1. AET0012PPT 2004-03-13 1 by Dr. Anwar El-Tawil Dr. Anwar El-Tawil Director ISO Programme for Developing Countries QUALITY MANAGEMENT SYSTEM ACCORDING TO ISO 9001-2000 1.General Requirements of QMS 2.Management Responsibility 3.Resource Management

2. AET0012PPT 2004-03-13 2 QMS ACC. TO ISO 9001-2008 - Application Application of ISO 9001 (1.2) l Requirements of ISO 9001 are generic  It can be applied to all organizations regardless of type, size or product l When some requirements cannot be applied due to  nature of organization or  nature of product  an exclusion is made l Exclusions are limited to requirements to Product realization. They shall not affect the organization’s ability to fulfil customer and regulatory requirements Exclusions shall be stated in the Quality Manual

3. AET0012PPT 2004-03-13 3 QMS ACC. TO ISO 9001-2008 - QMS Requirements General Requirements of QMS (4.1) l The Organization shall  establish,  document,  implement,  maintain and  continually improve a QMS l The Organization shall identify the processes needed for the QMS including:  management processes  provision of resources  product realization  measurement

4. AET0012PPT 2004-03-13 4 QMS ACC. TO ISO 9001-2008 - QMS Requirements General Requirements of QMS (4.1) (cont.) l For the processes identified above the Organization shall  determine their sequence and interaction,  determine criteria and methods to ensure their effective operation and control,  ensure availability of resources and information,  monitor, measure and analyze these processes,  implement actions to achieve planned results and continual improvement of these processes l Where the Organization outsources some processes, it shall ensure control over them

5. AET0012PPT 2004-03-13 5 QMS ACC. TO ISO 9001-2008 - QMS Requirements Example of Overview of Processes in an Organization Management Processes Financial Manag t. Production Manag t. Quality Manag t. Strategic Planning and Management Resource Manag t. Processes PersonnelTrainingEquipment&ITUtilitiesMaintenanceTransport Product Realiz n. Processes Orders/ Contracts Purchas- ing Product- ion Customer Calibrat- ion Market g./ Distrib n. Measuring & Monitoring Processes Process Monitoring Product Testing Customer Feedback QS Audit Data Analysis

6. AET0012PPT 2004-03-13 6 QMS ACC. TO ISO 9001-2008 - QMS Requirements Example of Process Description Identification of needs & specs. Approved Suppliers Purchase of New Material Approved supplier can supply material yes Call for Offers no Evaluate/Test OrderReception VerificationStorage Issue Management of Contract Input from Prod. Prod n.

7. AET0012PPT 2004-03-13 7 QMS ACC. TO ISO 9001-2008 - Documentation Documentation Requirements (4.2) l The QMS documentation shall include  Quality Policy and Quality Objectives  Quality Manual  Documented Procedures  Other documents needed for effective planning, operation and control of processes  Quality Records

8. AET0012PPT 2004-03-13 8 QMS ACC. TO ISO 9001-2008 - Documentation Document Hierarchy Q Policy Q Objectives Exclusions - Processes - Procedures Quality Manual Q u a l i t y R e c o r d s Other Documents ( Instructions etc)

9. AET0012PPT 2004-03-13 9 QMS ACC. TO ISO 9001-2008 - Documentation Other Aspects of Documentation (4.2 & ISO 9004) l The extent of QMS documentation can differ from one organization to the other due to  Size of Organization and type of activity  Complexity of processes and their interaction  Competence of personnel l Documentation can be in any form or medium l Criteria for generation, use and control of documentation:  Functionality  User friendliness  Resources needed  Policies and objectives  Benchmarking of documentation  Interfaces with customers and suppliers

10. AET0012PPT 2004-03-13 10 QMS ACC. TO ISO 9001-2008 - Documentation Quality Manual (4.2.2) l The Quality Manual includes (mandatory content): a) Scope of QMS, including exclusions and their justification b) Documented procedures of the QMS or reference to them c) Description of the interaction between the QMS processes

11. AET0012PPT 2004-03-13 11 QMS ACC. TO ISO 9001-2008 - Documentation Control of Documents (4.2.3) Ê Documents other than Q records: a documented procedure(1) shall define the following controls:  Approval for adequacy before issue  Review, updating and re-approval of docs  Identification of changes and of the revision status of docs  Availability of relevant versions of docs at points of use  Assurance of legibility and identifiability of docs  Identification of docs of external origin and their control  Prevention of unintended use of obsolete docs QMS documents shall be controlled. Quality records are subject to a special type of control

12. AET0012PPT 2004-03-13 12 QMS ACC. TO ISO 9001-2008 - Documentation Control of Quality Records (4.2.4) Ë Q Records They shall remain legible, readily identifiable and retrievable; a documented procedure(2) shall define the following controls for Q Records:  Identification  Storage  Protection  Retrieval  Retention time  Disposition

13. AET0012PPT 2004-03-13 13 QMS ACC. TO ISO 9001-2008 Management Responsibility Management Responsibility (ISO 9004) l Top management should consider actions such as:  establishing a vision, policies and strategic objectives;  leading the Organization by example;  communicating organizational direction and values regarding quality and the QMS;  participating in improvement projects;  obtaining feedback on the effectiveness and efficiency of the QMS;  creating an environment that encourages the involvement of people;  providing the structure and resources to support plans Leadership, commitment and active involvement of top management are essential for developing and maintaining an effective and efficient QMS

14. AET0012PPT 2004-03-13 14 QMS ACC. TO ISO 9001-2008 Management Responsibility Management Responsibility (ISO 9004) Leaders establish unity of purpose and direction of the Organization(Quality Principle 2)

15. AET0012PPT 2004-03-13 15 QMS ACC. TO ISO 9001-2008 Management Responsibility Management Commitment (5.1) a) communicating to the Organization the importance of meeting Customer as well as Statutory Requirements; b) establishing the Quality Policy; c) ensuring that Quality Objectives are established; d) conducting the Management Review and e) ensuring the availability of Resources Top management shall provide evidence of its commitment to the development, implementation and improvement of the QMS by

16. AET0012PPT 2004-03-13 16 QMS ACC. TO ISO 9001-2008 Management Responsibility Customer Focus (5.2)  Management shall ensure that  Customer requirements are determined and  Customer requirements are met  This enhances customer satisfaction

17. AET0012PPT 2004-03-13 17 QMS ACC. TO ISO 9001-2008 Management Responsibility Quality Policy (5.3 & ISO 9004) Quality Policy should be an equal part of the Organization’s overall policies and strategy (ISO 9004) Top management shall ensure that the Quality Policy a) is appropriate to the purpose of the organization; b) includes a commitment to comply with requirements and continually improve the effectiveness of the QMS; c) provides a framework for establishing and reviewing Q Objectives; d) is communicated and understood within the Organization; e) is reviewed for continuing suitability

18. AET0012PPT 2004-03-13 18 QMS ACC. TO ISO 9001-2008 Management Responsibility Aspects for Consideration in Establishing Quality Policy (ISO 9004) Top Management should use Quality Policy as a means of leading the Organization toward improvement of performance In establishing Quality Policy, top management should consider  L evel and type of future improvement needed for the Organization’s success  Expected or desired degree of customer satisfaction  Development of people in the Organization  Needs and expectations of interested parties  Resources needed to go beyond ISO 9001 requirements  Potential contributions of suppliers and partners

19. AET0012PPT 2004-03-13 19 QMS ACC. TO ISO 9001-2008 Management Responsibility Planning - Quality Objectives (5.4.1) Top management shall ensure that Quality Objectives including those needed to meet requirements for the product are l set at relevant functions and levels within the Organization l measurable consistent with the Quality Policy

20. AET0012PPT 2004-03-13 20 QMS ACC. TO ISO 9001-2008 Management Responsibility Inputs for Quality Planning (ISO 9004) The Organization’s strategic planning and the Quality Policy provide a framework for setting of Quality Objectives (ISO 9004) Inputs for effective and efficient planning include  Strategies of the Organization  Defined organizational objectives  Defined needs and expectations of customers and interested parties  Evaluation of statutory and regulatory requirements  Evaluation of performance data of the product  Indicated opportunities for improvement

21. AET0012PPT 2004-03-13 21 QMS ACC. TO ISO 9001-2008 Management Responsibility Outputs of Quality Planning (ISO 9004) Management should systematically review outputs to ensure the effectiveness and efficiency of the Organization’s processes Outputs of quality planning should define the product realization and support processes needed in terms such as:  Skills and knowledge needed by the Organization  Responsibility and authority for implementation of process improvement plans  Resources needed, such as financial and infrastructure  Metrics for evaluating the improvement of performance  Needs for improvement including methods and tools

22. AET0012PPT 2004-03-13 22 QMS ACC. TO ISO 9001-2008 Management Responsibility Responsibility and Authority (5.5.1) Top management shall ensure that responsibilities, authorities and their interrelation are defined and communicated within the Organization(ISO 9001, 5.5.1)

23. AET0012PPT 2004-03-13 23 QMS ACC. TO ISO 9001-2008 Management Responsibility Management Representative (5.5.2) The responsibility of a management representative can include liaison with external parties (customers, interested parties) on matters related to the QMS (ISO 9001, 5.5.2) Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes: a) ensuring that processes needed for the QMS are established, implemented and maintained b) reporting to top management on the performance of the QMS and any need for improvement, c) ensuring the promotion of awareness of customer requirements throughout the Organization

24. AET0012PPT 2004-03-13 24 QMS ACC. TO ISO 9001-2008 Management Responsibility Internal Communication (ISO 9004 & 5.5.3)  Communicating Q Policy, requirements, objectives and accomplishments aids performance improvement and involves people in the achievement of Q Objectives (ISO 9004)  Management should encourage communication and feedback from people as a means of involving them (ISO 9004) l Top management shall ensure that appropriate communication channels are established within the Organization and that communication takes place regarding the effectiveness of the QMS (ISO 9001, 5.5.3)

25. AET0012PPT 2004-03-13 25 QMS ACC. TO ISO 9001-2008 Management Responsibility Management Review (5.6)

26. AET0012PPT 2004-03-13 26 QMS ACC. TO ISO 9001-2008 Management Responsibility Management Review (5.6) l Top management shall review the Organization’s QMS at planned intervals, to ensure its suitability, adequacy and effectiveness. l This review shall include assessing opportunities for improvement and the need for changes in QMS including Q Policy, and Q Objectives l Records from the management reviews shall be maintained

27. AET0012PPT 2004-03-13 27 QMS ACC. TO ISO 9001-2008 Management Responsibility Review Input (5.6.2) l Input to management review shall include information on: a) results of audit, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective action, e) follow-up actions from previous management reviews, f) planned changes that could affect the QMS and g) recommendations for improvements

28. AET0012PPT 2004-03-13 28 QMS ACC. TO ISO 9001-2008 Management Responsibility Other Review Inputs (ISO 9004) l Inputs to evaluate efficiency as well as effectiveness and consider interested parties should also include:  financial effects of quality-related activities,  market related factors such as technology, research and development and competitor performance,  feedback on satisfaction of interested parties,  performance of suppliers,  other factors which may impact the Organization such as social or environmental conditions and relevant statutory and regulatory changes.

29. AET0012PPT 2004-03-13 29 QMS ACC. TO ISO 9001-2008 Management Responsibility Review Output (5.6.3) l Output from the management review shall include decisions and actions related to: a) improvement of the effectiveness of the QMS and its processes, b) improvement of product related to customer requirements and c) resource needs.  Top management can use the review process as a powerful tool for the identification of opportunities for performance improvement  Selected output should be communicated to people (ISO 9004)

30. AET0012PPT 2004-03-13 30 QMS ACC. TO ISO 9001-2008 - Resource Management Resource Management (6) Provision of Resources (6.1) l The Organization shall determine and provide the resources needed: a) to implement and maintain the QMS and continually improve its effectiveness and b) to enhance customer satisfaction by meeting customer requirements.

31. AET0012PPT 2004-03-13 31 QMS ACC. TO ISO 9001-2008 - Resource Management Human Resources (6.2) l Personnel performing work affecting product quality shall becompetent on the basis of appropriate  education,  training,  skills and  experience

32. AET0012PPT 2004-03-13 32 QMS ACC. TO ISO 9001-2008 - Resource Management Human Resources (6.2) (cont.) Competence, Awareness and Training (6.2.2) l The Organization shall a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of such actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, e) maintain appropriate records of education, training, skills and experience

33. AET0012PPT 2004-03-13 33 QMS ACC. TO ISO 9001-2008 - Resource Management Involvement of People (ISO 9004) l To achieve both effectiveness and efficiency and improve performance, the Organization should encourage involvement and development of people by:  providing ongoing training and career planning,  establishing individual and team objectives,  involving them in objective setting and decision making,  recognizing and rewarding,  creating conditions to encourage innovation,  reviewing people’s needs and measuring their satisfaction

34. AET0012PPT 2004-03-13 34 QMS ACC. TO ISO 9001-2008 - Resource Management Infrastructure (6.3) l The Organization shall determine, provide and maintain the infrastructure needed to achieve conformity of product to requirements. l Infrastructure includes, for example, a) buildings, workspace and associated utilities, b) process equipment, both hardware and software and c) supporting services such as transport or communication.

35. AET0012PPT 2004-03-13 35 QMS ACC. TO ISO 9001-2008 - Resource Management Provision and Maintenance of Infrastructure (ISO 9004) l The Organization should define, provide and maintain the infrastructure by:  defining it in terms of function, availability, cost, safety, security and renewal;  developing and implementing maintenance methods (including type and frequency of maintenance and verification by element of infrastructure based on its criticality and usage);  consideration of environmental issues such as pollution, waste and recycling;  identification and mitigation of risk associated with uncontrollable natural phenomena.

36. AET0012PPT 2004-03-13 36 QMS ACC. TO ISO 9001-2008 - Resource Management Work Environment (6.4) l The Organization shall determine and manage the work environment needed to achieve conformity to product requirements.  Management should ensure that the work environment has a positive influence on motivation, satisfaction and performance of people(ISO 9004)  A suitable work environment is a combination of human and physical factors (ISO 9004)

37. AET0012PPT 2004-03-13 37 QMS ACC. TO ISO 9001-20008 - Resource Management Creation of Suitable Work Environment (ISO 9004) l The Organization should consider:  creative work methods and opportunities for greater involvement of people,  developing and implementing maintenance methods (including type and frequency of maintenance and verification by element of infrastructure based on its criticality and usage;  consideration of environmental issues such as pollution, waste and recycling;  identification and mitigation of risk associated with uncontrollable natural phenomena.