Clause 8 Operation
8.3.1 Design and development - General
The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.
The primary requirement of this criteria is for the organization to establish a formal set of criteria, or 'code of practice', for their design and development process.
It is important to note, that organizations who perform changes to mature designs, whether major or minor, cannot exclude themselves from the design and development clauses of ISO 9001.
The organization is required to implement a design and development process that includes design and development planning, inputs, controls, outputs and changes.
The only guidance offered within the Standard is that the process should be appropriate to the provision of products and services.