Lead AuditorISO 9001:2026 Quality Management Systems

• The purpose of a QMS; quality management principles, the PDCA cycle and the process approach.
• First-, second- and third-party audits; the distinctions between management system certification, certification body accreditation and personnel certification.
• Auditing principles, professional ethics and auditor responsibilities; maintaining objectivity and confidentiality, and managing conflicts of interest.
• The role and applicability of ISO 19011 and ISO/IEC 17021-1 in auditing.

Practice: Analyse professional ethics scenarios; identify the audit team leader's responsibilities and limits of authority.

• Relate requirements for context, leadership, planning and support to process objectives, risks, opportunities and results.
• Audit the fulfilment of customer, statutory and regulatory requirements applicable to products and services.
• Audit design and development where applicable; supplier controls, production and service provision; measurement, release of products and services, and control of nonconforming outputs.
• Review internal audit results, management review, customer satisfaction and improvement; identify evidence of QMS conformity and effectiveness.
• Analyse the ISO 9001:2026 updates and their implications for auditing, focusing on quality culture, leadership and the distinction between risks and opportunities; identify appropriate audit questions and evidence.

Practice: Develop a “requirement – process – evidence” checklist; use a customer complaint to identify the processes to audit and the evidence to collect.

• Distinguish an audit programme from an individual audit plan; define objectives, scope, criteria, resources and associated risks.
• Review information about the organisation, its documentation and QMS performance; conduct a Stage 1 audit to assess readiness and prepare for Stage 2 of a certification audit.
• Select team members based on competence; assign responsibilities by process and location; determine audit duration in accordance with applicable requirements and relevant Global ACI documents.
• Develop the schedule, sampling approach and audit checklist; select on-site, remote or combined methods, ensuring access to information and data confidentiality.

Practice: Prepare an audit plan, assign responsibilities and develop a checklist; explain the rationale for the audit focus, duration and sampling approach.

• Chair the opening meeting; confirm the plan, contact points, safety requirements and arrangements for handling changes during the audit.
• Ask questions, listen, observe and review records; trace evidence along the process sequence or work backwards from results; cross-check information from multiple sources.
• Evaluate the links between processes, objectives, risks and performance; recognise sampling limitations and verify the reliability of electronic evidence.
• Conduct team meetings, monitor progress and adjust assignments; handle missing records, conflicting information, access restrictions and pressure from the auditee.

Practice: Role-play an opening meeting, interviews and team meetings; record evidence clearly with sufficient detail for verification and traceability.

• Distinguish audit evidence, findings and conclusions; collect and verify additional evidence when the basis for a conclusion is insufficient.
• Describe a nonconformity using three components: the requirement to be fulfilled, specific evidence and a statement of how the requirement has not been met.
• Classify nonconformities using the applicable criteria, considering their impact on the QMS's ability to achieve its intended results; do not report a nonconformity as an opportunity for improvement or draw conclusions without sufficient evidence.

Practice: Analyse evidence, prepare nonconformity reports and explain the basis for identifying and classifying the nonconformities to the group.

• Consolidate results against the audit objectives, scope and criteria; draw conclusions on QMS conformity and effectiveness, and clearly state the audit's limitations.
• Agree on conclusions within the team; prepare a clear, consistent report that is traceable to the evidence.
• Chair the closing meeting, explain findings and conclusions, address and record unresolved differences of opinion; communicate the next steps and distinguish the team's recommendation from the certification decision.

Practice: Complete the audit report; role-play the team leader presenting conclusions and addressing differing views at the closing meeting.

• Distinguish correction, cause analysis and corrective action; review the completeness and suitability of the action plans and evidence submitted by the auditee.
• Verify the implementation and effectiveness of corrective action; establish the basis for closing nonconformities or continuing follow-up, including during surveillance and recertification audits.
• Identify the competence needed by auditors under ISO 19011, ISO/IEC 17021-1 and ISO/IEC 17021-3; explore competence assessment through witnessed audits, audit logs and continuing professional development.

Practice: Review corrective action records, recommend closing nonconformities or continuing follow-up, and explain the rationale; develop a personal competence development plan.

• Practise auditing using the fictional organisation's records and the audit plan developed earlier; take the roles of audit team leader, auditor and auditee representative.
• Handle emerging situations, agree on findings and conclusions, complete the report and conduct the closing meeting.
• Instructors observe and provide individual feedback against competence criteria, guide participants in improving weaker skills and help them prepare for the final examination.

Deliverables: An audit file comprising the plan, checklist, evidence notes, nonconformity reports, audit report and corrective action review results.