News

Quality crusaders – here’s a quick summary of the new content and structure based on the Draft International Standard. Who would have thought we’d see ‘risk’ in a quality standard? Makes sense if you ask me…

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!