Certification of QMS
Thank you for the webinar, it was useful.
But I would like to consult a bit more….Could I?
This is regarding certified QMS according to ISO 13485.
MDR does not have indication that QMS must to be certified, there is indicated minimal requirements for QMS. Isn’t it enough?
In *** we have accredited notify body, and they told that there is no information or indications about certified QMS, we are new to this field, and as I understood form your webinar this is new changes, and that there still misunderstandings possible.
If you would be able to advice me I would be really grateful.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Yes, you are right, in the MDR there is no request that the quality management system must be certified. But, as I told yesterday on the webinar, the quality management system will be audited together with the MDR audit. So, once you will receive the MDR certificate it will mean that you have implemented and maintained the quality management system. For more information, see:
- EU MDR Article 5 – Placing on the market and putting into service https://advisera.com/13485academy/mdr/placing-on-the-market-and-putting-into-service/
- EU MDR Article 10 – General obligations of manufacturers https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/
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Dec 10, 2020