8.3 Design and development of products and services (8.3.3)

8. OPERATION

8.3 Design and development of products and services

8.3.3 Design and development inputs

The organization shall determine the requirements essential for the specific types of products and services to be designed and developed.

The organization shall consider:

• a) functional and performance requirements;
• b) information derived from previous similar design and development activities;
• c) statutory and regulatory requirements;
• d) standards or codes of practice that the organization has committed to implement;
• e) potential consequences of failure due to the nature of the products and services.

Inputs shall be adequate for design and development purposes, complete and unambiguous.

Conflicting design and development inputs shall be resolved.

The organization shall retain documented information on design and development inputs.