Design and development outputs are required by ISO 9001:2015 to:
Note that outputs must include or make reference to, any monitoring and measuring requirements and their acceptance criteria
Outputs must be suitable and adequate to allow verification and validation activities to be completed. Typical outputs might include:
Audit Check: Auditors may again select several design and development projects documented information (records) to determine that design and development outputs have been identified and depending on the stage of the individual projects:
• Have been verified / validated to confirm they meet the input requirements through appropriate means. • Outputs are adequate and suitable for their intended purpose, including monitoring and measuring requirements and their acceptance criteria. EG: Manufacturing tolerances, verification / validation test specifications and parameters etc.
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David Barker CQP MCQI