CE Mark Auditing - All they had for CE was a written Technical Justification

[nancyi]

I just finished an audit of our sister company. In their design specifications they state that 21 CFR 1040.10, 1040.11 and CE requirements must be met. I found the Annual reports and Product file for 21 CFR but all they had for CE was a written Technical Justification, There was no specific test or file kept. Their justification was this :
" The power supply is CE marked and has passed all LVD requirements. All bonding and protections agains human contact are contained in the power supplly enclosure."

For EMC they write: " All electrical components are fully enclosed in metal enclosures with conductive gaskets. All cables are enclosed in sealed metal conduit. In previous designs, this shielding method has proven to comply with all EMC standards. The power supply used is CE marked, and the Line power connections are filtered with the same filter assembly used in product that has proven to eliminate conducted emissions as well as radiated emissions from the power conductors."

I wrote this up as a nonconformance but they argue that it meets requirements. I am not an expert on CE, my experience lies with the 21 CFR requirements. HELP!! Thanks Nancy

[M Greenaway]

Interesting and deep audit question.

From a systems perspective it appears that they have identified CE marking as a design input, and the design record shows that this has been considered.

However whether or not their consideration of this is technically sound is another question, and I guess the question you are asking.

Without the technical know how yourself I would suggest you read up on the requirements for CE marking for this type of product.

Not terribly helpful - sorry

nancy,

I agree with martin. Check with UL and ask their advice. They charge for CE Marking, just like UL Listing because they are different. I, too, am no expert except to say we are UL listed for our Industrial Electrical Panels. The Inspector/Engineer indicated that when we are ready for CE marking, they would happily oblige.$$$$ I suspect the boys are handing you a line. Maybe it's because I fish, but that's what I smell.

PS I will copy your post and give it to our Electrical Engineer who is our UL Guru. I'll post his response, ASAP

[Aaron Lupo]

nancy, my experience with CE marking is in the medical device arena. Here is a couple websites that may provide some useful information.

http://www.radioregs.com/ce_mark.htm

http://www.cemarking.net/

Thanks ISO Guy for the references.
Nancy,

Our electrical guy is confused, now so am I. What was your nonconformance for? It doesn't appear that they are CE Marking. They are saying that they meet CE requirements in their design specifications of their entire widget. No? They are accepting the CE device to answer some required properties of the power supply?
Their vagueness of the rest of their explanation of EMC, whatever that is, begs for explanation. "has been to proven to comply" and "previous designs", "used in product proven to eliminate......". What they have done, IMHO, has put the burden of proof on anyone questioning their statement. In other words, as they told you, "we comply". You ask, "What product is that you refer to?" "What previous design are you referring to?"

How about a little more information on your actual nonconformance. Like, should be, blah blah blah...actual is blah blah blah?

[nancyi]

Thanks to everyone for the imput.
I Wrote the Nonconformance because they had no file or test data ect. to back up the statement that their privious unit built in 1998 passed EMC. All they had was the use of a power supply that has the CE mark. Even if the 1998 unit passed does that carry over to later models? There has been a heap of changes to the design since 1998. Is a written declairation by the mfg all that is required? Because We say so? Thanks Nancy