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ISO 9001: 2008 AUDITING

ISO 9001: 2008 AUDITING. Module 2 – A Review of ISO 9001:2008 Requirements Note: Standards and the comments of this section will be reviewed together. This is not an exact copy of the standard. ISO 9001:2000 Breakdown. 0 Introduction. 1 Scope. 2 Normative Reference. 3

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ISO 9001: 2008 AUDITING

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  1. ISO 9001: 2008 AUDITING Module 2 – A Review of ISO 9001:2008 Requirements Note: Standards and the comments of this section will be reviewed together. This is not an exact copy of the standard.

  2. ISO 9001:2000 Breakdown 0 Introduction 1 Scope 2 Normative Reference 3 Terms and Definitions 0.1 General 0.2 Process Approach 0.3 Relationship with ISO 9004 0.4 Compatibility with Other Mgmt. Systems 1.1 General 1.2 Application

  3. ISO 9001:2000 Breakdown 4 Quality Mgmt. System 5 Mgmt. Responsibility 6 Resource Mgmt. 7 Product Realization 8 Measurement, Analysis, & Improvement 4.1 General Requirements 4.2 Documentation Requirements 5.1 Mgmt Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, Authority & Communication 5.6 Mgmt. Review 6.1 Provision of Resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment 7.1 Planning of Product Realization 7.2 Customer-Related Processes 7.3 Design And Development 7.4 Purchasing 7.5 Production & Service Provision 7.6 Control of Monitoring & Meas. Devices 8.1 General 8.2 Monitoring & Measurement 8.3 Control of Non-Conforming Product 8.4 Analysis of Data 8.5 Improvement

  4. O Introduction 0.2 Process Approach (see Process Model in Section 3) • This standard promotes a process approach for development, implementation, and improving system effectiveness, as well as enhancing customer satisfaction by meeting customer requirements • Requires an organization to Determine and manage numerous linked activities. An activity or set of activities using resources and managed to enable transformation of input into outputs is considered a process • Identification and interactions of these processes as a system is considered the ‘process approach’ as it provides linkage between the individual processes and the overall system and their combination • Emphasizes the importance of • Understanding and meeting of the requirements • The need to consider processes in terms of added value • Obtaining results of process performance and effectiveness • Continual improvement of processes based on objective measurement • The model of a process-based QMS is shown in Figure 1, section 3 illustrates process linkages presented in clauses 4 to 8.

  5. O Introduction 0.3 Relationship with ISO 9004 • ISO 9001 and ISO 9004 have been developed as a ‘consistent pair’ designed to complement one another, but can be used independently; different scopes, but similar structure • ISO 9001 specifies requirements to use for internal applications by organizations, for certification or for contractual purposes, focusing on QMS effectiveness in meeting customer requirements • ISO 9004 provides guidance on a wider range of objectives of a QMS than ISO 9001, particularly for continual improvement of the organizations overall performance and efficiency as well as effectiveness. It is designed to help an organization to move beyond the requirements of ISO 9001 in pursuit of continual improvement of performance, but is not for certification or contractual purposes.

  6. 1 Scope 1.2 Application • All requirements of ISO 9001 are considered generic and are intended to be applicable to all organization, regardless of type, size and product • Any requirements that cannot be applied due to the nature of an organization and its product can be considered for exclusion • Any exclusions made cannot be considered as conforming to the standard unless they are limited to clause 7 where they do not affect the ability or responsibility of the organization to provide product that meets customer and applicable regulatory requirements

  7. 2 Normative Reference Reference standard ISO 9000: 2005 Quality Management Systems- Fundamentals and vocabulary. 2008 version is not available. ISO 9004: 2005 (2008 is not available)

  8. 3 Terms & Definitions • Terms and definitions are to be reviewed • The terms to describe the supply chain: 2000 Standard: SUPPLIER ORGANIZATION CUSTOMER (Interested Parties) 1994 Standard: SUBCONTRACTOR SUPPLIER CUSTOMER Wherever the term “product” occurs, it can also mean “service”.

  9. ISO 9001:2008 The changes to the standard are in blue lettering. Some word changes and notes added, no new requirements have been added. The changes are meant to help clarify the ISO requirements.

  10. 4 Quality Management System 4.1 General Requirements Organization establishes, documents, implements, maintains, and continually improves QMS • The organization shall; • determine the processes needed and their application throughout the organization • Determine the sequence and interaction of processes • criteria and methods to ensure effective operation and control • Ensure resource and information availability to support the operation and monitoring of processes • Monitor, measure where applicable and analyze processes • Implement actions to obtain planned results and continual improvement

  11. 4 Quality Management System 4.1 General Requirements (continued) • 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 to be applied to these outsourced processes shall be defined within the quality management system NOTE 1: Processes needed for the QMS referred to in this slide should include processes for management activities, provision of resources, product realization and measurement, analysis and improvement. NOTE 2: An outsourced process is a process that the organization needs for the quality management system and which the organization chooses to have performed by an external party.

  12. 4 Quality Management System • 4.1 Continued: NOTE 3: Ensuring control over outsourced processes does not absolve the organization from its responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as: a.) the potential impact of the outsourced process on the organizations capability to provide product that conforms to requirements b.) the degree to which the control for the process is shared c.) the capability of achieving the necessary control through the application of 7.4

  13. Explanation of 4.1 • Leading and operating an organization requires its successful management in a systematic and visible manner; resulting from the implementation and maintenance of a QMS that has been designed to continually improve its performance. • Organizations need to become customer-oriented by defining its systems and processes and clearly communicating for effective understanding, management and improvement. • Performance is based on measures and data developed for the effective and efficient operation and control of processes • Examples of activities to create a customer-oriented process: • Defining and promoting processes for organizational performance toward continual improvement • Acquiring and using process data regularly • Using self assessments and management review to evaluate

  14. 4 Quality Management System 4.2 Documentation Requirements 4.2.1 General • QMS documentation shall include; • Quality Policy and Quality Objectives • Quality Manual • Procedures and records required by ISO 9001: 2000 • Documents and recordsshall be determined by the organization to ensure effective planning, operation and control of its processes • Extent of QMS dependent on size of organization, type of activities, complexity and interaction of the processes and the competence of personnel NOTE 1: “Documented Procedure” means that the procedure is established, documented, implemented & maintained. A single document may address the requirements of one or more procedures.

  15. 4 Quality Management System 4.1 Note 1 continued; A requirement for a documented procedure may be covered by more then one document. NOTE 2: The extent of the QMS documentation can differ from one organization to another due to: a.) the size of the organization and type of activities b.) the complexity of the processes and their interface c.) the competence of personnel NOTE 3: The documentation can be in any form or type of media

  16. 4 Quality Management System 4.2.2 Quality Manual • The Quality Manual shall be established and maintained, including; • The scope of QMS, with details of and justifications for any exclusions • Permissible exclusions may be required where certain functions are absent e.g. Design & Development, Servicing, Customer Property, etc. This is excluded only from Element 7 : Product Realization. • The documented procedures or reference to them • A description of the interaction between the processes of QMS

  17. 4 Quality Management System 4.2.3 Control of Documents • Documents required by the QMS shall be controlled. Records shall be controlled per the requirements given in 4.2.4. • Documented procedures shall be established to define the controls needed for the: • Approval for adequacy prior to issue, • Review, update and re-approve documents, • To ensure changes and the current revisions status of documents are identified, • Ensure relevant versions of applicable documents are available at points of use, • Documents remain legible and readily identifiable • Ensure that 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 & apply suitable identification to them if they are retained for any purpose

  18. 4 Quality Management System 4.2.4 Control of Records Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the QMS shall be controlled Records shall remain legible, readily identifiable, and retrievable Records shall be established to define the controls needed for the: • Identification, • Storage, • Protection, • Retrieval, • Retention Time, and • Disposition of Records Documented procedure is required

  19. 5 Management Responsibility 5.1 Management Commitment Top Management shall provide evidence of its commitment to the development and implementation of the QMS and continually improving its effectiveness by; • Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, • Establishing the Quality Policy, • Ensuring quality objectives are established, • Conducting Management Reviews, and • Ensuring the availability of resources

  20. Explanation of 5.1 Management should consider: • Establishing vision, mission, policies, and strategy consistent with the organization’s purpose • Leading by example to develop trust • Communicating direction, objectives and values to all • Participating in improvement projects and programs • Obtaining feedback from all stakeholders • Identify processes that provide added value and the support processes that influence the effectiveness and efficiency of the realization processes • Create an environment to build involvement and development of people • Provide the structure and resources to support the goals and plans • Determine the measures for performance to gage success

  21. 5 MANAGEMENT RESPONSIBILITY • 5.2 Customer Focus • Top management shall ensure customer needs and expectations are determined and met with the aim of enhancing customer satisfaction

  22. Explanation of 5.2 • Determine the interested parties • Customers, end users • People within the organization • Owners, bankers, investors, public sector/community, unions • Suppliers, partners • Society affected by the organization or its products • Understand the needs and expectations of the customer (internal and external) • Translate needs into requirements • Identify and assess competition and market opportunities • Identify resources and develop programs to maintain them • Determine the potential benefits of supplier partnerships • Consider relationships with suppliers • Understand and apply statutory and regulatory requirements

  23. 5 Management Responsibility 5.3 Quality Policy • Top management shall ensure that the Quality Policy: • Is appropriate to the purpose of the organization, • Includes commitment to comply with requirements and continually improve the effectiveness of the QMS, • Provides a framework for establishing and reviewing quality objectives, • Is communicated and understood within the organization, and • Is reviewed for continuing suitability.

  24. 5 Management Responsibility 5.4 Planning 5.4.1 Quality Objectives • Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1a) are established at relevant functions and levels within the organization. These quality objectives shall be measurable and consistent with the Quality Policy.

  25. 5 Management Responsibility 5.4.2 Quality Management System Planning • Top Management shall ensure that a. the planning for the QMS is carried out to meet the requirement given in 4.1 as well as quality objectives, and b. Integrity of system is maintained when changes are planned and implemented to the QMS

  26. 5 Management Responsibility 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and Authority • Top management shall ensure that the responsibilities and authorities are defined and communicated within the organization.

  27. 5 Management Responsibility 5.5.2 Management Representative • Top management appoints a member of the organizations management who shall have responsibility & authority that includes: • Ensuring processes for QMS are established, implemented and maintained, • Reporting to top management on performance on QMS and any need for improvement, and • Ensuring the promotion of awareness of customer requirements throughout the organization Note: The responsibility of the management representative can include liaison with external parties on matters relating to the QMS

  28. 5 Management Responsibility 5.5.3 Internal Communication • Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the QMS.

  29. Explanation of 5.5.3 • Define and communicate the responsibility and authority for maintaining the system • Appoint Management Representative and provide appropriate authority • Define and implement the process to communicate the policies, requirements, objectives, and accomplishments • Meetings, recognition programs, postings, surveys, etc.

  30. 5 Management Responsibility 5.6 Management Review 5.6.1 General • Top management shall review the organization’s QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness • Management Review shall include assessing opportunities for improvement and the need for changes to the QMS, including the Quality Policy and Quality Objectives. • Records from Management Reviews shall be maintained (see 4.2.4).

  31. 5 Management Responsibility 5.6.2 Review Input • Includes • audit results, • customer feedback, • process performance, product conformity, • status of preventive and corrective actions, • follow-up actions from previous reviews; • changes that could affect the QMS; • improvement recommendations

  32. 5 Management Responsibility 5.6.3 Review Output • The output from the Management Review shall include any decisions and actions related to: • Improvement of the effectiveness of the QMS and its processes, • Improvement of product related to customer requirements, and • Resource needs.

  33. Explanation of 5.6 • Management Review should be developed as a tool to go beyond the requirements and provide a constant opportunity to make the system more efficient and effective • A platform to exchange input, ideas, discuss and evaluate the system and the business in an open format • Frequency is determined by the needs of the organization • Use the output from Reviews as a springboard toward improvement

  34. 6 Resource Management 6.1 Provision of Resources • The organization shall determine and provide the resources needed to: a) implement, maintain and continually improve the effectiveness of the quality management system b) To enhance customer satisfaction by meeting customer requirements

  35. Explanation of 6.1 Provision of Resources • Identify resources and make available to process performers • People • Infrastructure • Work environment • Information • Suppliers • Partners • Natural resources • Financial • Consider what is needed to improve the organization

  36. 6 Resource Management 6.2 Human Resources 6.2.1 General Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience. NOTE; conformity to product requirements can be affected directly or indirectly by personnel performing any task within the QMS.

  37. 6 Resource Management 6.2.2 Competence, Training & Awareness • The organization shall: a) determine the necessary competence for personnel performing work affecting product quality, b) where applicable provide training or take other actions to achieve the necessary competence c) evaluate the effectiveness of the 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, and e) maintain appropriate records of education, training, skills and experience (see 4.2.4)

  38. 6 Resource Management 6.3 Infrastructure • The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable; a. Buildings, workspace and associated utilities b. Process equipment (both hardware and software), and c. Support services (such as transport and communication or information systems)

  39. 6 Resource Management 6.4 Work Environment • Determine and manage the work environment needed to achieve conformity to product requirements NOTE: the term work environment relates to those conditions under which work is performed including physical, environment and other factors (such as noise, temperature, humidity, lighting or weather)

  40. Explanation of 6.4 Ensure environment has a positive influence on the people: • Open doors, creative thinking, positive attitude • Safety rules and guidance • Ergonomics • Workplace location • Social interaction • Facility • Utilities • Physical environment

  41. 7 Product Realization 7.1 Planning of Product Realization -- The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the QMS (see 4.1) -- In planning product realization, the organization shall determine the following, as appropriate: • Quality objectives and requirements for the product; • The need to establish processes and documents and to provide resources specific to the product; • Required verification, validation, monitoring, measurements, inspection, and test activities specific to the product and the criteria for product acceptance; • Records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)

  42. 7 Product Realization 7.1 Planning of Product Realization --The output of this planning shall be in a form suitable for the organization’s method of operations. NOTE 1: A document specifying the processes of the QMS (including product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as the quality plan. NOTE 2: The organization may also apply the requirements given in 7.3 to the development of product realization processes.

  43. Explanation of 7.1 • Driven by the need for continual improvement • Define the outputs of core processes as well as the necessary inputs and activities required for efficient and effective achievement • Define the interrelationships of processes • Consider verification and validation activities • Procedures should document processes necessary to support effective and efficient system operation • Process should considered performers for skills, safety, coordination of processes, review of process performance and potential for innovation

  44. 7 Product Realization 7.2 Customer Related Processes 7.2.1 Determination of Requirements Related to the Product --The organization shall determine a. Requirements specified by customer including delivery and post-delivery activities, b. Requirements not stated by the customer but necessary for the specified or intended use where known and, c. Statutory and regulatory requirements applicable to the product, and d. Any additional requirements considered necessary by the organization NOTE: Post delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposition.

  45. 7 Product Realization 7.2.2 Review of Requirements Related to the Product • Organization shall review the requirements related to the product. This review shall be conducted prior to the organization’s commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that: • Product requirements are defined, • Contract or order requirements differing from those previously expressed are resolved, and • Organization has the ability to meet the defined requirements Records of the results of the review and actions arising from the review shall be maintained. (4.2.4)

  46. 7 Product Realization 7.2.2 Review of Requirements Related to the Product (cont.) • Records of the Review and actions arising from the review shall be maintained • Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance • Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. NOTE: In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.

  47. 7 Product Realization 7.2.3 Customer Communication • Determine and implement effective arrangements for customer communication in relation to: • Product information • Enquiries, contracts or order handling (including amendments) • Customer feedback, including complaints

  48. Explanation of 7.2 • Define the mutually acceptable processes to communicate efficiently and effectively with all interested parties • Implement and maintain processes to ensure the understanding of needs and expectations as well as translating requirements for the organization • Understand the impact of the processes before initiating action; assure its mutual acceptability

  49. 7 Product Realization 7.3 Design and Development 7.3.1 Design and Development Planning -- The organization shall plan and control the design and development of product. --During the design and development planning, the organization shall determine • The design and development stages, • The review, verification and validation that are appropriate to each design and development stage, and • The responsibilities and authorities for design and development. --The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. --Planning output shall be updated, as appropriate, as the design and development progresses.

  50. 7 Product Realization 7.3.1 continued: NOTE: Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as suitable for the product and the organization.

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