• Understand ISO, QMS fundamentals, and ISO 9001:2015 requirements.
• Apply the process approach and PDCA cycle in auditing.
• Plan, conduct, and manage internal and external audits.
• Lead audit teams and manage audit programs effectively.
• Prepare audit reports, identify findings, and verify corrective actions.
• Apply risk‑based thinking and evaluate QMS performance.
• Demonstrate the competencies required of a certified Lead Auditor.

Day 1 – ISO Foundations & QMS Fundamentals

Module 1: Definition and Fundamentals

• International Organisation for Standardisation (ISO)
• Introduction to ISO 9001
• Basic terminology of QMS
• Principles of Quality Management
• ISO 9001 family of standards and versions
• ISO 19011:2018 overview
• Fundamentals of ISO 9001:2015

Module 2: Structure of ISO 9001:2015

• ISO 9001:2015 clauses and structure
• Process approach
• PDCA cycle
• Standards aligned with PDCA
• Scope and limitations of ISO 9001
• Benefits of ISO 9001

Day 2 – Internal Audit Structure & Auditor Competence

Module 3: Internal Audit Structure

• Auditing types, procedures, and planning
• Auditing techniques
• Phases of an audit
• Assessment of audit reports and documents

Module 4: Internal Auditor

• Roles of an internal auditor
• Responsibilities and ethical behavior
• Leadership skills for auditors
• Communication and interviewing skills

Day 3 – Audit Programme, Reporting & QMS Procedures

Module 5: Audit Programme

• Developing an audit programme
• Process audit checklist
• Scheduling and resource planning

Module 6: Audit Report

• Audit report structure and content
• Audit findings and classifications
• Follow‑up and corrective action verification

Module 7: QMS Procedures (ISO 9001:2015)

• Procedures related to ISO 9001:2015
• Scope of the QMS
• QMS objectives and policies
• Documentation and control requirements

Day 4 – QMS Operation, Risk Management & Quality Team Roles

Module 8: Operating a QMS Efficiently

• Challenges during QMS implementation
• Methods for effective QMS operation
• Implementation process and best practices

Module 9: Risk Management

• Risk and opportunity concepts
• Risk‑based thinking
• Conducting risk assessments
• Risk assessment methodology
• Risk register development and implementation

Module 10: Roles & Responsibilities of Lead Implementer & Quality Team

• Responsibilities of a Lead Implementer
• Maintaining QMS structure
• Corrective actions and records
• Sequential operation process
• Monitoring and measuring processes
• Error control and prevention

Day 5 – Lead Auditor Skills, Audit Activities & Evidence Collection

Module 11: Lead Auditor Training

• Roles and responsibilities of a Lead Auditor
• Team selection and planning
• Lead Auditor requirements, scope, and procedures
• Design and development considerations
• Tips for effective Lead Auditors
• Report preparation, findings, reconciliation, conclusions

Module 12: Audit Activities & Techniques

• Opening meeting procedures
• Daily discussion meetings
• Closing meeting structure
• Presentation of audit reports
• Non‑conformance reporting
• Audit tools and techniques

Module 13: Methods of Collecting Information

• Visual observation
• Examination of records
• Employee interviews
• Evidence validation and documentation

• Quality Managers and QMS Supervisors
• Internal Auditors and Audit Program Coordinators
• ISO 9001 Implementation Teams
• Consultants and Quality Professionals
• Individuals seeking Lead Auditor certification
• Anyone responsible for maintaining or improving a QMS