Review of the New Approach - Orgalime views on conformity assessment modules

Published: 14 April 2005

Policies & Issues: Internal Market - Compliance, Standards & Enforcement

Response to the European Commission - Mr. J. McMillan

Orgalime believes that the conformity assessment modules generally are efficient for their intended purpose and give rise to few significant problems. In particular, we urge regulators to continue to make use of Module 'A' (self declaration of conformity) as the default choice in any new or revised product legislation.  Module 'A' does not need any additional requirements in order to have credibility.

In order to adapt the modules to current practice, in addition to taking account of the revision of standard ISO 9001, Orgalime also proposes a slight amendment to module B in accordance with Directive 2004/22/EC Measuring instruments, where type testing may also be conducted in the form of evaluation of design documentation.  Such an amendment would be very advantageous for highly innovative and expensive instruments.

See encloosed our proposal in a graphical form.

References: EC letter ENTR/C1/GA/ah D(2005)4553 dated 24/02/2005

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