Perfect. Exactly what I was looking for. I guess I fell asleep again reading this directive before I reached this clause....lol
Thanks everyone for replying. Very good feedback/input from all of you. Cheers! Regan On Wed, Jan 15, 2020 at 12:04 AM Charlie Blackham < [email protected]> wrote: > Regan > > > > CE marking of course applies to all products manufactured on an ongoing > basis, and the requirement you refer to is in the Directives > > > > Quoting from the LVD as an example (Annex III, Module A) > > > > *3. Manufacturing * > > The manufacturer shall take all measures necessary so that the > manufacturing process and its monitoring ensure compliance of the > manufactured electrical equipment with the technical documentation referred > to in point 2 and with the requirements of this Directive that apply to it. > > > > To which the LVD guide adds > > > > The manufacturer has to ensure, that the manufacturing process permanently > leads to compliant electrical equipment. One means to achieve this could be > a supervised QM-System. > > > > You as the manufacturer need to decide what is prudent, for example: > > - NRTL audits generally concern themselves with safety critical > components – which assists with safety, but doesn’t cover EMC > - Alternative components may well meet all necessary safety standards > and have equivalent electrical performance for EMC compliance, but what > about RoHS? > > > > The manufacturing quote is similar in the EMC Directive: Annex II, Module > A, section 4 > > > > Regards > > Charlie > > > > > > *Charlie Blackham* > > *Sulis Consultants Ltd* > > *Tel: +44 (0)7946 624317* > > *Web: **https://sulisconsultants.com/* <https://sulisconsultants.com/> > > Registered in England and Wales, number 05466247 > > > > *From:* Regan Arndt <[email protected]> > *Sent:* 15 January 2020 00:23 > *To:* [email protected] > *Subject:* [PSES] CE marking quality manufacturing requirements > > > > Greetings team members, > > > > I seem to recall somewhere either in a directive or the blue guide where > it states (or implies) that part of the CE marking requirements entails > that the manufacture must have a product quality system/production > control..........and this is where I need clarification: Does it imply that > the quality system entail that *one must conduct an internal product > safety audit (or the like) *to reassure themselves that there has been no > deviation to the product design/documentation that originally supported > their CE marking testing/declaration. > > > > *Note that I am not referring to the module conformity assessment protocol > which involves a notified body, but just the simple self-declaration > scheme. My search always seems to point me towards the notified body > modules section, where they say that the 3rd party conducts factory audits, > etc. but there is nothing that states this for the non-notified body > involvement.* > > > > If there is no such production verification audit required, would it not > be prudent to do this? ….just like the NRTL program? My experience > indicates that most manufacturers do not conduct internal product audits > relating to CE marking unless they forced to because they also have a > certification mark on the product (i.e. NRTL program or other certification > scheme via a Notified Body). > > > > Thanks for any help you can provide me with an official exact > clause/text/excerpt from the OJ, guides and/or directives. > > > > Regan Arndt > > - > ---------------------------------------------------------------- > > This message is from the IEEE Product Safety Engineering Society emc-pstc > discussion list. To post a message to the list, send your e-mail to < > [email protected]> > > All emc-pstc postings are archived and searchable on the web at: > http://www.ieee-pses.org/emc-pstc.html > > Attachments are not permitted but the IEEE PSES Online Communities site at > http://product-compliance.oc.ieee.org/ can be used for graphics (in > well-used formats), large files, etc. > > Website: http://www.ieee-pses.org/ > Instructions: http://www.ieee-pses.org/list.html (including how to > unsubscribe) <http://www.ieee-pses.org/list.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: > Jim Bacher <[email protected]> > David Heald <[email protected]> > - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) 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: Jim Bacher: <[email protected]> David Heald: <[email protected]>
