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The company I work for is a biotechnology company and we hold ISO 9001 certification. We keep records as required by ISO, however, I was wondering if the quality department needs to perform a secondary review on all or some of the records.
I'm totally new to ISO 9001 standards but I'm assigned to prepare a quality manual and quality management system. Kindly guide me about the basic procedure and standards to read and understand.
Can a waste collection service exclude clause 8.3 for its scope?
If ISO 9001:2015 does not require a QMS Manual then what should be in its place
Who exactly is the "top management" when implementing ISO 9001?
Can I have more details of the context of Organisation, and Risks, and Opportunities?
How can the risks be effectively monitored, analyzed and evaluated, and then reported during management review meetings?
Could You advise how to write correctly the Quality Manual, how to structure it? What are the main parts of the Quality Manual?
As I understood, there aren't any straight standard requirements to get an internal audit certificate for conducting the audit. Does it mean the Certification body cannot raise any NCR during certification if the company internal audit was conducted via non-qualified auditors?
Referring to ISO 9001:2015 Clause 7.5.2 and 7.5.3 - On my external documents, I send my customers such as invoices and PODs do my identification numbers, revision and revision date, etc. have to be visible on the documents?