U NDERS T ANDING of ISO 9001:2008

1. UNDERSTANDINGof ISO 9001:2008

2. Course Contents • Module 1: Modern Concepts of Quality • Module 2: ISO 9001:2008 requirements • Module 3: Quality System Documentation • Module 4: Accreditation

3. Learning Objectives To the purpose of a quality management be able to: • Describe the objective of Quality Management System • Explain the QMS 8 Principles • Explain ISO 9000:2008, 9001and 9004 and their interrelationship • Explain ISO 9001:2008 and its application to industrial and service organizations. • Understand QMS documentation requirements. • How to register and approve QMS

4. Module 1 Modern concepts of Quality

5. Quality is Fitness for Purpose Quality is User Dependent Quality is Fitness for Use Quality is Conformance with Requirements Quality

6. Quality Degree to which a set of inherent characteristics fulfils requirements ISO 9000:2005

7. Quality Control • Part of quality management, focussed on fulfilling requirements for quality ISO 9000:2005 Depends on final Inspection of product / Service • Aims at carrying out work properly at first time.

8. Quality Assurance • Part of quality management, focused on providing confidence that quality requirements are fulfilled ISO 9000:2005 Mythological Planning to prevent the occurrence of non-conformance

9. QMS Principles & P-D-C-A Continuous Improvement Cycle • Planning and prioritization • Implementation • Measurement and evaluation • Review and improvement

10. Quality Management • Coordinate activities to direct and control an organization with regard to quality ISO 9000:2005 • Management system to direct and control an organization with regard to quality assurance

11. Quality Management Quality Assurance Customer Focus Quality of product through employees participation and follow a mythological management Quality Control Monitor of Processes َQuality of productthrough Monitoring Processes Quality of product through control of processes Final Inspection Quality of product by filtering 1950s 1970s 1990s

12. Quality Management System Principles • There are eight main principles defined as the general structure for improving the performance of any organization. They can also be defined as a method to achieve and maintain success as follows:

13. 1. CUSTOMER FOCUS • How are customer expectations and needs determined? • How are customer requirements determined? • What steps are taken to ensure they are fulfilled? • How do they know the customer is satisfied?

14. Everything has a cost • We usually remember those organizations that fulfill our requirements to the extent that we pay more to get the service they provide. • There are survey statistics prove the following:- • Pay extra 10% of the value for a better service. • the Excellent service impression is passed among 9-12 persons. • The bad service impression is approximately passed to 20 persons. • 91% of clients won’t deal with the organization in case of providing bad service. • 82% of clients keep dealing with the company that give due care to quickly handle their complaints.

15. Types of Customers An person or Dept. receives or influenced by the products or processes carried out by the organization: • External Customers • They are not numbered among work team within the organization. • Customer (User/ Consumer / Patient) • Governmental Bodies (Ministry of Health), Insurance Companies. • Surrounding Society • Internal Customers • They are work members within the organization. • Workers • Organization Owners.

16. Leadership Leaders establish unity of purpose and directions of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.

17. Leadership • Commitment • Participation • Model

18. Who wins the battle!!!! An army of rabbits led by a lion. An army of lions led by a rabbit

19. An Army of lions led by a lion Typical Quality Model

20. 3- Involvement of People Workers at all levels are the backbone of any organization and their full involvement enables their abilities to be used for the organization's benefit.

21. Team Work TOGETHER EVERYONE ACHIEVE MORE 11 1 1 = + 111 1 1 1 = + +

22. The employee works over 8 hours for the sake of (SALARY) • The employee works over 10 hours for the sake of (GOOD MANAGER ) • The employee works over 24 hours for the sake of (AN IDEA HE IMPLICITLY BELIEVED IN)

23. What is the difference between the happy and the miserable? • The wise man whispers saying:- • The happy use the same spoons….but not to eat but to feed each other. Ego We Misery Happiness

24. Contributing to the Success of System • Each individual within the company is able to help, and his help is necessary when he:- • examines the organization processes • designs the quality system adopted within the organization • performs documentation process • reviews and monitor the system.

25. System Application • We have to take down documents by ourselves to ensure their authenticity. The adopted system shall be based on what we actually do and not what we shall do. • Individual plays a key role in monitoring and reviewing the Q. system and recording the results accurately and honestly.

26. Maintaining the System Every individual in the organization can take part in this mission as an auditor or auditee. It is to be noted that the aim of audit is to discover nonconformities before occurrence and not blaming.

27. System Improvement Every individual in the organization can take part in developing and improving work and also encouraging others for that. For this, all of us are partners in achieving product quality (goods/services) through the quality of performance

28. 4. Process Approach • A desired result is achieved more efficiently when activities and related resources are managed as a process.

29. MANAGEMENT ACTIVITIES RESOURCES Basic process model INPUT OUTPUT = CUSTOMER SATISFACTION

30. Research market Create specification Develop solution Test with market Market and sell Manufacture MARKETING DEVELOPMENT AND MARKETING DEVELOPMENT MARKETING OPERATIONS PROCESS Example “Bringing new products to market” SALES

31. 5. Quality System Concept Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.

32. Common way in practical life when there is on quality management concept

33. Continual Improvement Continual improvement of the organization’s overall performance should be a permanent objective of the organization.

34. Evaluate and select a solution Analyse, evaluate data Implement the selected solution Establish the objectives Monitor, analyse and evaluate results Search for solutions to achieve the objectives Formalise the changes Process Continual Improvement

35. 7. Factual Approach to Decision Making • Effective decisions are based on the analysis of data and information.

36. 8. Mutual Benefits Relationship • An organization and its suppliers are independent and mutually beneficial relationship enhances the ability of both to create value.

37. Development of QA standards 1963 Mil-Q-9858A US Military 1969 AQAP NATO 1970 10 CFR50 US Fed. Reg. 1971 ASME Boiler code Mech. Eng. 1973 Def-Stan UK MoD 1979 BS 5750 British Standard 1987 ISO 9001:2000 International Standard 1994 ISO 9001:1994 Revision International Standard • ISO 9001 Revision International Standard 2008 ISO 9001 Revision International Standard

38. ISO Standard-setting Process • Work is performed through Technical Committees • Member countries send delegates to TC proceedings • Specific operating rules for standard development and adoption • Member countries vote on Committee Draft (CD), Draft International Standards (DIS), and Final Standards (FIS)

39. ISO Standard-setting Process • Standards are reviewed/ revised every five years • Efforts are made to coordinate standards in different fields (e.g. ISO 9000, ISO 14001 and OHSAS 18001)

40. Quality Systems ISO Family of Standards ISO 9000 - fundamentals and vocabulary ISO 9001 - requirements ISO 9004 - guidelines for performance improvements ISO 19011 - guidelines for systems auditing.

41. 9004 perspective: Excellence in business 9004 9001 9001 perspective: Quality of product and services Relationship: ISO 9001 / ISO 9004

42. Economical Feasibility of Implementing ISO 9001:2008 Quality System ISO 9000 Implementation Product Quality Reduction of Internal Failure Cost Reduction of External Failure Cost Customer Satisfaction Reduction of Appraisal Increasing Sales Volume Reduction cost of bad Quality Increasing Profitability

43. Module 2 ISO 9001:2008 requirements

44. 4- Quality Management Process Model Continual improvement of the quality management system Management responsibility Customer Customer Measurement, analysis and improvement Satisfaction Resource Management Requirements output input Product realization Product

45. 4.1 General Requirements The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

46. The organization shall a) Identify the processes needed for the quality management system and their application throughout the organization (see 1.2), b) Determine the sequence and interaction of these processes, c) Determine criteria and methods needed to ensure that both the operation and control of these processes are effective, • Ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) Monitor, measure and analyze these processes, and f) Implement actions necessary to achieve planned results and continual improvement of these processes.

47. 4.2 Documentation Requirements 4.2.1 General The QMS Documentation shall include: • Documented statements of a policy and quality objectives • A quality manual • Documented procedures • Documents to ensure effective planning, operation and control • Records

48. 4.2.2 Quality manual • The organization shall establish and maintain a quality manual that includes:- a) The scope of the quality management system, including details of and justification for any exclusions (see 1.2), b) The documented procedures established for the quality management system, or reference to them, and c) A description of the interaction between the processes of the quality management system.

49. 4.2.3 Control of documents • Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4. • A documented procedure shall be established to define the controls needed a) To approve documents for adequacy prior to issue, b) To review and update as necessary and re-approve documents, c) To ensure that changes and the current revision status of documents are identified.

50. d) To ensure that relevant versions of applicable documents are available at points of use, e) To ensure that documents remain legible and readily identifiable, f) To ensure that documents of external origin are identified and their distribution controlled, and g) To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.