Home » ISO 9001:2015 Quality Management System » ISO 9001:2015 Clause 5 Leadership

ISO 9001:2015 Clause 5 Leadership

by Pretesh Biswas, APB Consultant

ISO 9001:2015 Clause 5 Leadership


As per ISO Leadership is defined as ” Leadership is 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. If the scope of the management system covers only part of an organization, then top management refers to those who direct and control that part of the organization.” Leadership is the ability to motivate groups of people towards a common goal. It is an important skill in today’s business world. Without strong leadership, many otherwise good businesses fail.

Difference between Management and leadership:

Management is mostly about processes. Leadership is mostly about behaviour. Management relies heavily on tangible measurable capabilities such as effective planning; the use of organizational systems; and the use of appropriate communications methods. Leadership instead relies most strongly on less tangible and less measurable things like trust, inspiration, attitude, decision-making, and personal character. These are all necessary to motivate an organization to achieve its management systems objectives.



The clause no 5 “Management Responsibilities” in ISO 9001:2008  is now addressed in two clauses in ISO 9001:2015 with  “Clause 5 Leadership”  and “Clause 6 Planning”. The “Leadership” clause has three sub clauses ie
Clause 5.1  Leadership and Commitment
Clause 5.2 Policy
Clause 5.3 Organizational roles, responsibilities and authorities.

The planning subclause ( 5.4 in ISO 9001:2008) is now a new clause Planning in ISO 9001:2015. Sub clause 5.6 “Management Review” in ISO 9001:2008 is now addressed in sub clause. The concept of appointing an MR is not required in ISO 9001:2015. The responsibilities of implementing lies with top management.

The ISO 9001:2015 places particular emphasis on leadership, not just management as set out in previous standards. This means top management now has greater accountability and involvement in the organization’s management system. They need to integrate the requirements of the management system into the organization’s core business process, ensure the management system achieves its intended outcomes and allocate the necessary resources. Top management is also responsible for communicating the importance of the management system and heighten employee awareness and involvement. At first glance, clause 5 appears to be just a reiteration of what’s gone before –policy, organisational roles, responsibilities and authorities etc. However, there is an emphasis on  leadership, not just management. On further examination there is more here; top management now have to have a greater involvement in the management system. They have to make sure that the requirements of the management system are integrated into the organisation’s business processes – the management system is not just a bolt-on. The ‘business’ is whatever activities are at the heart of the organisation’s reason for existing. In addition, they have to demonstrate their commitment by making sure that the management system achieves its intended outcome(s) and has adequate resources. Additionally they have to inform everyone that management system is important and that everyone should participate in its effective implementation. The involvement of top management in the  management system is now explicit and hands-on. The Quality policy has also been strengthened. It has to include commitments to satisfy applicable requirements and continually improve the management system. As well as being communicated  internally it has to be made available to interested parties.Process approach 2015

Clause 5.1 Leadership and commitment

5.1.1 General

The top management has to to demonstrate their leadership, and commitment to the quality management system. This can be done by  taking accountability for the effectiveness of the organization’s quality management system. Top management needs to ensure that the organization’s quality policy and  quality objectives are established for the QMS and is compatible with the organization’s overall strategic direction and also with the Organization’s context. Top management shall also ensure that the requirements of the quality management system are an integral part of the organization’s business practises and they should promote the use of risk based thinking and  and use of process approach throughout their organization. Top management must ensure that the required resources needed for effective implementation of QMS are available. Top Management must ensure that importance of effective Quality management is communicated throughout the organization as well as the conforming to the QMS requirements.The Top Management must ensuring that the quality management system achieves its intended outcomes outputs, by  engaging, directing, and supporting persons to contribute to the effectiveness of the quality management system and promoting improvement. The Top Management should be supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. The meaning of “Business” means those activities that are core to the purposes of the organization ‘s existence, irrespective of the fact whether the organization is for profit, Not for profit, public or private.

It is the responsibility of top management to provide leadership and direction for quality management within the organization. They must establish strategic quality management policies, directives and objectives consistent with the purpose and capabilities of the organization. The quality policies and quality objectives are to be established for the quality management systems that are compatible with the strategic direction of the organization. The organization should have clarity in their mission and vision. and policies are to be developed in line with the mission. The objectives are to be in line with the vision of the company. The strategies are to be developed and modified from time to time depending on the situation by keeping the target of achieving the vision. The organization needs to specify the strategies for the year and give yearly targets. This work is to be done by the top management and not to be assigned to people down the line or to an outside consultant. They can take the help, but not give up the responsibility.They must establish the organizational structure and internal environment that motivates personnel to achieve the organization’s quality management goals and objectives.

Ensuring the integration of the quality management system requirements into the organization’s business processes is the prime responsibility of the top management. If the top management is not committed and taking ad hoc decisions. shortcuts. and unethical means of achieving their interests. the system cannot be implemented effectively. The organization can somehow get certified by the auditors. but cannot achieve stakeholder satisfaction and shall fail in a long run.

Promoting the awareness of the process approach is a technical work and help of an expert is needed to guide the people, including the top management to implement it. However, the responsibility lies with the top management. They need to strive, appoint an expert. get themselves educated, bring the concepts in their routine work, and then insist others to follow. Ensuring that the quality management system achieves its intended outcomes /outputs requires the clear identification of key result areas for achieving the objectives. preparing the action plans, working as per that plan, reviewing the action and results, and taking suitable corrective and preventive actions. The top management is the driving force to educate, guide. coach, remove the obstacles. encourage. review, recognize the performers. modify the goals, and to be a role model in implementing the systems. If the top management is not committed and does not work as per 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 responsibility.

Promoting improvement  is the need of a competitive environment, where the customers are dictating the terms and their expectations are changing very fast. This situation is arrived at when there is more production than what the customer needs, and materials remain unsold. Although reducing the production is the logical solution, it is not implemented by the organizations as others try to increase the production and enter in their areas. In the earlier system, when governments were controlling the total production by allocating limits. the industry could make huge profits. but the countries which were not having initiative for innovation and continual improvements did not develop. So it is the responsibility of the top management to push the organization to innovative approaches not only for developing new products, reducing the wastes, improving efficiency, reducing the cost of operations. identifying unwanted process. and eliminating them but also for improving aesthetic values of their products and improving their services to the customer and society. Improving the quality of staff is also very important if an organization has to improve. The leadership taken by the top management in enhancing the knowledge. skills, and ability of staff is very important for an organization not only to improve but also to survive as others are improving.

They must provide adequate resources to develop, implement, maintain and improve the QMS. They must periodically review QMS performance to determine it suitability, adequacy and effectiveness.. Auditors are expected to review documents and records showing top managements  role in planning and implementing the processes that apply clause 5 requirements. The processes within your organization that perform these activities must be identified. These processes would typically include – business planning, quality planning, management review, internal communication, organization structure etc.  Top management would be the process owner of all these processes. Top management must communicate regularly to the organization 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. Effectiveness may be measured by asking – how much of the planned activities did we get done? Or to what extent did we achieve planned results? Clause 5.1 does not require a ‘documented Information’. However, you must identify and document for 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 your 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 (e.g. at head-office), 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.

5.1.2 Customer focus

Top management are required to take the lead on demonstrating  leadership and commitment to customer focus  by ensuring that all applicable statutory, regulatory and customer requirements are determined, well understood by the organization and are consistently met.  The organization has to determine all the risk and opportunities that can affect the conformity of the product and services or has the ability to affect the enhancement of customer requirement. The associated risk and opportunities must be adequately addressed. At all times the focus of enhancing customer satisfaction should be maintained. 

Organizations depend on their customers. So it is important that customer relationships be effectively managed. Accordingly, you must understand current and future needs of customers; you must meet their requirements and strive to exceed their expectations.

The customer satisfaction is the aim especially for the people working in a business organization. They strive to achieve the same. but in a number of cases they fail because of some problems. They are risks in achieving customer satisfaction. The top management needs to facilitate people in identifying those risks in advance and help them to devise alternate solutions to meet the customer expectations.  To ensure this you must understand your customer’s specific needs and requirements in terms of products, price, delivery communication, service and support. You must have an effective communication process between your customer and your organization, for discussion, review, timing, action and responsibility on the above issues. You must have an effective process for communication and review of the above requirements to relevant personnel or departments within your own organization.It is top management role to provide the leadership and commitment of time and resources to ensure this happens. Auditors will look for evidence of this. Clause  8.2.1 will get in the details of Customer communication and Clause 8.2.2 gets further into the details of understanding and processing customer requirements. Clause 9.1.2 sets requirements for monitoring and measuring customer satisfaction. Clause 5.1.2 provides the top management’s overall responsibility for customer relationship management, while clause 8.2.1 & 8.2.2 provides the front end and clause 9.1.2 provides the back-end, of the underlying and detailed activities of customer relationship management. The requirements of clause 5.1.2 – customer focus can be included the following processes – business planning; communications; sales and marketing; and customer satisfaction feedback; etc. You must also identify what specific documents may be needed for effective planning, operation and control of these processes. Examples of such documents may include a business plan, statement of customer related policies and objectives etc

pdf Sample business plan template

The success of a business organization lies in effectively meeting the customer requirements. Hence. it is the responsibility of the top management to ensure that customer requirements are understood clearly by all in the organization who are involved in providing the products and services to the customer. Goods and services provided should not be violating any of the legal and regulatory requirements including the safety norms. For example, if any material is being exported to the USA. complying with Customs—Trade Partnership Against Terrorism (C-TPAT) becomes mandatory. where one has a control over the packing area ensuring that only specified people are
involved in packing, their backgrounds are thoroughly verified, the packing area is under the vigilance of CCTV cameras, and all precautions are taken to meet the statutory requirements.

5.2 Policy

5.2.1 Establishing the Quality Policy

Top management are required to establish, implement and maintain a quality policy that is in line with the purpose and context of the organization while at the same time supporting its strategic direction. It should  provide a framework for the organization’s quality objectives and  must include a commitment to satisfy applicable requirements and must be the basis on which the continual improvements in the quality management system can be achieved.

5.2.2 Communicating the Quality Policy

The Quality policy should be applied within the organization by ensuring that it communicated and understood within the organization. The Quality policy should be maintained as a documented information and as appropriate should be made available to relevant Interested parties.

Developing a QMS must be a strategic business decision and therefore top management must provide the necessary direction and leadership, starting with establishing the quality policy and objectives. Your quality policy provides top management’s vision on quality management for the organization. It provides the organization with focused direction, i.e. high level goals and objectives for quality management. Your quality policy must be consistent with the scope of your QMS and other business, management and organizational strategies within the organization. Clause 5.2.2 a requires that you document your quality policy and clause 5.1.1c requires that you specify your commitment to ‘satisfy applicable requirements’ and  clause 5.2.1 d ‘continually improve the effectiveness of your QMS’. Clause 4.3 specifies requirements for the scope of your QMS. The wording of the quality policy should preferably specify what requirements are being complied with customer, regulatory, ISO 9001, etc. It must also clearly state your commitment to continually improve the effectiveness of the QMS. it may also include other complementary and important policies for business growth, product or manufacturing technology, workforce competence, business flexibility, etc. What you state in your quality policy must lead to establishing quality objectives, e.g. if you state in your quality policy that you will “meet customer requirements”, then from this, you might derive customer focused objectives for – product defects; customer complaints and returns; on time delivery, etc. Similarly, for the phrase -“meet ISO 9001 requirements”; from this you might derive process objectives for effectively using ISO 9001 requirements to manage, control and improve all of your QMS processes. Check out the process performance indicators. Stating that you will continually improve the effectiveness of your QMS  in your quality policy – can lead to a number of objectives, as your QMS is composed of many processes and you could have one or more objectives for each process. Therefore, each statement in your quality policy may result in one or more quality objectives. These quality objectives do not need to be stated in your quality policy, but top management must clearly be involved in providing direction, establishing and reviewing these objectives. Leadership needs to establish, review and maintain a policy, but also needs to ensure that it is applied within the organization. As and when required your policy should be made available to the relevant interested parties.  Your internal communication process should cover how the quality policy is communicated throughout the organization. There are many ways of doing this. Personnel must understand the importance and impact of the quality policy on the work they do.  The quality policy is not written in stone. It must be reviewed  periodically by top management, for significant changes in your organization, e.g. management, ownership, relocation, product, shift in customer base, etc. Such changes may result in changes to the quality policy. The establishment of the quality policy should be part of the business planning or QMS planning processes. A review of the quality policy for continuing suitability should be part of your management review process. As a quality document, the quality policy is also controlled by 7.5.3 control of documented Information.

pdf Samples of documented statements of Quality policy

 5.3 Organizational Roles, Responsibilities, and Authorities

Top management must ensure that the responsibilities and authorities for relevant roles are assigned, communicated, and understood within the organization. Top Management must assign the responsibility and authority to ensure that the system conforms to the requirements of ISO 9001 and  that the processes are delivering their intended outputs; Top Management must assign the responsibility and authority for report on the performance of the system, on opportunities for improvement, and on the need for change or innovation, and especially for reporting to top management; Top Management must assign the responsibility and authority to ensure the promotion of customer focus throughout the organization and ensure that integrity of system is maintained when changes to system are planned and implemented.

Top management must establish the organization necessary to deploy the QMS. It must define the structure, hierarchy and lines of reporting. Additionally,  it must ensure that duties, responsibilities and authority of all personnel are defined and communicated. All personnel must be clear on their duties, responsibilities and authority in meeting customer and regulatory requirements. Organization charts, job descriptions, Standard operating procedures, work instructions, etc, are some of the many ways that top management may use to define and document this. These must be communicated and deployed, as applicable, throughout the organization. Orientation training, appointment postings, training on procedures and work instructions, etc, are some of the many ways in accomplishing this.The organization structure and lines of reporting; responsibility and authority of managerial functions and departments may be established by top management  and the responsibilities and authorities for the rest of the organization may be established by the HR function working with various process owners. Again, this would depend on the size, complexity and culture of the organization.The effective planning, operation and control of internal communication processes may be demonstrated through the performance indicators. Some of the roles (responsibilities and authorities including) which the Top management needs to identify but not limiting to are:

  1. Understanding the company mission, vision, policies, and objectives carefully, and communicating the same in simple language down the line. The role should ensure that people have understood the same and will be able to demonstrate it in their routine activities.
  2. Helping Head of the Departments (HODs) in deriving the departmental objectives. policies and goals. considering the company objectives and policies. The concerned HOD is responsible for writing the policy and goals for his/her department and sections.
  3. Liasoning with standard bodies and getting the latest applicable national and international standards required for implementing and maintaining ISO 9000 series of standards.
  4. Explaining the concepts of ISO 9000 throughout the organization. Help of expert professionals can be obtained in giving training.
  5. Communicating the importance of meeting customer as well as regulatory requirements during the training program or in any other occasion found suitable for this purpose. Liasoning  with marketing. quality, and production people in understanding the real concerns and requirements of customers and ensure that they are communicated down.
  6. Proactively discussing with the people and ensuring that all have understood the real essence of the quality policy, quality objectives and goals, their role in achieving the goals and in complying with the statutory, legal and regulatory requirements.
  7. Identifying the processes required for implementing quality management systems that can help achieving company goals is a very important step in the implementation of the quality management system.
  8. There should be a role for  helping the HODs in identifying the controls in processes identified and documented. This should be done by considering the company objectives, goals, requirements of quality management systems. and legal and regulatory requirements
  9. Getting the documents, viz., work procedures, work instructions, job descriptions, process parameters, and specifications, etc.. prepared by the concerned personnel and bringing them under control
  10. Over a period of time, we see a number of formats are developed in an organization, and some of them may be a duplication of work. Scrutinizing all the formats used in the organization and standardizing them is a very important activity. There must be a role  to collect all the forms, list them, index them. discuss them with the concerned people. modify them to reduce the number of forms. and make them more effective and user-friendly.
  11.  Maintaining the master list of all documents, records and forms. and the distribution charts is one of the prime responsibilities of the MR.
  12. Interpreting the customer requirements and communicating down the line are important activities in any organization.
  13. As the technology advances and the company adopt new technology and systems, there is a need to amend the procedures and the documents. Making arrangements for adequacy adequate audits in the case of any changes in the system. process. or the people.
  14. Preparing the procedures. instructions. and manuals and documenting them are not the end of implementation. Everyone needs to read, understand. and implement them in their routine works. Training the people to adapt to the systems.
  15. We need a team of internal quality auditors to periodically audit the systems throughout the organization. Identifying the potential internal quality auditors and arranging their training programs.
  16.  Developing procedures for internal quality audits and training the users for the implementation.
  17. Internal audits need to be planned in advance and communicated to the users for the effective implementation of the systems.  Planning internal quality audits and making arrangements for the audits.
  18.  Liasoning with the certifying body and top management and getting audits done.
  19.  Following up for closing of non-conformities in time.
  20.  Following up with the certifying body in getting certificate.
  21.  Maintaining of  records for  internal quality audits. management review. external audits, auditor’s attendance and performance, auditor‘s training, trends in performance, follow-up for the actions decided in the management review and the correspondences relating to the implementation of quality management systems.
  22. Reporting the progress in the implementation in the quality management systems to the top management from time to time.
  23. Getting  information proactively on the changes coming in the quality management systems and alarming the people in the organization in time.
  24. ensuring the integrity of the management system is maintained when changes are planned and implemented.

Some of the above tasks may be delegated, but it is the management’s responsibility to ensure they are planned, implemented and achieved.  The implementation and adherence to systems is the responsibility of the top management. Unless the top management drives and follows up, the system cannot be implemented effectively. The above task may be given to one person or to a group of persons depending on the size of the organization.

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Pretesh Biswas

Pretesh Biswas