Leadership and Performance Evaluation in ISO 9001:2015


Demonstrating Leadership and Commitment

ISO 9001:2015 puts new pressure on leadership. By removing the role of “management representative," top management must now be fully engaged with the quality system to remain compliant.

As mentioned in my first post in this series, QMS is now the responsibility of leadership, who must ensure that the quality policy and objectives align with the organization’s strategic direction.

Clause 5 holds leadership accountable. They must establish and communicate the quality policy, assign role responsibilities and authorities, and ultimately, ensure the effectiveness of the QMS, all with customer focus in mind.

As a quality practitioner, it’s encouraging to see this change. From my experience, top management has always been on the sidelines - commending you when audits go well and critical when they don’t, without fully understanding the collaboration and coordination that goes on to have a truly effective QMS. They are now expected to have a significant presence during the certification audit, spending more time with auditors and answering the difficult questions.

Leadership commitment and alignment to the organization’s strategic direction will enable quality to become everyone’s responsibility and not just a department.


Keeping Leadership Engaged

Leadership must be strategic in assessing the performance and effectiveness of the QMS. They cannot be expected to know every detail, but it is important that they have timely and accurate data to make risk-based decisions and prioritize actions.

Clause 9 outlines several required performance evaluation activities. These are not new, but are key to ensuring leadership engagement and compliance to the standard.

  • A strong risk analysis program will ensure you are monitoring, measuring, and evaluating critical factors necessary for an effective QMS. Real-time reports and dashboards enable leadership to have data readily available for review. Establish regular intervals for evaluating data and retain documentation of the results.
  • Internal audits are a powerful tool for self-assessment. From my experience, they are often treated as an afterthought and rushed to fulfill a requirement. But an effective internal audit program will ensure you are successful and not caught off guard in your certification or regulatory audits. Internal audit data provided to leadership can help to prioritize corrective actions, continual improvement projects, and resources.
  • Management review is a critical activity that allows leadership to evaluate data from many inputs. Management review meetings can sometimes be overwhelming with the sheer amount of data that is presented. It’s important to have quality data reviewed regularly with top management. As mentioned above, real-time dashboards and reports are a great way to do this. Most importantly, management review is not just for review, but for action. Unless your QMS is perfect, which we know none are, you should always look for opportunities for improvement.

Having greater leadership involvement in the quality management system is a big step in the right direction. When leadership is involved, it creates an alignment of business and quality objectives and a clearer vision. With clear communication and understanding, people are encouraged and motivated to share in the common goal of pursuing excellence.

In our next posts, we will outline how Vault QualityOne can assist you in obtaining ISO 9001:2015 certification and help you stay compliant.

Please feel free to reach out to us if you have questions as you go through your certification or recertification endeavors. We would love to hear from you!