New Content Structure: The first obvious change to users is the new ‘harmonised’ content structure, which fits with the new 14001 (environment) and the new 45001 (safety) management systems standards and facilitates better alignment and integration for organisations with multiple systems. Alignment also allows for consistency in definitions of some of the important terms used in the standards.

Leadership: The new standard increases clarity and requirements relating to the role of top management and measurable commitment and involvement.

Risk: Maybe the most significant change in thinking (yet to see how much it will result in changes to practices) is the introduction of the concept of ‘risk’ and ‘risk-based thinking’. While many users may feel the idea of risk may always have been implicit in the standard, the revisions require it to be considered and integrated into the entire system. ISO 14001 and the new 45001 already define risk in terms relevant to the content of the standard, so the new ISO 9001 will define risk in terms of product or service conformity and customer satisfaction.

Context of the Organisation: The new standard places a stronger focus on the understanding of the ‘context’ of an organisation and the needs and expectations of stakeholders (e.g. clients or customers, end users, suppliers or regulators).

Terminology: A new term, ‘documented information’, is introduced. This term covers information and data processed by software to make it more relevant or ‘user friendly’ to the organisation, and is likely to replace the traditional terms ‘documents’ and ‘records’. The term ‘preventive action’ has been removed from the draft wording because it is considered unnecessary to have a specific clause on preventive action with the introduction of risk-based thinking will uses elimination as the first step in a risk management hierarchy.

So…a few things for quality crusaders to think about – let me know what you think of the changes by leaving a comment.

Catch you soon!

The draft version of ISO 9001:2015 is now available for purchase – click here to purchase a copy.

Catch you soon!

• Sept 2015: The revised ISO 9001 will be adopted and published, and the transitional period for organisations with certifications will begin.
• Jan 2015: FDIS for ballot.
• Nov 2014: Final Draft International Standard (FDIS).
• March 2014: Draft International Standard (DIS).
• April 2013: First Committee Draft 1 (CD1) prepared for feedback.

Catch you soon!

The last major revision of ISO 9001 the standard dates back to 2000. In 2008 only minor amendments were made, and the current standard does not consistently reflect the advances of the past decade so ISO has been preparing an overhaul.

The revision process went through several internal draft stages in 2013 and early 2014 and is now expected to be concluded in September 2015. The new standard will be based on the new common or ‘harmonised’ structure for all ISO management system standards and introduces several new concepts, including “risk based thinking”. Adding the word ‘risk’ to the quality standard certainly generated some debate! More to come later when the draft becomes available (expect Oct 2014).

Catch you soon!