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Clause 8 Operation

8.3.3 Design and development inputs

Clause Criteria

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.


Documenting the inputs into the design and development process is the main requirement of this criteria. The text provides an explicit set of requirements which an organization must consider, and address where applicable.

It is important that the inputs, as defined, adequately provide for the design and development activities.

Note: There may be a difference in the customer requirements and design capabilities (or possibilities).

Chief Explainer:

Phil Byrne

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