Clause 8 Operation
8.3.2 Design and development planning
Clause Criteria
In determining the stages and controls for design and development, the organization shall consider:
a) the nature, duration and complexity of the design and development activities;
b) the required process stages, including applicable design and development reviews;
c) the required design and development verification and validation activities;
d) the responsibilities and authorities involved in the design and development process;
e) the internal and external resource needs for the design and development of products and services;
f) the need to control interfaces between persons involved in the design and development process;
g) the need for involvement of customers and users in the design and development process;
h) the requirements for subsequent provision of products and services;
i) the level of control expected for the design and development process by customers and other relevant interested parties;
j) the documented information needed to demonstrate that design and development requirements have been met.
Explanation
The organization is required to describe how it provides for the planning and control of its design and development processes. Consider the nature and complexity of the work, compliance obligations, control of unintended consequences, etc.
The organization will need to provide some objective evidence as to what the planning activities include.
Note that an auditor will seek objective evidence of how the interfaces between other processes are managed.
Chief Explainer:
Phil Byrne