Exclusion is an issue only connected with certification of a management system and not with its design. If the management system is captured by viewing the organiuzations from the perspective of how it creates and retains customers, everything that affacts its ability to create and retain customers will be included in that perspective.
Any requirement of ISO 9001 can be excluded or deemed not applicable providing it can be justified on the basis that it does not relate to anything the organization needs to do to satisfy its customers.
Design and development
Clause 8.3.1 of ISO 9001 states “The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services”. It therefore follows that if your organization designs the products or services that are provided to its customers the design and development requirements apply.
There are two requirements that apply when certain conditions prevail i.e. clause 8.5.2 when traceability is a requirement and clause 126.96.36.199 when measurement traceability is a requirement. No exclusions need be declared for these if there are no requirements, but in circumstances where these requirements would normally be invoked in contracts or regulations be prepared to demonstrate traceability is not required.
© Transition Support Last edit 24/11/2023
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