Audit Preparation

  • Review corrective actions for previous IA findings

  • Review corrective actions for previous EA findings

  • Review corrective actions for any customer complaints

  • Review corrective actions for any customer audit findings

5.1 Management Commitment

  • Is there evidence of commitment by top management toward the development, implementation and improvement of the quality management system and continually improving its effectiveness by:

  • a) communicating to the organization the importance of meeting customer’s, statutory and regulatory requirements?



  • b) establishing the quality policy?

  • c) ensuring that quality objectives are established?

  • d) conducting management reviews, and

  • e) ensuring the availability of resources?

5.2 Customer Focus

  • Does top management ensure that customer requirements are determined?

  • Does top management ensure that customer requirements are met?

  • Is this with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1)?

  • AS9100C - How does top management ensure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not, or will not be achieved?

5.3 Quality Policy

  • How has top management ensured 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 quality management system?

  • c) provide a framework for establishing and reviewing quality objectives?

  • d) is communicated & understood within the organization? and

  • e) is reviewed for continuing stability?

5.4 Planning

5.4.1 Quality Objectives

  • How has top management ensured that quality objectives, including those needed to meet requirements for product (see 7.1a), are established at relevant functions & levels within the organization? Quality objectives shall be measurable and consistent with the quality policy.

  • Are the quality objectives measurable?

  • Are the quality objectives consistent with the quality policy?

5.4.2 Quality Management System Planning

  • Does top management ensure that:

  • a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives?

  • b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented?

5.5.1 Responsibility and Authority

  • Does top management ensure that responsibilities and authorities are defined and communicated within the organization?

5.5.2 Management Representative

  • Has top management appointed a member of its management:

  • who, irrespective of other responsibilities, has responsibility and authority that includes ensuring that processes needed for the quality management system are established, implemented and maintained?

  • reporting to top management on the performance of the quality management system and any need for improvement?

  • ensuring the promotion of awareness of customer requirements throughout the organization?

  • Has top management appointed a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility & authority that includes:

  • a) ensuring that processes needed for the quality management system are established, implemented and maintained?

  • b) reporting to top management on the performance of the quality management system, & any need for improvement?

  • c) ensuring the promotion of awareness of customer requirements throughout the organization, and

  • AS9100C - d) the organizational freedom and unrestricted access to top management to resolve quality management issues?

  • NOTE: The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.

5.5.3 Internal Communication

  • How does top management ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness if the quality management system?

5.6.1 Management Review - General

  • Does the top management review the organization’s quality management system, at planned intervals, to ensure its continuing stability, adequacy and effectiveness?

  • Does this reviews include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy & objectives?

  • Are records from management reviews maintained? (see 4.2.4)

5.6.2 Review Input

  • Does management review inputs including:

  • Results of audits?

  • Customer feedback?

  • Process performance and product conformity?

  • Status of preventive and corrective actions?

  • Follow-up actions from previous management reviews?

  • Changes which could effect the quality management system?
    and

  • Recommendations for improvement?

5.6.3 Review Output

  • Does the output from management reviews include decisions & actions related to:

  • a) Improvements to the quality management system and its processes?

  • b) Improvements to product related to customer requirements?

  • c) Resource needs?

>>>> END OF CHECKLIST <<<<

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