8.0 Operation

ISO Navigator Pro

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.

If you're looking for integrated ISO 9001:2015 and ISO 14001:2015 EQMS documentation, please click here.

8.3 Design and development of products and services

8.3.3 Inputs

This requirement expands upon the requirements from ISO 9001:2008 Clause 7.3.2 - Design and Development Inputs 7.3.1. You should seek and record evidence that your organization has documented and retained information concerning the need for internal and external resources and the potential consequences of design or development failure.

Define which inputs are required to carry out the design and development process. The 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:

  1. Determining functional and performance characteristics;
  2. Determining statutory and regulatory requirements;
  3. Determining relevant information from previous designs;
  4. Determining requirements essential to the product;
  5. Maintaining records.

The auditor will need to review evidence that the inputs 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 requirement.

Free internal audit checklists

Check out our free internal audit checklists. The audit checklist is just one of the many tools which are available from the auditor’s toolbox that help ensure your audits address the necessary requirements.

Client list

Over 8,000 companies and globally recognized brands have relied on our templates to provide a path to improve, collaborate, and to enhance their operations to achieve certification, please see our client list for more information.