What is the API Q1 Manual Estructure?



Good morning everyone,
Please I need your Help, according to API Q1, the manual is a copy of this document? (API Q1)???
I think I can make a summary of my system in the manual, and make references of each procedure, but in an audit I participated a couple of months ago, the lead auditor specified that I have to change the manual, exactly like de API Q1, is that correct? In that case which is the contribution I am giving to the system if it just a copy of something made by someone else?

thank very much for your help......


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It is not good to copy someone or other company Quality Manual (QM) because it may not reflect your company's business operations.

the auditor you mentioned seem to favour the documenting the QM based on applicable clauses in API Q1 std. which i think it is the foolish auditor do that because this way makes the auditor job easier. Remember we pay the auditor to do his job according to the scope of work and his job is to inform any discrepancies found which non-compliance to API Q1.

As long as you or applicant / API Monogram Licensee has meet all the requirements specified in the API Q1 and other applicable product standards, it will be fine. Auditor is NOT a consultant and his main job is to report non-conformances within the API Q1 and other applicable API product std. to the auditee.

There are 2 ways of documenting the QMS system:
1. You can always start with your own company business operations flow processes.

2.You also can document QMS processes based on the applicable clauses as per ISO 9001 or API spec. Q1 standard. then you may copy the exact QM of someone else or buy the QM template from the online consultant.

I strongly recommend you can document the whole company business flow operation processes: from sales and marketing process right up to the delivery of products to client.
After that you can make cross reference to the applicable clauses of the API Q1 std. or ISO 9001 std. Thus your QMS documentation truly reflect and customise to your company work practices and company policies.

A lot of consultants and QA/ QC Managers adopt the easy path that is to documents QMS based on clauses in the API Q1 or ISO 9001. If you read them it does not make sense to tell or reflect your company operation or business, corporate work culture or even company strategy. Furthermore it also look like a very boring stuff to read and follow as copy and paste QMS system does not reflect the operations.

if you are not sure, you need to source someone who is very experience to customise your business operation including your QA/ QC inspection and testing program and system development.
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