The 2015 release of ISO 9001 replaced “Management responsibility” with “Leadership and commitment.” This for some organisations was the most significant and far-reaching change in the update.

Where Top Management are already currently heavily involved in the management system processes, this shift in emphasis had little practical implications, other than the requirement to demonstrate compliance to an external auditor.

Where the management system is treated as a “bolt on” administered by the quality department however, a considerable culture shift was required!

Clause 5.1.1 of the standard requires top management to:

1. Take accountability for the effectiveness of the quality management system.
2. Ensure that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organisation. (See article 4.1)
3. Ensure the integration of the quality management system requirements into the organisation’s business processes.
4. Promote the use of the process approach and risk-based thinking.
5. Ensure that the resources needed for the quality management system are available.
6. Communicate the importance of effective quality management and of conforming to the quality management system requirements.
7. Ensure that the quality management system achieves its intended results.
8. Engage, direct and support persons to contribute to the effectiveness of the quality management system.
9. Promote improvement.
10. Support other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

Clause 5.1.2 requires top management to take the lead in demonstrating the organisation’s commitment to its customers.IE They must ensure that:

1. Customer and applicable statutory and regulatory requirements are determined, understood, and consistently met.
2. Risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed.
3. The focus on enhancing customer satisfaction is maintained. (IE on an ongoing basis.)

Comment:

In the 2015 release the need for a specific ‘Management Representative was removed. (This is not to say that Quality Managers are no longer required, and most large organisations retained this as a discrete role.) The aim then was rather to ensure that senior management can be seen to be actively involved and working alongside employees in order to ensure that the quality objectives are achieved.

Audit Check:

Auditors are being advised to further involve and challenge senior management in audits. EG: Not just to invite them to opening and closing meetings, but also to interview top managers to discuss audit findings directly and seek evidence of their commitment and if they are “hands on”. For example, determining if top management are heavily involved in Management Review meetings which are held as planned and are effective in their execution.

As a guideline, where the word “ensuring” is used in sub- clause 5.1.1, top management may still assign this task to others for completion. IE: Delegation with follow up confirmation. However, where the words “promoting”, “taking”, “engaging”, communicating”, or “supporting” appear, these activities cannot be assigned and must be undertaken by top management themselves.

Note also that as “risks and opportunities” must now be considered by top management when maintaining customer focus, evidence may be sought to validate this approach has been taken.