I am trying to ascertain if I need to write a Quality Manual to comply with ISO 9001:2015. I see some clauses require ‘documented information’. Do I just address those or the entire document?
Thank you for the question.
To begin with, the new ISO 9001:2015 Standard does not present a requirement for a Quality Manual. Those requirements are now part of Clause 4.3 and 4.4 of the new standard. That information “shall” be maintained as documented information.
You would be wise to 1] Acquire a copy of the 9001:2015 standard if you haven’t already done so. 2] Check in ASQ.org for information explaining the new terminology related to the standard. 3] Consider pursuing the services of a quality consultant for thorough guidance.
ASQ Senior Member, CQT, CQI