Title Page

  • Site conducted

  • Document No.

  • Audit Title

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel

A. Verification of Previous Findings

  • Review corrective actions for previous planning audit findings.

  • Review corrective actions for any customer complaints.

  • Review corrective actions for any customer audit findings

6. Planning

6.1 Actions to address risk and opportunities

6.1.1

  • When planning for the quality management system, has the organization considered:<br>a) the issues referred to in 4.1?

  • b) the requirements referred to in 4.2?

  • Has the organization determined the risks and opportunities that need to be addressed to:<br>a) give assurance that the quality management system can achieve its intended result(s)?

  • b) enhance desirable effects?

  • c) prevent, or reduce, undesired effects?

  • d) achieve improvement?

6.1.2

  • Has the organization planned:<br>a) actions to address these risks and opportunities?

  • b) how to:<br>1) integrate and implement the actions into its quality management system processes (see 4.4)?

  • 2) evaluate the effectiveness of these actions?

  • Have actions taken to address risks and opportunities been proportionate to the potential impact on the conformity of products and services?

  • NOTE 1: Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

  • NOTE 2: Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new customers, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs.

6.2 Quality objectives and planning to achieve them

6.2.1

  • Has the organization established quality objectives at relevant functions, levels and processes needed for the quality management system?

  • Are the quality objectives:<br>a) consistent with the quality policy?

  • b) measurable?

  • c) taking into account applicable requirements?

  • d) relevant to conformity of products and services and to enhancement of customer satisfaction?

  • e) monitored?

  • f) communicated?

  • g) updated as appropriate?

  • Has the organization maintained documented information on the quality objectives?

6.2.2

  • When planning how to achieve its quality objectives, has the organization determined:<br>a) what will be done?

  • b) what resources will be required?

  • c) who will be responsible?

  • d) when it will be completed?

  • e) how the results will be evaluated?

6.3 Planning of changes

  • When the organization determines the need for changes to the quality management system, have the changes been carried out in a planned manner (see 4.4)?

  • Has the organization considered:<br>a) the purpose of the changes and their potential consequences?

  • b) the integrity of the quality management system?

  • c) the availability of resources?

  • d) the allocation or reallocation of responsibilities and authorities?

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