July 20, 2015 – ISO 9001 “Quality Management Systems” has reached the final stage of its latest revision process (the new edition is expected September 2015), and ISO member countries have two months to form a national position and vote on the latest draft before the September 9, 2015, deadline.

A vote on an earlier draft (draft international standard, or DIS) of the revised ISO 9001 was approved in November 2014 by around 90% of members, says ISO, but the committee also received over 3000 comments with suggestions on possible improvements. Now that a final DIS (FDIS) has been completed and translated, ISO members will proceed with a national consultation before submitting their final vote.

“Compared to the DIS, changes are relatively minor,” explained Nigel Croft, chair of the subcommittee revising the standard. “The most extensive ones have been to the Introduction and figures, which have been greatly simplified, with some of the explanatory text being moved to an informative Annex.”

Croft went on to explain that other than a general “tidying-up” of the overall text, and greater consistency in the use of specific terms, there have been a number of “small technical changes”. For example, “top management must now promote the use of risk-based thinking in addition to a process approach”.

“We have also added explanations about the process environment applied to service organizations, and greater requirements for production and service activities to prevent human error.”

So how does this new version compare with earlier iterations? Croft says the first versions of ISO 9001 (1987 and 1994) were “quite prescriptive”, with many specific requirements for documented procedures and records. In 2000, ISO introduced the process approach, which focused on managing processes, and required less documentation. This approach was maintained in the 2008 edition.

“We have now gone a step further,” said Croft. “ISO 9001-2015 is even less prescriptive than its predecessor, but with an underlying philosophy that ‘output matters’.”

For example, are processes achieving their planned results? Is the system delivering on its promise to provide confidence in an organization’s ability to offer conforming products and services? In other words, ISO 9001-2015 is “very much performance-based, with a focus on what has to be achieved rather than how to achieve it”.

“We have achieved this by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization, while taking into consideration the context in which the organization operates,” added Croft.

To obtain a copy of the ISO 9001 FDIS contact your national member body. In Canada, it is the Standards Council of Canada (SCC).

— With files from Maria Lazarte