How to Meet the Leadership Requirements in ISO 9001:2015 – Part 2

In part 1 we defined the role top management and talked about some ways of demonstrating management commitment. In part 2 we’ll look at the differences between management and leadership and discuss in detail what is involved in demonstrating the commitment mentioned in part 1. Note: The shift from management to leadership brings with it the concept that the Standard is a business model; that the QMS is not just for quality, but instead, a‘management system.’

Difference between Management and Leadership:
Management is concerned with process, leadership with attitude and behavior. Management relies on measurable capabilities, effective planning, organizational systems and the use of appropriate communications. Leadership relies on soft skills like trust, inspiration, decision-making, and personal character. These are the skill-sets needed to achieve the quality objectives.

Introduction:
Clause 5 “Management Responsibilities” in ISO 9001:2008 is broken into two clauses in ISO 9001:2015 – “Clause 5 Leadership” and “Clause 6 Planning.” The planning elements (5.4.1 & 2) in ISO 9001:2008 are now in sub clause 6.2. Sub clause 5.6 “Management Review” is now in sub clause (9.3) and sub clause 5.5.3 “communication” is now in sub clause 7.4. The appointing of Management Representative is no longer required because the responsibilities of implementing and maintaining the management system rest with top management alone.

Leader 2

Initially, clause 5 appears to be nothing more than a re-statement of what has come before; policy, organizational roles, responsibilities and authorities, etc. However, there is a noticeable emphasis on leadership, not just management. If we look closer, there is a lot going on here. Top management must now take ownership of management system. They must make sure that the management system is not a stand-alone entity but is incorporated into the business processes. In addition, management must demonstrate commitment by making sure that there are adequate resources such that the management system can achieve its intended outcome(s). Additionally, they must inform staff that the management system is important and that everyone should participate in its effective implementation. The role of top management has finally grown up, has finally grown into that something originally envisioned so many revisions ago.

Clause 5.1 Leadership and commitment
5.1.1 General
Top management must demonstrate leadership and commitment to the management system. This can be done by assuming responsibility and accountability for its effectiveness. The 2008 revision required top management to ensure the organization’s quality policy and quality objectives be established compatible with the overall strategic direction and organizational context. This is still true today except now there is the additional requirement to make the policy available to interested parties, as appropriate.

When establishing quality policies, directives and objectives, top management must ensure they are consistent with the purpose and capabilities of the organization. Quality objectives should be deployed annually and have regular updates, as milestones are met. This is to be done by the top management and not delegated to an ‘underling’ or to an outside consultant. Top management can be assisted by, but not abdicate responsibility to someone else.

Top management must ensure that the requirements of the management system are integrated into the organization’s business practices, that they promote the use of risk based thinking and use a process approach. Awareness of the process approach may require a paradigm shift and help of an expert to guide staff, including the top management to implement. However, this responsibility still lies with top management. They are the ones who need to be trained, bring the concepts to the ‘front lines’ and then insist others follow.

Top management must ensure that the importance of effective quality management is communicated throughout the organization as well as conforming to the management system requirements. Top management must ensure that the management system achieves its intended outcomes by engaging, empowering, and supporting staff to contribute to its effectiveness and to promote continual improvement. Top management must additionally support other relevant management roles to demonstrate leadership as it relates to those areas of responsibility. Top management must establish the organizational structure and internal environment that motivates personnel to achieve the organization’s quality management goals and objectives.

Top management should communicate regularly on the importance of meeting customer and regulatory requirements. The communication process should define what needs to be communicated, to whom, the methods used, the frequency and the means for determining communication effectiveness. Top management may communicate in any number of ways including meetings, documented policies, memos, directives, email, etc.Top management must ensure that the resources needed for effective implementation, maintenance and improvement of the management system are available. They must periodically review QMS performance to determine it suitability, adequacy and effectiveness. Auditors are expected to review documents and records showing top management’s role in planning and implementing the processes that apply to clause 5 requirements. The processes within the organization that relate to these activities must be identified. These processes would typically include – quality planning, management review, internal communication, organization structure etc.

Top management must ensure that the resources needed for effective implementation, maintenance and improvement of the management system are available. They must periodically review QMS performance to determine it suitability, adequacy and effectiveness. Auditors are expected to review documents and records showing top management’s role in planning and implementing the processes that apply to clause 5 requirements. The processes within the organization that relate to these activities must be identified. These processes would typically include – quality planning, management review, internal communication, organization structure etc. Top management would be the process owner of all these processes.

Ensuring that the management system achieves its intended outcomes/outputs requires the clear identification of key areas for achieving the objectives, preparing the action plans, reviewing the action and results, and taking suitable corrective and preventive actions. Top management is the driving force to educate, guide, coach, encourage, review, and be a role model in implementing the systems. If the top management is not committed and does not work within the boundaries of the system, it cannot expect the same to be implemented by others. Hence, engaging, directing, and supporting persons to contribute to the effectiveness of the quality management system become its prime directive.

Effectiveness may be measured by asking – how much did we get done? Or to what extent did we achieve planned results? Clause 5.1 does not require “documented Information,’ however, you must identify and document the processes (e.g. process map, process flow diagram etc. the processes for business planning; quality planning; management review; internal communication; organization structure; etc.) as part of the QMS. You must also identify what specific documents are needed for effective planning, operation and control of these processes. These documents may include a procedure, business plan, statement of policies and objectives etc. Look at the risks related to your business, products, processes and resources in determining the nature and extent of documented controls you need to have for this clause. Where some of clause 5 activities are performed off-site (i.e. at headquarters,) your QMS must identify the off-site processes within your QMS and ensure that such processes comply with ISO 9001 requirements. The expectation is to flow down to the off-site facility the relevant ISO 9001 requirements that you would have to implement had you carried out the process at your own facility.

We will continue this discussion with Customer Focus in part 3.

How to Meet the Leadership Requirements in ISO 9001:2015 – Part 1

The importance of leadership in ISO 9001 is not new. But, why has it become such a big deal now? Because success of the Quality Management System (QMS) relies on resources necessary to keep it going once it has been implemented – and that comes from top management.

Definition

ISO defines top management as the “person or group of people who directs and controls an organization at the highest level. Top management has the power to delegate authority and provide resources within the organization.” –ISO 9000:2015 (3.1.1) so the intent of Clause 5 Leadership relates directly to those individuals defined above as top management.

Principle 2: Leadership

The second management principle, upon which the Standard is founded, is dependent on top management’s ability to “[Leaders] establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.” ISO 9004:2009 provides the following additional commentary:

a) Key benefits:

  • people will understand and be motivated towards the organization’s goals and objectives,
  • activities are evaluated, aligned and implemented in a unified way,
  • miscommunication between levels of an organization will be minimized.

b) Applying the principle of leadership typically leads to:

  • considering the needs of all interested parties including customers, owners, employees, suppliers, financiers, local communities and society as a whole,
  • establishing a clear vision of the organization’s future,
  • setting challenging goals and targets,
  • creating and sustaining shared values, fairness and ethical role models at all levels of the organization,
  • establishing trust and eliminating fear,
  • providing people with the required resources, training and freedom to act with responsibility and accountability,
  • inspiring, encouraging and recognizing people’s contributions.

Clause 5 Leadership

Section 5 of the Standard is titled Leadership and most of the requirements are very close to those in the ISO 9001:2008 version under Management Responsibility. The three subsections require that top management demonstrates leadership and commitment with respect to the QMS, such as being accountable for the effectiveness of the QMS, ensuring resources are available, promoting continual improvement, ensuring the Quality Policy and objectives are in place and consistent with the goals of the organization and the QMS and defining the organization’s roles, responsibilities, and authorities.

leadgraph1

The other subsections cover the need for customer focus and requirements for the Quality Policy. These requirements are also present in the 2008 revision, with slight modifications. The role of Management; to ensure that the QMS remains suitable, adequate, and effective has not been diminished, even though some requirements, such as the role of Management Representative, have been removed. Top management still remains important.

How will you meet the requirements?

As mentioned, all of these requirements have been present in previous versions of the Standard so radical change is not needed. What is required is a clear demonstration that top management is involved in the QMS. Here are some things that can prove top management has a commitment to the QMS:

  • QMS effectiveness is measured, and management is involved in assessing this.
  • The Quality Policy and objectives are in place per management direction, communicated in the organization,and tracked for progress.
  • The QMS is part of the business processes, not just a ‘stand-alone’ system.
  • Resource needs are reviewed and addressed by management.
  • Continual improvement is promoted and supported by management.
  • There is a way to ensure customer and legal requirements are understood and met, and staff understands why this is important.
  • There is a management focus on customer satisfaction.
  • Organizational roles, responsibilities, and authorities are assigned, understood, and known to those employees who need to assess a person in a certain role.

It is also important to note that the requirements for management review are still present in the 2015 revision, so this significant method of feedback to top management on the maintenance of the QMS is still here. This process continues to play a critical role in demonstrating that top management is fully engaged in the QMS.

Involving top management isn’t optional!

It has long been said, “If you want your QMS to succeed, you need support of top management,” and, “Why would you waste all the effort to implement a system, if management isn’t going to support it?”

Without management’s support, a quality system will be set adrift in deference to other priorities and the benefit of using continual improvement to focus on customer needs will be lost. Furthermore, unless you’ve realized that ISO 9001 is not just a set of rules with the sole purpose of certification but a business plan, a compilation of best practices intended to be imbedded within and across the entire enterprise you have missed the point. This is the part of it, you cannot achieve without full commitment from top management.

The Process Approach

The process approach is a philosophy. The organization is a set of processes all interacting together (as both suppliers and customers) to produce (provide) the products or services sought by the end-user.

  • The management system integrates processes and measures to meet objectives
  • Processes define interrelated activities and checks, to deliver intended outputs
  • Detailed planning and controls can be defined and documented as needed, depending on the organization’s context.

Using a process approach means shifting focus away from basic compliance to embrace “improvement.”

  • A process is commonly defined as a number of reproducible, interacting activities that together convert an input into an output.
  • An input is something that drives or starts the process, such as people, resources, or materials. Multiple inputs can, and usually do, exist.
  • An output is a deliverable resulting from the process, addressing the expectation of a customer (either external or internal). Typically, an output is a product, a service, or the input into another process.

NOTE: Inputs and outputs may be tangible (e.g. materials, components or equipment) or intangible (e.g. data, information or knowledge)

Process Approach

Flowchart conceptual design courtesy of MasterControl

The process approach is a review of the sequence and interaction of processes and their inputs and outputs. It looks at the organization as an active system of processes that addresses business risk and customer requirements.

The process approach in ISO 9001:2015

In accordance with the requirements of ISO 9001 the following sequence of actions provides examples of how an organization may choose to build and control the processes of its quality management system. Performance can be managed and improved by applying the Plan‐Do‐Check‐ Act (PDCA) cycle. This applies equally to the system as a whole, to individual processes and to operational activities.

Process 1

Process 2

Process 3

The process approach in ISO 9001:2015 courtesy of the International Organization for Standardization ISO/TC
176/SC 2/N1289

Resource link: www.iso.org/tc176/sc02/public