The MD Annex II states "The manufacturer of machinery or his authorised representative shall keep the original EC declaration of conformity for a period of at least 10 years from the last date of manufacture of the machinery.". Don't know if this implies that every unique original with signature and/or serial number needs to be kept or only the original that is then signed for each unit or batch or whatever a manufacturer decides to do.
Annex VII states the technical file shall include "a copy of the EC declaration of conformity;" Don't know if this implies a copy of every unique original with signature and/or serial number needs to be kept or only the original that is then signed for each unit or batch or whatever a manufacturer decides to do. In any case, we know the technical file must be kept for 10 years as well as the DoC, it seems to me filing as many copies of DoCs as one might have with the technical file (either electronically or hard copy) would logical. -Dave From: Kunde, Brian [mailto:[email protected]] Sent: Monday, March 16, 2015 3:37 PM To: [email protected] Subject: Re: [PSES] Nameplate and DoC requirements Machinery Directive Exactly my point. Complicated. And once you put a serial number on the DoC it becomes a Static Document with its unique document number and it has to be filed somewhere so it can be recovered someday if anyone asks for it. BTW, google searching this topic, someone wrote a paper back in 2008 what says for the Serial Number you can put something like, "Serial Number 3001 onward". Does anyone do that? Do you think that will really fly? Another question. According to the MD 1.7.4.2 , the DoC does not have to be contained within the provided instructions but a "document setting out the contents of the EC declaration of conformity showing the particulars of the machinery, not necessarily including the serial number and the signature". So can we make the official DoC available only upon request? Yet, Article 5_1(e) states, "ensure that it [DoC] accompanies the machinery;". So I guess you cannot get around shipping the DoC with the product, right? Thanks. The Other Brian From: John Allen [mailto:[email protected]] Sent: Monday, March 16, 2015 3:08 PM To: [email protected]<mailto:[email protected]> Subject: Re: [PSES] Nameplate and DoC requirements Machinery Directive Good evening I think that a digital one should be OK because that is how my last (contract) employer (a large US-based multinational) has been doing it recently. But, in outline,: - only specified people must be able make the insertion - the chain of authorities from the CEO (etc.) to the person(s) actually inserting the digital version must be very explicitly defined, and the latter needs to inform the former person of exactly what is being done on each occasion the signature is to be used, and, possibly, will need to receive the authority before it is actually inserted; - the electronic process for insertion of the signature must very carefully controlled, and the insertion must be permanently logged on the system in question. Don't think that a scanned version would be very good because of possible miss-use of the image. John Allen W.London, UK - -----Original Message----- From: Jim Hulbert [mailto:[email protected]] Sent: 16 March 2015 18:19 To: [email protected]<mailto:[email protected]> Subject: Re: [PSES] Nameplate and DoC requirements Machinery Directive Does the signature on a DoC need to be "original" or would an digital (or scanned) signature be acceptable? Jim Hulbert -----Original Message----- From: John Woodgate [mailto:[email protected]] Sent: Monday, March 16, 2015 1:40 PM To: [email protected]<mailto:[email protected]> Subject: Re: [PSES] Nameplate and DoC requirements Machinery Directive In message <64D32EE8B9CBDD44963ACB076A5F6ABB026D3725@Mailbox-Tech.lecotech.local<mailto:64D32EE8B9CBDD44963ACB076A5F6ABB026D3725@Mailbox-Tech.lecotech.local>>, dated Mon, 16 Mar 2015, "Kunde, Brian" <[email protected]<mailto:[email protected]>> writes: > To do what they want we would have to type up a custom DoC for every >instrum! > ent we build with a dedicated document number, have it signed, and >store copies either paper or electronic file for 10 years. That's crazy. Since you are making one at a time per customer order. I don't see it's so crazy to have a 'dynamic' DoC. After all, you have a different invoice for each unit you ship. so why is it difficult to have a (mildly) different DoC? Of course, you store electronically. -- OOO - Own Opinions Only. With best wishes. See www.jmwa.demon.co.uk<http://www.jmwa.demon.co.uk> When I turn my back on the sun, it's to look for a rainbow John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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