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1.0 PURPOSE
The purpose of this checklist is to provide the Audit Team the basic mechanism for documenting compliance to the ISO 9000 series registration. Other documents are used to supplement specific industry requirements.
2.0 HOW TO USE
This checklist is to be used in conjunction with Registration and On-going Surveillance, and Customer Surveys, Document Number 5. It is used to document the quality manual review, the readiness visit, the registration assessment, compliance to the Standard and traceability to any nonconformities.
During the quality manual review, use the QUALITY MANUAL column to enter the paragraph in the quality manual that meets the requirement. If the requirement is missing or not met, enter ISSUE “#”. Issues are consecutively numbered. Use the INSTRUCTIONS/RECORDS /EVIDENCE column to describe the Issue, Comment and/or Note.
During the readiness visit, use the QUALITY MANUAL column to indicated if the Issue is closed and how it is closed. In the PROCEDURE/REVISION column, enter the procedure, paragraph and revision (the revision may be entered during the registration assessment) that meets the requirement. If additional Issues are encounter during this visit, they should be entered into this column. Use the INSTRUCTIONS/RECORDS /EVIDENCE column to describe the Issue, Comment and/or Note.
During the registration assessment, In the INSTRUCTIONS/RECORDS/EVIDENCE column enter the evidence that the requirement is implemented. In the YES/NCR column, enter YES, the nonconformity number” or N/A.
- If the answer is YES, record how the customer meets the requirement in the INSTRUCTIONS/RECORDS/EVIDENCE column. If more space is needed use the AUDITOR NOTE space at the end of the quality element section and/or SUPPLEMENTAL NOTE FORM.
- If the answer is no, a Non-conformance Record shall be written. In the YES/NCR column, record the “Number of the Non-conformance Record”. Again, if more space is needed for note taking and cre
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