ISO 9001 leadership requirements: demonstrating commitment

By Aaron Hoare

July 25, 2024

Last updated: February 14, 2025

A major change that formed part of the 2015 ISO 9001 revision surrounded leadership requirements. The “management commitment” clause was replaced with “leadership and commitment.” For most organizations who already demonstrate effective leadership, this should come naturally. However, in organizations where management may have viewed quality as the sole responsibility of the quality department, some feathers may be ruffled.

We are expecting that the requirements around ISO 9001 leadership and commitment may evolve once more when the planned 2026 revision of ISO 9001 comes into force. As soon as the revision is clarified, we will update our ISO 9001 resources, including those on leadership and commitment. For now, we will talk about leadership and commitment in ISO 9001:2015.

The ISO 9001 leadership and commitment requirements aim to ensure management are actively “taking accountability of the effectiveness of the organization’s quality management system (QMS) and promoting a culture of quality throughout their organization.” So how exactly does management go about demonstrating leadership under ISO 9001:2015?

Understand the context of your organization

As stated in ISO 9001, top management must demonstrate leadership and commitment with respect to the quality system by “ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the strategic direction and the context of the organization.”

Understanding the context of the organization is an important consideration for ISO 9001 leadership and commitment and helps to ensure that the management system is designed and suitably adapted for a specific organization, as opposed to a “one size fits all” approach. Before management can demonstrate leadership, they first must have a clear vision of their organization’s strategic direction, objectives, and culture. They also must consider how both internal and external issues can impact the organization’s strategic objectives and the planning of the QMS. Once context is understood, the QMS can be developed around the context of the organization, and quality key performance indicators (KPIs) can be set.

Consider risks and opportunities

An important aspect of management showing commitment and demonstrating leadership under ISO 9001 is that they are able to demonstrate risk-based thinking. As stated in ISO 9001, top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that “customer requirements and applicable statutory and regulatory requirements are determined and met,” and “the risks and opportunities that can affect conformity on products and services and the ability to enhance customer satisfaction are determined and addressed.”

Management must first determine the risks and opportunities in their organization, analyze and prioritize risks and opportunities, then implement actions to address risk. Finally, they must check the effectiveness of these actions. Risks will be determined by looking at the context of the organization and how they might affect the organization’s strategic direction.

While management will not necessarily have to conduct a formal risk assessment or maintain a risk register under ISO 9001, they will need to monitor, measure, analyze, and evaluate the risks and opportunities. Again, the method employed will depend on the context of the organization.

Track quality metrics

As stated in ISO 9001, top management shall demonstrate leadership and commitment with respect to the quality management system by “taking accountability of the effectiveness of the organization’s QMS”. Top management will also assign responsibility for “reporting on the performance of the quality management system, on opportunities for improvement, and on the need for change and innovation.”

By defining quality metrics, management encourages the quality department to report on essential KPIs and assist in determining improvements to the QMS. This covers both of the above clauses. Management ensures metrics are visible and regularly reviews these in meetings and check-ins with the quality team.

Many organizations are now utilizing quality management software that incorporates reporting on key metrics, such as Ideagen’s quality solutions, to provide instant access to real-time management information. With graphical widgets displaying KPIs determined by management, this enables management to improve understanding and communication with all staff, improve governance, risk and compliance (GRC) process efficiency, and drive continuous performance improvement.

By playing such an active and informed role in the continual improvement of the QMS, management can effectively demonstrate leadership under ISO 9001.

Moving forward with a clear leadership strategy

As Bill Aulet, managing director of the Martin Trust Centre for MIT Entrepreneurship, argues, “culture eats strategy for breakfast.” His thoughts are reflected in the objectives of ISO 9001, encouraging management to not only define strategy but also drive the organization forward by demonstrating true leadership.

While leadership was always an aspect of ISO 9001:2008, ISO 9001:2015 reinforces and highlights the value that effective leadership and commitment are essential for organizational growth.

Great leaders provide a clear vision, inspiration, and motivation, and improve staff relations. ISO 9001 ensures top management steps forward and takes charge, instilling a culture of quality in their organization.

Invest in the right tools for leadership and commitment to quality

Effective leadership and commitment to quality are critical components of ISO 9001 compliance. Investing in the right QMS solution ensures that leaders can set clear quality objectives, monitor progress, and foster a culture of continuous improvement. Ideagen provides robust QMS solutions that enable leaders to effectively manage quality initiatives, track performance metrics, and maintain compliance with ISO 9001 standards. By leveraging Ideagen’s tools, organizations are better equipped to uphold their commitment to quality excellence and achieve operational success.

Aaron is an experienced content writer specializing in quality and compliance, with a focus on regulatory standards and enhancing operational practices. With a strong background in the life sciences and manufacturing industries, he excels at creating clear, impactful content that supports organizations in achieving sustainable excellence and meeting complex industry requirements.