Hi Chris, for guidance see EN ISO/IEC 17050-1, clause 10:
10 Continuing validity of the declaration 10.1 The issuer of the declaration of conformity must have procedures in place to ensure continued conformity with the stated requirements of the declaration. 10.2 The issuer of the declaration of conformity must have procedures in place to re-evaluate the declaration, in the event of changes significantly affecting the product's design or specification, changes in the standards to which compliance of the product is stated, changes in the ownership, structure of management of the supplier, if relevant, or in the case of any information indicating that the product may no longer comply with the requirements of the conformity assessment system. Therefore you need a "product conformity MONITORING system" to control regulations (EC Directives, national laws) and standards (UL, ANSI, IEC, ISO, ETSI, CEN, CENELEC,.....) AND the "date of cessation for the superseded standard (OJEU)" during the product life cycle.. An other question is the "product liability". We have often the discussions with our customers to the following: What does it mean "state of the art"? Is it "mandatory" to apply a NEW ratified european standard" which is NOT yet published in the OJEU!? That is the BIG question! And the answer is different. A lawyer or a judge answer "yes" because the new standard has a better "state of the art" (to avoid hazards!). The answer of the commission: it´s not yet published in the OJEU. Therefore not applicable for the "declaration of conformity". In general (see "Blue Guide of the European Commission" as reference): EACH product of a production series MUST fulfill the essential requirements! That does not mean that you must test each product. But you need a system. That is "internal production control". That is one of the important "modifications" of the new EMC Directive: see Annex II, number 2 and 8. That was my idea to write a book together with a lawyer. See also ISO guide 67 "Conformity assessment - Fundamentals of product certification" Mit freundlichen Grüßen Yours sincerely Dipl.-Ing. Michael Loerzer Managing Director Regulatory Affairs Specialist Chairman of the Product Conformity Group (DIN ANP German Committee of Standards Users) GLOBALNORM - Global Regulatory Compliance Fon: +49 30 6392-3860, Direct Call: 3861 Fax: +49 30 6392-3863 Rudower Chaussee 29 12489 Berlin Germany www.globalnorm.ca www.Globalnorm.de ----- Original Message ----- From: <[email protected]> To: "'Emc-Pstc'" <[email protected]> Sent: Wednesday, February 22, 2006 1:05 PM Subject: 'Evaporation' of compliance certification with time? > Gentlemen, and ladies, and others..... > > Does anyone have an opinion on the longevity of a Compliance Certificate? > > Take the situation..... > > If we make a product, test it, certify it, and sell this in the normal way, > how long can we carry on selling this product (assuming that there are no > design changes, but changes due to obsolescent parts or 'more modern' > parts) relying on the original test results and certificate to provide > evidence of Compliance? > > My own gut feeling is that three years is perfectly OK, and 20 years is too > long, so somewhere in between those two figures may be about right I > suppose. > > Does anyone have an opinion, a precedent, or rationale for this subject? > > Thankyou for your attention. > > Chris Dupres. > > > *******************Internet Email Confidentiality Footer******************* > The contents of this e-mail message (including any attachments hereto) are > confidential to and are intended to be conveyed for the use of the > recipient to whom it is addressed only. 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Website: http://www.ieee-pses.org/ > > To post a message to the list, send your e-mail to [email protected] > > Instructions: http://listserv.ieee.org/request/user-guide.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] > > All emc-pstc postings are archived and searchable on the web at: > > http://www.ieeecommunities.org/emc-pstc - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/request/user-guide.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] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
