeat business and referrals Performance advantage through improved organizational capabilities

6. Eng R. L. Nkumbwa-2010 Copperbelt University 6 Vocabulary ISO - International Organization for Standardization QMS - Quality Management System SupplierOrganization Customer

7. Eng R. L. Nkumbwa-2010 Copperbelt University 7 CAPA – Corrective Action and Preventive Action PMT – Process Management Team Process – any activity or set of activities, that uses resources to transform inputs to outputs.

8. Eng R. L. Nkumbwa-2010 Copperbelt University 8 General ISO 9000 describes fundamentals of a QMS. ISO 9001 specifies the requirements for a QMS. ISO 9004 provides guidelines to consider for the QMS. ISO 19011 provides guidance for auditing QMS and Environmental Systems.

9. Eng R. L. Nkumbwa-2010 Copperbelt University 9 General (Cont’d) Adoption of a quality management system should be a strategic decision of an organization. The QMS requirements specified in the standard are complimentary to requirements for products. This standard can be used by internal and external parties. The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this standard.

10. Eng R. L. Nkumbwa-2010 Copperbelt University 10 Quality Management Principles Eight quality management principles have been identified that can be used by top management to lead the organization towards improved performance.

11. Eng R. L. Nkumbwa-2010 Copperbelt University 11 Quality Management Principles (Cont’d) Customer focus –Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

12. Eng R. L. Nkumbwa-2010 Copperbelt University 12 Quality Management Principles (cont’d) Leadership –Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.

13. Eng R. L. Nkumbwa-2010 Copperbelt University 13 Quality Management Principles (cont’d) Involvement of people –People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.

14. Eng R. L. Nkumbwa-2010 Copperbelt University 14 Quality Management Principles (cont’d) Process Approach –A desired result is achieved more efficiently when activities and related resources are managed as a process

15. Eng R. L. Nkumbwa-2010 Copperbelt University 15 Quality Management Principles (cont’d) System approach to management –Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.

16. Eng R. L. Nkumbwa-2010 Copperbelt University 16 Quality Management Principles (cont’d) Continual Improvement –Continual improvement of the organization’s overall performance should be a permanent objective of the organization.

17. Eng R. L. Nkumbwa-2010 Copperbelt University 17 Quality Management Principles (cont’d) Factual approach to decision making –Effective decisions are based on the analysis of data and information

18. Eng R. L. Nkumbwa-2010 Copperbelt University 18 Quality Management Principles (cont’d) Mutually beneficial supplier relationships –An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

19. Eng R. L. Nkumbwa-2010 Copperbelt University 19 Process Approach Determining the needs and expectations of customers and other interested parties Establishing the quality policy and objectives of the organization Determining the processes and responsibilities necessary to attain the quality objectives Determining and providing the resources necessary to attain the quality objectives

20. Eng R. L. Nkumbwa-2010 Copperbelt University 20 Process Approach (Cont’d) Establishing methods to measure the effectiveness and efficiency of each process Applying these measures to determine the effectiveness and efficiency of each process Determining means of preventing nonconformities and eliminating their causes Establishing and applying a process for continual improvement of the quality management system

21. Eng R. L. Nkumbwa-2010 Copperbelt University 21 Model of a Process-based Quality Management System

22. Eng R. L. Nkumbwa-2010 Copperbelt University 22 Compatibility With Other Management Systems This International Standard had been aligned with ISO 14001: 2004 to enhance compatibility Does not include requirements specific to other management systems, but enables organizations to integrate other systems (such as environmental, OHSA, or financial mgmt.)

23. Eng R. L. Nkumbwa-2010 Copperbelt University 23 Key Changes to the 2008 Standard Customer Satisfaction must be measured Outsourced processes –Must be able to demonstrate control over process –Must be in quality manual and other public documents

24. Eng R. L. Nkumbwa-2010 Copperbelt University 24 Key Changes to the 2008 Standard (Cont’d) Process Management –PMT (Process Mgmt. Team) that meets regularly –Process map that shows steps and functions –Customer driven measures –Training and Communication Plan –Methods for monitoring and measuring –Methods for solving problems (CAPA)

25. Eng R. L. Nkumbwa-2010 Copperbelt University 25 Key Changes to the 2008 Standard (Cont’d) Structure of a QMS –Communicate to rest of company –How much documentation is enough? Customer Property – Must have process for controlling. Internal Auditing – has changed, special training required.

26. Eng R. L. Nkumbwa-2010 Copperbelt University 26 Summary ISO 9001 : 2008 is a process approach system. This standard is aligned to work with other management systems. Other processes (such as out sourcing) must be controlled.