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ISO 13485 queries

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Guest user Created:   Oct 29, 2020 Last commented:   Nov 02, 2020

ISO 13485 queries

Among the questions I have during the implementation of the QMS there are the following:

  • The change control procedure does not seem to take in consideration the NBOG guidance or MDCG-13 or to advise the registrar.
  • Is there a tri-party quality agreement between sterilizer/contract manufacturer/ legal manufacturer?
  • Records retention seems always be for 2 or 5 years.  I couldn’t see anything for 10 years per MDR.
  • Statistical procedure seems to be missing.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Nov 02, 2020
Among the questions I have during the implementation of the QMS there are the following: The change control procedure does not seem to take in consideration the NBOG guidance or MDCG-13 or to advise the registrar.

In our toolkit we do not have a change control procedure, since in the ISO 13485:2016 standard there is no requirement for the register. Change control is covered in the Management review procedure and covers all requirements from the ISO 13485:2016, point 4.1.4.

We considered that changes in the documentation would be initiated by the person listed as the document owner. All updates and reviews must be performed in line with the frequency defined in the List of Internal Documents. All changes to the document must be made by using "Track Changes," making visible only the revisions to the previous version, and must be briefly described in the "Change History" table; if the Track changes option is unavailable, or if the changes are too numerous, then the Track changes option is not used.

Furthermore, each document should preferably have a "Change History" table used to record every change made to the document.

For more information about common mistakes with ISO 13485:2016 documentation control and how to avoid them, please see the following article:

Is there a tri-party quality agreement between sterilizer/contract manufacturer/ legal manufacturer?

We have a Quality agreement for the subcontractor (10.7_Appendix_7_Quality agreement subcontractor). It is general, so you can specify it for your outsourced processes.

Records retention seems always be for 2 or 5 years. I couldn’t see anything for 10 years per MDR.

Thank you for pointing this out to us. We will correct it.

Statistical procedure seems to be missing.

There is no strict requirement in the ISO 13485:2016 for the documented statistical procedures. We have partially covered it in the 20_Procedure_for_Data_Analysis_Premium_EN.

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Oct 29, 2020

Nov 02, 2020