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 input 7.3.2

Define which inputs are required to carry out the design and development process. The customer requirement inputs should be determined according to the design and development activities. For example which employees are required or what information is required for every step of the development. Determine design and development inputs by determining:

  1. Functional and performance characteristics
  2. Statutory and regulatory requirements
  3. Relevant information from previous designs
  4. Requirements essential to the product
  5. The types of records that are required

An auditor might want to review evidence that the inputs (7.3.2) have been addressed based on the nature of the product being produced, that they have been reviewed for adequacy and that records are maintained of the activity.

An organization may include design personnel in the contract review stage; these records may suffice the review of design input requirements.