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4 Quality Management System |
Yes or No |
Section or Paragraph |
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4.1 General Requirements |
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1. |
Has the organization defined its processes to ensure its products meet customer and applicable regulatory requirements? |
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2. |
Does the organization manage (measure, monitor, and analyze) its processes to ensure its products conform to customer requirements? |
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3. |
Does the organization implement actions necessary to achieve planned results and continual improvement of their processes? |
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4. |
Does the organization ensure the availability of resources and information necessary to support the operation and monitoring of their processes? |
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4.2 Documentation Requirements |
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4.2.1 General |
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5. |
Does the quality management system documentation include:
a) Documented statements of a quality policy and quality objectives?
b) A quality manual?
c) Documented procedures required by this international standard?
d) Documents needed by the organization to ensure the effective planning, operation and control of its processes?
Note: The decisions to develop a procedure can differ from one organization to another based on such factors as size and type of organization, complexity, and interaction of processes, and components of personnel involved in performing the work. |
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| 6. |
Does the organization ensure that all personnel have access to quality management system documentation and are aware of relevent procedures? |
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4.2.2 Quality Manual |
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7. |
Has the organization established a written quality manual that includes the following: a) The scope of quality management system, including details of and justification for any exclusion (see 1.2)?
b) A description of the interaction between the processes of quality management system? |
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4.2.3 Control of Documents |
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8. |
Is a documented procedure to control documents including quality records established and does the procedure include the following controls:
a) To review and update as necessary and re-approve documents?
b) To ensure the documents remain legible and readily identifiable?
c) To prevent unintended use of obsolete documents?
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4.2.4 Control of Records |
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9. |
Are records established and maintained to provide evidence of
a) Product conformity to requirements?
b) Effective operation of the quality management system? |
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| 10. |
Are records identifiable, legible, and readily retrievable? |
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5 Management Responsibility |
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5.1 Management Commitment |
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11. |
Has top management provided evidence of its commitment to the development and implementation of the organization’s QMS? |
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12. |
Has top management communicated the importance of meeting customer as well as statutory and regulatory requirements? |
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5.2 Customer Focus |
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13. |
Has top management ensured customers’ requirements have been determined and are fulfilled with the aim of enhancing customer satisfaction? |
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5.3 Quality policy |
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14. |
Does top management ensure the policy is appropriate to the purpose of the organization? |
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15. |
Is there a specific commitment in the quality policy to comply with requirements and continually improve the effectiveness of the QMS? |
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16. |
Does the quality policy provide the framework for establishing and reviewing quality objectives? |
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17. |
Is the quality policy reviewed for continuing suitability? |
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5.4 Planning |
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5.4.1 Quality objectives |
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18. |
Has the top management established quality objectives including those needed to meet requirements for product at each (relevant) function and level? |
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19. |
Are quality objectives measurable? |
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20. |
Are quality objectives consistent with the quality policy? |
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21. |
Do objectives support the organization’s quality policy commitment to continual improvement? |
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22. |
Do objectives include those requirements needed for products? |
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5.4.2 Quality management system planning |
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23. |
Has top management ensured that:
a) The planning of the QMS is performed to meet the quality objectives and requirements?
b) The integrity of the QMS is maintained during changes initiated in processes and activities? |
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5.5 Responsibility, authority and communication |
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5.5.2 Management representative |
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24. |
Does the MR provide input to organization top management on the performance of the QMS and needs for improvement? |
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25. |
Does the MR promote awareness of customer requirements throughout the organization? |
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5.5.3 Internal Communication |
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26. |
Has the organization established processes to ensure various levels and functions within the organization communicate about the effectiveness of the quality management system? |
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5.6 Management Review |
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5.6.1 General |
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27. |
Does management review include an evaluation of the QMS to ensure its continuing suitability, adequacy, and effectiveness? |
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28. |
Does the review evaluate the need for changes to the organization’s QMS? |
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5.6.2 Review input |
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29. |
Do management reviews include information inputs to the following areas:
a) Customer feedback
a) Process performance and product conformity
b) Status of preventive and corrective actions
c) Follow-up actions from previous management reviews
d) Planned changes that could affect the quality management system
e) Recommendations for improvement? |
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5.6.3 Review output |
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30. |
Do outputs from management review include actions to:
a) Improvements of the effectiveness of the quality management system and its processes
b) Improvement of product related to customer requirements
c) Resource needs? |
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6 Resource Management |
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6.1 Provision of Resources |
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31. |
Does management determine and provide resources needed to:
a) Implement, maintain and improve, the quality system
b)
Enhance customer satisfaction by meeting customer requirements? |
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6.2 Human Resources |
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6.2.2 Competence, awareness, and training |
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32. |
Does the organization identify how they determine and provide competent personnel to perform work affecting quality? |
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33. |
Does the organization provide training or take other actions to satisfy competence needs? |
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34. |
Does the organization evaluate the effectiveness of training or other actions? |
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35. |
Does the organization ensure personnel are informed about the relevance and importance of their activities and how they contribute to the achievement of the quality objectives? |
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36. |
Are appropriate records of education, training, skills and experience maintained? |
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37. |
Is the work environment suitable to ensure conformity to product requirements? |
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7 Product realization |
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7.1 Planning of product realization |
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38. |
Has the organization planned (defined the sequence and content of) the processes and sub-processes it needs to produce its product or provide its services?
NOTE: The output of this planning shall be in a form suitable for the organization’s method of operations. |
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7.2 Customer-related processes |
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7.2.2 Review of requirements related to the product |
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39. |
Does the organization review all requirements of the product, including those specified by the customer? |
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40. |
Is the review conducted prior to commitment to supply a product (e.g. submission of quotes, acceptance of orders, acceptance of changes to orders)? |
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| 41. |
Does this review ensure that:
a) Product requirements are adequately defined?
b) The organization has the ability to meet the requirements?
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| 42. |
When requirements are changed, does the organization ensure that relevant documents are revised and that relevant personnel are made aware of the changed requirements? |
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7.2.3 Customer communication |
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43. |
Has the organization identified and implemented effective arrangements for communication with its customers in relation to:
a) Product information?
b) Enquiries, contracts or order hauling, including amendments?
c) Customer feedback, including customer complaints? |
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7.3 Design and development |
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7.3.1 Design and development planning |
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44. |
Does the organization plan and control the design and development of product? |
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7.4 Purchasing |
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7.4.1 Purchasing control |
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| 45. |
Does the organization ensure that purchased product conforms to specified purchase requirements? |
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46. |
Has the organization established criteria for selection, evaluation, and reevaluation of its suppliers? |
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7.4.2 Purchasing information |
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| 47. |
Do purchasing documents fully describe the product to be purchased? |
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7.5 Production and service provision |
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7.5.1 Control of production and service provision |
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48. |
Does the organization plan and carry out production and service under controlled conditions? |
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7.5.1.2 Control of production process changes |
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49. |
Are changes affecting processes, production equipment, tools and programs documented? |
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| 50. |
Are production equipment, tools and programs validated prior to use and maintained and inspected periodically according to documented procedures? |
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7.5.2 Validation of processes for production and service provision |
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51. |
Does the organization validate any processes where the resulting output cannot be verified by subsequent monitoring or measurement (this includes processes where deficiencies become apparent only after the product is in use or the service has been delivered)?
NOTE: These processes are frequently referred to as special processes. |
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| 52. |
Do validation processes include re-validation? |
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7.5.3 Identification and traceability |
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53. |
Has the organization identified the product by suitable means throughout product realization? |
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| 54. |
Where traceability is a requirement, does the organization control and record unique identification of the product? |
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7.5.4 Customer property |
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55. |
Has the organization identified, verified, protected and safeguarded customer property provided for use or incorporation into the product? |
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| 56. |
Has the organization defined methods to identify and record customer products that are lost, damaged, or otherwise made unsuitable and report such to the customer? |
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7.5.5 Preservation of product |
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