Originally posted on LinkedIn by Paul Harding

In the previous 2008 edition of the ISO 9001 Quality management systems requirements standard there was a mandatory requirement for top management of an organization to appoint a management representative to perform certain tasks in establishing and maintaining the Quality Management System. In practice this position varied, depending on the understanding of the requirement by senior executives, from that of an administrative position to one of complete control of the QMS. In other words the Management Representative was either a

Scribe or a Champion.

In my experience of interacting with “ISO 9001” certified organizations I have come across many scribes but rarely have I seen a true champion. The revised 2015 standard now calls for more leadership and commitment from top management who must also take accountability for the effectiveness of the QMS. A champion or a number of champions may still be appointed but if the auditors and Certification Bodies are true to the revised requirements in the standard, scribes will no longer be acceptable as a substitute for leadership.

The new standard also requires that top management ensure that the quality policy and objectives for the QMS are compatible with the context and strategic direction of the organization and are integrated into the organization’s business processes. Furthermore the new standard also requires that top management engage, direct and support persons in order to contribute to the effectiveness of the QMS. In essence this now means top management need to link strategy and operations in their organizations.

In one of my previous posts on this Pulse site I spoke about “Should executives be auditors?” and the article focused on how executives can effectively address this issue of taking accountability for the performance of the organization. The methodology described was based on the Focus, Alignment, Integration and Review (FAIR) approach. Focused activities in the form of new strategic goals and objectives need to be aligned across various business processes. Once this has taken place the new activities need to be integrated into the existing operations. Finally executive involvement is recommended in order to review the outcomes of the integration process at the various levels and stages of application. This is now what the 2015 new standard requires but will anything change or will it be “ISO 9001” business as usual?

Change from management responsibility to leadership

There have now been significant changes in the new ISO 9001:2015 Quality management systems – Requirements standard where the requirement for management responsibility has been replaced for a requirement for leadership. How is this change going to affect the application of the requirements to satisfy conformance to the new ISO 9001:2015 standard?

If we follow the definition of leadership found in ISO 9000:2015 Quality management systems – Fundamentals and vocabulary, we see that; “Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives.” ISO 9000:2015 goes on to give a rationale for this statement. “Creation of unity of purpose and direction and engagement of people enable an organization to align its strategies, policies, processes and resources to achieve its objectives.” So what are the possible actions that top management of an organization could take to comply with the leadership requirement found in ISO 9001:2015?

According to ISO 9000:2015 these actions could include:

 

The new standard also requires the integration of the quality management system requirements into the organization’s business processes. The ISO 9000:2015 Quality management systems – fundamentals and vocabulary standard does not give a definition of a “business process” only that of a “process”. However, there is a note under leadership in ISO 9001:2015 that says “business” can be interpreted broadly to mean those activities that are core to the purpose of the organization’s existence. So we must now ask the question: Is ISO 9001:2015 talking about the Management of a Quality System or are we now finally talking about the Quality of a Management System?