Clause 4.1 of ISO 9001 requires that we determine and control our QMS processes. If we have no authority for design, we have no control either.
Going back to the guidance document on the ISO website, in one of the examples it says:
(my emphasis)
Going back to the guidance document on the ISO website, in one of the examples it says:
XYZ Electronics was justified with its decision to exclude sub-clause 7.3 Design and development from its QMS since it does not have any authority or accountability for design of the mobile phone product. Its customer provides the design.
