Choosing a Registrar - Registrar Recommendations

[Helmut Jilling]

Our company is currently 9001 registered and we're using NQA (National Quality Assurance) but we are in the process of going after 13485 and are shopping around for Registrars. I've got quotes from NSAI, LRQA, and TUV and I'm looking for some feedback on the non-monetary side of the decision. Any help/ feedback is greatly appreciated...
Thanks,

One of the registrars I am with does 13485 - DQS or DQS USA, depending on which side of the Atlantic Ocean you are located on. They are a very proactive registrar and we focus on providing value added (non-bureaucratic) audits.

 

[Barahir]

Yesterday we just completed our first audit with SRI. The auditors themselves were both thorough (or as thorough as one can be auditing an entire QMS in 1.5 days) and seemed to know what they were doing. We came away with 9 nonconformances.

Three were in the "D'OH!" category where something that normally was done like clockwork didn't get done (likely due to the high volume of management changeover last year). Easy fixes, we just need to put some controls in place to make sure that personnel changeover doesn't let something fall through the cracks.

Most were in the "uh-oh" category where either we knew we had a weakness and needs some minor to major work.

One was in the "Huh?" category where we got a nonconformance to the AIAG MSA Manual, which I didn't think was normative to TS-2. Still trying to figure that one out.

 

[Helmut Jilling]

...One was in the "Huh?" category where we got a nonconformance to the AIAG MSA Manual, which I didn't think was normative to TS-2. Still trying to figure that one out.

Good question. The manuals themselves are not normative, but the Big 3 TS Customer Specifics make them mandatory. A better practice might be for auditors to cite the clause in the TS standard, and reference the specific requirement described in the MSA book.

 

[Barahir]

But if I'm a direct supplier to a Big 3 customer (and therefore do not have to subscribe to their CSR's) then it shouldn't be normative to me, right?

The actual nonconformance was over bias, linearity and stability studies (we've never used them, just Gage R+R), and I'm not going to complain about the nonconformance because I'm sure that the studies are useful and we probably should be doing them. Now it looks like I get to make another trip up to AIAG for some MSA training. Southfield, joy.

(And I imagine that the MSA book was normative under QS-3, so we should have been doing them and if that's the case it's a wonder we never got hit on it during one of the twice a year audits from 1998-2006.)

 

[Helmut Jilling]

But if I'm a direct supplier to a Big 3 customer (and therefore do not have to subscribe to their CSR's) then it shouldn't be normative to me, right?

I think you mean to say you are a tier 2? If so, your point might be correct, but most tier 1's actually require their suppliers to do them as well.

The actual nonconformance was over bias, linearity and stability studies (we've never used them, just Gage R+R), and I'm not going to complain about the nonconformance because I'm sure that the studies are useful and we probably should be doing them. Now it looks like I get to make another trip up to AIAG for some MSA training. Southfield, joy.

(And I imagine that the MSA book was normative under QS-3, so we should have been doing them and if that's the case it's a wonder we never got hit on it during one of the twice a year audits from 1998-2006.)

Yes, these were required for years under QS. However, the blue books weren't normative, the studies requirement came out of the QS standard and interpretations.

Yes they are useful, and if you use programs like GageTrak and GagePak, the studies can be executed automatically from the same data entered for Gage R&R.

Don't think you need to do training for these, if you already know how to do Gage R&R. Check your software.

 

[Paul Simpson]

One of the registrars I am with does 13485 - DQS or DQS USA, depending on which side of the Atlantic Ocean you are located on. They are a very proactive registrar and we focus on providing value added (non-bureaucratic) audits.

I'm sure they're great Helmut. Hardly an unbiased opinion, though!

 

[Barahir]

I think you mean to say you are a tier 2? If so, your point might be correct, but most tier 1's actually require their suppliers to do them as well.

Yes, I meant to say we aren't Tier 1. We're Tier 2 in only one instance, and Tier 3 for the most part. None of the CSR's from our customers require us to use the blue books. Sometimes I wonder what the value is in an additional 20 page document from the customer that gives absolutely no additional requirements beyond "Do whatever the Standard says."

Yes they are useful, and if you use programs like GageTrak and GagePak, the studies can be executed automatically from the same data entered for Gage R&R.

We do use the GageTrak software program and I'm scheduled to head to Chicago in April for a training session on that (we've used it since 1997 - and have upgraded to newer versions since then - but the guy who was trained on it left the company last year so someone needs trained). I'd just like to get some MSA and SPC training since I'm "the guy" for the company in those two areas and it would be nice to know what I'm supposed to be in charge of.

 

[Helmut Jilling]

I'm sure they're great Helmut. Hardly an unbiased opinion, though!

well, in the spirit of fairness, I did say I worked for them. Of course, that means I have a lot of first hand knowledge about them.

You can safely assume I would not work for them if I did not feel they were very good. As a TS auditor, I would have several options, but I specifically selected DQS. They are first rate.

I also like the other registrar I work for - Smithers Quality Assessments - but I don't believe they do 13485.

 

[JLLASER]

We are gearing up for our first certification to ISO9001. We are considering several different CBs, but I was wondering if anyone had some thoughts concerning SQA. Also, has anyone used Orion or Platinum? Thanks!

 

[Coury Ferguson]

We are gearing up for our first certification to ISO9001. We are considering several different CBs, but I was wondering if anyone had some thoughts concerning SQA. Also, has anyone used Orion or Platinum? Thanks!

I have not worked with any of these particular Registrars, and I have not personally heard anything negative about Smithers Quality Assurance (SQA), Orion, or Eagle.

Anyone else?