8.0 Operation

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ISO Navigator Pro™ is a free tool that provides practical, expert guidance for businesses wishing to interpret the fundamentals of ISO 9000:2015 to help understand, and better implement, the requirements of ISO 9001:2015, ISO 14001:2015 and OHSAS 18001:2007. The ISO Navigator Pro™ database divides the requirements into four sequential stages; Plan, Do, Check and Act.

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8.3 Design and development of products and services

8.3.2 Planning

This requirement expands upon the requirements from ISO 9001:2008 Clause 7.3.1 – Design and Development Planning. It is likely that if your organization already complies with ISO 9001:2008, you will already be undertaking the activities required by this clause.

You should seek and record evidence that your organization has considered the explicitly referenced considerations relating to the design and development process set out above. You should also ensure that your organization has retained documented information to confirm the identified design and development requirements were met and that design reviews were undertaken.
You must have an overall plan for your design.

Your plan must specify the design and development stages, activities and tasks; responsibilities; timeline and resources; specific tests, validations and reviews; and outcomes. There are many tools available for planning ranging from a simple checklist to complex software. Plan and control product design and development by:

  1. Determining all design development phases;
  2. Determining all review, verification and validation techniques for each phase;
  3. Determining responsibility for design and development;
  4. Determining authorities for design and development;
  5. Maintaining records.

Although the standard does not require a documented procedure, the design process needs to demonstrate how the process is controlled and planned. The organization, however, will need to provide some type of objective evidence as to what the planning activities include. This 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 likely want to see objective evidence of how the interfaces between other processes are managed, either through statements, or in associated procedures, process mapping, and matrix approach or in the time line planning.

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