Choosing Registrar

[kasnna]

Please bear with me, as I am new to all of this. We are a small contract manufacturer of medical device machined components sold to OEM medical device manufactures.
We are in the process of preparing for ISO 13485 certification and choosing a registrar.
We want to choose a CB that our future clients will respect. We were initially considering Perry Johnson but got the impression that they may not have the best reputation. BSI was recommended to us. ANAB was not an option on the BSI application but all of our business is domestic. Would it be beneficial or detrimental in any way to choose RvA?

 

[John Broomfield]

Please bear with me, as I am new to all of this. We are a small contract manufacturer of medical device machined components sold to OEM medical device manufactures.
We are in the process of preparing for ISO 13485 certification and choosing a registrar.
We want to choose a CB that our future clients will respect. We were initially considering Perry Johnson but got the impression that they may not have the best reputation. BSI was recommended to us. ANAB was not an option on the BSI application but all of our business is domestic. Would it be beneficial or detrimental in any way to choose RvA?

kasnna,

By. “domestic” do you mean USA?

Being. as you’re about to make a marketing decision this your most important selection criterion:

“choose a CB that our future clients will respect”

Who are your future clients? Which accreditation do they respect the most? The answers to these questions should should shortlist suitable accredited registrars.

John

 

[Sidney Vianna]

Would it be beneficial or detrimental in any way to choose RvA?

For the most part, it would be totally irrelevant in this case. The IAF, a coalition of willing AB’s, allow the coexistence of pathetically ineffective AB’s with more serious and responsible ones under their umbrella.

As long as you attain accredited certification with a reasonably recognized CB your customers will take that at face value, despite many stakeholders increasingly questioning the credibility of such certificates.

Good luck.

 

[yodon]

While your direct customers (end users) may not care much, but when you go for CE marking, if your registrar is not accredited, you could be facing difficulties getting through the process. I believe you can look at the list of accredited registrars here.

 

[Ed Panek]

We have two QMS covering two parts of our company. One is 13485 and their audits are detailed and effective. The other auditor is for 9001 and their audits are a mix of sales presentations and some auditing which is not impressive.

 

[Sidney Vianna]

but when you go for CE marking

What directive would apply to a machine shop?

 

[yodon]

What directive would apply to a machine shop?

Oops, read too fast (just saw manufacturer of medical device).

That does change the conversation and actually DOES make this relevant for their customers (the legal manufacturer of the device). When THEY get audited, if their CM has a certification that is not through an accredited registrar, the auditor may require an audit of the CM (can't rely on their certification since not through an accredited organization).

My company (contract R&D) were registered through a company that was not accredited (very long story) and our customers were telling us that since we provided software development services, their auditors were going to have to audit us. We switched AOs to an accredited one and now our customer's auditors can rely on our cert.

At least that's my experience / understanding.

 

[kasnna]

Thank you for all of the responses. I've tackled a project that seems a lot more involved than I anticipated.

I am unfamiliar with many of the acronyms used here. IAF, AB, CM, AO. Would someone be willing to give me a little more info on the basics of certification?

 

[ScottK]

Have you spoken to any of the registrars yet? I'm doing the same right now for a new ISO9001 registration and have 4 proposals and am waiting on one more before choosing.
Most of them have pretty knowledgeable account managers that will walk you through their process and talk to you about accreditations and such.

I'm of the same opinion of Perry Johnson, though.... very no frills and not as highly thought of as the big guys in the US- BSI, the TUV's, Bureau Veritas, SGS. I've been audited by most of them over the years. My best experience has been with BSI. Worst was SGS - the auditors were fine but the office was a mess. Both of those were for 13485.

Going with a big name will only get you so much with existing customers. Prospective customers are going to be the ones looking at your certificate. Some won't care, some might. As a Supplier Quality Manager all I really care about if I see a registrar that I don't recognize is "are they accredited?"
I won't used registrar as selection criteria unless is so close that I need something to differentiate and I know that one registrar is more rigorous in their audits than another, in general.

 

[LUFAN]

Thank you for all of the responses. I've tackled a project that seems a lot more involved than I anticipated.

I am unfamiliar with many of the acronyms used here. IAF, AB, CM, AO. Would someone be willing to give me a little more info on the basics of certification?

International Accreditation Forum: association of Conformity Assessment Accreditation Bodies. Think UKAS, ANSI, ANAB, etc.
Accreditation Body: See UKAS et.al above
Contract Manufacturer: Manufactures a finished device to another establishment's specifications. See my response below
Auditing Organization: The equivalent term for "Registrar" for MDSAP. AOs issue MDSAP certificates.

That does change the conversation and actually DOES make this relevant for their customers (the legal manufacturer of the device). When THEY get audited, if their CM has a certification that is not through an accredited registrar, the auditor may require an audit of the CM (can't rely on their certification since not through an accredited organization).

Yodon is saying if A is the Legal Manufacturer, and B is the Contract Manufacturer, when A is audited by a Registrar/AO/Notified Body, the Registrar/AO/Notified Body may not be satisfied if the parts A are getting from B, are manufactured under an certification that holds no weight. That would likely depend on the risk of the part and how it works its way into the finished device. If A has weak supplier controls of B (maybe no audit, just relying on cert (that holds no weight)), may be low hanging fruit for an Auditor.

Please bear with me, as I am new to all of this. We are a small contract manufacturer of medical device machined components sold to OEM medical device manufactures.
We are in the process of preparing for ISO 13485 certification and choosing a registrar.
We want to choose a CB that our future clients will respect. We were initially considering Perry Johnson but got the impression that they may not have the best reputation. BSI was recommended to us. ANAB was not an option on the BSI application but all of our business is domestic. Would it be beneficial or detrimental in any way to choose RvA?

I've worked with Intertek much over the past 5ish years for 13485/MDSAP, and have had mostly good experiences. Their office support can be uncontactable at times, but have found with the right buttons pushed, it's less of a deal. I've also worked with UL, and I would say their Auditors were terrible and would not recommend.