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

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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.

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