Dave Yes.
A manufacturer may well (will really) need some form of QA system in place to assure conformity of series production, but FQA per Annex X, that is one which is approved by a Machinery Directive Notified Body, is only required for products identified in Annex IV (and only when FQA option is being followed). Regards Charlie -----Original Message----- From: Nyffenegger, Dave [mailto:[email protected]] Sent: 30 April 2014 16:02 To: [email protected] Subject: [PSES] Machinery Directive 2006/42/EC Hi folks, Article 12-3 of the directive states that for all products identified in Annex IV one of the following is required- Assessment of conformity per Annex VIII, Examination procedure per Annex IX plus Annex VIII point 3, or Full quality assurance procedure per Annex X. My understanding of the directive is apart from this there is no requirement to have a full quality assurance procedure in place. Is that correct? thanks David P. Nyffenegger, PMP, SM-IEEE Product Development Manager Bell and Howell 3791 South Alston Avenue Durham, NC 27713 Phone: 919.767.6419 Web: www.bellhowell.net - ---------------------------------------------------------------- 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]> - ---------------------------------------------------------------- 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]>

