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Dear All,
I am a long time lurker who has found this forum extremely informative on a variety of occasions. Thank you very much for the wealth of information!
I am a QA manager in the middle of updating our QMS to make it ISO9001-compliant.
This time I could not find anything by searching the forum, even though I am sure the question has already been discussed plenty of times. The ISO 9001 states in 4.2.3 a) that documents should be approved for adequacy prior to use. Let's assume that the document is developed by the person who is capable of evaluating it's adequacy, such as myself an engineer developing a technical document. Can it be approved by the same person? If not, what if a company has only one engineer who is reporting directly to the president - will it have to hire a second one just for the sake of compliance with this language?
If the self-approval is possible, I am thinking of assigning document-issuing authority to certain functions in the company, for example all drawings must be issued by the engineers. Anybody can draft and prepare them, but an engineer has to post the final version to our document library. In that case document release will constitute either self-approval if the document was developed by the issuer, or approval if the document was developed by someone who does not have issuing authority. Will this pose a problem during the ISO certification?
Thanks in advance for the feedback!
I am a long time lurker who has found this forum extremely informative on a variety of occasions. Thank you very much for the wealth of information!
I am a QA manager in the middle of updating our QMS to make it ISO9001-compliant.
This time I could not find anything by searching the forum, even though I am sure the question has already been discussed plenty of times. The ISO 9001 states in 4.2.3 a) that documents should be approved for adequacy prior to use. Let's assume that the document is developed by the person who is capable of evaluating it's adequacy, such as myself an engineer developing a technical document. Can it be approved by the same person? If not, what if a company has only one engineer who is reporting directly to the president - will it have to hire a second one just for the sake of compliance with this language?
If the self-approval is possible, I am thinking of assigning document-issuing authority to certain functions in the company, for example all drawings must be issued by the engineers. Anybody can draft and prepare them, but an engineer has to post the final version to our document library. In that case document release will constitute either self-approval if the document was developed by the issuer, or approval if the document was developed by someone who does not have issuing authority. Will this pose a problem during the ISO certification?
Thanks in advance for the feedback!

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