Does ISO 9001 Requirement for Document Approval (a service organization)

QUALITYTRAINER

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#1
Hi,

I work in a small ISO 9001 service organization that generates a lot of specs and plans that require customer approval. I'm getting a lot of push-back on implementing a requirement for customer 'wet' signatures of all specs and plans calling for customer approval. My previous history was in a medical device company and ISO 9001 is mild in comparison to ISO 13485.

If we were to send specs and plans to the customer and ask them to reply (via email) indicating their approval of the attached specs or plans is that enough for ISO 9001. I don't feel comfortable with this and I need to get some expert opinion. A majority of our customers are Life Science Companies, so they do comply with cGMP and ISO 13485.

Any feedback would be welcome. :thanks:
 
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Sidney Vianna

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#2
If we were to send specs and plans to the customer and ask them to reply (via email) indicating their approval of the attached specs or plans is that enough for ISO 9001.
Yes. Processes have to be agile enough to support your context and the needs of internal and external parties.

The process also has to be robust enough to make clear the status of the documents. So, if you send a batch of documents for customers review and approval and they send you back an email, approving some and commenting on others, how do you keep track of what is approved and what is not?

Physical signatures on documents have never been a requirement of ISO 9001 since 1987. The standard has to be flexible enough to accommodate all possible scenarios.
 
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