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for module E) should note that these standards have been superceded by BS EN ISO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 development |
No 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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