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Internal Auditing Audit

Revision: a
Plan - Audit Preparation
Audit Date: Lead Auditor:
Other Auditors: Clause: 9.2 Internal Auditing
QA Manual Rev: QA Manual Clauses:
List other applicable documents, Process Owner and Inputs:
Do - Compare Documentation vs. Requirements
Read the applicable sections of documents listed above and compare to the clauses of the QMS standard.
QUESTION YES / NO / N/A EVIDENCE / NOTES
In general, does the documentation meet the requirements of the QMS standard? Yes  No  N/A 
Review Customer requirements that may be applicable. In general, does the documentation meet Customer requirements? Yes  No  N/A 
Review statutory and regulatory requirements that may be applicable. In general, does the documentation meet regulatory requirements? Yes  No  N/A 
Improvement Suggestions:
Check - Compare Actual Practice vs. Requirements
Compare the requirements of documents referenced above against everyday practice of employees.
CLAUSE QUESTION YES / NO / N/A EVIDENCE / NOTES
9.2 a) internal audits are performed at planned intervals Yes  No  N/A 
9.2 b) internal audits determine whether the QMS is effectively implemented and maintained Yes  No  N/A   
9.2 b.1) the QMS conforms to planning requirements - standards and Company requirements to: --- ---
9.2 1) determine appropriate quality objectives and requirements for the audit Yes  No  N/A 
9.2 2) establish appropriate processes - documents and provide resources Yes  No  N/A 
9.2 3) determine appropriate verification - validation - monitoring - inspection and test and criteria for audit acceptance Yes  No  N/A 
9.2 4) determine appropriate records for the internal audit process and maintenance of records Yes  No  N/A 
9.2 c) audit planning defines the considerations taken for the status and importance of QMS processes - audited area and the results from previous audits Yes  No  N/A 
9.2 d) audit planning defines the criteria - scope - frequency and methods of performing the audit Yes  No  N/A 
9.2 e) Auditor selection and the performance of audits ensures objectivity and impartiality of the audit process Yes  No  N/A 
9.2 f) Auditors do not audit their own work Yes  No  N/A 
9.2 g) an audit procedure is documented that defines the responsibilities and requirements for planning - performing - reporting and for maintaining audit records Yes  No  N/A 
9.2 h) the responsible manager ensures actions are taken without undue delay to eliminate nonconformances and their causes Yes  No  N/A 
9.2 i) follow-up activities include verification of actions - reporting of verification results and defines requirements for: --- ---
9.2 1) reviewing actions taken to eliminate the cause of nonconformances to prevent recurrence Yes  No  N/A 
9.2 2) determining that corrective action is appropriate to the affect of the nonconformance Yes  No  N/A 
9.2 3) review of nonconformances and Customer complaints Yes  No  N/A 
9.2 4) determination of the cause of nonconformance Yes  No  N/A 
9.2 5) evaluation of the need for action to ensure nonconformances are not recurring Yes  No  N/A 
9.2 6) determination and implementation of necessary action Yes  No  N/A 
9.2 7) recording the results of actions Yes  No  N/A 
9.2 8) reviewing corrective actions Yes  No  N/A 
9.2 j) planning of the internal audit uses ISO 19011 for direction Yes  No  N/A 
9.2 k) detailed tools and techniques are developed - such as check sheets - process flowcharts or any similar method to support audit of the quality management system requirements Yes  No  N/A 
9.2 l) selected internal audit tools are effective in measuring the overall organization performance Yes  No  N/A 
9.2 m) internal audits meet contract and/or regulatory requirements Yes  No  N/A 
Review previous audits and RFS's against this process - add comments below.
Comments:
Act - Verify the Effectiveness of the Process
Review the applicable process map.
QUESTION YES / NO / N/A EVIDENCE / NOTES
Are the inputs accurate and complete that are listed on the process map as compared to actual practice? Yes  No  N/A 
Are the inputs being properly provided to the process operators?
Are individuals competent and trained in the process?
Do individuals understand the quality policy?
Yes  No  N/A 
Are the process steps accurate and complete as compared to true practice?
Who supports this process and how does this process support other processes?
Yes  No  N/A 
Are there sufficient check steps (inspections, tests, reviews, approvals, sign-offs, etc.) to ensure the outputs meet requirements before passing onto the next process? Yes  No  N/A 
Does the process appear controlled, understood and adequately meet the requirements of applicable documentation? Yes  No  N/A 
Are process objectives defined, measured and understood? Yes  No  N/A 
Does the process appear effective in meeting those objectives and is there continual improvement? Yes  No  N/A 
Provide brief details on any areas that were found to be well-implemented, particularly effective or worth noting as positive traits of the process. List records reviewed - attachments A/R.
Summarize Observations and Findings for RFS System
Summary:
Check One: Documentation does not meet the standard  Documentation does not match actual practice  Practice does not meet the standard  Practice does not meet documentation requirements  Document control issue  Minor error(s) in document  Other 
Explain Other:
Opportunities for Improvement
Summary:
Check One: Documentation could be improved  Practice could be improved  Documentation and Practice could be improved  Other 
Explain Other:
Review and Submit Audit Report
All auditors on the audit team must submit their audit reports for summary and review by the lead auditor.
Lead Auditor: Review the completeness of this report prior to submitting it to the Quality Manager. Be sure findings show objective evidence, everything is written clearly and all checklist questions are answered.
Lead Auditor Name: Date:
Deliver Audit Report to Appropriate Managers
Send Report To: Accounting Manager  Administrative Assistant  Contracts Manager  EHS Manager  Engineering Manager  Facilities Manager  Human Resources Manager  Manufacturing Manager  Plant Manager  Purchasing Manager  Quality Manager  R&D Manager  Other 
Explain Other: