Clause 8 Operation
8.3.5 Design and development outputs
Clause Criteria
The organization shall ensure that design and development outputs:
a) meet the input requirements;
b) are adequate for the subsequent processes for the provision of products and services;
c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;
d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.
The organization shall retain documented information on design and development outputs.
Explanation
The organization must ensure that design and development output; is a clear description of the product, containing detailed information for those carrying out operations activities.
The criteria prompts us to ask: How does the organization manage design and development outputs with regard to validations, requirements of subsequent processes, etc.?
A Certification Auditor will expect that the organization can demonstrate that the outputs have been verified against the design inputs. This can be accomplished by reviewing documents, plans, etc.; interfacing with the customer and other relevant processes and by comparison to previously proven designs.
Outputs may also include product preservation methods, identification, packaging, service requirements, etc. as appropriate.
Chief Explainer:
Phil Byrne