ISO 9001:2008 Requirements

1. ISO 9001:2008 Requirements Quality Management Systems

2. COURSE OBJECTIVES Participants to be aware of the following: • Basic concepts on ISO9001:2008 • Benefits/Importance of ISO9000 • ISO9000 Requirements

3. ISO • formed and began its official function on 23rd February 1947 • non-governmental organization • mission is the promotion of the development of standardization and related activities in the work with a view to: • Facilitate the international exchange of goods and services, and; • To develop co-operation in the spheres of intellectual, scientific, technological, and economic activity

4. The word “ISO” is not as many people think the acronym for the organization but is derived from the Greek word “isos” meaning equal ISO – International Organization for Standardization

5. ISO 9000 Quality Standards focus on the SYSTEM, not the Product.

6. A hierarchy of technical committees (TCs); sub-committees (SCs) and working groups (WGs) carries out the work of ISO. • Within these committees there are: • Qualified industry representatives • Research institutes • Consumer bodies • Government authorities, and • Worldwide international organizations whose objective is the resolution of global standardization issues.

7. The administrative responsibility for a standards committee is accepted by one of the national standards bodies. The Central Secretariat of ISO, located in Geneva, co-ordinates the dissemination of documentation; facilitates clarification with chairmen and the agreement of technical content by committees; coordinates meetings and generally provides overall support.

8. BENEFITS OF STANDARDIZATION TO ISO9001 • Improved productivity • More Market Competitiveness • Better Export Capability

9. 1. Provides opportunities to streamline the company’s processes Integrates systems and procedures using the ISO Framework2. Identifies critical points in the organization to be controlled and measured (quality objectives)3. Provides a structured approach in identifying areas for improvement/enhancement4. Establishes clear position descriptions - identifies overlapping functions, reinforces performance management system5. Establishes an efficient records and files management system6. Promotes total organization involvement/sense of ownership. BENEFITS OF GOING INTO ISO Based on Customers’ Feedback

10. Rationale for the QMS • Quality management systems can assist organizations in enhancing customer satisfaction • Encourages organizations to analyze customer requirements, define the processes that contribute to the achievement of a product which is acceptable to the customers, and keep these processes under control. • Provides the framework for continual improvement to increase probability of enhancing customer satisfaction and the satisfaction of other interested parties. • Provides confidence to the organization and its customers that it is able to provide products that consistently fulfill the requirements.

11. Internal Quality Audit (IQA) - Site - 1st party assessment • - Internal Quality Audit (IQA) • Desk Study • Compliance Audit • - Follow-up • Assessment (if any) • - 3rd Party • Certification • - Surveillance Visit Internal Quality Audit (IQA) - Customer Assessment 2nd Party Certification APPLICATION/CERTIFICATION FRAMEWORK 1st PARTY ASSESSMENT 2nd PARTYASSESSMENT 3rd PARTYASSESSMENT

12. 8. Factual Approach to Decision-Making 1. Customer Focus 7. Mutually Beneficial Suppler Relationship 2. Leadership 6. Continual Improvement 3. Involvement of People 5. System Approach To Management 4. Process Approach 8 Quality Management Principles

13. Eight Quality Management Principles a. 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.

14. Eight Quality Management Principles b. 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.

15. Eight Quality Management Principles c. 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.

16. Eight Quality Management Principles d. PROCESS APPROACH • A desired result is achieved more efficiently when activities and related resources are managed as a process.

17. Eight Quality Management Principles e. 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.

18. Eight Quality Management Principles f. CONTINUAL IMPROVEMENT • Continual improvement of the organization’s overall performance should be a permanent objective of the organization

19. Eight Quality Management Principles g. FACTUAL APPROACH TO DECISION-MAKING • Effective decisions are based on the analysis of data and information

20. Eight Quality Management Principles h. MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS • An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

21. Quality Management Systems Approach • An approach to developing and implementing a quality management system consists of several steps including the following: Determining the needs and expectations of customers and other interested parties; Establishing the quality policy and quality 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

22. con’t… 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 the nonconformities and eliminating their causes; Establishing and applying a process for continual improvement of the quality management system Such an approach is also applicable to maintaining and improving an existing quality management system.

23. Continual Improvement of the Quality Management System Customers (and other interested parties) Customers (and other interested parties) Management Responsibility Measurement, analysis & improvement Resource Management Product Realization Product Satisfaction Requirements MODEL OF QMS

24. Documentation Enables communication of intent and consistency of action. Its use contributes to: Achievement of conformity to customer requirements and quality improvement; Provision of appropriate training Repeatability and traceability Provision of objective evidence, and Evaluation of the effectiveness and continuing suitability of the quality management system Generation of documentation should not be an end in itself but should be a value-adding activity.

25. Types of Documents - Documents that provide consistent information, both internally and externally, about the organization’s quality management system; such documents are referred to as quality manuals; Documents that describe how the quality management system is applied to a specific product, project or contract; such documents are referred to as quality plans Documents stating requirements; such documents are referred to as specifications;

26. con’t… d. Documents stating recommendations or suggestions; such documents are referred to as guidelines; e. Documents that provide information about how to perform activities and processes consistently; such documents can include documented procedures, work instructions, and drawings; f. Documents that provide objective evidence of activities performed or results achieved; such documents are referred to as records.

27. con’t… Each organization determines the extent of documentation required and the media to be used. This depends on factors such as - • type and size of the organization, • the complexity and interaction of processes, • the complexity of products, • customer requirements, • the applicable regulatory requirements, • the demonstrated ability of personnel, and • the extent to which it is necessary to demonstrate fulfillment of quality management system requirements.

28. Evaluating the QMS When evaluating quality management systems, there are four basic questions that should be asked in relation to every process being evaluated - Is the process identified and appropriately defined? Are responsibilities assigned? Are the systems implemented and maintained? Is the process effective in achieving the required results?

30. 1. Scope 1.1 General This International Standard specifies requirements for a QMS where an organization • Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements • Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

31. 1. Scope 1.1 General Notes: • In this International Standard, the term “product” applies to the product intended for, or required by, a customer or the product realization processes. This applies to any intended output resulting from product realization processes, including purchasing. • Statutory and regulatory requirements may be expressed as legal requirements.

32. 1. Scope 1.2 Application • All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. • Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

33. Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization’s ability or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

34. 2. Normative Reference ISO 9000:2005 Quality management systems - Fundamentals and vocabulary.

35. 3. Terms and Definitions • The terms and definitions given in ISO 9000:2000 apply. • Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.

36. 4. Quality Management System 4.1 General Requirements • Establish, document, implement and maintain a QMS and continually improve its effectiveness in accordance with the requirements of this International Standard.

37. 4. Quality Management System 4.1 General Requirements • Processes needed for the QMS and their application • Sequence and interaction of these processes • Criteria and methods needed to ensure that processes are effective • Availability of resources and information • Monitor, measure (where applicable) and analyze the processes • Implementation of planned results and continual improvement of these processes

38. 4. Quality Management System 4.1 General Requirements Notes: Processes needed for the QMS include processes for management activities, provision of resources, product realization and measurement, analysis and improvement. An outsourced process is identified as one being needed for the organization’s QMS but chosen to be performed by a party external to the organization.

39. Where an organization chooses to OUTSOURCE any process that affects product conformity with requirements, the organization shall ensure control over such processes. The type and extent of control of such outsourced processes shall be identified within the QMS

40. 4. Quality Management System 4.1 General Requirements • Influencing factors for the type and nature of control to be applied to the outsourced process: • the potential impact of the outsourced process • the extent to which the control for the process is shared; • the capability of achieving the necessary control through the application of clause 7.4. • Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all • customer, statutory and regulatory requirements.

41. Sample Business Process

42. 4. Quality Management System 4.2 Documentation Requirements 4.2.1 General Documentation shall include: • Quality Policy and Quality Objectives • A Quality Manual • Documented procedures required by this International Standard (IQA, Control of Non-Conforming, Document & Data Control, Control of Records, Corrective Action, Preventive Action) • Documents, including records, needed to ensure the effective planning, operation and control of processes

43. 4. Quality Management System 4.2 Documentation Requirements 4.2.2 Quality Manual Includes: • Scope of the QMS, including permissible exclusions • Documented procedures established for the QMS • Description of the interaction between the processes of the QMS

44. 4. Quality Management System 4.2 Documentation Requirements 4.2.3 Control of Documents To define controls - • Approve documents for adequacy prior to issue • Review and update as necessary and re-approve documents, • Changes and the current revision status of documents are identified • Relevant versions of applicable documents are available at points of use • Documents remain legible and readily identifiable • Documents of external origin determined by the organization to be necessary for the planning and operation of the QMS are identified and their distribution controlled • Prevent unintended use of obsolete documents, and to apply suitable identification to them if they are retained

45. 4. Quality Management System 4.2 Documentation Requirements 4.2.4 Control of Records • Records established to provide evidence of conformity to requirements and of the effective operation of the QMS shall be controlled • Shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. • Shall remain legible, readily identifiable and retrievable.

46. 5. Management Responsibility 5.1 Management Commitment Provide evidence of its commitment to the development and implementation of the QMS and continually improving its effectiveness by: • Internal Communication • Quality Policy • Established Quality Objectives • Management Reviews • Availability of Resources

47. 5. Management Responsibility 5.2 Customer Focus • Customer requirements are determined and are met with the aim of enhancing customer satisfaction.

48. 5. Management Responsibility 5.3 Quality Policy • Appropriate to the purpose of the organization • Commitment to comply with the QMS requirements and to continuously improve • Quality Objectives are established and reviewed • Communicated and understood by all • Reviewed for continuing suitability

49. 5. Management Responsibility 5.4 Planning 5.4.1 Quality Objectives • Established at relevant functions and levels within the organization. • Shall be measurable with the quality policy.

50. 5. Management Responsibility 5.4 Planning 5.4.2 Quality management system planning • To meet the requirements given in 4.1, and the Quality Objectives • The integrity of the QMS is maintained when changesto the system are planned and implemented