Quality at the Top
The move from management commitment to “Leadership” is perhaps the most significant and far-reaching change contained within ISO 9001:2015, although the actual impact will depend very much on where each organisation is starting from.
For those where the most senior members of the organisation currently play an active role in driving its quality management system forward, the changes will simply be a formalisation of what is happening.
However, for those organisations where top management have effectively devolved responsibility for their quality management system to their management representative, the ramifications of the ISO 9001:2015 changes will be significantly greater.
A hands on approach
ISO 9001:2015 requires top management to be much more “hands on” with respect to their quality management systems than ISO 9001:2008.
Where the word “ensuring” is used in sub-clause 5.1.1, top management may still assign this task to others for completion, that is: delegation plus confirmation.
Where the words “promoting”, “taking”, “engaging” or “supporting” appear, these activities cannot be assigned and must be undertaken by top management themselves.
Importantly, implementers will need to make top management aware of the new requirements, and the fact that they will now be audited as a matter of routine.
Sub-clause 5.2.1 sets out the requirements of top management in respect of the organisation’s quality policy. Must is now an important word, indicating the commitment that needs to drive the quality policy.
Top management must establish a quality policy that is appropriate to the purpose and context of the organisation and crucially, it must support its strategic direction.
It must additionally provide a framework for the setting and review of quality objectives, and include commitments to satisfy any applicable requirements and to continually improve their quality management system.
It is the responsibility of top management to implement and maintain the quality policy.
This development can be seen in a historical sense, comparing previous standards’ requirements.
ISO 9001:2008 required top management to “establish” the quality policy (5.1), and to “ensure” that it is reviewed for continuing suitability. ISO 9001:2015 requires that the top management “establish, implement and maintain” a quality policy. ISO 9001:2015 requires that the quality policy is also appropriate to the context of the organisation, not just its purpose.
This will require the review and possible update of the organisation’s quality policy if there is any change in the context of the organisation or the relevant requirements of the relevant interested parties.
Quality, strategy and communication
Another reinforcement of the concept that the QMS is not just an add-on to business is a crucial requirement that the quality policy is in tune with the organisation’s strategic direction.
Any change in strategic direction will now require a rethink of the quality policy.
The policy must include a commitment to continually improve the QMS. ISO 9001:2008 required a commitment to continual improve the effectiveness of the QMS. The policy must now provide a framework for the setting and reviewing of quality objectives.
Furthermore, sub-clause 5.2.2 sets out specific requirements in respect of the organisation’s quality policy communication. As in the 2008 edition, the policy must be available as documented information.
It must be communicated, understood and applied inside the organisation and must be available to relevant interested parties as appropriate.
For quality professionals this means as an item of documented information, the quality policy can now be held in any manner that meets the requirements of ISO 9001:2015 clause 7.5.
Quality professionals should note that there is now an explicit requirement for the quality policy to be applied throughout the organisation.
How this is done is up to the organisation, but linkage to quality objectives, process design, acceptance criteria, monitoring and measurement data and management review should be considered.
The new requirement for the quality policy to be available to relevant interested parties, as appropriate, means that the organization will need to consider how this is done – on a website, social media, literature and flyers.
Andrew Holt is technical content executive at the Chartered Quality Institute.