Audit
4.2.3 Control of Documents
Do you have a documented procedure for document control?
Are the issued documents (policy, procedures, forms manual) with effectivity date, revision number and proof of approval? This include the quality objectives, master lists.
Are the documents available or accessible to the relevant functions?
Are obsolete documents identified? Does the personnel know if there are already obsolete documents in the organization?
4.2.4 Control of Records
Ask for the Master List of Quality Records and see if all the records being used are included in the Master List. Are all records that are being used included in the master list?
Get a sample record and see if these are filled up properly and if the forms used are the ones indicated in the forms manual.
- compliant
- non-compliant
- observation/opportunity for improvement
Ask the personnel: Do you know your quality policy? How do you explain it?
Ask the personnel: what is your understanding of the quality policy?
- compliant
- non-compliant
- observation/opportunity for improvement
- compliant
- non-compliant
- observation/opportunity for improvement
- compliant
- non-compliant
- observation/opportunity for improvement
- compliant
- non-compliant
- observation/opportunity for improvement
- compliant
- non-compliant
- observation/opportunity for improvement
Ask the personnel: Do you know what equipment you need in order to do your job? How are these maintained? (6.3 Infrastructure)
- compliant
- non-compliant
- observation/opportunity for improvement
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