CENELEC requirements do not necessarily pertain to NRTL requirements; which are driven by United States OSHA requirements...
When acting as an NRTL, I've yet to see any two agencies perform a FUS audit using the same procedure, having the same requirements. If a safety-critical component does not bear a mark that would indicate that it is an NRTL recognized component, then most NRTLs will require that the mfr be audited. If your company has an approved quality-control process, and can demonstrate that your receiving performs 100% test IAW the scoped standard, then they would probably accept the component if the report specifies the mfr and test requirements in the construction details. luck, Brian > -----Original Message----- > From: [email protected] [mailto:[email protected]]On Behalf > Of Jon Griver > Sent: Sunday, September 04, 2005 10:32 PM > To: [email protected] > Subject: Fw: NRTL Factory Inspection Question ... > > > Doug, > > CENELEC has a document, CCA-201, "Factory Inspection Procedures, CCA > Harmonized Requirements", which defines the manufacturer's > premises/factory > location as "the location where the final assembly and/or testing of > certified products normally takes place and the > Certification Mark is > applied". > > The document also defines sub-contractors and out-workers, > but states that > inspecting them is the manufacturer's responsibility. > > In my experience the European Test Houses use this document > as guidelines > for their own procedures. I don't know if the document is > used by NRTL's. > but at least the NRTL's with European main offices should > know of the > document. > > In my experience, labelling the certified product is > literally a symbolic > act. The substantive act is final assembly and testing, > particularly safety > testing (hipot, etc.) if this is necessary for the product, > and this defines > where inspection should take place. > > Regards, > > Jon Griver > http://www.601help.com > The Medical Device Designer's Guide to IEC 60601-1 > > > > > > Recently, I had a discussion with an NTRL regarding > product factory > > inspections. > > I was under the impression that where the label was > applied, that was > > where > > the factory inspection would occur. And, if the contract > noted a different > > company where the manfacturing was done and being that was > typically > > (not always) where the lable was applied, that was > inspections would > > happen. > > > > Not so, according to these people. This was in response to > a hypothetical > > situation I gave them to consider. > > > > For instance, say your company has sells a product in your > companys name. > > But, you have assembly done at any number of contractors. > And the NRTL > > label is applied at your company. Even if the contractors > aren't on the > > contract with the NRTL for whatever reason, the factory > inspector will > > inspect as much as possible the product at your site, then > inspect the > > contractor site even though it is not on the contract. > Basically at their > > discretion. > > > > The result of this is ... if say your company has ten > contractors on a > > list > > of approved vendors with which do business (just as an > example for the > > sake of argument) for possible assembly contracts and at > any time you > > do business with just one of those contractors, this all > really means you > > must inform the NRTL of all ten 'posible' manufactoring > locations and > > all ten, including your own company, are to be inspected > on a quarterly > > basis and thus increase your factory inspection cost by a > factor of 10. > > > > For some reason, this all sounds a little unreasonable to me. > > > > What say you? > > > > Regards, Doug McKean This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/listserv/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
