With the requirements of ISO 9001:2015, is it still possible to exclude “design and development” in the application phase and to give an a-priori reduction on the time allocation?
In the opinion of RvA, the new standard requires that “The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.” Though it is accepted that for some organisations, an appropriate process may be a simple process to audit, however, all organisations will perform some form of design and development (if only to enable changes to the internal processes and services). The appropriateness of the process will have to be audited (especially in initial audits).
It is our opinion that a statement like “the scope of certification does not specify ‘design and development’ and therefore we reduce 10 – 30 % of audit time” is not in line with the current requirements and intent of ISO 9001:2015 and of ISO 17021-1, cl. 9.1.4. 2.a.
March 2018
The consensus view of the CC is that YES, it is possible to exclude design and development but that such an exclusion must be justified.
It is agreed that most organisations carry out some type of design and development although it may not always be Recognised as such.
Design and development could be excluded of the scope of the QMS of an organization provided the organization has demonstrated (§ 4.3 and annex A5 of ISO 9001) that it has not to fulfill the requirement of § 8.3 of ISO 9001.
But the CB shall evaluate this demonstration and the real scope of the organization before deciding it can or not reduce audit time; This could be an output of stage I.