Conformance1

Tools for conforming to standards, goals and processes

Leadership

  • How is leadership defined in ISO 9001:2015?
  • How can companies meet the leadership requirements of ISO 9001:2015?
  • What are some common questions auditors often ask executive leadership?

How is leadership defined under ISO 9001:2015 standards?

Leadership has always played an important role within ISO 9001, as it is one of the seven quality management principles that form the backbone of the standard. When preparing to become ISO 9001:2015 certified, it is essential to have leadership affirm the importance of the Quality Management System (QMS). Without their support, the QMS will not function properly. 

Top management is defined in ISO 9000:2015 Clause 3.1.1, as the person or group of people who directly control the organization at the highest level. Top management should be thought of within the scope of the QMS. For example, pretend a company has headquarters in Detroit and manufacturing plants in Grand Rapids and Cincinnati. If the scope of the QMS includes the entire company, then “top management” refers to the CEO of that company. However, if the scope of the QMS only encompasses manufacturing functions, then it refers to the person/people at the highest level at a manufacturing plant. A QMS with a scope that only covers the Grand Rapids manufacturing plant would mean that their top management is managing director of that factory. 

Clause 5 of ISO 9001:2015 defines specific leadership roles, responsibilities, and commitments. This clause is essential to understand when thinking about leadership and can be broken down into the following sub-clauses. 

  • 5.1 Leadership and Commitment
  • 5.2 Policy
  • 5.3 Organizational Roles, Responsibilities, and Authorities

How can organizations meet ISO 9001:2015 leadership requirements?

The ISO 9001:2015 standards mark a significant shift in what tasks top management is expected to perform compared to the ISO 9001:2008 standard. In general, top management is required to be more involved. Organizations, where senior leaders play an active role in their organization’s QMS, may see changes in the ISO 9001 standards as a simple formality. However, organizations where top management delegates the majority of the QMS responsibilities to a management representative may see these changes as being extremely significant. 

Leadership and Commitment (5.1)

Sub-clause 5.1.1 identifies aspects of the QMS where top management is expected to show leadership and commitment. Here are the requirements top management must meet in this sub-clause. 

  • take accountability for the effectiveness of the system
  • ensure the quality policy and quality objectives are established and are compatible with the context and strategic direction of the organization
  • ensure the integration of the system requirements into the organization’s business processes
  • promote awareness of the process approach and risk-based thinking
  • ensure that the resources needed for the system are available
  • communicate the importance of effective quality management and of conforming to system requirements
  • ensure that the quality management system achieves its intended results
  • engage, direct, and support persons to contribute to the effectiveness of the system
  • promote improvement
  • support other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

Note where the word “ensure” is used in this clause. Top management may assign these tasks to others for completion; after delegation, top management must confirm these activities are occurring. Top management cannot assign tasks where words “take”, “promote”, “engaging”, or “supporting” appear. These tasks can only be completed by the top management. 

Sub-clause 5.1.2 centers around an organization being customer-focused. Top management must communicate that the objective of the business is to satisfy the customer. Organizations are customer-focused when they establish a process to:

  • Determine and understand customer requirements
  • Address risks and opportunities that could impact their ability to meet customer requirements
  • Focus on enhancing customer satisfaction 

While checking for customer focus, an organization must assess whether customer satisfaction is being accurately determined and if appropriate corrective action is taking place when things go wrong. The customer feedback process should be closely scrutinized before attempting certification. Organizations should determine how this process is planned, implemented, and improved. These factors are vital in being able to provide substantive information about how successfully the management system performs. Organizations should seek and record evidence that top management is actively involved in the management of the QMS. While performing an internal audit, be prepared to challenge your management’s commitment.

Quality Policy (5.2)

ISO 9001:2015 requires an organization’s quality policy to match its purpose and context. Once an organization determines its context and relevant requirements from interested parties, the top management is required to review the quality policy with this information in mind. Top management must establish, implement, and maintain a quality policy that: 

  • Is appropriate to the purpose and context of the organization and supports its strategic direction
  • Provides a framework for setting quality objectives
  • Includes a commitment to satisfy applicable requirements
  • Includes a commitment to continually improve the system

Below is a well-written example of a quality policy by the Phelps Dodge Copper Products & Refining Corporation. 

QUALITY PLEDGE

We are committed to being very aggressive in our attitude towards quality and customer service, primarily since we want to be ranked as the “best” in our business. Quality is not just another goal, it is our basic strategy for survival and future growth. We will achieve this growth through continual improvement of the effectiveness of our Management System.

PRIORITY

Our customers demand and warrant a high-quality product—it is our responsibility to give them what they want If we don’t, they’ll find someone who can. If customer requirements are unclear, then it is our job to seek out a better understanding of their requirements/specifications. If we fail at any time, then we must determine what went wrong and assure that it doesn’t happen again.

OBJECTIVES

Our quality objectives are to furnish high-quality products, on time, and at the lowest cost. The attainment of such objectives will lead to customer satisfaction, enhanced copper performance at the application level, and ongoing improvements in process efficiency. Once an objective is achieved, it should be recognized and reset to stimulate further quality improvement. To reach our objectives, we will have to maintain a constant focus on quality with full dedication, commitment, and teamwork. We monitor our progress toward our objectives through our action plans for each objective.

VISION

Our journey is Total Quality Management–fully satisfying our customer’s requirements through a process of continual improvement. It’s critical to understand that Total Quality Management is not a short term program. It’s a long term commitment aimed at continually improving the way we work, providing a safe work environment, managing our business processes, and supplier selection/retention. It is our goal to posture our company for market expansion, thereby providing improved job security and quality of life for all.

Employees are not required to memorize the quality policy. However, they should be aware of it, know where they can find it, and be able to dictate how it applies to their work. Organizations should make sure that their quality policy is easily available to employees either in their physical workspace or online depending upon their position. It’s also recommended to come up with keywords or short sentences to help employees learn the policy more easily. That way if an auditor asks them a question regarding the policy, they will be able to recall it more easily. 

Roles, Responsibilities, and Authorities (5.3)

It is top management’s responsibility to ensure responsibilities and authorities are assigned, communicated, and understood within an organization. They must assign authority to:

  • Ensure the system is in line with ISO 9001:2015 requirements
  • Ensure the process delivers intended outputs
  • Report on system performance and opportunities to improve the system
  • Promote customer focus throughout the whole organization
  • Ensure the system can withhold change when improvements or setbacks occur

One way to ensure conformity is to develop and disseminate a list of key figures in the QMS. This list could include figures’ job descriptions, responsibilities, and an organizational chart of these figures. This should accurately define and communicate the organizational structure of the QMS. Note that this is simply a suggestion and other methods of meeting this requirement are possible. 

Organizations must also provide objective evidence to prove that they are following this guideline. A few examples include: 

  • Communication of roles, responsibility, and authority
  • Processes and procedures that fulfill the requirements and are readily available to employees
  • Awareness of expectations demonstrated at all levels of a company
  • Reporting on the operation and performance of the management system

Take note that an organization no longer needs to appoint a Management Representative under the ISO 9001:2015 standards. The duties of the Management Representative must still occur, but they can be assigned to different employees or the quality system manager. 

What are common questions auditors ask leadership? 

To some, it might feel ludicrous that a CEO might have to subject themselves to an audit. They simply don’t have enough time, and they have people around them who are supposed to take care of the QMS. To receive certification, this will need to happen. Before an audit occurs, top management must have a good understanding of the QMS. While this may seem like a burden to some companies, it is a great opportunity to improve a QMS and create a well-functioning organization. Below are a few questions top management will need to be able to answer. 

How are you accountable for the effectiveness of the QMS?

Top management must show commitment to this system. They are expected to make decisions and be able to justify those decisions. Top management must be able to make the final decision regarding QMS activities. 

How do you promote the use of the process approach and risk-based thinking? 

Management must know the process approach and risk-based thinking. However, this question has more to do with how they promote both of these things. It is not only necessary that top management be knowledgeable, but they must also be able to disseminate important information. 

How do you engage with, direct, and support those who contribute to QMS effectiveness?

This question is not about giving responsibilities to someone else. Auditors want to see how upper management communicates with everyone involved in the QMS. 

How do you promote improvement? 

Improvement should be thought of relative to quality objectives. However, this is not a question of how well top management recognizes improvement. Auditors want to know how the top management works with everyone in the QMS to encourage improvement and innovation. 

How do you support the management to demonstrate their leadership?

This question is all about how top management ensures their management staff feels empowered to speak about QMS with their department or grouping. How does top management ensure that mid-level managers can speak intelligently on this topic?