8.0 Operation

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8.3 Design and development of products and services

8.3.4 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 in order to ensure that:

  1. The results from undertaking the design and development process are clearly defined;
  2. The design and development reviews take place in accordance with planned arrangements;
  3. The design and development outputs meet the design and development inputs (verification);
  4. The resulting products and services are fit for their intended use or specified application where this is known to the organization (validation).

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 records of design verification as these records will indicate the results of verifications and determine any necessary corrective actions. Perform design and development verification by:

  1. Determining whether the outputs meet the input requirements for the design;
  2. Maintaining records.

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:

  1. Ensuring the product meets the specified requirements;
  2. Maintaining records.

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.

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