ISO 9001 – Leadership Overview Clause 5: 5.1 – 5.3

Do you need a better understanding of Clause 5 Leadership of the ISO 9001 standard? In this next series of blog posts, we will be diving deeper into Clause 5. Follow along through each section to get a better understanding of Clause 5 sections 5.1 – 5.3. Starting with an overview of Clause 5 and everything that it entails.

Leadership consists of 3 clauses:

Clause 5.1: Leadership and Commitment

In this section top management must demonstrate leadership and commitment to the QMS by taking accountability for its effectiveness. Leadership must ensure that the implementation of QMS aligns with the strategic direction of the organization. Some key aspects include:

· Customer Focus

· Engagement of people

· Integration into business processes

International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:

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.

NOTE Reference to “business” in this International Standard 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.

5.1.2 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.

Clause 5.2: Policy

In 5.2 Policy, management is required to establish, implement and maintain a quality policy. A quality policy is written as a formal statement outlining the commitment to quality and its goals for the QMS. These key requirements for the policy include:

· Framework for setting quality objectives

· Appropriateness to the organization

· Communication and understanding

International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:

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.

Clause 5.3 Organizational Roles, Responsibilities, and Authorities

In this clause, ensuring that management roles, responsibilities and authorities within the organization are clearly defined, assigned and communicated properly. This ensures accountability and any confusion of who is responsible for specific elements of the QMS. These key points include:

· Authority to make decisions

· Assignment of responsibilities

· Management representative

International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:

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.

In conclusion, Clause 5 Leadership in ISO 9001:2015 highlights that top management plays a vital role in guiding the organization’s quality efforts. Clause 5 ensures that leadership drives QMS from the top and embeds the organization’s overall strategic objectives and culture as a responsibility across all levels of the organization. In the next series of blog posts, we will be diving deeper into each section of Clause 5. This includes 5.1 Leadership and commitment, 5.2 Policy and Clause 5.3 Organizational Roles, Responsibilities, and Authorities.

References:

ISO. (2015). ISO 9001:2015 Quality management systems – Requirements. International Organization for Standardization\

https://www.iso.org/standard/62085.html

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Context of the Organization

https://www.wilkshireconsulting.com/single-post/iso-9001-context-of-the-organization-overview