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 planning 7.3.1

Who is going to do it? How and when will they communicate? You must have an overall plan for your design. The plan must specify the design and development stages, activities and tasks; responsibilities; timeframe and resources; specific tests, validations and reviews; and outcomes. Plan and control product design and development by determining:

  1. All design development phases
  2. All review, verification and validation techniques for each phase
  3. Responsibility for design and development
  4. Authorities for design and development
  5. The types of records that are required

Although the standard does not require a documented procedure, the design process needs to demonstrate how it is controlled and planned. The organization will need to provide objective evidence as to what the planning activities include and can be accomplished with the use of time-lines, Gantt charts or any other planning method such as Microsoft project manager.

In addition, auditors would expect see objective evidence of how the interfaces between other processes are managed, either through statements in associated procedures or process mapping.