Perhaps the auditor is the one with the simple mind :-) Original Message From: Brian O'Connell Sent: Friday, November 6, 2015 1:29 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Reply To: Brian O'Connell Subject: Re: [PSES] One DoCs vs multiple DoCs
Makes little sense to this simple mind. The manufacturer's D of C has nothing to do with any particular NB, and an NB cannot issue a product declaration per meaning of ISO17050-1, -2. The D of C could, and should, cite the NB's report as basis for presumption of conformity to particular directive(s), so the issue would seem to be that of poor formatting or poor syntax. Brian Sr Burrito Manufacturing Representative for the Dark Side -----Original Message----- From: Jon Griver [mailto:jgri...@601help.com] Sent: Thursday, November 05, 2015 9:36 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] One DoCs vs multiple DoCs I recently participated in a Notified Body audit at a medical device manufacturer. The manufacturer had a single Declaration of Conformity for the MDD and RoHS. The auditor told the manufacturer to separate the Declarations. The reason given was that the Notified Body's name and number appear on the MDD Declaration, and if the RoHS Declaration was included in the same Declaration, then it may be assumed that the Notified Body was involved in the supervision of the manufacturer's compliance with RoHS, which it is not. Jon Griver www.601help.com -----Original Message----- From: Nyffenegger, Dave [mailto:dave.nyffeneg...@bhemail.com] Sent: Friday, 6 November, 2015 06:38 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] One DoCs vs multiple DoCs The EC Blue Guide says "Where several pieces of Union harmonisation legislation apply to a product, the manufacturer or the authorised representative has to provide a single declaration of conformity in respect of all such Union acts190. It is accepted that the single declaration may be a dossier made up of relevant individual Declarations of conformity." -Dave -----Original Message----- From: T.Sato [mailto:vef00...@nifty.ne.jp] Sent: Thursday, November 05, 2015 5:37 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] One DoCs vs multiple DoCs On Thu, 5 Nov 2015 19:51:03 +0000, "Kunde, Brian" <brian_ku...@lecotc.com> wrote: > With the RoHS Directive kicking in at different times for different Categories of products, I'm starting to see the RoHS Directive listed on Declaration of Conformities. However, I have also noticed many companies generating two different DoCs; one for Safety and EMC and the other for RoHS only. > > Can someone explain to me chapter and verse on the EU's position regarding multiple DoCs? > > Our company's product category will soon be applicable to RoHS and we would like to know if multiple DoCs are OK to do or not. I've heard Not, but then again, I see reputable companies doing it so what's the deal? Maybe it is under the manufacture's choice. However, recent directives such as 2014/30/EU and 2014/35/EU says: "... a single EU declaration of conformity shall be drawn up in respect of all such Union acts." Regards, Tom - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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