On November 1st, ISO/TC 176, the committee responsible for the ISO 9000 series of quality management standards, posted a new terms and definitions document to their website that has been significantly updated from the official terms and definitions contained in the current revision of ISO 9000 that was published in 2015.
ISO 9000 contains terms and definitions that apply to all quality management and QMS standards that are developed by ISO/TC 176, as well as sector-specific QMS standards developed by other sub-committees but utilizing the ISO 9001 framework. The current revision of ISO 9000, ISO 9000:2015, contains 146 terms and definitions, but there have been significant changes and additions to the terms and definitions since the 2015 publication that have not yet been included in a revision or amendment of the standard. For comparison, the up-to-date list as of 9/29/22, which can be downloaded HERE, contains 229 terms and definitions.
The table’s 229 terms and definitions are further broken down by the following:
- 73 terms and definitions that have been left unchanged from ISO 9000:2015
- 8 terms and definitions that were included in ISO 9000:2015 but have since been revised; the standards giving rise to the revisions are denoted in the table
- 83 terms and definitions that have been introduced since the publication of ISO 9000:2015; the standards giving rise to the additions are denoted in the table
- 65 terms and definitions that have been left unchanged and are used in ISO 9001:2015
Thanks to ISO 10010 and ISO 10014 there are several notable additions to define benchmarking efforts and the identification of best practices, and – additions that should come as a surprise to no one – ISO/TS 54001 Quality Management Systems – Particular Requirements for the Application of ISO 9001:2015 for Electoral Organizations at all Levels of Government has prompted several additions that define items like challenged ballots and electoral equipment. Ecomm, not surprisingly, was also in the spotlight, with ISO 10008:2022 Quality Management – Customer Satisfaction – Guidelines for Business-to-Consumer Electronic Commerce Transactions prompting additions of words like ‘content’ to the official lexicon. It was also welcome to see ‘dashboard’, being defined as a “combination of numerical and graphical data displays used to present the performance and trends of key results”, prompted by ISO 10014:2021 Quality Management Systems – Managing an organization for quality results – Guidance for realizing financial and economic benefits, make an appearance.
Most base quality management terms and concepts have been left unchanged from ISO 9000 and ISO 9001 – you won’t see updates to solid auditing principles and language or anything related to inspection and metrology. Nonconformity is still the ‘non-fulfillment of a requirement’. The entire ‘Q’ section is largely unchanged – although ‘quality culture’ does appear as a new addition – but one item that has remained unchanged that perhaps shocked me a bit was ‘risk’. We’ve written in the past how the inclusion of risk and opportunities has created several issues within TC 176 and with ISO 9001:2015, but, more importantly, how the definition of risk had created a divergence with the medical device QMS standard, ISO 13485, which did not adopt the HLS from ISO 9001:2015 and instead retained the structure of ISO 9001:2008 in the 2016 revision. The first note in the definition reads: “an effect [of uncertainty] is a deviation from the expected – positive or negative. Allowing risk to be correlated with a positive has been problematic for years; I honestly thought I’d see this term getting an update.
The document is certainly an interesting read and worth taking the time to become familiar with. It’s nice to see the time-tested and well-defined principles remaining unchanged – albeit the definition of risk remaining as-is comes as a bit of a shock – while TC 176 also illustrates their understanding of a world that has drastically changed since 2015 with the additions of items, for instance, dealing with eCommerce and quality management for elections. We’ve written enough about speculation regarding early revision of ISO 9001, and we already know that a specification is being developed for its future iteration, so we won’t spend any time with further speculation on the matter here – but the updated and added terms and definitions certainly give us an idea of what we should expect to see embedded in future iterations of the committee’s quality management standards.