Transferring an ISO 13485 certificate to a new CB - Do I have to start from scratch?

hngrad1977

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#1
If a company is registered to ISO 13485:2016 and changes registrars during the audit cycle, is the new registrar required to perform a full scale audit or do they finish the audit cycle. I could not find any information on this.
 
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Sidney Vianna

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#3
If a company is registered to ISO 13485:2016 and changes registrars during the audit cycle, is the new registrar required to perform a full scale audit or do they finish the audit cycle. I could not find any information on this.
In certification language, that's called a certificate transfer (from one CB to another). The document that governs accredited certificate transfer between registrars is the IAF Mandatory Document # 2. You can also peruse IAF Mandatory Document # 9, should you wish, but the answer to your question is in IAF MD2.

Good luck.

PS. As the IAF Mandatory Documents get revised, from time to time, future readers of the post should ensure the documents hyperlinked therein are current and within their effectivity period. Browse the IAF Mandatory Documents @ IAF Publications: Mandatory Documents
 
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