Chapter 3
ISO 9001:2015 Section 5
Leadership
5.1 LEADERSHIP AND COMMITMENT
5.1.1 General
Similar to clause 5.1 in ISO 9001:2008, but many new requirements were added. This section provides an introduction to the topic of leadership within the context of the quality management system (QMS) and beyond. The 2008 version of ISO 9001 included just four items that top management was required to demonstrate commitment to, but the 2015 version asks leadership to commit to 11 different items. What does that tell you about the topic of leadership? It gains in importance every time ISO 9001 is revised. The current list of commitments in ISO 9001:2015 is impressive in that it really puts leadership front and center in the QMS.Let’s take a look at each commitment and discuss how top management might address each one.
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Be accountable for the QMS. This is a new and powerful requirement. It tells leadership that they are ultimately responsibility for the outcome of the QMS. If things don’t work out as expected, it’s not the responsibility of the quality manager, lab supervisor, shift leader, or anybody else. All roads lead back to leadership. The intent is that top management take an active role in the functioning of the QMS. Management review will be one of the key tools for making this happen.A number of the next requirements for top management start with the word “ensuring.” This means that top managers ensure that these things happen. They may not perform the task themselves, but at the very least they delegate the tasks and
review the outcome of the work. Top management should be able to talk intimately about all these topics and explain how their leadership and commitment drove the processes forward.
Make sure a quality policy and objectives are in place and are consistent with the organization’s strategy. This sentence contains multiple requirements. First, top management ensures that there is a quality policy and quality objectives. Because these two documents are so foundational, it’s very likely that top management would take a hands-on role in developing them. Second, the policy and objectives must agree with the strategic direction of the organization. That requires, of course, that there be a strategic direction, which is usually defined in a business plan, strategic plan, budget, or some other executive planning tool. If the strategic plan includes big actions, then it would be appropriate for the quality policy and objectives to mirror those actions in some way, possibly by mentioning them or providing metrics that lead in the same direction.
The policy and objectives also need to be congruent with the context of the organization that was determined in clause 4.1. If the environmental scanning required in clause 4.1 revealed that hazardous waste disposal was the most important issue facing the company, then the policy and objectives should reflect this. All we’re doing here is making sure that all of our high-level documents agree with each other. Top management should be comfortable explaining and illustrating this.
Make sure that the QMS is used to help manage the business. This is a new requirement in ISO 9001:2015. Unfortunately, QMSs often exist in a vacuum, disconnected from the rest of the organization’s decision making. The QMS processes are the way that we should holistically manage our organizations, and they must be fully incorporated into our business processes. For instance, the corrective action required by ISO 9001 is how we solve problems within the organization. Management review is how top management reviews data and information and makes decisions. Internal auditing is how we ensure process discipline. Get the idea? In short, we’re not implementing ISO 9001:2015 just to get certified, we’re implementing the standard to manage our business. Top management should be able to demonstrate how ISO 9001:2015 processes are the true business processes within the organization, not puppet processes to impress an auditor.
Advocate the process approach and how risk affects the business. This is a completely new requirement in ISO 9001:2015. First, it requires that top management be advocates for the process approach. Recall clause 4.4, which
requires that processes be formally determined and defined. The process approach means that we manage activities from start to finish, considering all the process activities that they represent, including inputs/outputs, resources, monitoring, measurement, improvement, training, and other considerations. We don’t just try to manage one or two pieces of the process, we understand and manage all parts of the process. Risk-based thinking is the second part of the requirement. Risks and opportunities are addressed in clause 6.1 of the standard. The philosophy behind risk-based thinking is that we apply our resources in a proactive manner and as efficiently as possible. It follows these steps: 1. Scan the environment and objectively look inward at the organization. 2. Identify the organization’s risks and opportunities. 3. Determine which risks and opportunities are the most significant. 4. Determine actions to proactively manage the risks and opportunities.
5. Continually evaluate the effectiveness of the actions to address risks and opportunities.
Make sure that resources are available for the functioning of the QMS. Nothing happens without resources, and it’s usually top management who provides them. Through existing processes like strategic planning and management review, the need for resources is identified and a plan is developed for their provision. Top management should address how resources have been determined and provided, giving specific examples as they relate to the QMS. Tell everybody how important the QMS is and why it’s critical to conform to its requirements. This is a communication requirement that is directly fulfilled by top management. Leadership doesn’t delegate this one. They are effectively saying, “Hey, this ISO 9001 stuff is real and I believe in it. You should believe in it, too.” This message could be delivered in a variety of ways, with in- person probably being the most effective. Besides just talking the talk, actually demonstrating involvement in the QMS goes even further. Top management’s involvement in the following processes will communicate more than words ever could:
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Motivating and participating in corrective action✓
Analyzing customer feedback✓
Assisting in the identification of risks and opportunities✓
Participating in internal audits, either as an auditor or an auditee✓
Evaluating progress against quality objectives and helping to develop plansfor their achievement
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Adding to organizational knowledge✓
Leading management review and sharing the results with the rest of the organizationMake sure that the QMS produces the expected outcomes. A QMS consumes considerable resources to implement and maintain, so there should be some payback. This payback is in the form of planned results, such as less waste, higher customer satisfaction, and higher profits. The most obvious way for top management to monitor intended results would be through tracking the progress of quality objectives. Participating in management review and reviewing QMS data streams would be two other ways.
Show leadership in getting employees involved in the QMS. This is another requirement that asks top management to get engaged in an area in which it might not have previously been involved. Top management must have direct oversight with the people involved with the ISO 9001 effort. The most obvious way to satisfy this requirement would be through vigorous participation during management review and in carefully analyzing all its inputs.
Encourage improvement activities. This is a completely new requirement. It actually includes a couple of different requirements. Top managers must be aware of the improvement efforts within the organization. Then they must communicate their support and promotion of the improvement efforts. A more hands-on way of meeting the requirement would be for top management to directly participate in improvement activities, though this isn’t always possible. Participation on at least a periodic basis is well worth the time and effort.
Assist other managers in showing QMS leadership. This requirement asks top management to get other managers “whipped into shape.” Middle management is frequently one of the weakest parts of the organization. Middle managers have the power to throw up many obstacles to efforts and processes that they don’t believe in. They are much more likely to support the QMS, though, if top management emphasizes that their support is needed and they must participate in a positive way.
Many of the requirements for top management’s leadership are redundant. Achieving one of them is likely to actually achieve two or three. Beyond just meeting requirements, top management’s direct involvement is absolutely necessary to have a successful QMS.