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 26 July 2008
Department for Innovation, Universities and Skills (DIUS)
 
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ISO 9001:2000 - Providing a presumption of conformity to the requirements of Modules D, E and H in New Approach Directives

Manufacturers who have applied one of the three 1994 standards to meet the conformity assessment requirements of a 'New Approach' directive (i.e. BS EN ISO 9001:1994 for module H, BS EN ISO 9002:1994 for module D and BS EN ISO 9003:1994 for module E) should note that these standards have been superceded by BS EN ISO 9001:2000. It may not be necessary however, to meet all of the requirements of the standard to retain the presumption of conformity to the relevant requirements of modules D and E and the permitted exclusions are set out in the Foreword to BS EN ISO 9001:2000.

The following text has been taken from the Foreword to BS EN ISO 9001:2000 (It does not appear in BS EN ISO 9004:2000 Performance improvement.)

"Where organisations wish to implement quality management systems in conformance with modules E, D or H, they may use BS EN ISO 9001:2000. In seeking compliance with modules D, E or H organisations may exclude specific requirements.

Only those requirements in clause 7 of BS EN ISO 9001:2000 pertaining to the difference between modules D, E and H may be excluded whilst retaining the presumption of conformity.

 

Module E
Permissible exclusions		Module D
Permissible exclusions		Module H
Permissible exclusions
Sub-clause 7.1: planning of product realisation
Sub-clause 7.2.3:customer communication
Sub-clause 7.3: design and development
Sub-clause 7.4: purchasing
Sub-clause 7.5.1: control of production and service provision
Sub-clause 7.5.2: validation of processes for production and service provision
Sub-clause 7.5.3: identification and traceability		Sub-clause 7.3: design and developmentNo exclusions permitted
It should be noted that no explicit requirements in modules H, D and E relate to the concepts of "customer satisfaction" and "continual improvement". As a consequence, non-compliance with requirements of BS EN ISO 9001:2000 explicitly related to these concepts does not infringe upon the presumption of conformity to the appropriate module.

 

It should be noted that where the exclusions described in sub-clause 1.2 of BS EN ISO 9001:2000 are exceeded, conformity to BS EN ISO 9001:2000 shall not be claimed." (End of extract from Foreword.)

[Foreword to ISO 9001: 2000 reproduced with the permission of BSI under licence number 2001/SK0344. Complete editions of the standard are available from BSI Customer Services (Tel + 44 (0) 20 8996 9001).]

'Permissible' in the headings of the Table means 'permissible' in terms of retaining a presumption of conformity to the requirements of a module, not in claiming conformity to the standard, that is determined by the criteria in sub-clause 1.2.

 

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