IATF 16949:2016 QMS REQUIREMENTS (Clause 5)

5. Leadership

5.1 Leadership and commitment

5.1.1 General

Top management shall demonstrate leadership and commitment with respect to the quality management system by:

a) taking accountability for the effectiveness of the quality management system;

b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization;

c) ensuring the integration of the quality management system requirements into the organization’s business processes;

d) promoting the use of the process approach and risk-based thinking;

e) ensuring that the resources needed for the quality management system are available;

f) communicating the importance of effective quality management and of conforming to the quality management system requirements;

g) ensuring that the quality management system achieves its intended results;

h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;

i) promoting improvement;

j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

5.1.1.1 Corporate responsibility

The organization shall define and implement corporate responsibility policies, including at a minimum an anti-bribery policy, an employee code of conduct, and an ethics escalation policy ("whistle-blowing policy").

5.1.1.2 Process effectiveness and efficiency

Top management shall review the product realization processes and support processes to evaluate and improve their effectiveness and efficiency. The results of the process review activities shall be included as input to the management review (see Section 9.3.2.1.).

5.1.1.3 Process owners

Top management shall identify process owners who are responsible for managing the organization's processes and related outputs. Process owners shall understand their roles and be competent to perform those roles (see ISO 9001, Section 7.2).

5.1.2 Customer focus

Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:

a.customer and applicable statutory and regulatory requirements are determined, understood and consistently met;

b. the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;

c. the focus on enhancing customer satisfaction is maintained.

5.2 Policy

5.2.1 Establishing the quality policy

Top management shall establish, implement and maintain a quality policy that:

a. is appropriate to the purpose and context of the organization and supports its strategic direction;

b. provides a framework for setting quality objectives;

c. includes a commitment to satisfy applicable requirements;

d. includes a commitment to continual improvement of the quality management system.

5.2.2 Communicating the quality policy

The quality policy shall:

a) be available and be maintained as documented information;

b) be communicated, understood and applied within the organization;

c) be available to relevant interested parties, as appropriate.

5.3 Organizational roles, responsibilities and authorities

Top management shall ensure that the responsibilities and authorities for

relevant roles are assigned, communicated and understood within the organization.

Top management shall assign the responsibility and authority for:

a) ensuring that the quality management system conforms to the requirements of this International Standard;

b) ensuring that the processes are delivering their intended outputs;

c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management;

d) ensuring the promotion of customer focus throughout the organization;

e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

5.3.1 Organizational roles, responsibilities, and authorities — supplemental

Top management shall assign personnel with the responsibility and authority to ensure that customer requirements are met. These assignments shall be documented. This includes but is not limited to the selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development, capacity analysis, logistics information, customer scorecards, and customer portals.

5.3.2 Responsibility and authority for product requirements and corrective actions Top management shall ensure that:

a) personnel responsible for conformity to product requirements have the authority to stop shipment and stop production to correct quality problems;

NOTE Due to the process design in some industries, it might not always be possible to stop production immediately. In this case, the affected batch must be contained and shipment to the customer prevented.

b) personnel with authority and responsibility for corrective action are promptly informed of products or processes that do not conform to requirements to ensure that nonconforming product is not shipped to the customer and that all potential nonconforming product is identified and contained;

c) production operations across all shifts are staffed with personnel in charge of, or delegated responsibility for, ensuring conformity to product requirements.