Re: [PSES] CE marking quality manufacturing requirements
Perfect. Exactly what I was looking for. I guess I fell asleep again reading this directive before I reached this clauselol 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 < char...@sulisconsultants.com> 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 > *Sent:* 15 January 2020 00:23 > *To:* 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> > > 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 > Mike Cantwell > > For policy questions, send mail to: > Jim Bacher > David Heald > - This message is from the IEEE Product Safety Engineering Society emc-pstc
Re: [PSES] CE marking quality manufacturing requirements
These are phrases with a high degree of conformal viability, but most companies using this Route A (SME's) do not have the slightest idea how to start "a quality system that entails" In practice this can be done by : * Have the product be approved according to one or more harmonised standards (seek advice on choice) * Document all (CE) required modifications after compliance is achieved , add them to the production files, and complete it with the test report to obtain a "technical construction file" * Create the EU Declaration of Conformity (acc. to the above harmonised standards) * Freeze the product manufacturing status * Implement a control scheme on _purchase_ and_production_ with a focus on earlier failures and _improvements_ and _invisible safety "measures"_ o /_Purchase_ /as components may change without notice, possibly driven by costs, but also by performance increase (/BTW never rely on unspecified /undocumented component properties -even if it passed tests- as these may change without notice)/ o _/Improvements/_ as detected during the approval process are by definition difficult to implement for a variety of reasons (!!) o _/Invisible safety measures/_ shall be explicitly checked upon (such as insulation rings and washers) o _Unnotable on fail safety measures _shall be explicitly checked upon (such as varistors, fuse values, double/paralled safety features) * Carry out a basic safety test for electrical safety on insulation acc to a suitable standard * Define an equivalent test method that is able to detect EMC failures (based on approval test results) (even a properly tuned SW/VHF receiver can detect sudden changes in emissions) * Keep a test log per serialized equipment (preferred) , batch or other logical production unit * Mark the product for inspection and verified. This will more or less cover the most failures in production. Please add your 2 cents Just my few cents Gert On 15-1-2020 11:37, Matthew Wilson | GBE wrote: Look at https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0082:0128:en:PDF This is, “DECISION No 768/2008/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 on a common framework for the marketing of products” See Annex II Module A1 and Module A2 in that document. The choice is down to the manufacturer how to achieve this requirement but yes I think this implies, “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.” HTH Matthew Wilson, Technical Director, GB Electronics (UK) Ltd. Disclaimer:This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you have received this email in error please delete it from your system, do not use or disclose the information in any way and notify the sender immediately. The contents of this message may contain personal views which are not the views of the company, unless specifically stated. GB Electronics (UK) Ltd is a company registered in England and Wales under number 06210991. Registered office: Ascot House Mulberry Close, Woods Way, Goring By Sea, West Sussex, BN12 4QY. *From:*Regan Arndt *Sent:* 15 January 2020 00:23 *To:* 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
Re: [PSES] CE marking quality manufacturing requirements
Look at https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0082:0128:en:PDF This is, “DECISION No 768/2008/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 on a common framework for the marketing of products” See Annex II Module A1 and Module A2 in that document. The choice is down to the manufacturer how to achieve this requirement but yes I think this implies, “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.” HTH Matthew Wilson, Technical Director, GB Electronics (UK) Ltd. Matthew Wilson Technical Director GB Electronics (UK) Ltd matthew.wil...@gbelectronics.com https://gbelectronics.uk +44 (0)1903 244 500 Ascot House//Mulberry Close//Woods Way Goring-by-Sea//West Sussex//BN12 4QY//UK Disclaimer: This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you have received this email in error please delete it from your system, do not use or disclose the information in any way and notify the sender immediately. The contents of this message may contain personal views which are not the views of the company, unless specifically stated. GB Electronics (UK) Ltd is a company registered in England and Wales under number 06210991. Registered office: Ascot House Mulberry Close, Woods Way, Goring By Sea, West Sussex, BN12 4QY. From: Regan Arndt Sent: 15 January 2020 00:23 To: 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 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://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2Femc-pstc.html&data=02%7C01%7Cmatthew.wilson%40gbelectronics.com%7Cc27738c97b4140d3cf5208d799512248%7C0991060a48f54e72abaa7189692c6192%7C1%7C0%7C637146446061876079&sdata=%2FkIQFFGjhAYeewCr1kIWG6eptLFemsP%2BJMeKjIJmpKw%3D&reserved=0> Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/<https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fproduct-compliance.oc.ieee.org%2F&data=02%7C01%7Cmatthew.wilson%40gbelectronics.com%7Cc27738c97b4140d3cf5208d799512248%7C0991060a48f54e72abaa7189692c6192%7C1%7C0%7C637146446061886072&sdata=M8TETbKblnArR%2BNRFDLhCc9J%2Bq6EOak4ys%2B9KiHaM3M%3D&reserved=0> can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/<https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2F&data=02%7C01%7Cmatthew.wilson%40gbelectronics.com%7Cc27738c97b4140d3cf5208d799512248%7C0991060a48f54e72abaa7189692c6192%7C1%7C0%7C637146446061886072&sdata=Rt1g6rJHm%2F%2B8CZ8dW4igpQ%2B9DxljISiuEAn6tFmGUbM%3D&reserved=0> Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe)<https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ieee-pses.org%2Flist.html&data=02%7C01%7Cma
Re: [PSES] CE marking quality manufacturing requirements
Good morningRegan 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 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 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 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://urld
Re: [PSES] CE marking quality manufacturing requirements
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/ Registered in England and Wales, number 05466247 From: Regan Arndt Sent: 15 January 2020 00:23 To: 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 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 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 mailto:sdoug...@ieee.org>> Mike Cantwell mailto:mcantw...@ieee.org>> For policy questions, send mail to: Jim Bacher mailto:j.bac...@ieee.org>> David Heald 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 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 Mike Cantwell For policy questions, send mail to: Jim Bacher: David Heald:
[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 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 Mike Cantwell For policy questions, send mail to: Jim Bacher: David Heald:
