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:PDFThis 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 <reganar...@gmail.com> *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. 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