Good morning Regan I agree with you that most manufacturers don’t conduct audits In my opinion I recommend the following actions
1. Implement safety test in the production. For example Annex F of EN 61010-1:2010 indicate some routine test 2. Spot check. Select a sample of a batch and perform a representative test (for example Radiated Emissions for EMC) But at the end is manufacturer responsibility to decide what level of test to do. I hope that it helps. Let me know if you have additional questions. Kind Regards / Saludos cordiales / Mit freundlichen Grüßen Daniel Rodríguez From: Charlie Blackham <char...@sulisconsultants.com> Sent: Wednesday, 15 January 2020 09:05 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] CE marking quality manufacturing requirements Caution: This email originated from outside of the organization. DO NOT CLICK on links or open attachments unless you recognize the sender and know the content is safe. 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://urldefense.com/v3/__https:/sulisconsultants.com/__;!!Nkc5UzxO!_46FSYSwQrWeuNlnFnjaHoK6jP6qpzr4cUnq_2phMVcZRt2dpLlkd2NSpliDlbCH$> Registered in England and Wales, number 05466247 From: Regan Arndt <reganar...@gmail.com<mailto:reganar...@gmail.com>> Sent: 15 January 2020 00:23 To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG> 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 <emc-p...@ieee.org<mailto:emc-p...@ieee.org>> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html<https://urldefense.com/v3/__http:/www.ieee-pses.org/emc-pstc.html__;!!Nkc5UzxO!_46FSYSwQrWeuNlnFnjaHoK6jP6qpzr4cUnq_2phMVcZRt2dpLlkd2NSpvGDZW2J$> Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/<https://urldefense.com/v3/__http:/product-compliance.oc.ieee.org/__;!!Nkc5UzxO!_46FSYSwQrWeuNlnFnjaHoK6jP6qpzr4cUnq_2phMVcZRt2dpLlkd2NSpkjvQYkI$> can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/<https://urldefense.com/v3/__http:/www.ieee-pses.org/__;!!Nkc5UzxO!_46FSYSwQrWeuNlnFnjaHoK6jP6qpzr4cUnq_2phMVcZRt2dpLlkd2NSpmG_AGXJ$> Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe)<https://urldefense.com/v3/__http:/www.ieee-pses.org/list.html__;!!Nkc5UzxO!_46FSYSwQrWeuNlnFnjaHoK6jP6qpzr4cUnq_2phMVcZRt2dpLlkd2NSpsS7iYLf$> List rules: http://www.ieee-pses.org/listrules.html<https://urldefense.com/v3/__http:/www.ieee-pses.org/listrules.html__;!!Nkc5UzxO!_46FSYSwQrWeuNlnFnjaHoK6jP6qpzr4cUnq_2phMVcZRt2dpLlkd2NSpkeJg8nP$> For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org<mailto:sdoug...@ieee.org>> Mike Cantwell <mcantw...@ieee.org<mailto:mcantw...@ieee.org>> For policy questions, send mail to: Jim Bacher <j.bac...@ieee.org<mailto:j.bac...@ieee.org>> David Heald <dhe...@gmail.com<mailto:dhe...@gmail.com>> - ---------------------------------------------------------------- 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 <emc-p...@ieee.org<mailto:emc-p...@ieee.org>> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html<https://urldefense.com/v3/__http:/www.ieee-pses.org/emc-pstc.html__;!!Nkc5UzxO!_46FSYSwQrWeuNlnFnjaHoK6jP6qpzr4cUnq_2phMVcZRt2dpLlkd2NSpvGDZW2J$> Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/<https://urldefense.com/v3/__http:/product-compliance.oc.ieee.org/__;!!Nkc5UzxO!_46FSYSwQrWeuNlnFnjaHoK6jP6qpzr4cUnq_2phMVcZRt2dpLlkd2NSpkjvQYkI$> can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/<https://urldefense.com/v3/__http:/www.ieee-pses.org/__;!!Nkc5UzxO!_46FSYSwQrWeuNlnFnjaHoK6jP6qpzr4cUnq_2phMVcZRt2dpLlkd2NSpmG_AGXJ$> Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe)<https://urldefense.com/v3/__http:/www.ieee-pses.org/list.html__;!!Nkc5UzxO!_46FSYSwQrWeuNlnFnjaHoK6jP6qpzr4cUnq_2phMVcZRt2dpLlkd2NSpsS7iYLf$> List rules: http://www.ieee-pses.org/listrules.html<https://urldefense.com/v3/__http:/www.ieee-pses.org/listrules.html__;!!Nkc5UzxO!_46FSYSwQrWeuNlnFnjaHoK6jP6qpzr4cUnq_2phMVcZRt2dpLlkd2NSpkeJg8nP$> For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org<mailto:sdoug...@ieee.org>> Mike Cantwell <mcantw...@ieee.org<mailto:mcantw...@ieee.org>> For policy questions, send mail to: Jim Bacher <j.bac...@ieee.org<mailto:j.bac...@ieee.org>> David Heald <dhe...@gmail.com<mailto:dhe...@gmail.com>> CONFIDENTIALITY NOTICE: This e-mail communication and any attachments may contain proprietary and privileged information for the use of the designated recipients named above. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message. - ---------------------------------------------------------------- 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 <emc-p...@ieee.org> 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 <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
