QMS Audit - duplicate

Audit Checklist

• QMS Audit

• Factory / Department - 1
  Address

• Conducted on

  Date

• Auditor(s)

• Process to Audit - Quality Management System

• Standard Procedures for this process - 50, 51

• Standard Procedures Audited - 50, 51

• Applicable Clauses of ISO9001 standard

Section 1

• In general, does SBG documentation meet the requirements of ISO 9001 ?

  Compliant

  Non-Compliant

  N/A

• Review any customer requirements that may be applicable to this processes. (If there are none, enter “N/A”) In general, does SBG documentation meet these requirements?

  Yes

  No

  N/A

• Review any statutory or regulatory requirements that may be applicable to this process. (If there are none, enter “N/A”) In general, does SBG documentation meet these requirements?

  Yes

  No

  N/A

• Review previous audits for this process. Review previous ACAR issued against this process, or as a result of previous audits for this process. Add additional checklist questions here, based on the previous audits, ACARs or other documents or requirements, as you see fit.

  Media

• Do personnel in this department know how to view Standard Procedures via the computer system?

• Are the Quality Manual and Procedures controlled as stated in procedure 50?

• Evidence

  Media

• Are the standard procedures relevant and up to date?

• Evidence

  Media

• Are the training records up to date as per procedure 51?

• Evidence

  Media

• Are copies of the standard procedures backed up on the system as stated in procedure 50?

• Evidence

  Media

• Are the internal Audits going ahead as planned?

• Evidence

  Media

• Is the NCR database monitored regularly and is it relevant?

• Evidence

  Media

• Do the auditees have any suggestions for procedural or process enhancements, which will augment the continuous improvement of the system?

• Evidence

  Media

• Are the procedure steps accurate and complete as compared to true practice?

  Yes

  No

  N/A

• Are there sufficient check steps (inspections, tests, reviews, approvals, sign-offs, etc.) that ensure the process outputs meet requirements before passing onto the next process?

  Yes

  No

  N/A

• Does the process appear to adequately meet the requirements of ISO 9001 and the SBG documentation?

  Yes

  No

  N/A

• Does the process appear to adequately meet all customer or regulatory requirements?

  Yes

  No

  N/A

• Does the Auditee have any suggestions for procedural or process enhancements, which will augment the continuous improvement of the system?

• Evidence

  Media

Sign Off

• I, the undersigned, have completed this audit in an accurate manner. I have attached evidence as required and declare this assessment complete.

• Full name and signature of auditor

  Sign