Information

  • Document No.

  • Audit Title

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel

Scope of Audit:

  • Scope:

Opening Meeting

  • List attendees of opening meeting and there roles

  • Add signature

  • Complete attendance register

  • List the objectives of the audit: - not to reject system - re-currence may point to system failure - can't cover all aspects - where no non-conformance exists, does not mean non exists. Sample of activities only

  • Review of audit programme:

  • Company representative

  • Function of company representative:

  • Time of closing meeting:

  • Confidentiality

  • Reasons for aborting audit

  • Invite questions

Overview of organization:

  • Comments:

Results of previous audits:

ISO 9001:2008 - Management Responsibility - Clause 5

  • Is the company quality policy displayed or on hand on the project / site / office? (Look for display)

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Has the company quality policy been communicated to all employees on the project / site/ office? (Ask employees on site)

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • What measurable goals or objectives have been established to support the policy? (Look for documented evidence)

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Are these goals:<br>-implemented <br>-maintained <br>-communicated

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Are these objectives being achieved, if not what action plan is in place to correct?

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • How are the objectives reviewed for opportunities of continual improvement?

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • How does top management communicate the importance of meeting customer requirements? (What method)

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Does top management ensure availability of resources?

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

ISO 9001:2008 - Customer Communication - Clause 7.2.3.

  • Is there records of contractual meetings with the customer?

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Is there records of technical meetings with the customer?

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Is there records of Quality meetings with the customer?

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Was any customer complaints raised to date recorded on action requests forms?

  • Comments

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Was customer complaints handled effectively (find root cause, correct, document, evaluate effectiveness

  • Comments

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

ISO 9001:2008 - Identification and Traceability - Clause 7.5.3.

  • Is incoming materials, in-process materials, and final products clearly identified?

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Walk through storage and production areas to verify conformance to procedures - note any exceptions in comments section

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Are there traceability requirements for this site?

  • Comments

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Are the traceability requirements being met? (Walk around and look at product) state results in comments section

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Is inspection an test status of incoming material, in-process material and final products identified?

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Walk through facility and verify conformance to procedure

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

ISO 9001:2008 - Human Resources - Clause 6.2.1. & 6.2.2.

  • Are the necessary competence of personnel on site determined? (Evidence required)

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Are actions taken to achieve the necessary competence - state actions in comments section

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Is the effectiveness of the action taken evaluated? How - state in comments section

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Is personnel made aware of the relevance and importance of their activities?

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Is appropriate records maintained of education, training and experience?

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Is the training procedure established and implemented for this site?

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

  • Have training needs been identified?

  • Comments:

  • RATING: 4 = Fully Implemented and effectively applied 3 = Implemented – partly effective 2 = Implemented / Partly Implemented – not satisfactory 1 = No evidence of effective application (even if implemented) 0 = Not addressed at all

Closing meeting

  • Attendance register

  • Re-emphasize confidentiality

  • Adit sample only, where no non-conformance reported does not mean non exist

  • Summaries good practices

  • Copy of hand written report

  • Present summary

  • List all observations and areas of improvement:

  • List of all non-conformances

  • Invite questions:

  • Advance action request report within seven working days

  • Request action request report within fourteen days

  • Follow up date for clearing of findings

Signatures

  • Signature Auditor:

  • Date of audit

  • Signature Lead Auditor:

  • Date purposed for corrective actions:

  • Signature Auditee:

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