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Auditing ISO 9001:2015 Clause 5,0 - Leadership
by Walt Prystaj
Auditing Clause 5 of ISO 9001:2015, "Leadership," involves evaluating the top management’s role in directing the Quality Management System (QMS) and fostering a culture that supports quality. Below is a guide for auditing Clause 5, including objectives, sample questions, and evidence to look for.
Objectives for Auditing Clause 5
1. Assess Top Management’s Commitment to the QMS: Ensure that management demonstrates a commitment to quality, compliance, and continual improvement.
2. Evaluate Customer Focus: Confirm that customer requirements are understood, met, and that customer satisfaction is prioritized.
3. Check the Establishment and Communication of the Quality Policy: Verify that the quality policy is appropriate, communicated, and understood within the organization.
4. Review the Allocation of Organizational Roles, Responsibilities, and Authorities: Ensure that roles and responsibilities are defined and communicated to support the QMS.
Audit Plan for Clause 5
1. 5.1 Leadership and Commitment
• Objective:
Verify that top management demonstrates leadership and commitment to the QMS and is actively involved in its implementation.
• Sample Questions:
o How does top management demonstrate its commitment to the QMS and quality objectives?
o Can you provide examples of how management supports a culture of quality and continual improvement?
o How does management ensure that resources are available for maintaining and improving the QMS?
• Evidence to Look For:
o Meeting minutes from management reviews that show active involvement in QMS planning and discussions.
o Records of resource allocation and investment in training, technology, or other areas that support the QMS.
o Examples of top management’s involvement in improvement initiatives or quality-related projects.
2. 5.1.2 Customer Focus
• Objective:
Ensure that customer requirements are identified, understood, and met, and that customer satisfaction is a primary focus.
• Sample Questions:
o How does the organization identify and understand customer requirements?
o What actions does management take to enhance customer satisfaction?
o How are customer satisfaction and feedback monitored, and how does management use this information to make decisions?
• Evidence to Look For:
o Customer feedback records, surveys, and analysis reports.
o Examples of actions taken to address customer feedback or improve customer satisfaction.
o Policies, procedures, or guidelines that prioritize customer requirements in planning and operations.
3. 5.2 Quality Policy
• Objective: Verify that a quality policy is established, appropriate to the organization, and communicated effectively.
• Sample Questions:
o How was the quality policy developed, and who was involved in its creation?
o How does the policy align with the organization’s objectives and context?
o How is the quality policy communicated to employees, and how do they demonstrate their understanding of it?
• Evidence to Look For:
o Documented quality policy that is current, accessible, and relevant to the organization’s goals.
o Records of communication efforts, such as training sessions or postings of the quality policy in visible areas.
o Employee interviews to verify their understanding of the quality policy and how it relates to their work.
4. 5.3 Organizational Roles, Responsibilities, and Authorities
• Objective:
Ensure that roles, responsibilities, and authorities for the QMS are assigned, communicated, and understood.
• Sample Questions:
o How are roles and responsibilities for the QMS determined and assigned?
o Who is responsible for ensuring the QMS conforms to ISO 9001:2015 requirements, and how is this responsibility communicated?
o How does management ensure that responsibilities related to customer requirements are clear and fulfilled?
• Evidence to Look For:
o Organizational charts and job descriptions specifying roles related to the QMS.
o Documents or communications (e.g., emails, meeting minutes) outlining QMS responsibilities and authorities.
o Evidence from interviews with employees showing they understand their roles in the QMS and their responsibility for quality.
Practical Tips for Auditing Clause 5
1. Review Documentation: Familiarize yourself with the quality policy, job descriptions, and management review records before the audit to understand the context of leadership within the organization.
2. Interview Top Management: Engage directly with top management to gain insights into their commitment to the QMS and how they foster a culture of quality.
3. Observe Communication and Understanding: Speak with a variety of employees to assess their understanding of the quality policy and their roles in the QMS.
4. Verify Evidence of Customer Focus: Check for feedback mechanisms, customer satisfaction metrics, and documented actions showing a commitment to meeting customer expectations.
Example Evidence to Collect
• Quality Policy Documentation: Current quality policy with evidence of regular review and alignment with organizational goals.
• Management Review Records: Meeting minutes showing top management’s active role in the QMS, discussions on quality objectives, and resource planning.
• Customer Feedback Records: Reports and records showing how customer feedback is gathered, analyzed, and used to drive improvements.
• Role Descriptions and Organizational Charts: Clearly defined roles and responsibilities related to quality, as well as evidence of their communication to relevant staff.
• Employee Understanding: Interviews or surveys showing that employees understand the quality policy and their responsibilities within the QMS.
By using these objectives, questions, and evidence, you can thoroughly audit Clause 5 of ISO 9001:2015 to verify that top management is committed to supporting and directing the QMS in alignment with ISO standards.
