Section 1.3 Exclusions
Where any requirement of ISO 9001: 2000 can not be applied due to the nature of our organization, its activities and its products, they will be considered for exclusion.
An ISO 9001: 2000 requirement may be excluded only when both of the following conditions are met:
- the requirement must be within ISO 9001 clause 7, Product Realisation, and
- the exclusion may not affect our ability, nor absolves us from the responsibility, to provide product that meets customer and applicable regulatory requirements.
Quality Assurance Manager is responsible for identifying those requirements of ISO 9001 that do not apply to our organization or products, and to propose exclusions of such requirements from the scope of the quality system.
The Managing Director has the responsibility and authority for examining whether the proposed exclusions are appropriate and for approving them. Evaluation and approval of exclusions are conducted within the framework of management reviews of the quality system (refer to procedure P 561, Management Review).
Any exclusions taken are documented in this section of the Quality Manual. The excluded requirements are precisely identified with reference to specific clauses and/or statements in the standard. There is also a brief justification why the exclusion is taken and why it is appropriate.
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Exclusion: ISO 9001: 2000 section 7.3, Design and/or Development, including all subsections
Justification: our company does not design or develop products. Instead, customers specify all product characteristics. Our engineering activities are limited to developing methods and means of production, fabrication, or installation. -
Exclusion: ISO 9001: 2000 section 7.5.9, Servicing
Justification: our company does not service its products. -
Exclusion: ISO 9001: 2000 section 7.6, Control of Measuring and Monitoring Devices
Justification: our company does not use any instruments, equipment, or devices to assure or verify conformity of product to specified requirements. The product is verified visually or by a review of documentation that all processing steps are complete.