IS0 9001:2015

Clause 8.3.5 Design and development outputs

Design and development outputs are required by ISO 9001:2015 to:

  1. Meet the input requirements,
  2. Be suitable for subsequent processes for the provision of products and services,
  3. Include or refer to, appropriate monitoring and measuring requirements and their acceptance criteria,
  4. Define the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision. Documented information on design and development outputs must also be retained. IE: Records!


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:

  • Product specifications or drawings suitable for manufacturing,
  • Finished goods handling, packaging and storage requirements,
  • Necessary purchasing information such as component and raw materials specifications,
  • Any special or critical quality and safety characteristics which must be controlled in production,
  • Any post-delivery servicing or maintenance manuals and associated information, such as spares lists for the finished product.

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.

This article is the property of David Barker Consulting © and is free for you to use. If you wish to reproduce elsewhere, please be so kind as to ask permission first and credit me as your source. If you need any further assistance, feel free to use my contacts page to get in touch and let me know how I can help!

David Barker CQP MCQI

ISO 9001:2015

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