M
MDQSA
Is it a requirement to have a procedure for a Declaration of Conformity?
Which standard are you registered to? Any?
M
MDQSA
We are registered to ISO 13485:2003 and looking to incorporate the MDD requirements (93/42/EEC) into our QMS this year. Is that helpful?
M
MDQSA
Thank you so much. We're cleaning up our QMS right now, purging it of NVA procedures, and I had really hoped I wouldn't need to add one more SOP.
Thanks again.
R
RLewing
For our purposes I have cut it short by making a template for a special review meeting. It includes a list of applicable harmonized standards (based on the list in the Official Journal) and a checklist.
The shortlist of harmonized standards needs of course be compiled, but if your design input review did its job, you have the list already.
The checklist is based directly on requirements of the applicable directive(s). In our case we apply "2006/95/EC Principal Elements of the Safety Objectives for Electrical Equipment Designed For Use within Certain Voltage" and "98/37/EC - Machine Directive", and we have about two dozen issues to be checked. Based on my previous experience of the MDD, I would say that the same principle should work well -checklist might be longer.
Having a detailed procedure or taking this kind of shortcut naturally depends on the skill levels of your personnel.
The shortlist of harmonized standards needs of course be compiled, but if your design input review did its job, you have the list already.
The checklist is based directly on requirements of the applicable directive(s). In our case we apply "2006/95/EC Principal Elements of the Safety Objectives for Electrical Equipment Designed For Use within Certain Voltage" and "98/37/EC - Machine Directive", and we have about two dozen issues to be checked. Based on my previous experience of the MDD, I would say that the same principle should work well -checklist might be longer.
Having a detailed procedure or taking this kind of shortcut naturally depends on the skill levels of your personnel.
R
Roland Cooke
It's not a requirement, but I generally advise my clients to create procedures for handling compliance to their various regional regulations.
For Europe this would include what their obligations under the MDD are, and how they are managed. For example, what goes in a DoC, who signs it, what happens when that person leaves, who is responsible for ensuring the DoC remains valid etc etc.
For Europe this would include what their obligations under the MDD are, and how they are managed. For example, what goes in a DoC, who signs it, what happens when that person leaves, who is responsible for ensuring the DoC remains valid etc etc.
We just had our stage one assessment for ISO13485 and were told by the auditor that it was a requirement to have a procedure for creating the declaration of conformity. I asked where this was a documented requirement and he told me that there was no documented requirement but it was a requirement of the registrar. I am planning on creating a template as others here have suggested.
P
Persson - 2010
Content of EC Declaration of Conformity
The "EC Declaration of Conformity" should include in general the follows:
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EC DECLARATION OF CONFORMITY
1.
No xxxxxx (unique identification of the product):
2.
Name and address of the manufacturer and/or his authorised representative:
3.
This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):
4.
Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):
5.
The object of the declaration described above is in conformity with the relevant Community harmonisation legislation: ………
6.
References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:
7.
Where applicable, the notified body ... (name, number)… performed … (description of intervention) … and issued the certificate: ….
8.
Additional information:
Signed for and on behalf of: ………………………….
(place and date of issue)
(name, function) (signature)
-----------------------------------------------
K
Kary13
I also prepared a template that was actually submitted in our technical file...
However, I have one question regarding this DOC: Do we have to supply it with each equipment we sell or is it something that we should 'keep in our files" saying that we declare being conform with all the applicable standards?
I am trying to figure out what's the difference between the final QC inspection which ends up in the final release of the product and the DOC to be supplied with the device... I guess it gives out more details but... any thoughts???
However, I have one question regarding this DOC: Do we have to supply it with each equipment we sell or is it something that we should 'keep in our files" saying that we declare being conform with all the applicable standards?
I am trying to figure out what's the difference between the final QC inspection which ends up in the final release of the product and the DOC to be supplied with the device... I guess it gives out more details but... any thoughts???
