Open to Interpretation
The formal process to field ISO 9001:2015 feedback and questions
by Paul Palmes and Dale Isaacs
“The organization shall” is a well-known phrase found throughout International Organization for Standardization (ISO) standards. Its purpose is to introduce a requirement. What follows these three words must be addressed by an organization, appropriately implemented and capable of verification. Unfortunately, sometimes the requirements following a “shall” phrase can be a bit confusing.
There are countless consultants, fellow standards users, blog sites, books and articles that can—and often do—provide excellent guidance for mystifying and confusing clause content and terminology. But in the working committee of the standard itself, there is another opportunity to ask questions about the meaning of a clause: the interpretations process.
How it works
The U.S. Technical Advisory Group (TAG) to ISO Technical Committee (TC) 176 (quality management systems) and the U.S. TAG to ISO/TC 207 (environmental systems) are two national committees that incorporate a formal interpretations process into their ongoing activities.
In the case of U.S. TAG to ISO/TC 176, the U.S. task group on interpretations (TG22) process is documented in a published procedure and available publicly.1 TG22 employs a formal process that normally requires the following approach (see Figure 1):
- The user must submit his or her question via the form attached to the published procedure.
The question must be a request for interpretation, not for information or explanation, and should seek clarification about what the standard requires, not how the requirements could or should be fulfilled or applied. There must be a brief narrative posed as a yes/no question, reference to the appropriate clause and the scenario that gave rise to the question. Interpretations must apply broadly to the entire user community, not just an individual organization.
For example, a user could cite Clause 9.2.1—Internal audit (“The organization shall conduct internal audits at planned intervals”2) and ask whether it requires the organization to audit its entire quality management system annually. The same clause might lead a user to ask whether a planned interval could be monthly or quarterly, for example. In both cases, the answer must be stated as a simple yes or no.
- The TG22 chair and TAG administrator apportion users’ questions to a small subgroup of TAG members who previously volunteered to respond to these questions. Their job is to reach out to others in their networks for further input before formulating their final position—yes or no—and providing the answer to the TG22 chair. If there is consensus, the user is provided with the TAG’s response.
Lack of consensus is subject to further discussion in the subgroup to achieve a consensus opinion, or to advise the user that a consensus was not possible given the circumstances. Consensus doesn’t necessarily mean unanimous agreement—it means absence of sustained opposition to substantial issues.3
- The results also are sent to the standard’s international technical committee as valuable material to consider for the next round of revisions. The standard’s writing group is especially interested in the answers because these interpretations often identify omissions, unintended or undesired word choices, and possible weaknesses in the original text.
TG22 also contributes to the international Interpretations Committee (ISO/TC 176, subcommittee (SC) 2, WG22) in cases where individual member national standards bodies are unable to reach consensus in their country or wish to post the request for global consensus.
International requests are handled in the United States using the same procedure with one exception: After expert opinions are submitted, the U.S. TAG votes by ballot to support the yes/no opinion. TG22’s process is fully compliant with ISO/TC 176/SC 2’s “Guidance for Handling Requests for Interpretation of the Requirements of ISO 9001.”4
It’s interesting to note that until recently, requests for interpretation were slow. There is no clear reason for the uptick, but it may be due to an increased awareness of the interpretations process itself through word of mouth, blogs and articles.
The current chair of TG22’s interpretations committee is this column’s co-author, Dale Isaacs, said one of the recent changes made to the interpretations process was to paraphrase the mantra of the U.S. Supreme Court, appropriating the committee’s tagline to now read, “We don’t write the standard—we just interpret it.”
Likewise, and as reflected in the procedure, each yes/no opinion must be accompanied and supported by ISO 9001, and its supporting standards and documents. It must cite the specific clause, section or area of the document that supports the basis for the opinion.
Arguments such as, “That’s how it’s always been done,” or, “It has always been interpreted that way,” without supporting established reference are unacceptable. According to TG22, this requirement lends more credibility to each interpretation and supports the sixth quality management principle: evidence-based decision-making.
Because consensus means lack of sustained objection, it’s logical for a majority of TG22 members to have one opinion and a minority to have another. Like U.S. Supreme Court decisions that may shape future case law, the basis of those majority or minority opinions may influence how future standards are written.
Also, like U.S. Supreme Court opinions, sometimes the minority opinion is used to establish future case law when circumstances or context changes. “We thought that, if done correctly, this could help in writing future versions of standards,” Isaacs said.
Of the many resources used by TG22 when rendering interpretations, among the most helpful are ISO 9000:2015 and ISO/TS 9002:2016. Many of the interpretation requests submitted to TG22 can be explained by referencing the definition of terms in ISO 9000:2015—knowing the proper definition of a key word enables the understanding of a phrase. Any number of auditors can attest to the difficulties of communicating with people who simply don’t understand a word’s technical definition, which in turn often creates misinterpretations of clause content.
In addition, ISO/TS 9002 is invaluable to understanding the intent of some ISO 9001:2015 clauses. It was written by many of the same people who wrote ISO 9001:2015. But because it’s a guidance document, the authors enjoyed a far greater latitude of approach and writing style.
ISO/TS 9002 provides guidance with clause-by-clause correlation to clauses 4 through 10 of ISO 9001. It gives evidence of what an organization can do and provides examples, descriptions and options that aid in understanding the requirements of ISO 9001—and often aid TG22 in responding to interpretation requests.
While no one can argue that it would be wonderful if every user fully understood the intricate interactions, requirements and interpretations of ISO 9001:2015, that isn’t—nor has ever been—the case. The interpretations process managed by TG22 performs a valuable service in helping users understand the “shalls” crucial to implementing these important standards. An additional resource for questions involving other standards is ASQ’s Ask the Standard Experts blog, which can be found at asqasktheexperts.com.
References and note
- “ISO 9001 Resources,” ASQ, asq.org/quality-resources/iso-9001.
- International Organization for Standardization (ISO), ISO 9001:2015—Quality management systems—Requirements, clause 9.2.1.
- ISO and International Electrotechnical Commission (IEC), ISO/IEC Directives and Policies.
- Information on the international process can be found at https://committee.iso.org/home/tc176sc2.
Paul Palmes is principal consultant with Business Systems Architects Inc. in Fargo, ND, and Prescott, WI. He is chair of the U.S. Technical Advisory Group to the International Organization for Standardization Technical Committee 176 (ISO/TC 176), and chair of ISO/TC 176, subcommittee 1, responsible for ISO 9000:2015.
Dale Isaacs is the owner of Brentwood Management Consulting in Franklin, TN, an industrial and systems engineer and an ISO 9001 lead auditor. He is the Secretary of the U.S. Technical Advisory Group to the International Organization for Standardization Technical Committee 176 (ISO/TC 176) and chair of ISO/TC 176, U.S. TG22, responsible for interpretations for ISO 9001.