Normative References for ISO 13485

[duff999]

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!

 

[Sidney Vianna]

Do you follow the definitions from ISO 9000:2015 in your QMS?

 

[duff999]

Do you follow the definitions from ISO 9000:2015 in your QMS?

We do have a terms and definitions library, but it does not align with ISO 9000. If it should, we will revise the document.

 

[Sidney Vianna]

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[duff999]

View attachment 28783​

Thank you for this information. So if I have my thinking right, I should align our current terms and definitions with ISO9000:2015?

 

[John C. Abnet]

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.