ISO 9001:2015, 5.1

ISO/DIS 9001:2015, in 3.05, defines Top Management as the person or group of people who directs and controls an organization at the highest level (for the scope of the quality management system).

Clause 5 of ISO/DIS 9001:2015 has three sub-clauses:

5. Leadership
5.1 Leadership and Commitment
5.2 Quality Policy
5.3 Organizational Roles, Responsibilities, and Authorities

This article summarizes the ISO/DIS 9001:2015 requirements in Clause 5.1 and highlights the changes from ISO 9001:2008. Other articles in this newsletter describe clauses 5.2 and 5.3.

5.1 Leadership and Commitment
5.1.1. Leadership and Commitment to the Quality Management System

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

  • take accountability of the effectiveness of the system;
  • ensure the quality policy and quality objectives are established for the system and are compatible with the strategic direction and the context of the organization;
  • ensure the quality policy is communicated, understood, and applied within the organization;
  • ensure the integration of the system requirements into the organization’s business processes;
  • promote awareness of the process approach;
  • ensure that the resources needed for the system are available;
  • communicate the importance of effective quality management and of conforming to system requirements;
  • ensure that the quality management system achieves its intended results;
  • engage, direct, and support persons to contribute to the effectiveness of the system;
  • promote continual improvement;
  • support other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

Note: Reference to “business” in ISO 9001 can be interpreted 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.

Changes:

  • This clause replaces old clause 5.1 on management commitment
  • New requirements to demonstrate leadership and accountability
  • Adds that policy and objectives must be compatible with strategic direction
  • Quality policy must be applied, not just communicated and understood
  • System requirements must now be integrated into business processes
  • Notice the “ensure” requirements that someone else can do it
  • Versus “take”, “promote”, “communicate”, “engage”, and “support”
  • More of a hands-on role for top management

5.1.2 Customer Focus

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

  • customer requirements and applicable legal requirements are determined and met;
  • risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
  • focus on consistently providing products and services that meet customer and applicable legal requirements is maintained;
  • focus on enhancing customer satisfaction is maintained.

Changes:

  • This clause replaces old clause 5.2 on customer focus
  • Determining legal requirements included from old clause 7.2.1
  • Primary clause for customer requirements is new 8.2.2 and 8.2.3
  • Adds the requirement to determine and address risks