Starting ISO 13485:2003 Registration - Introduce Myself

Al Rosen

Staff member
Super Moderator
#11
ontheopenroad said:
Similar issue here. My current company is a contract manufacturer. We do not make finished devices, and do not market/brand any finished products. We have a major customer for whom we are a major component manufacturer. They are "encouraging" us to pursue registration to 13485 because they are registered to 13485. I keep telling them that there is really no use in doing so.

If you are a medical device manufacturer, compliant with 9001 and the QSR, you probably have MOST of the necessary controls in place to be compliant with 13485.

I'm thinking about reviewing my QMS and making it "compliant" with 13485 without seeking "certification" to 13485, to appease the customer, but to prevent having to pay for the certification.
If you have a major contribution to a product sold in canada, your customers registrar may want to audit you on your customer's dime. He may want you to be registered by a CAMDCAS Registrar to save this cost. This issue, I believe, has been discussed in other threads, so try doing a search for more discussion.
 
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Roland Cooke

#12
Well along with the marketing / customer reasons for going for ISO13485, there is another less obvious reason - the quality/competence of the assessors and the registrar.

Strictly speaking all assessors, whatever their background, should be equally capable. Of course this isn't really true, for all sorts of reasons.

But my experience is that ISO13485 assessors tend to be a bit more focussed because of their compliance training and perhaps general level of industry exposure. Quite possibly true of automotive / aerospace assessors as well I imagine.
(Of course there is always the chance that they are sometimes too focussed, but there you go.)

YMMV of course
 
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