ISO 9001 Lead Auditor

By the end of the course, participants should be able to: 1. Explain the purpose and benefits of a Quality Management System. 2. Understand the structure and requirements of ISO 9001:2026. 3. Interpret ISO 9001 requirements from an auditor's perspective. 4. Explain quality management principles. 5. Understand organisational context and interested parties. 6. Evaluate leadership, quality culture and commitment. 7. Evaluate risks and opportunities. 8. Apply the process approach and PDCA cycle during audits. 9. Explain the principles of management system auditing. 10. Establish audit scope, objectives and criteria. 11. Prepare an effective audit plan. 12. Develop audit questions and working documents. 13. Conduct opening and closing meetings. 14. Collect and verify objective audit evidence. 15. Interview personnel effectively. 16. Identify conformity and nonconformity. 17. Write clear nonconformity statements. 18. Prepare and present audit findings and conclusions. 19. Prepare an audit report. 20. Evaluate corrective actions and conduct audit follow-up. 21. Lead and manage an audit team. 22. Apply appropriate professional behaviour as a Lead Auditor.

Successful participants should be able to: • Interpret ISO 9001:2026 requirements. • Apply ISO 19011 auditing principles. • Plan and manage QMS audits. • Prepare audit plans and checklists. • Conduct process-based audits. • Lead an audit team effectively. • Communicate professionally with auditees. • Gather and evaluate objective evidence. • Determine whether audit criteria have been fulfilled. • Identify and classify audit findings. • Write evidence-based nonconformity reports. • Conduct audit meetings. • Prepare professional audit reports. • Evaluate corrective actions. • Follow up audit findings. • Support organisational QMS improvement. • Perform first-, second- and third-party QMS audits, subject to applicable competence and certification requirements. Understand ISO 9001:2026 → Plan the Audit → Conduct the Audit → Evaluate Evidence → Report Findings → Follow Up Corrective Actions → Lead QMS Audits Effectively. On completion, successful participants should possess the knowledge and practical foundation required to plan, conduct, lead, report and follow up ISO 9001 Quality Management System audits professionally and effectively.

The course is suitable for: • Quality Managers • Quality Assurance Managers • QMS Managers and Coordinators • Internal Auditors • QMS Auditors • Prospective Lead Auditors • Quality Engineers • Quality Professionals • Compliance Managers • Risk and Governance Professionals • Operations Managers • Process Owners • Management System Consultants • ISO 9001 Implementers • Supplier and Procurement Auditors • Certification and conformity assessment personnel • Professionals responsible for QMS audits • Individuals seeking to develop ISO 9001 Lead Auditor competence

Participants should preferably have basic knowledge of: • Quality Management Systems; • ISO 9001 requirements; • Quality management principles; • Process approach; • Plan-Do-Check-Act (PDCA); and • Risk-based thinking.

The course makes reference to: • ISO 9001:2026 – Quality management systems — Requirements • ISO 9000 – Quality management systems — Fundamentals and vocabulary • ISO 19011 – Guidelines for auditing management systems • Relevant ISO management system terminology and guidance • Applicable auditing and conformity assessment principles

DAY 1 – ISO 9001:2026 Requirements and QMS Fundamentals Module 1: Introduction to Quality Management • Purpose of a Quality Management System. • Benefits of ISO 9001. • Quality management principles. • Process approach. • PDCA cycle. • Risk-based thinking. • QMS terminology and concepts. Module 2: Understanding ISO 9001:2026 Review and interpretation of: • Clause 4 – Context of the organisation • Clause 5 – Leadership • Clause 6 – Planning • Clause 7 – Support • Clause 8 – Operation • Clause 9 – Performance evaluation • Clause 10 – Improvement Key areas include: • Organisational context. • Interested parties. • Leadership and accountability. • Quality culture and ethical behaviour. • Quality policy and objectives. • Risks and opportunities. • Resources and competence. • Communication. • Documented information. • Operational controls. • Customer requirements. • Design and development. • External providers. • Production and service delivery. • Performance monitoring. • Internal audit. • Management review. • Nonconformity and corrective action. • Continual improvement. Exercise: Interpretation of ISO 9001 requirements from an auditor's perspective. ________________________________________ DAY 2 – Auditing Principles and Audit Planning Module 3: Fundamentals of QMS Auditing • Purpose of an audit. • Audit terminology. • Audit principles. • Audit programme. • First-party audits. • Second-party audits. • Third-party audits. • Auditor competence and responsibilities. • Confidentiality and independence. • Professional auditor behaviour. Module 4: Planning the Audit • Audit objectives. • Audit scope. • Audit criteria. • Audit feasibility. • Selecting the audit team. • Assigning responsibilities. • Reviewing QMS information. • Developing the audit plan. • Preparing audit working documents. • Sampling. • Audit trails. • Process-based auditing. • Risk-based approach to auditing. Workshop: Develop an ISO 9001 audit plan and audit checklist. ________________________________________ DAY 3 – Conducting the QMS Audit Module 5: Opening and Conducting the Audit • Opening meeting. • Confirming audit arrangements. • Communicating during the audit. • Interview techniques. • Asking effective audit questions. • Observation of activities. • Reviewing documented information. • Sampling records. • Following audit trails. • Auditing processes and interfaces. • Gathering objective evidence. • Verifying audit evidence. Module 6: Evaluating Audit Evidence Participants learn how to: • Compare evidence with audit criteria. • Determine conformity. • Identify potential nonconformities. • Distinguish facts from assumptions. • Record audit evidence. • Develop audit findings. • Reach evidence-based conclusions. Practical Exercise: Auditor–auditee interview and evidence-gathering role play. ________________________________________ DAY 4 – Reporting, Lead Auditor Skills and Audit Follow-Up Module 7: Nonconformity and Audit Reporting • Understanding nonconformity. • Evidence supporting nonconformity. • Writing clear nonconformity statements. • Linking findings to audit criteria. • Reviewing findings with the audit team. • Preparing audit conclusions. • Conducting the closing meeting. • Preparing the audit report. Workshop: Write and review sample nonconformity reports. Module 8: Lead Auditor Responsibilities • Role of the Lead Auditor. • Managing the audit team. • Allocating audit activities. • Managing time and resources. • Communicating with the auditee. • Managing difficult audit situations. • Resolving differences within the audit team. • Maintaining impartiality and confidentiality. • Professional judgement. • Leading opening and closing meetings. • Reaching audit conclusions. Module 9: Corrective Action and Follow-Up • Correction and corrective action. • Root-cause considerations. • Reviewing proposed corrective actions. • Evaluating corrective-action evidence. • Verifying effectiveness. • Closing audit findings. • Conducting follow-up audits. • Continual improvement. Module 10: Lead Audit Simulation Participants undertake a practical audit exercise covering: 1. Audit preparation. 2. Audit planning. 3. Opening meeting. 4. Auditor interviews. 5. Evidence collection. 6. Identification of findings. 7. Nonconformity reporting. 8. Audit-team meeting. 9. Audit conclusions. 10. Closing meeting. 11. Audit reporting. End-of-Day Review: Examination preparation and course revision. ________________________________________ DAY 5 – MULTIPLE-CHOICE EXAMINATION Cognicert ISO 9001:2026 Lead Auditor Examination Day 5 is dedicated to assessment of participants' understanding of the course. The multiple-choice examination may assess knowledge and understanding of: • Quality management principles. • ISO 9001:2026 requirements. • QMS terminology. • Process approach and PDCA. • Risk-based thinking. • ISO 19011 auditing principles. • Audit programmes. • Audit planning and preparation. • Audit scope, objectives and criteria. • Conducting QMS audits. • Interview and evidence-gathering techniques. • Audit findings and nonconformities. • Audit reporting. • Corrective-action follow-up. • Lead Auditor responsibilities. • Auditor competence and professional behaviour.

Day 5 – Multiple-Choice Examination Certificate: Cognicert ISO 9001 Lead Auditor Certificate Participants are assessed through: • Course participation. • Practical exercises and workshops. • Audit simulation activities. • Knowledge checks. • Day 5 Multiple-Choice Examination.

The course uses a practical and interactive learning methodology, including: • Instructor-led presentations. • Clause-by-clause explanation. • Practical examples. • Group discussions. • Case studies. • Individual exercises. • Group exercises. • QMS documentation review. • Audit planning workshops. • Audit checklist exercises. • Auditor–auditee role plays. • Evidence-gathering exercises. • Nonconformity-writing exercises. • Opening and closing meeting simulations. • Lead audit simulation. • Question-and-answer sessions. • Daily knowledge reviews. • Multiple-choice examination. The emphasis is on learning by doing, enabling participants to apply ISO 9001 requirements and auditing principles to realistic organisational situations.

Participants who successfully fulfil Cognicert's applicable course and examination requirements will be awarded the: Cognicert ISO 9001 Lead Auditor Certificate The certificate demonstrates successful completion of the Cognicert ISO 9001 Lead Auditor training and assessment requirements.

5 Days Training: 4 Days