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  • 1. Introduction to ISO 9001:2008
  • 2. Evolution of quality standards ISO 9001 2008 ISO 9001 1987 ISO 9001 1994 ISO 9001 2000
  • 3. Quality System Standard
    • generic (ISO 9000)
    • industry related (AS 9000, TL 9000)
  • 4. ISO 9002 and 9003
    • Prior to ISO 9001:2000, there were ISO 9002 and ISO 9003 too. These were subsets of ISO 9001 with certain exclusions.
    • ISO 9002 & ISO 9003 (1987 and 1994) incorporated in ISO 9001:2000 and withdrawn
  • 5. Process approach
    • Process approach to quality management encouraged
    • An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process.
  • 6. Processes: Activities or set of activities Input Output Controls Resources
  • 7. Processes - understand interactions Process A Process D Process B Process C Input Output Controls Resources
  • 8. Customer satisfaction C U S T O M E R S C U S T O M E R S Management responsibility Resource management Measurement, Analysis and improvement Product Product realisation Continual Improvement of the Quality Management System R e q u i r e m e n t s S a t i s f a c t i o n Input Output
  • 9. Relationship with ISO 9001 and ISO 9004
    • Designed to complement each other
    • Can be used independently
    • Different scope - similar structure
    • ISO 9001 can apply for certification or contractual purposes and focuses on effectiveness
    • ISO 9004 provides wider focus on quality management
  • 10. 1 Scope (1.1 General)
    • Standard specifies QMS requirements for use to:
    • demonstrate organisation’s ability to consistently provide product meeting customer & applicable statutory & regulatory (legal) requirements
    • enhance customer’s satisfaction through effective application of the system including processes for its continual improvement and assurance of conformity to customer and applicable statutory & regulatory requirements
  • 11. 1.2 Application
    • Requirements are generic
    • Requirement may be excluded if cannot be applied due to the nature of organisation and its product
    • Exclusions must:
      • Not affect ability or responsibility to provide conforming product
      • Be limited to Clause 7
  • 12. 2 Normative reference
    • ISO 9000 : 2005, Quality management systems - Fundamentals and vocabulary.
  • 13. 3 Terms and definitions
    • The term “product” also means “service”
  • 14. 4.1 General requirements
    • Establish, document, implement and maintain a QMS and continually improve its effectiveness in accordance with the standard
  • 15. 4.1 General Requirements
    • Determine the processes necessary for QMS
    • Determine the sequence and interaction of processes
    • Determine criteria & methods to ensure effective operation & control of the processes
    • Ensure availability of resources and information needed to support the operation & monitoring of the processes
    • Monitor, measure where applicable and analyse processes
    • Implement actions necessary to achieve planned results & continual improvement
  • 16. 4.1 General Requirements
    • Manage the processes in accordance with the standard
    • Ensure control of outsourced processes affecting product conformity
    • Define control of outsourced processes within the QMS
    • Control over outsourced processes does not absolve the organization of its responsibilities
  • 17. 4.2 Documentation requirements
    • 4.2.1 General
    • QMS documentation:
      • Quality policy, objectives
      • Quality manual
      • Documented procedures and records
      • Documents, including records determined by the organisation
  • 18. 4.2.1 General
    • Documented procedure means that it must be established, documented, implemented and maintained
    • Extend of documentation may differ due to
      • Size & type of organisation
      • Complexity & interaction of processes
      • Competence of personnel
    • Documentation may be in any type of media
  • 19. 4.2.2 Quality manual
    • Quality manual must include as minimum:
      • The scope of QMS including details of, and justification for, any exclusions
      • Documented procedures or reference thereto
      • Description of the interaction between the processes of the QMS
  • 20. 4.2.3 Control of documents
    • Documented procedures to:
      • approve documents prior to issue
      • review, update as necessary and re-approve documents
      • to identify the changes and the current revision status of documents
      • to ensure documents remain legible, readily identifiable
      • ensure relevant versions of applicable documents are available at points of use
      • ensure that documents of external origin necessary for planning and operation of QMS are identified and distribution controlled
      • obsolete documents are prevented from unintended use and identified if kept for any reason
  • 21. 4.2.4 Control of records
    • Records to provide evidence are controlled
    • Documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of quality records.
    • Records must be legible, readily identifiable and retrievable.
  • 22. 5 Management responsibility
    • 5.1 Management commitment
    • 5.2 Customer focus
    • 5.3 Quality policy
    • 5.4 Planning
      • 5.4.1 Quality objectives
      • 5.4.2 QMS planning
    • 5.5 Responsibility, authority and communication
      • 5.5.1 Responsibility & authority
      • 5.5.2 Management representative
      • 5.5.3 Internal communication
    • 5.6 Management review
      • 5.6.1 General
      • 5.6.2 Review input
      • 5.6.3 Review output
  • 23. 5.1 Management commitment
    • Provide evidence of commitment to the development implementation and continual improvement of QMS by:
      • communicating the importance of meeting customer and statutory and regulatory requirements
      • establishing quality policy & objectives
      • management reviews
      • provision of resources
  • 24. 5.2 Customer focus Determine customer requirements Meet requirements Customer satisfaction
  • 25. 5.3 Quality policy
    • appropriate to the purpose of the organisation
    • commitment to comply with requirements
    • continually improve the effectiveness of the QMS
    • framework for establishing & reviewing quality objectives
    • communicated and understood
    • reviewed for continuing suitability
  • 26. 5.4.1 Quality objectives
    • Establish quality objectives
    • Measurable & consistent with the quality policy
    • Include those needed to meet requirements for product
  • 27. 5.4.2 Quality management system planning
    • Planning of the QMS is carried out in order to meet requirements given in 4.1, as well as the quality objectives
    • Maintain the integrity of the QMS integrity when changes are planned and implemented
  • 28. 5.5 Responsibility, authority and communication
    • 5.5.1 Responsibility and authority
    • define and communicate responsibilities and authorities
  • 29. 5.5.2 Management Representative
    • Member of the organization’s management
    • Ensures that processes needed for the QMS are established, implemented and maintained
    • Reports on performance of QMS including needs for improvement
    • Promotes awareness of customer requirements
  • 30. 5.5.3 Internal communication
    • Communication processes are established
    • Communication takes place regarding the effectiveness of QMS
  • 31. 5.6 Management Review
    • 5.6.1 General
    • Review of the QMS by top management at planned intervals to:
      • ensure QMS suitability, adequacy & effectiveness
      • assess opportunities for improvement
      • evaluate the need for changes to QMS including policy & objectives
    • Records maintained.
  • 32. 5.6.2 Review input
      • audit results
      • customer feedback
      • process performance
      • product conformity
      • status of PAs and CAs
      • follow up actions from earlier reviews
      • changes that could affect the QMS
      • recommendations for improvement
    Management Review
  • 33. 5.6.3 Review output
    • improved effectiveness of the QMS
    • improvement of product
    • resource needs
    Management Review
  • 34. 6 Resource Management
    • 6.1 Provision of resources
    • 6.2 Human resources
      • 6.2.1 General
      • 6.2.2 Competence, training and awareness
    • 6.3 Infrastructure
    • 6.4 Work environment
  • 35. 6.1 Provision of resources
    • Determine & provide the resources needed to:
      • implement, maintain the QMS and continually improve its effectiveness
      • enhance customer satisfaction
  • 36. 6.2 Human Resources
    • 6.2.1 General
    • Personnel performing work affecting conformity to product requirements must be competent on the basis of :
        • appropriate education
        • training
        • skills
        • experience.
  • 37. 6.2.2 Competence, training and awareness
    • Determine the necessary competence
    • Provide training or take other action to satisfy those needs
    • Evaluate the effectiveness of actions taken
    • Ensure staff aware of relevance and importance of their activities and contribution to achieving objectives
    • Maintain appropriate records of education, training, skills and experience
  • 38. 6.3 Infrastructure
    • Determine, provide & maintain the infrastructure needed to achieve product conformity. Infrastructure includes, as applicable:
      • buildings, workspace
      • equipment
      • supporting services
  • 39. 6.4 Work environment
    • Determine and manage the work environment needed to achieve product conformity.
  • 40. 7 Product realization
    • 7.1 Planning of product realization
    • 7.2 Customer related processes
    • 7.3 Design & development
    • 7.4 Purchasing
    • 7.5 Production & service provision
    • 7.6 Control of measuring & monitoring equipment
  • 41. 7.1 Planning of product realization
    • Planning must determine as appropriate:
      • quality objectives and requirements for the product
      • the need for processes, documentation, resources specific to the product
      • verification and validation activities & acceptance criteria
      • Records to provide evidence
  • 42. 7.2 Customer related processes
    • 7.2.1 Determination of requirements related to product
    • 7.2.2 Review of requirements related to product
    • 7.2.3 Customer communication
  • 43. 7.2.1 Determination of requirements related to product
    • Organisation must determine:
      • requirements specified by the customer
      • requirements not specified but necessary
      • statutory and regulatory requirements applicable to product,
      • any additional requirements
  • 44. 7.2.2 Review requirements related to the product
    • Review requirements before commitment to supply product & ensure that:
      • product requirements are defined
      • difference between contract requirements from those previously expressed resolved
      • organisation has ability to meet the requirements
    • Record the results of review and actions
    • Confirm requirements, when customer does not provide documented requirements
    • When requirements are changed ensure that documents are amended and relevant persons are made aware of the changes.
  • 45. 7.2.3 Customer communication
    • Effective arrangements for communication with customers relating to :
      • product information
      • enquiry, contract & order handling including amendments
      • customer feedback including complaints
  • 46. 7.3 Design & development (not applicable in L&M)
    • 7.3.1 Design & development planning
    • 7.3.2 Design & development inputs
    • 7.3.3 Design & development outputs
    • 7.3.4 Design & development review
    • 7.3.5 Design & development verification
    • 7.3.6 Design & development validation
    • 7.3.7 Control of design & development changes
  • 47. 7.3.1 Design & development (D&D) planning
    • Plan & control D&D of the product.
    • Planning to include:
      • D&D stages
      • required review, verification and validation activities
      • responsibilities & authorities for D&D
    • Interfaces between groups must be managed
    • Planning to be updated as the D&D progresses
  • 48. 7.3.2 Design & development inputs
    • Determine & record product requirements including:
      • functional & performance requirements
      • applicable statutory and regulatory requirements
      • information from previous similar designs
      • any other essential requirements
    • Review input for adequacy
    • Requirements must be complete, unambiguous and not in conflict with each other
  • 49. 7.3.3 Design & development outputs
    • D&D output in a form suitable for verification
    • D&D output must
      • meet the input requirements
      • provide information for purchasing, production and service provision
      • contain or reference acceptance criteria
      • define characteristics essential for proper & safe use
    • Approve output prior to release
  • 50. 7.3.4 Design & development review
    • At suitable stages systematic reviews of D&D to:
      • evaluate the ability to meet requirements
      • identify problems and propose follow up
    • Involve all functions concerned
    • Record the results and any necessary actions
  • 51. 7.3.5 Design & development verification
    • Verify D&D to ensure that output meets the input requirements
    • Record the results of verification and necessary actions
  • 52. 7.3.6 Design & development validation
    • Perform D&D validation to confirm that product is capable of meeting the requirements for the specified or intended use
    • Whenever applicable to be completed prior to delivery
    • Results of validation and necessary actions must be recorded
  • 53. 7.3.7 Control of design and development changes
    • Design & development changes must be identified and records maintained
    • Changes must be reviewed, verified and validated as appropriate and approved before implementation
    • Record results of review of changes and any necessary actions
  • 54. 7.4 Purchasing
    • 7.4.1 Purchasing process
    • 7.4.2 Purchasing information
    • 7.4.3 Verification of purchased product
  • 55. 7.4.1 Purchasing process
    • Ensure that purchased product meets requirements
    • Type & extend of control depends on effect purchased product may have on the final product
    • Evaluate and selects suppliers based on their ability to supply conforming product
    • Establish criteria for selection, evaluation and re-evaluation of suppliers
    • Results of evaluation and any necessary actions must be recorded
  • 56. 7.4.2 Purchasing information
    • Purchasing information must include where appropriate:
      • requirements for approval of product, procedures, processes and equipment
      • requirements for qualification of personnel
      • quality management system requirements
    • Ensure adequacy of specified purchase requirements prior to their communication to supplier
  • 57. 7.4.3 Verification of purchased product
    • Establish & implement inspection or other activities needed to ensure purchased product conformity
    • Where organisation or its customer propose verification at supplier’s premises, organisation must specify in purchasing information:
      • verification arrangements
      • method of product release
  • 58. 7.5 Production and service provision
    • 7.5.1 Control of production and service provision
    • 7.5.2 Validation of processes for production and service provision
    • 7.5.3 Identification & traceability
    • 7.5.4 Customer property
    • 7.5.5 Preservation of product
  • 59. 7.5.1 Control of production and service provision
    • Plan and carry out production & service provision under controlled conditions. Controlled conditions include as applicable:
      • a) availability of information describing product characteristics
      • b) availability of work instructions, as necessary
      • c) the use of suitable equipment
      • d) availability & use of monitoring and measuring equipment
      • e) implementation of monitoring and measurement
      • f) the implementation of product release, delivery and post delivery activities
  • 60. 7.5.2 Validation of processes
    • Validate processes where outcome is not verified and as a consequence, deficiencies may become apparent after delivery
    • Validation shall demonstrate the ability of processes to achieve results
    • For these processes establish:
      • criteria for review and approval of the process
      • approval of equipment and qualification of personnel
      • use of defined methods & procedures
      • requirements for records
      • revalidation
  • 61. 7.5.3 Identification and traceability
    • Where appropriate identify product by suitable means throughout product realization
    • Identify status with respect to measurement & monitoring requirements throughout product realization
    • Where traceability is required control the unique identification of product
    • Maintain records
  • 62. 7.5.4 Customer property
    • Care for customer’s property while it is under organisation’s control or being used by organisation
    • Identification, verification, protection & safeguarding customer property provided for use or incorporation
    • Any customer property that is lost, damaged or found unsuitable must recorded & reported to customer
      • Customer property includes intellectual property & personal data
  • 63. 7.5.5 Preservation of product
    • Preserve the product during internal processing and final delivery to intended destination
    • Include identification, handling, packaging, storage and protection
    • This applies to constituent parts of a product
  • 64. 7.6 Control of monitoring & measuring equipment
    • Determine monitoring and measurements to be made & measurement & monitoring equipment needed to provide evidence of conformity of product
    • Ensure measuring and monitoring is carried out consistently with monitoring and measurement requirements
    • Suitability of measuring/monitoring software must be confirmed prior to use and re-confirm as necessary
  • 65. 7.6 Control of monitoring & measuring equipment
    • Calibrate or verify or both at specified intervals or prior to use against international or national standards. Where no such standard exist record the basis
    • Adjust or re-adjust as necessary
    • Have identification to determine calibration status
    • Safeguard from adjustments invalidating calibration
    • Protect from damage or deterioration during handling, maintenance& storage
    • record results of calibration
    • assess and record validity of previous results when device found to be out of calibration
  • 66. 8 Measurement, analysis and improvement
    • 8.1 General
    • 8.2 Monitoring/measurement
      • 8.2.1 Customer satisfaction
      • 8.2.2 Internal Audit
      • 8.2.3 Monitoring & measurement of processes
      • 8.2.4 Monitoring & measurement of product
    • 8.3 Control of nonconforming product
    • 8.4 Analysis of data
    • 8.5 Improvement
      • 8.5.1 Continual improvement
      • 8.5.2 Corrective action
      • 8.5.3 Preventive action
  • 67. 8.1 General
    • Plan & implement measurement, monitoring analysis and improvement processes needed to:
      • demonstrate conformity to product requirements
      • ensure conformity of the QMS
      • continually improve the effectiveness of the QMS
  • 68. 8.2.1 Customer satisfaction
    • Organisation shall monitor information related to customer perception as to whether the organisation has met customer requirements.
    • The methods for obtaining and using this information must be determined
  • 69. 8.2.2 Internal audit
    • Conduct internal audits at planned intervals to determine if :
      • QMS conforms to the planned arrangements, requirements of the standard and organisation’s requirements
      • QMS is effectively implemented & maintained
    • Plan the audit programme considering:
      • status and importance of the processes and the areas
      • results of previous audits
    • Define audit criteria, scope, frequency & methodologies
  • 70. 8.2.2 Internal audit
    • Select auditors to ensure objectivity and impartiality.
    • Auditor must not audit own work.
    • The documented procedure must cover:
      • responsibilities & requirements for planning and conducting audits
      • reporting results and maintaining records
    • Corrective actions without undue delay
    • Follow up to verify actions taken & report verification results
  • 71. 8.2.3 Monitoring and measurement of processes
    • Apply suitable methods for monitoring and, where applicable, measurement of QMS processes
      • These methods shall demonstrate the ability of the processes to achieve planned results
      • Where planned results are not achieved corrections and corrective actions must be taken
  • 72. 8.2.4 Monitoring and measurement of product
    • Monitor & measure product characteristics to verify conformity at appropriate stages
    • Evidence of conformity with the acceptance criteria must be maintained.
    • Records must indicate the person(s) authorising release of the product for delivery to the customer
    • Release or delivery must not proceed until all the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer
  • 73. 8.3 Control of nonconforming product
    • Nonconforming product must be identified and controlled to prevent unintended use or delivery
    • Documented procedure to define controls, responsibility and authority
    • When the nonconforming product is corrected it must be re-verified to demonstrate conformity
  • 74. 8.3 Control of nonconforming product
    • Organisation must deal with nonconforming product by one or more of the following ways:
      • action to eliminate detected nonconformity
      • concession
      • preclude original intended use or application
      • Taking actions appropriate to the effects, when nonconformity is detected after delivery
    • Records of the nature of nonconformity and any subsequent action including concessions must be maintained
  • 75. 8.4 Analysis of data
    • Determine, collect & analyse appropriate data to demonstrate the suitability and effectiveness of QMS and to evaluate where continual improvement of the QMS can be made
    • Data from measurement & monitoring & other relevant sources
    • Analyze data to provide information on:
      • customer satisfaction
      • conformity to product requirements
      • process, product characteristics and their trends including opportunities for preventive action
      • suppliers
  • 76. 8.5 Improvement
    • 8.5.1 Continual improvement
    • Organisation shall continually improve the effectiveness of the QMS through use of:
      • quality policy
      • quality objectives
      • audit results
      • analysis of data
      • corrective actions
      • preventive actions
      • management review
  • 77. 8.5.2 Corrective action
    • Take actions to eliminate the causes of nonconformities to prevent recurrence.
    • Corrective actions appropriate to the impact of the problem
    • Documented procedure shall define requirements for:
      • reviewing nonconformities (including customer complaints)
      • determining the causes of nonconformities
      • Evaluating the need for corrective action
      • determining & implementing action needed
      • recording results of action taken
      • reviewing the effectiveness of the corrective action taken
  • 78. 8.5.3 Preventive action
    • Determine action to eliminate the causes of potential nonconformances to prevent occurrence.
    • Actions appropriate to the impact of the potential problem
    • Documented procedure must define the requirements for
      • determining potential nonconformances & their causes
      • evaluating the need for preventive action
      • determining and implementing action needed
      • recording the results of action taken
      • reviewing the effectiveness of the preventive action taken

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