Proof QMS compliance for class I


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Hi all
I help my client to setup a QMS acc. to ISO 13485. Within their scope they have only class I product. So NB involvement is not required. However, their distributor ask for QMS certificate. How can they prove that they comply with ISO 13485 without any certificate issued by a NB?

Thank you


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I think you're confusing yourself with terminology. There are two types of certificates/certifications you're bringing up. The distributor wants proof of QMS certification (13485), you're mentioning a product certificate (related to product classification type).

Any organization which has some vested interest in Medical Devices can certify (Certification) their QMS to the requirements of ISO 13485. Outside of manufacturers of finished devices, component manufacturers, service providers, packagers, etc. can certify to ISO 13485 should they wish to. While often used interchangeably, that organization which is accredited to perform an ISO 13485 audit is called a registrar. Registrars are often also Notified Bodies, for example, BSI. Upon successful completion of a QMS certification audit cycle, organizations are issued a certificate indicating they are certified to the requirements of ISO 13485 with an indicated scope of their QMS (contract manufacturing, servicing, manufacturing, etc.)

To sell medical devices in Europe, the legal manufacturer of a medical device requiring a notified body approval, reach an agreement with an NB to perform a conformity assessment. If the assessment if successful, a Certificate is issued by that NB for that product or product family. In order to get that certificate, that manufacturer must also demonstrate they have a QMS in place. There is no requirement that the manufacturer has a certification to ISO 13485 per MDD/IVDD/MDR/IVDR, however the NB performing the assessment would essentially perform the same QMS certification audit if the QMS was not certified. It's been my experience, it is uncommon that an organization's QMS is uncertified if they are the legal manufacturer.

Your client has no obligation to have a certified QMS unless defined by internal agreements between the parties. However, this is an example where it would be simply easier to have it be to provide the certification provided by the registrar. Just to be very clear, a QMS Certificate and NB Certificate are different things.

Without that certification, you may see if the distributor will accept a copy of the internal audit report performed by your client which demonstrates conformance to the requirements of 13485. That said, depending on the size of your client, if they are small and performing their own internal audits, that is likely not enough assurance and you may consider bringing in an outside auditor to perform an internal audit on their behalf to ensure objectivity and impartiality.
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