CB accredited by non-aligned AB - industry views?

[Shonver]

What is the medical industry view on certificates issued by a certification body (CBs) that is accredited by an accreditation body (ABs) that is not aligned to the country's regulatory authority?

Traditionally, the state RA will accredit the CB, but some CBs claim accreditation by independent ABs. This practice, it seems, is not illegal. However, I would like to know if such an arrangement poses a risk to Medical Device manufacturers.

FWIW, I have read responses to this scenario under "Registrars and National / International Organizations" section, but they generally referred to standards other than medical.

 

[pkost]

It depends how you assess your suppliers, in the EU there is no requirement for a manufacturer to hold 13485 and there is no requirement for a CB to use an AB. However if you rely on the certifaction of your supplier as evidence that they have adequate controls in place, how can you trust their certificate? It may have been provided by a CB with an AB but can you trust the AB?

Considering the increasing burden on manufacturers to control their critical sub contractors, I would probably not care too much about the CB/AB, I would rely on my own audits to assure myself that the quality can be met.