Normative References for ISO 13485

duff999

Quite Involved in Discussions
#1
Hi Folks

We are doing a gap assessment to get ready for our stage 1 audit for ISO 13485. One of the items asks if Normative References are applied appropriately. Can someone help explain what I need to do to comply with this?

I appreciate the help!
 
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John C. Abnet

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#6
Thank you for this information. So if I have my thinking right, I should align our current terms and definitions with ISO9000:2015?
Don't overthink this @duff999 ;
I'm not sure I'd consider the term "align with" when considering a normative reference. As @Sidney Vianna ...mentioned, the only normative reference given for 13485 is the ISO 9000:2015. Use it to help you/your organization better understand the purpose and meaning of the terms used within the ISO 13485 standard.

If indeed your organization has its own internal terms/definitions "document", then yes, I would definitely recommend that written (or simply in use), the terms your organization uses are consistent with how ISO 9000 defines them.

Hope this helps.
Be well.
 
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