The ISO 9001:2015 Lead Auditor Course develops the knowledge and practical competence required to plan, lead, conduct, report and follow up quality management system audits.
Participants gain a detailed understanding of ISO 9001 requirements and learn how to assess whether an organisation’s quality management system is effectively implemented, maintained and continually improved. The course applies the auditing principles and practices established in ISO 19011 and introduces the requirements relevant to third-party management system certification audits.
Through practical exercises, case studies and simulated audit activities, participants learn how to evaluate processes, gather and verify objective evidence, identify nonconformities, communicate findings and lead an audit team professionally.
The course covers first-party, second-party and third-party audits and is suitable for participants seeking to develop their careers as quality management system auditors or lead auditors.
Module 1: Quality Management System Fundamentals
- Purpose and benefits of a quality management system.
- The ISO 9000 family of standards.
- Quality management terminology and concepts.
- The seven quality management principles.
- Process approach and process interaction.
- Plan–Do–Check–Act cycle.
- Risk-based thinking and organisational resilience.
- Relationship between quality, compliance and customer satisfaction.
Module 2: Interpretation of ISO 9001:2015
- Context of the organisation.
- Understanding interested parties and their requirements.
- Determining the scope of the quality management system.
- Leadership, accountability and quality policy.
- Risks, opportunities and quality objectives.
- Resources, competence, awareness and communication.
- Control of documented information.
- Operational planning and control.
- Customer communication and determination of requirements.
- Design and development.
- Control of externally provided processes, products and services.
- Production and service provision.
- Release and control of nonconforming outputs.
- Monitoring, measurement, analysis and evaluation.
- Internal audit and management review.
- Nonconformity, corrective action and continual improvement.
- ISO 9001:2015/Amd 1:2024 climate-action considerations.
Module 3: Auditing Principles and Audit Programmes
- Purpose and value of management system auditing.
- Principles of auditing.
- Integrity, fair presentation and due professional care.
- Confidentiality, independence and evidence-based decision-making.
- Risk-based approach to auditing.
- First-party, second-party and third-party audits.
- Audit programme objectives, risks and resources.
- Selection and competence of audit-team members.
- Monitoring and improving an audit programme.
Module 4: Initiating and Planning an Audit
- Establishing contact with the auditee.
- Determining audit feasibility.
- Defining audit objectives, scope and criteria.
- Selecting audit methods.
- Appointing the audit-team leader and team members.
- Understanding the organisation and its processes.
- Reviewing previous audit results and performance information.
- Preparing the audit plan.
- Allocating audit responsibilities.
- Developing audit checklists and working documents.
- Establishing sampling strategies and audit trails.
Module 5: Document Review and Audit Preparation
- Reviewing QMS scope and organisational context.
- Evaluating policies, objectives and process information.
- Reviewing documented information.
- Evaluating statutory, regulatory and contractual requirements.
- Identifying potential audit trails.
- Determining readiness for the audit.
- Preparing for on-site, remote or hybrid audit activities.
Module 6: Conducting Audit Activities
- Conducting the opening meeting.
- Confirming communication arrangements.
- Interviewing personnel at different organisational levels.
- Observing activities and working conditions.
- Reviewing records and documented information.
- Following process-based audit trails.
- Evaluating process inputs, activities, controls, outputs and performance measures.
- Sampling and verifying audit evidence.
- Managing time and audit-team resources.
- Conducting audit-team review meetings.
- Managing difficult, disruptive or sensitive audit situations.
Module 7: Audit Findings and Nonconformities
- Comparing audit evidence with audit criteria.
- Determining conformity and nonconformity.
- Understanding correction, corrective action and preventive thinking.
- Writing clear and evidence-based nonconformity statements.
- Linking evidence, requirements and statements of nonconformity.
- Reviewing findings with the auditee.
- Identifying opportunities for improvement.
- Avoiding consultancy and conflicts of interest.
- Reaching audit conclusions.
Module 8: Audit Reporting, Follow-Up and Audit-Team Leadership
- Preparing the audit report.
- Ensuring accuracy, completeness and traceability.
- Presenting positive findings, nonconformities and conclusions.
- Conducting the closing meeting.
- Handling questions, disagreement and appeals professionally.
- Communicating audit conclusions to management.
- Distributing and controlling the audit report.
- Maintaining confidentiality and audit records.
- Containment, correction and corrective action.
- Root-cause analysis principles and techniques.
- Reviewing corrective-action plans.
- Evaluating the suitability of proposed actions.
- Verifying implementation and effectiveness.
- Closing nonconformities.
- Conducting follow-up audits.
- Using audit results to support continual improvement.
- Responsibilities and authority of the audit-team leader.
- Managing audit-team competence and performance.
- Assigning roles and coordinating audit activities.
- Resolving disagreements within the audit team.
- Communicating with the audit client and auditee.
- Maintaining impartiality and professional conduct.
- Evaluating auditors and supporting their development.
- Practical audit simulation and course examination.
