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ISO 9001:2000 QUALITY MANAGEMENT SYSTEM REQUIREMENTS

ISO 9001:2000 QUALITY MANAGEMENT SYSTEM REQUIREMENTS. REQUIREMENTS 1.0 SCOPE ISO 9001:2000 – Clause 1.1 “General”

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ISO 9001:2000 QUALITY MANAGEMENT SYSTEM REQUIREMENTS

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  1. ISO 9001:2000 QUALITY MANAGEMENT SYSTEM REQUIREMENTS • REQUIREMENTS 1.0 SCOPE ISO 9001:2000 – Clause 1.1 “General” • This clause includes also the requirement to address customer satisfaction “through the effective application of the system, including processes for continual improvement and prevention of non-conformity. • ISO 9001:2000 – Clause 1.2 “Application” This clause is a general description of the use of the term “Application”

  2. INTENT: All requirements of this international standard are generic and are intended to be applied to all organizations Regardless of TYPE, SIZE AND PRODUCT provided: WHY: Where any requirement of this international standard cannot be applied due to the nature of the organization or product, THIS CAN BE CONSIDERED FOR EXCUSION.

  3. WHAT: Where exclusions are made,claims of conformity of this international standard are are not acceptable unless: Exclusions are limited to requirements within CLAUSE 7 WHEN:…And such exclusions do not affect the organization’s ability and responsibility to provide product that fulfills customer and applicable regulatory requirements

  4. TERMS AND DEFINITIONS • This clause states that the terms and definitions given in ISO 9000:2000 QMS fundermentals and vocabulary apply to ISO 9001:2000 • The following diagram applies: • SUPPLIERORGANIZATIONCUSTOMER

  5. REQUIREMENTS 4.1 General Requirements • More emphasis has been put on the need for continuous improvement • Clarification on the necessary steps to implement the QMS is given

  6. Steps; - Identify the processes needed for QMS - Determine the sequence and interaction of these processes -Determine criteria and methods required to ensure the effective operation and control of these processes - Ensure the availability of information necessary to support the operation and monitoring of these processes I.e.provide necessary information to the right personnel.

  7. 4.2 Documentation requirements 4.2.1 General The QMS documentation shall include: • Documented statement of QUALITY POLICY and QUALITY OBJECTIVES • Quality Manual • Documented procedures required by the standard • Documents needed by the organization to ensure effective planning, operation and control of its processes • Quality records required by the international standard.

  8. The documented procedures required by the standard are: • CONTROL OF DOCUMENTS (4.2.3) • CONTROL OF QUALITY RECORDS (4.2.4) • INTERNAL AUDIT (8.2.2) • CONTROL OF NON-CONFORMING PRODUCT (8.3) • CORRECTIVE ACTION (8.5.2) • PREVENTIVE ACTION (8.5.3)

  9. 4.2.2 QUALITY MANUAL The term “Quality Manual” is defined as “a document specifying the QMS of an organization” There are no requirements here for the inclusion of the following in this sort of quality manual: • Quality Policy • Quality objectives NOTE: Although it is not required here, nothing prevents the organization from doing so.

  10. 5.0 MANAGEMENT RESPONSIBILITY All the sub clauses of the main clauses start with “Top management shall…” Provide - see clause 5.1 Ensure – see clause 5.2, 5.3, 5.4.1, 5.4.2, 5.5.1, 5.5.3 Appoint – see clause 5.5.2 Review – see clause 5.6.1

  11. 5.1 “MANAGEMENT COMMITMENT” Requires that Top Management shall provide evidence of its commitment of the • Development of the QMS • Implementation of the QMS • Continually improving its effectiveness

  12. By: • Communicating to the organization the importance of meeting customer as well us statutory and regulatory requirements • Establishing the quality policy • Providing a frame work for establishing and reviewing quality objectives • Requires that the quality policy is communicated and understood within the organization.

  13. 5.1 QUALITY OBJECTIVES QUALITY OBJECTIVES shall be measurable and consistent with the Quality Policy Under 5.4.1, requirement for quality objectivesat relevant functionsand levels within the organization has been stressed. 5.4.2 QMS PLANNING Top management shall ensure that:- Planning of the QMS is carried out in order to meet the requirements given in 4.1; as well as quality objectives and The integrity of the QMS is maintained when changes to the QMS are planned and implemented

  14. .5.2 MANAGEMENT REPRESENTATIVE (MR) Management shall appoint a member of management who irrespective of other responsibilities shall have responsibility and authority that includes: - 5.5.2 (C) Ensuring the promotion and awareness of customer requirements throughout the organization.

  15. 5.5.3 – INTERNAL COMMUNICATION Top management has been made responsible for the establishment of appropriate communication process” within the organization. Communication has been focused on the “EFFECTIVENESS of the QMS” and not the processes of the QMS.

  16. 5.6 “MANAGEMENT REVIEW” 5.6.1 General The following requirements have been included here: “This review shall include assessing opportunities for improvement of the QMS…

  17. 5.62 REVIEW INPUT Attention should be given to input and output related sub-clauses:- INPUT RELATED SUB-CLAUSES: Focus on very specific “information” • Customer feedback • Process performance and product conformity; and • Status of preventive and corrective actions • Planned changes that could affect the QMS. The inputs to management review shall include information on recommendations for improvement.

  18. .5.3 REVIEW OUTPUT RELATED SUB-CLAUSES: - Improvement of the effectiveness of QMS and its processes • Improvement of product related customer requirements, and • Resource needs “Decisions” also needs to result as outputs from the review process

  19. 6 – RESOURCE MANAGEMENT 6.1 “PROVISION OF RESOURCES” The requirement for an organization to determine and provide resources needed:-

  20. To implement and maintain the QMS and continually improve its effectiveness and, • Enhance customer satisfaction. 6.2.1 GENERAL HUMAN RESOURCES The focus of this clause is on “personnel performing work affectingproduct quality”.

  21. 6.2.2 “COMPETENCY, AWARENESS AND TRAINING The organization shall: - • Determine the necessary competence for personnel performing work affecting quality • Provide training or take other actions to satisfy these needs • Evaluate the effectiveness of the actions taken • 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 • Maintain appropriate records of education, training, skills and experience (see 4.2.4)

  22. 6.3 – “INFRASTRUCTURE” The organization to determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes: - • Building, workshops and associated utilities • Process equipment both hardware and software • Supporting services such as transport or communication. The primary requirements is to ensure processes are carried out under controlled conditions.

  23. 6.4 “WORK ENVIRONMENT” The organization to determine and manage the conditions of the work environment needed to achieve conformity to product requirements. The terms “conditions” provides flexibility to the organization in deciding WHICH “Work place conditions” they need to “determine and manage” here.

  24. PRODUCT REALIZATION 7.1 PLANNING Organization to plan and develop processes (documented procedures) by determining: • Quality objectives • Requirements of the product. • Processes • Documents • Resources specific to the process.

  25. PRODUCT REALIZATION 7.1 PLANNING Organization to plan and develop processes (documented procedures) by determining: • Quality objectives • Requirements of the product. • Processes • Documents • Resources specific to the process. • Verification

  26. Validation • Monitoring • Inspection and test activities • Criteria for product acceptance • Appropriate records • (evidence of planning and product meeting requirements)

  27. 7.2 CUSTOMER RELATED PROCESSES Organization to determine 7.2.1 Customer requirements (related to the product) • stated (delivery and post Delivery) • not stated (necessary for intended use) • Statutory and regulatory requirements • records to be maintained

  28. 7.2.2 REVIEW • For adequacy of the requirements • Records of review to be maintained 7.2.3 CUSTOMER COMMUNICATION Organization to determine and effect effective arrangements for communicating with customers in relation to • Product information • Enquiries • Customer feedback including complaints The arrangements should be formal.

  29. DESIGN AND DEVELOPMENT 7.3.1 PLANNING Plan and control design and development of the product by determining • Design and development stages • Review, verification and validation appropriate at each stage • Responsibilities and authorities

  30. 7.3.2 INPUTS Determined and recorded • Functional and performance requirements • Applicable statutory and regulatory requirements • Information derived from previous similar designs.

  31. 7.3.3 OUTPUTS • To be provided in a form that enables verification against inputs • Approved prior to release SHALL • Meet input requirements • Provide information for purchasing, production and service provision • Contain/reference product acceptance criteria • Specify characteristics essential for safe and proper use.

  32. 7.3.4 REVIEW • Be systematic and at suitable stages • Identify any problems • Propose all necessary actions. 7.3.5 VERIFICATION according to planned arrangements ENSURE: OUTPUTS meets input requirements.

  33. 7.3.6 VALIDATION According to planned arrangements ENSURE: Product is capable of meeting specified application requirements (prior to delivery or implementation of the product.) 7.3.7 CONTROL OF (CHANGES) • Changes be identified • Records maintained • Reviewed • Effective of changes on constituent parts be evaluated (if already delivered)

  34. 7.4 PURCHASING 7.4.1 PROCESS • Ensure a system of ensuring purchasing products conforms to specified purchase requirements • Establish criteria for selection, evaluation (re-evaluation) of suppliers • Evaluate, and select suppliers

  35. 7.4.2 INFORMATION • Describe product to be purchased • Indicate requirements for approval of product • State QMS requirements • (Ensure adequacy of specified purchase requirements prior to communicating to the supplier) 7.4.3 VERIFICATION OF PURCHASED PRODUCTS • Establish & implement inspection activities • Ensure purchased product meets specified purchase requirements

  36. 7.5 PRODUCTION & SERVICE PROVISION 7.5.1 CONTROL Plan and carry out activities under controlled conditions by ensuring • Availability of information (describe product characteristics) • Availability of work instructions • Use of suitable equipment • Availability/use of Monitoring and Measurement devices • Implement Monitoring and Measurement • Implement release, delivering/post delivery activities

  37. 7.5.2 VALIDATION OF PROCESSES: (VALIDATE SPECIAL PROCESSES – Process where resulting output cannot be verified by subsequent Monitoring and Measurement or where deficiencies become apparent only after the product is in use). Establish arrangements for these processes by. • Define criteria for review/approval • Approval of Equipment and Qualification of personnel • Use of specified methods, procedures • Re-validation

  38. 7.5.3 IDENTIFICATION & TRACEABILITY Shall • Identify product by suitable means throughout product realization • Identify product status with respect to Monitoring/Measuring requirements. FOR TRACEABILITY Shall Record and control the unique identification

  39. 7.5.4 CUSTOMER PROPERTY Shall Exercise care with customer property • Identify, verify, protect and safeguard • Record any loss, damage, unsuitability for use • Report to the customer • Records maintained

  40. 7.5.5 PRESERVATION Shall Preserve conformity (of product) Throughout Internal processing • Delivery to intended destination Shall include Identification • Handling • Packaging • Storage • Protection (Apply to constituent parts of the product)

  41. 7.6 CONTROL OF MONITORING/MEASUREMENT DEVICES Shall determine:- • Monitoring/measurement to be undertaken • Monitoring/measurement devices needed Shall establish

  42. Process to ensure monitoring/measurement is carried out in Constituent with monitoring/measuring requirements. Measuring equipment shall Be calibrated (or verified at specified intervals) prior to use. • Traceability to international or national standards • Be adjusted/re-adjusted as necessary • Be identified to enable calibration status to be determined • Be protected from damage

  43. 8. MEASURING, ANALYSIS AND IMPROVEMENT 8.1 General Plan, implement monitoring, measurement analysis and improvement processes TO: Demonstrate conformity of product • Ensure conformity and continued improvement of QMS • By applicable methods (e.g. statistical technique)

  44. 8.2 MEASUREMENT AND MONITORING 8.2.1 (Customer Satisfaction) Top management to ensure Effective, Efficient methods are used to identify areas of improvement. • Information relating to customer perception. e.g. satisfaction surveys for customer and other interested parties

  45. 8.2.2 INTERNAL AUDIT. Shall Conduct Internal Audit at Planned intervals • Plan audit program • Define audit criteria, scope, frequency • Clarify auditors impartially • Define responsibilities for various audit activities

  46. 8.2.3 OF PROCESS Shall apply suitable methods for monitoring (and where possible) measurements of QMS processes When planned results not achieved Correction & corrective action to be taken

  47. 8.2.4 OF PRODUCT Monitor & Measure • Product characteristics • Maintain evidence of conformity with acceptance criteria • Indicate authority for release and service delivery Condition No proceeding until planned arrangements have been satisfactorily completed Or Approved by relevant authority (or by customer)

  48. 8.3 CONTROL OF NON-CONFORMING PRODUCTS • Establish a documented procedure for specific activities. • Take action to eliminated detected nature of non-conformity • Authorize use, release/acceptance under concession (relevant authority/or customer • Take action of preclude original intended use • Record nature of non-conformity subsequent actions taken • Maintain the records

  49. Detection after delivery/use Take action appropriate to the effects, potential effects, of the non-conformity

  50. 8.4 ANALYSIS & DATA Shall Determine • Collect • Analyze

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