Chapter Three ISO 9000:2000 Quality Management System

1. Chapter Three ISO 9000:2000 Quality Management System

2. Introduction Quality Systems – Approach recognizes continuous Improvement in Quality can be best achieved through planning and preventing problems form arising at source with the introduction of Quality Control Tools and Techniques. Quality Assurance – Recognizes the inherent inefficiency of waiting for the mistakes to happen. Analysis of Nonconformance in a systematic manner. Design Quality into the process and practices Quality Control – ensures certain level of quality in a product/service. Whatever actions a business deems necessary to provide for the control and verification of certain characteristics of a product or service. Quality Inspection –identifying defects in the Product/service before they reach the customer by “Inspection Stage or stages. Against the specification

3. Why Standards Matter • Standards make an enormous and positive contribution to most aspects of our lives. • Standards ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, efficiency and interchangeability - at an economical cost. • When products and services meet our expectations, we tend to take this for granted and be unaware of the role of standards. • However, when standards are absent, we soon notice.

4. International Organization for Standardization (ISO) • Central Secretariat in Geneva, Switzerland, that coordinates the system. • ISO, officially began operations on 23rd February 1947. • ISO standards are developed by “Technical Committees” comprising experts from the industrial, technical and business sectors which have asked for the standards, and usage.

5. ISO: International Organization for Standardization The name derived from the Greek word “isos” meaning "equal". From "equal" to "standards" that lead to the choice of "ISO" as the name of the organization. ISO is a non-governmental organization with its members drawn from 120 countries, currently is made up of 130 national standards institutes or organizations.

6. ISO: International Organization for Standardization • To date, ISO's work has resulted in over 19 000 International Standards, representing some 750 000 pages in English and French (terminology is often provided in other languages as well).

7. History of ISO 9000 Series • In the year 1985 the Quality Management systems Concept came into the Existence by ISO • In the year 1987 First Guidelines as requirements of Quality Management Systems has been published for the Purpose of Certification. • In the year 1994 First revision took place to make it more practical for the Implementation and Simple to understand. Four Standards published ISO 9001, ISO 9002, ISO 9003, ISO 9004. • In year 2000 Second revision took place to make it generic for the application in any type of Industry and simplified form the Audit Point of View. • 15th November 2008 Third revision published to give more clarity for implementation and use.

9. ISO 9000 and ISO 14000 in brief • ISO 9000 and ISO 14000 are among ISO's most well known standards ever. • They are implemented by more than a millionorganizations in some 175 countries. • ISO 9000helps organizations to implement quality management system. • ISO 14000helps organizations to implement environmental management system.

10. Management System • Management system means “What the organization does to manage its processes, or activities in order that its products or services meet the organization’s objectives, such as satisfying the customer's quality requirements, complying to regulations, or meeting environmental objectives”

11. Management System • To be really efficient and effective, the organization can manage its way of doing things by systemizingit, i.e.: • Nothing important is left out. • Everyone is clear about who is responsible for doing what, when, how, why and where. • ISO Management system standards provide organizations with an international, state-of-the-art model to follow.

12. Management System • Large organizations, or ones with complicated processes, could not function well without proper and effective managementsystems. • Companies in fields such as aerospace, automobiles, defense, or health care devices have been operating management systems for years. • The ISO 9000 and ISO 14000 management system standards now make these successful practices available forall organizations.

13. Quality management ISO 9000 is for quality management. • Quality refers to all those features of a product (or service) which are required by the customer. • Quality management means what the organization does to: • Ensure that its products or services satisfy the basic customer's quality requirements and • Comply with any regulations applicable to those products or services.

14. Quality management • Quality management also means what organization does to • Enhance customer satisfaction and exceed their expectations, and • Achieve continual improvement of its performance.

15. Principles of Management Systems • Customer focus • Leadership • Involvement of people • Process approach • System approach to management • Continual improvement • Factual approach to decision making • Mutually beneficial supplier relationships

16. Generic Standards ISO 9000 and ISO 14000 are genericstandards. Generic means that the same standards can be applied: • To any organization, large or small, whatever its product or service, • In any sector of activity, and • Whether it is a business enterprise, a public administration, or a government department.

17. Generic Standards Generic also signifies that • No matter what the organization's scope of activity is, if it wants to establish a quality management system, ISO 9000 gives the essential features • Or if it wants to establish an environmental management system, ISO 14000 gives the essential features.

18. Processes, not Product • Both ISO 9000 and ISO 14000 concern the way an organization goes about its work. • They are not product or service standards, they are process standards. • They can be used by both product manufacturer and service providers • Processes affect final products or services. • ISO 9000 gives the requirements for what the organization must do to manage its processes affecting quality of its products and services.

19. Schematic Representation of Process

20. ISO: International Organization for Standardization The ISO 9000 family of standards represents an international consensus on good management practice. Its primary aim is to give organizations guidelines on what constitutes an effective quality management system, which in turn can serve as a framework for continuous improvement. • The ISO 9000 family of International Standards for quality management has 12,900 standards published since it began operations in 1947.

21. The ISO Survey

22. ISO: International Organization for Standardization • ISO 9001: Is one of the standards and it is a model for quality assurance in design, development, production, installation and servicing. ii) ISO 9002: Is a model for quality assurance in production, installation and servicing for an already established design.

23. ISO: International Organization for Standardization • ISO 9003: This is a model for quality assurance in final inspection and testing. • ISO 9004: This is quality management and quality systems elements: guidelines. This provides the users in the process of developing in-house quality systems.

24. ISO: International Organization for Standardization ISO 9000 is not a product quality label or guarantee. Compliance with the standards verifies product repeatability: products produced under a specified standard will have similar dimensions of quality In conclusion, ISO 9000 should be seen as a first step in continuing improvement while the customer requirement may be more than the general application of the standard

25. ISO: International Organization for Standardization A quality management system is the way organization directs and controls those businesses activities, which are associated with quality. Broadly, it consists of organizational structure together with the planning, processes, resources and documentation that you use to achieve your quality objectives, to provide improvement of your products and services and to meet your customer’s requirements.

26. ISO: International Organization for Standardization • Quality Management system standards should not be confused with product standards • The use of product standards, quality management system standards and quality improvement approaches are all means of improving your customers’ satisfaction and the competitiveness of your business and they are not exclusive of each other

27. ISO: International Organization for Standardization • ISO 9000:2000 promotes the adoption of a process approach • Process approach refers to the application of system of processes within an organization, together with the identification and interactions of these processes, and there management • An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as their combination and interaction

28. Process approach emphasizes the importance of: • Understanding and meeting requirements • The need to consider processes in term of added value • Obtaining results of process performance and effectiveness, and • Continual improvement of processes based on objectives measurement

29. Conceptual model of ISO 9000: 2000 Quality Management Systems

30. Deming Prizes (1951) 30

31. Malcolm Baldrige National Quality Award (1987)

32. Australian Quality Award (1988)

33. European Quality Award (1991)

34. The Ethiopian Quality Award (EQA) Assessment Model (2007)

35. EQA 1. Leadership • Commitment to excellence and continuous improvement • Development and deployment of policies & strategies • Allocation of appropriate resources • Motivation and recognition of employee’s effort • Customer relationship management • Leader’s involvement in achieving organizational objectives • Public responsibility

36. EQA 2. Policy and strategy • Relevant policy and procedures • Sound & focused strategy • Deployment of policies and strategies

37. EQA 3. Resource management • Targeted human resource development & management • Optimized material resource management system • Effective financial resource management • Efficient facilities management • Knowledge based information resource management

38. EQA 4. Processes • Optimized product/ service process • Synergized service processes • Proper planning & control • Integrated business process • Review and improvement of process EQA 5. Customer satisfaction/focus • Exceeding external customers’ expectation • Meeting internal customers’ satisfaction • Review and evaluation of customers’ satisfaction • Level of product/ service quality

39. EQA 6. Business Performance • Degree of financial performance • High market share • Increased productivity EQA 7. Impact on society • Significant socio-economic impact • Enhanced environmental impact

40. System Requirements Management Responsibility Resource Management Product Realization Measurement Analysis & improvement General requirements Management Commitment Provision of resources Planning General Customer related processes Monitoring & measurement Documentation Requirements Customer focus Human resources Quality policy Control Infrastructures Design & development Planning Analysis of data Work environment Purchasing Responsibility, authority & communication Improvements Production & service provision Management Reviews Quality Management System

41. Benefits of implementing quality management system Internal benefits • Improved management confidence • Improved awareness of company objectives • Improved communications • Responsibilities and authorities are adequately defined • Improved traceability to root cause of quality problems • Improved utilization of resources

42. Fewer rejects, therefore, less repeated work and warranty costs • Errors rectified at the earliest stage, and not repeated • Continuous improvement • Increased productivity • Increased profits and company growth

43. External benefits • Easy access to international market through demonstration of competence and improving competitiveness • Improved customer satisfaction • Consistency in quality of products and services • Customer confidence (reduces the amount of inspection) • Improved company image

44. Role of employees in quality management • Accept ownership and responsibility to solve problems • Actively seek opportunities to make improvements • Actively seek opportunities to enhance their competencies, knowledge and experience • Freely share knowledge and experience in teams and groups

45. Being innovative and creative in furthering the organization’s objectives • Better representing the organization to customers, local communities and society at large • Deriving satisfaction from their work • Be enthusiastic and proud to be part of the organization • Focusing on the creation of value for customers

46. Market Impact Of ISO 9000 • The customer is the focal point for all businesses to survive in any market – locally, nationally, and globally • Customer’s needs and requirements are important • ISO 9000 establishes a set of rules and regulations to avoid poor-quality products and services for a variety of customers

47. Importance to Marketing and Sales • The degree of positive impact depends on the degree of involvement in the certification process • Customers can be confident in a company that knows the importance of quality assurance • A stepping stone to improve quality products and true customer focus

48. Reasons for Companies to Comply • A study conducted by Rayner and Porter: • 80% of the firms considered marketing as the main reason to be certified by ISO 9000

49. Other reasons: • Comply with public projects • Government requirements • Overseas trade and market • Pressure from larger businesses • Reduce time failure • Reduce costs of customers’ claims • Improve customer service and customer loyalty • To get things done right the first time

50. Benefits from Certification A study conducted by McAdam and McKeown Northern Ireland/Europe • 37% - Increased productivity • 23% - Internal benefits (i.e. reduced cost) • 14% - Greater control • 37% - of the businesses received benefits within the first year of ISO 9000 Certification