Requirements for Declaration of Conformity - Compliance to MDD

T

tata347

#21
I know this is a very old post but doesnt your attachement go against the standard ISO 17050 that states there should be confirmity documenation listed including the qulaity system??

Every year i get hit on this and our auditor just told me that I dont even need to state the EN/ISO document on the DoC..

Anyone??
 
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Ronen E

Problem Solver
Staff member
Moderator
#22
I know this is a very old post but doesnt your attachement go against the standard ISO 17050 that states there should be confirmity documenation listed including the qulaity system??

Every year i get hit on this and our auditor just told me that I dont even need to state the EN/ISO document on the DoC..

Anyone??
Hi,

It could be very helpful if you were more specific in your reference ("your attachment"), preferably stating the document and the clause you relate to. If you could also state the specific clause in ISO 17050 that would be even better.

Thanks,
Ronen (Moderators team).
 
O

onpoint

#23
Another question along the same line, related to the Conformity Assessment Route on the Declaration of Conformity (DoC).

We received an NC after a Technical Review stating that our EC Declaration of Conformity does not fully meet the requirements of Annex II. The conformity assessment route (Annex II section 3.2) was not included in the declaration.

What was included on the DoC in this space was Annex II excluding section 4.

Our devices are Class IIA per Rule 7 of Annex IX.

Help in understanding which on is correct and WHY would be appreciated. I looked at the NC-MED consensus statement S99/01 (or S/01/99 depending on how you look at) and it was no help.

Thanks - Mary
 
O

onpoint

#24
Hi Marcelo - I am new to Elsmar Cove and the whole asking questions / posts thing and would appreciate your help. I added a question to this very old thread about Requirements for the Declaration of Conformity and would appreciate your in-sight.

The post / question will be from "onpoint".

Thanks - Mary
 

Ronen E

Problem Solver
Staff member
Moderator
#25
Another question along the same line, related to the Conformity Assessment Route on the Declaration of Conformity (DoC).

We received an NC after a Technical Review stating that our EC Declaration of Conformity does not fully meet the requirements of Annex II. The conformity assessment route (Annex II section 3.2) was not included in the declaration.

What was included on the DoC in this space was Annex II excluding section 4.

Our devices are Class IIA per Rule 7 of Annex IX.

Help in understanding which on is correct and WHY would be appreciated. I looked at the NC-MED consensus statement S99/01 (or S/01/99 depending on how you look at) and it was no help.

Thanks - Mary
Hello Mary and welcome to the Cove :bigwave:

The MDD doesn't spell out a requirement to state the conformity assessment route (at any level of detail) on the DoC. All it requires is a declaration that the applicable requirements of the directive have been met.

NB-MED S/01/99 doesn't include such a requirement (or recommendation) either, and it is outdated anyway.

The closest I saw was in DECISION No 768/2008/EC, Annex III (#7) - it requires a "description of intervention" where a NB is involved. Basically the NB works by the requirements in the relevant Annex / sections, so noting the Annex and sections could be a concise way to describe their intervention; however, this is not prescribed in the Decision, and I could conceive of other ways as well...

Insisting on "Annex II section 3.2" instead of "Annex II excluding s. 4" seems to me either over-pedantic or just petty (or both :)). Perhaps it's the result of some legal advice the NB received in the past. Either way, I would have taken the practical approach and just modified it to their liking. As I usually say, pick your battles. Sometimes it's more important to be wise than right.

Cheers,
Ronen.
 
O

onpoint

#26
Ronen E,

Thank you for your response and ever so accurate assessment of the Assessor that left the finding :). We have as you suggested simply gave him what he wanted, but in trying to put together a work instruction on how to correctly complete a DoC fully understanding the requirement (and where he pulled it from) is important. Having to write a work instruction based on the particular whim of an assessor makes it a challenge.

Thanks again.... Mary
 

Ronen E

Problem Solver
Staff member
Moderator
#27
Ronen E,

Thank you for your response and ever so accurate assessment of the Assessor that left the finding :). We have as you suggested simply gave him what he wanted, but in trying to put together a work instruction on how to correctly complete a DoC fully understanding the requirement (and where he pulled it from) is important. Having to write a work instruction based on the particular whim of an assessor makes it a challenge.

Thanks again.... Mary
I understand where you are coming from... but we need to be realistic and not expect to produce "auditor-proof" work instructions. There will always be the odd auditor who would trip you over something you didn't foresee. In my opinion your work instruction should stick with the regulation, ie not call out stating the conformity assessment route. I would take exception only if you received a clear, formal written guidance from your NB (the body, not an individual auditor), prescribing what they expect on a DoC and including that item.

You never know, the next auditor might actually be reasonable... :)

In general, I don't see the process of receiving and fixing minor NCs as bad. In my opinion it's a natural part of the continuous improvement cyclic nature of modern quality management systems (I'm not saying that all those fixes are necessary or even add value, just that it's an inevitable part, a little unavoidable evil that comes with the good).

Cheers,
Ronen.
 
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