8.0 Operation

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8.3 Design and development of products and services

8.3.4 Design and development controls

This requirement is comparable to the requirements from ISO 9001:2008 Clauses 7.3.3, 7.3.4, 7.3.5 and 7.3.6. You should seek and record evidence that your organization has applied the necessary controls to its design and development process and has retained the following documented information:

  1. Defined outcomes including such as specifications, design intent, functional and performance requirements, customer/end user expectations;
  2. Design review process with functional representation from the customer, engineering, production, quality, project management etc.), design review gates (e.g. preliminary design review, detail design review, critical design review), commercial/technical considerations, authorized progression to next stage;
  3. Verification activities such as modelling, simulations, alternative calculations, comparison with other proven designs, experiments, tests, and specialist technical reviews;
  4. Validation activities such as functional testing, performance testing, trials, prototypes, demonstrations, and simulations;
  5. Management of actions arising from design reviews, verification or validation activities e.g. action registers, ownership, timescales, escalation, changes to risk profile.

Design verification is a comparison between the outputs the inputs. Does the available evidence indicate that the design will meet the requirements? The verification could consist of calculations, simulations, prototype evaluation, tests or comparison against samples. You must maintain documented information of design verification activities; as these records will indicate the results of verifications and determine any necessary corrective actions. Perform design and development verification by determining whether the outputs meet the input requirements for the design. Maintain records of verification activities and approvals.

Design verification should be carried out to check that the outputs from each phase meet the stated requirements for the phase. Requirement verification should be undertaken to ensure that the design fulfils the the input requirements, as applicable, while expressing the necessary functional and technical requirements.

Design validation is similar to verification, except this time you should check the designed product under conditions of actual use. If you are designing dune buggies, you might take our creation for a spin on the beach. If you are making beverages, you might conduct a consumer taste test. Verification is a documentary review; while validation is a real-world test. Perform design and development validation by ensuring the product meets the specified requirements. Maintain records of validation activities and approvals.

The organization shall have records that the product designed will meet defined user needs prior to delivery of the product to the customer, as appropriate. Methods of validation could include simulation techniques, proto-type build and evaluation, comparison to similar proven designs, beta testing, field evaluations, etc. Irrespective of the methods used, the validation activity should be planned, executed with records maintained as defined in the planning activity.

Retain documented information to demonstrate that the any test plans and test procedures have been observed, and that their criteria have been met, and that the design meets the specified requirements for all identified operational conditions e.g. reports, calculations, test results, data, and reviews.

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