Re-writing ISO 9001:2015... through Interpretation

ISO 9001:2015 was designed to include many ambiguous/vague requirements because the responsible committee (ISO TC176/SC2) was convinced that in order for the standard to be accepted by a large international user base, it must recognize cultural relativism. Cultural relativism is the idea that a person's beliefs, values, and practices should be understood based on that person's own culture, rather than be judged against the criteria of another. (See Context of the Organization... and "Interested Parties")

Consequently, interpretation of the requirements of ISO 9001:2015 & AS 9100:2016 changes when crossing cultural boundaries. And since culture is most often rooted in socio-political beliefs, economy, laws, regulations, etc., interpretation of the requirements of ISO 9001:2015 & AS 9100:2016 are often “nation dependent”.

So “who” provides interpretation?

In many cases, it is the organization implementing the standard who also interprets the requirements. The term “the organization shall determine…” appears 19 times (ISO 9001, 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, 7.1.5.1, 7.1.5.2, 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.

However, there are 2 separate “official” interpretations for ISO 9001:2015… one from ISO, and another from each country (where determined by that country to be necessary), Interpretations from the individual countries are non-binding “opinions”. For example:

While requests for “official” ISO 9001:2015 Interpretations from US TC 176 - TG22 are submitted using a form titled “Interpretation Request Form”, the TAG 176 – SC2 - TG22 “Standard Operating Procedure” titled “US Guidance for handling requests for interpretation of the requirements of ISO 9001” clearly states 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.

And there is a 3rd official “clarifications” (i.e., interpretations) document from IAQG for AS 9100:2016: "IAQG AS 9100:2016 Series Clarifications". It 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.

How ASQ attempted to create a new requirement through Interpretation

When reading the US TC 176 - TG22 - Interpretations, these appear fairly typical of what one might expect… with one notable exception. On the third row from the top, we see where the following question was asked (in the “Request” column): “Does ISO 9001:2015 require internal audits to be process‐based vs. clause/element‐based?

In the “Answer” column, we see where the answer was originally “No”, but changed to “Yes”. This in itself is odd.

In the “Notes” column, we see the following explanation for this reversal in interpretation/opinion: “Best practice given in ISO19011 and 17021 recommend Process‐based audits although there is no direct “SHALL” requirement for process-based audits. Being changed to “Yes” as a result of the revision and release of ISO 19011:2018 which is referenced by ISO 9001:2015‐9.2.2.

So the reason for the change was the release of ISO 19011:2018… which was merely referenced by ISO 9001:2015‐9.2.2. This doesn't explain how a “reference” suddenly became a requirement.

The actual language of the reference in ISO 9001:2015, sec. 9.2.2 is: “NOTE: See ISO 19011 for guidance.

AND we see on page vi of ISO 9001:2015 the following statement: “Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement.

This was apparently the justification for the change… that a “clarification” document now adds requirements.

However, there is a MAJOR flaw in this logic. In ISO 9001:2015, “Annex B (Informative), Other International Standards on quality management and quality management systems developed by ISO/TC 176”, the first paragraph (last sentence) states: “Guidance or requirements contained in the documents listed in this annex do not add to, or modify, the requirements of this International Standard.

ISO 19011 “Guidelines for auditing management systems” is listed on page 27.

Another problem with this interpretation is that 19011:2018 “Guidelines for auditing management systems” does NOT contain any requirements (i.e., the word “Shall” does not appear in the body of the guidelines). However, it does use the word “should” many times. And as we see on ISO 9001:2015, page vi:
In this International Standard, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;

The reason that I titled this section “How ASQ attempted to create a new requirement through Interpretation” is because, as mentioned earlier, the TAG 176 – SC2 - TG22 “Standard Operating Procedure” titled “US Guidance for handling requests for interpretation of the requirements of ISO 9001” clearly states 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.”

In other words, the US TC 176 - TG22 - Interpretations can be ignored because it is non-binding.