Generally speaking, multiple groups interpret ISO 9001 and/or AS 9100.
1 – First, there is you
The words “the organization shall determine…” appears 19 times (ISO 9001/AS9100, sec. 4.1, 4.2, 4.3, 4.4.1, 6.2.2, 7.1.1, 7.1.2, 7.1.3, 7.1.4, 126.96.36.199, 188.8.131.52, 7.1.6, 7.2, 7.4, 8.3.3, 8.4.1, 9.1.1, 9.1.2 & 10.1). And there are several other instances where the language suggests that the organization must “determine” what is (or is not) required.
2 – Next, there are the “official” standards bodies who interprets ISO 9001 / AS 9100
There “official” interpretations for ISO 9001:2015 come from ISO. And are available online from: Official ISO 9001:2015 Interpretations from ISO TC/176/SC2
While “opinions” come from some national standards bodies (such as ASQ), these are non-binding. ASQ’s “opinions” are misleading because they title them “interpretations”. It is only when you read the SOP# SC2-TG22-001, “US Guidance for handling requests for interpretation of the requirements of ISO 9001“, that you see in bold text: “Since the US TAG to ISO TC176 (TAG) does not provide explanations of ISO 9001, responses provided under this procedure are opinions and are not to be offered as an official interpretation.“
With that clarification… the ASQ non-binding “opinions” are available from: US TC 176 – TG22 – Interpretations
Also misleading, but the reverse of the above, are the official “clarifications”, which are actually binding interpretations, from IAQG for AS 9100:2016: “IAQG AS 9100:2016 Series Clarifications“. The “clarifications” document clearly states: “These clarifications are binding where the standard leadership believes a published response is necessary since it has a profound impact upon the use of the standard or when a significant disputes exists.”
3 – Accreditation Bodies
Next, there are the undocumented requirements that some accreditation body auditors invoke on the Certification Bodies (CBs). While these are few, they’re often the most frustrating because these could be simply the whims of accreditation body auditors. And these interpretations can be perceived by the CBs as non-negotiable interpretations expected to be adopted by the CB and executed through their auditors.
4 – And finally, the interpretation of the auditors qualified in ISO 9001 / AS 9100
While auditors may convey interpretations promoted by their Certification Body (CB), I’ve heard several ISO 9001 & AS 9100 auditors describe how they find most of their interpretations “between the lines” of the standard – and audit to their perceived “intent” of the standard rather than official interpretations. In either case, these interpretations can be challenged through the appeal process with your CB.
What should you do?
Whether you’re currently ISO 9001 / AS 9100 registered or plan to seek registration, you should download and review the “Official ISO 9001:2015 Interpretations from ISO TC/176/SC2“. And if seeking AS 9100 registration, also download and review the “IAQG AS 9100:2016 Series Clarifications“.
Ensure that you incorporate the above “official” interpretations into your QMS… and freely share them with your auditors. Unlike AS 9100 auditors, amazingly few ISO 9001 auditors are aware of the above “official” interpretations.
If you’re already registered / certified, then contact your registrar to ensure that you have clear instructions for exactly how to appeal a disputed nonconformity. Don’t wait until you have a nonconformity to dispute, because at that point, you’ll have a “deadline” to contend with for your response. Due to the ambiguity and nebulous nature of many ISO 9001:2015 & AS 9100:2016 requirements, there has been a significant increase in the number of nonconformities overturned by CBs in favor of their clients.
Find out more about Richard Randall and his work in quality here.