8.0 Operation

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8.3 Design and development of products and services

8.3.5 Outputs

This requirement is comparable to the requirement from ISO 9001:2008 Clauses 7.3.3 – Design Development Outputs. You should seek and record evidence that the additional requirement to retain documented information concerning design outputs. You should also check the need for design outputs to reference monitoring and measuring requirements.

The design and development output is the result of design and development process. The output is a clear description of the product, containing detailed information for production. Design and development outputs must reconcile with design and development inputs by:

  1. Determining whether the outputs meet the input requirements for the design;
  2. Determining whether the outputs provide suitable information for purchasing;
  3. Determining whether the outputs provide reference to product acceptance criteria;
  4. Determining whether the outputs accurately specify essential characteristics;
  5. Maintaining records.

The auditor should expect to see objective evidence that the outputs (7.3.3 a – d) have been verified against the design inputs. This can be accomplished by reviewing documents, plans, etc. interfacing with the customer or internal processes and by comparison with past proven designs. Outputs may also include product preservation methods, identification, packaging, service requirements, etc. as appropriate.

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