Guidance

Design and development

The ISO Navigator™ database hyperlinks the ISO 9000 principles and the ISO 9001 requirements; and explains them in plain English with practical guidance.

ISO 9001: Design and development output 7.3.3

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.

Outputs may also include product preservation methods, identification, packaging, service requirements, etc. as appropriate. The output would normally be used as basis for purchasing and process control.

Design and development outputs must reconcile with design and development inputs by determining:

  1. Whether the outputs meet the input requirements for the design
  2. Whether the outputs provide suitable information for purchasing
  3. Whether the outputs provide reference to product acceptance criteria
  4. Whether the outputs accurately specify essential characteristics
  5. The types of records that are required

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.