ISO 9001:2015 Leadership

Clause 5.1 Leadership and commitment

The Requirement

5.1.1 General

The top management has 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 are 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 practices and they should promote the use of risk-based thinking and the use of process approaches throughout their organization. Top management must ensure that the required resources needed for the effective implementation of QMS are available. Top Management must ensure that the importance of effective Quality management is communicated throughout the organization as well as conforming to the QMS requirements. The Top Management must ensure 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.

5.1.2 Customer focus

Top management is 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 risks and opportunities that can affect the conformity of the product and services or have the ability to affect the enhancement of customer requirements. The associated risk and opportunities must be adequately addressed. At all times the focus of enhancing customer satisfaction should be maintained. 

Checklist Questions

1. Does the top management demonstrate leadership and commitment w.r.t. the QMS by taking accountability of the effectiveness of the QMS?
2. How are the quality policy and objectives established for the QMS and how are they compatible with the strategic direction and the organizational context?
3. How is the quality policy communicated within the organization? Show how this is understood and applied.
4. How are the requirements of the QMS integrated into the business processes?
5. How do you promote awareness of the process approach?
6. How do you ensure that resources needed for the QMS are available?
7. How do you communicate the importance of effective quality management?
8. How do you communicate the importance of conforming to the QMS requirements?
9. How do you ensure that the QMS achieves its intended results?
10. How do you engage, direct and support people to contribute to the effectiveness of the QMS?
11. How do you promote continual improvement?
12. How do you support other relevant management roles to demonstrate leadership in their areas of responsibility?
13. Show me how top management demonstrates leadership and commitment w.r.t. customer focus ensuring requirements and applicable statutory and regulatory requirements are determined and met.
14. How are risks and opportunities that can affect the conformity of products and services determined?
15. How is the ability to enhance customer satisfaction determined and addressed?
16. How is the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements maintained?
17. How is customer satisfaction maintained?

Implementation Guidelines

1. The top management must establish strategic quality management policies, directives, and objectives consistent with the purpose and capabilities of the organization.
2. The top management must establish the organizational structure and internal environment that motivates personnel to achieve the organization’s quality management goals and objectives.
3. Ensuring the integration of the quality management system requirements into the organization’s business processes is the prime responsibility of the top management.
4. The responsibility of promoting the awareness of the process approach lies with the top management.
5. The top management must ensure that the quality management system achieves its intended outcomes /outputs by 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.
6. The top management must provide adequate resources to develop, implement, maintain and improve the QMS.
7. The top management must periodically review QMS performance to determine its suitability, adequacy, and effectiveness.
8. Business planning, quality planning, management review, internal communication, organization structure, etc. are process required from the top Management
9. Top management must communicate regularly to the organization on the importance of meeting customer and regulatory requirements. Top management may communicate in any number of ways including meetings, documented policies, memos, directives, email, etc.
10. The organization must understand the current and future needs of customers in terms of products, price, delivery communication, service, and support. It must meet their requirements and strive to exceed their expectations.
11. The organization must have an effective communication process between  customer and  organization, for discussion, review, timing, action, and responsibility
12. Customer focus can be included in the following processes – business planning; communications; sales and marketing; and customer satisfaction feedback; etc. It 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
13. Reference to “business”  can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence; whether the organization is public, private, for-profit, or not for profit

5.2 Policy

The Requirement

5.2.1 Establishing the Quality Policy

Top management is 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 documented information and as appropriate should be made available to relevant Interested parties.

 Checklist Questions

1. How does top management establish, review and maintain a quality policy?
2. How is the quality policy determined to be appropriate to the purpose and context of the organization?
3. Does the quality policy provide a framework for setting and reviewing quality objectives?
4. Does the quality policy contain a commitment to satisfy applicable requirements?
5. Does the quality policy include a commitment to continual improvement of the QMS?
6. Where is the quality policy available as documented information?
7. How is the quality policy communicated? How it is understood and applied within the organization.
8. How have you made it available to relevant interested parties?

Implementation Guidelines

1. The quality policy should provide top management’s vision on quality management for the organization. It must provide the organization with focused direction, i.e. high-level goals and objectives for quality management.
2. The quality policy must be consistent with the scope of the QMS and other business, management, and organizational strategies within the organization.
3. The quality policy must specify the commitment to ‘satisfy applicable requirements’  such as being complied with the customer, regulatory, ISO 9001, etc and   ‘continually improve the effectiveness of your QMS’
4. The quality policy must clearly state a 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.
5. The 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.
6. As and when required, the Quality policy should be made available to the relevant interested parties.
7. The quality policy is communicated throughout the organization.
8. The quality policy must be reviewed periodically by top management, for significant changes in your organization, e.g. management, ownership, relocation, product, a shift in customer base, etc.

 5.3 Organizational Roles, Responsibilities, and Authorities

The Requirement

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 the 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 the system is maintained when changes to the system are planned and implemented.

 Checklist Questions

1. How does top management ensure that responsibilities and authorities for relevant roles are assigned, communicated, and understood within the organization?
2. How does top management assign the responsibility and authority for ensuring that the QMS conforms to the international standard?
3. How does top management assign the responsibility and authority for ensuring processes are delivering their intended outputs?
4. How are the performance of the QMS, opportunities for improvement, and the need for change or innovation reported to top management?
5. How is customer focus promoted within the organization?
6. How is the integrity of the QMS maintained when changes to the QMS are planned and implemented? 

Implementation Guidelines

1. Top Management must define the structure, hierarchy, and lines of reporting to ensure that duties, responsibilities, and authority of all personnel are defined and communicated.
2. 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.
3. Organization responsibilities and authorities 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.
4. The top Management must ensure that the integrity of the management system is maintained when changes are planned and implemented.
5. Some of the tasks may be delegated, but it is the management’s responsibility to ensure they are planned, implemented, and achieved.

Documented Information if applicable

1. Sample Quality Policy
2. Job Responsibility

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