ISO 9001:2015 Clause 5 Leadership
- Top management must manage, not delegate, quality
- Leadership has defined responsibilities for ensuring quality execution
- Emphasis on customer focus with specific applications ranging from support for customer regulatory requirements, risks, and enhancing customer satisfaction
- Management’s responsibilities include quality policy establishment, communication and organization-wide responsibility and authority
Section 5 Leadership
Section 5.1: Leadership and Commitment
The 2015 standard is similar to 2008 concerning management commitment and responsibility with four exceptions.
- Quality management can no longer be delegated. The Organization’s leaders are responsible for the QMS being implemented and effective.
- The established quality policy and quality objectives must be compatible with the context and strategic direction of the organization.
- Leadership must ensure integration of the QMS into the organization’s business processes.
- Leadership must assign the responsibilities and authorities for ensuring that processes are delivering their intended outputs.
- Learn more about Leadership’s Responsibilities and Commitment
Expanding upon this, this section requires organization leadership to:
- Implement the process approach and risk-based thinking
- Provide the necessary support to fully implement and sustain the QMS
- Communicating to the organization the importance of conforming to QMS requirements
- Ensuring the QMS meets its goals
- Engage, direct, and support individuals contributing to the QMS (i.e. Provide employees with training, get employees invovled)
- Create a culture of continuous improvement
An important distinction made by this section now broadens the idea of a “business” to virtually any type of organization that wishes to use ISO 9001 as its quality management system including non-profit and government entities.
Leadership must demonstrate their commitment to customer focus, particularly by fully understanding and monitoring customer requirements and satisfaction. The requirements for Leadership regarding customer focus include:
- Determine, understand and consistently meet customer and applicable statutory and regulatory requirements
- Determine and address risks and opportunities around product and service conformity and enhancing customer satisfaction
- Maintain focus on enhancing customer satisfaction
Leadership is to establish, communicate and enforce a quality policy that accomplishes the following:
- Is in line with the purpose, context, and strategic direction of the organization
- Provides a framework for quality objectives
- Includes a commitment to satisfy applicable requirements
- Includes a commitment to continual improvement
Learn more about Quality Policy
Section 5.3: Organizational Roles, Responsibilities and Authorities
Responsibilities and authorities for relevant roles must be assigned, communicated and understood within the organization. Specifically, roles that impact the organization’s ability to meet the requirements of 9001:2015, ensure processes are delivering their intended outputs, report QMS performance and improvement, plan and implement changes to the QMS, and promote customer focus.
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