Application of ISO 9001:2000
It is intended that Clients seeking to implement ISO 9001:2000
will comply with all the
requirements of the standard that are applicable to the products
within the scope of their QMS.
However, it may be found that some of the requirements of
Product realisation (Clause 7) cannot be applied due to
the nature of the organisation and its product. If this is the
case then these requirements can be considered for exclusion
(limited scope) provided that the exclusions :
- are limited within Clause 7
- do not affect the organisations ability (or responsibility)
to provide product that meets :
- customer requirements
- applicable regulatory requirements
- are defined and justified in the Quality Manual (Cl.
4.2.2)
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