Organisations are required by ISO 9001: 2015 to consider the following requirements as inputs into the design and development process:
Inputs are required to adequate, complete and unambiguous for the design and development process undertaken and any conflicting inputs must be resolved.
Documented information on design and development inputs is required to be retained.
Note the two specific requirements introduced in the 2015 release of the standard:
(Many businesses utilise formal tools such as Failure Mode Effects Analysis (FMEA) for Risk identification / mitigation planning purposes, but such methodologies are not specifically prescribed in the standard.)
Typical inputs could include:
Auditors will wish to check to confirm that organisations have a planned methodology for the identification of relevant inputs and that the process has been appropriately executed, so as to ensure that all necessary inputs have been identified and obtained.
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David Barker CQP MCQI