Published: 9 Aug 2016

Andrew Holt identifies the most significant change contained within ISO 9001:2015, that of ‘leadership’, and what it means for quality professionals.

The move from ‘Management responsibility’ 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.

Sub-clause 5.1.1 identifies specific aspects of the quality management system where top management are expected to demonstrate both leadership and commitment. (When ISO 9001:2015 uses the term ‘top management’ it is referring to a person or a group of people at the highest level within an organisation, that is, the people who coordinate, direct, and control the organisation.)

This means a top list for top management:

  • This starts with top management taking accountability for the effectiveness of their organisation’s quality management system.
  • They must ensure that their organisation’s quality policy and quality objectives are consistent with the organisation’s overall strategic direction and the context in which the organisation is operating. Top management must also work alongside their people in order to ensure that the quality objectives are achieved.
  • In addition, top management must ensure that the quality policy is communicated, understood and applied across the organisation.
  • Top management must also ensure that quality management system requirements are integral to the organisation’s business processes – that is, the quality management system must not be just a ‘bolt-on’.
  • They must promote awareness and the adoption of the use of both the ‘process approach’ and ‘risk-based thinking’, and must make sure that the resources required for the effective operation of the quality management system are made available.
  • Top management must stress the importance of effective quality management and of conforming to the requirements of the quality management system.
  • They must make sure that the quality management system is achieving the results intended and must lead people to contribute to the effective operation of the system.
  • They must drive continual improvement and develop leadership in their managers. All this amounts to a considerable amount of focus for top management.

What this means for quality professionals

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 now.

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.

ISO 9001:2015 requires top management to be much more ‘hands on’ with respect to their
 quality management systems than ISO 9001:2008 does.

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.

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.

Developing the quality policy

There is also additional emphasis on top management and leadership on developing a quality policy within the organisation.

Sub-clause 5.2.1 sets out the requirements of top management in respect of the organisation’s 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 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.

What this means for quality professionals

ISO 9001:2008 requires 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 organization or the relevant requirements of the relevant interested parties.

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.

Andrew Holt is technical content executive at the CQI and writes for Quality World magazine.