Exclusions tto iiso 9001::2008

Exclusions to ISO 9001:2008
From The Registrar's Point of View

Exclusions to ISO 9001:2008
• 1.2 Application states:
– Where any requirement(s) of this International Standard cannot be applieddue to the nature of an organization and its product, this can be considered for exclusion. – Where exclusions are made, claims of conformity to this International Standard are not acceptable unlessthese exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicablestatutory and regulatory requirements.

Exclusions to ISO 9001:2008
• Justification – appropriate?
– Who is the customer? – What is the product – What are the requirements (stated and not stated)related to the product?

• Expressed in the Quality Manual
– Per sub-clause 4.2.2 of ISO 9001:2008

• Exclusions of partial clauses in 7, i.e., 7.5.1.f post delivery activities

Exclusions toISO 9001:2008
• Not acceptable justifications for exclusion:
– We’ve always excluded it – We outsource it – Regulatory agencies don’t demand compliance but the requirements affect ability to meetcustomer requirements

Exclusions to ISO 9001:2008
• Examples:
Exclusion for Design of services:
– Small consulting firm performing internal audits – Methodology and tools were based on guidance ISO19011:2002 – Customized service - the output is a written audit report and supporting data – Wishes to exclude 7.3 Design and Development with justification that, as a service provided, it cannothave any design and development activities

Exclusions to ISO 9001:2008
Analysis/Conclusion –
– Not justified exclusion – Has developed customized service to meet customer requirements – Developedmethodologies and tools, including delivery of written report

Exclusions to ISO 9001:2008
• Exclusion of Validation of Processes
– Small machine shop, providing finished metal parts to...