The clauses of the standard

Guidance on Clause 1.2 - 'Application' (cont.)

Application of ISO 9001:2008

It is intended that Clients seeking to implement ISO 9001:2008 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 :

- 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)