PROGRAM DETAILS

Program Overview:

This intensive 5-day training program is designed to equip participants with the knowledge and skills required to perform and lead internal and external audits of quality management systems (QMS) in accordance with ISO 9001:2015 and ISO 19011:2018 guidelines. The course provides a comprehensive understanding of quality management principles, the structure and requirements of ISO 9001, and the essential competencies of a lead auditor. Through a combination of theoretical learning, case studies, role-playing, and practical auditing exercises, participants will develop the confidence to plan, conduct, report, and follow up on QMS audits.

This program also emphasizes risk-based thinking, continual improvement, customer focus, and the importance of aligning audit outcomes with organizational objectives. It is ideal for professionals seeking certification as lead auditors or aiming to lead quality initiatives in their organizations. Participants will be assessed through written and practical evaluations, and those who meet the criteria will be awarded a Lead Auditor certificate, qualifying them to lead ISO 9001 audits globally.

Learning Objectives:

By the end of this training, participants will be able to:

• Understand the structure and requirements of ISO 9001:2015.

• Interpret and apply ISO 19011:2018 audit guidelines.

• Plan, conduct, report, and follow up on QMS audits.

• Evaluate audit evidence and identify nonconformities.

• Lead an audit team with professionalism and objectivity.

• Communicate audit findings effectively to stakeholders.

• Promote continual improvement through audit outcomes.

Target Audience:

• Quality assurance and quality control professionals

• Internal auditors and compliance officers

• Management representatives and QMS consultants

• Professionals seeking ISO 9001 Lead Auditor certification

• Anyone responsible for implementing or maintaining a QMS

Training Methodology:

• Lectures & Presentations: Structured theoretical modules with visual aids

• Case Studies: Real-world scenarios and best practice analysis

• Group Exercises: Team-based activities and audit role plays

• Practical Auditing Sessions: Simulated audits and evidence review

• Assessments: Written tests and observed auditing performance

• Interactive Discussions: Peer learning and instructor feedback

Program Contents:

Day 1: Introduction to Quality Management & ISO 9001:2015

• Principles of quality management
• Structure and purpose of ISO 9001:2015
• Key terminology and definitions
• Process approach and PDCA cycle
• Context of the organization and leadership requirements

Day 2: ISO 9001 Requirements & Documentation

• Planning and support (Clause 6 & 7)
• Operational control and performance evaluation (Clause 8 & 9)
• Improvement (Clause 10)
• QMS documentation requirements
• Interpreting ISO 9001 clauses in real-life contexts

Day 3: Auditing Principles and ISO 19011 Guidelines

• Audit types and principles
• Auditor responsibilities and ethics
• ISO 19011:2018 auditing process
• Risk-based auditing approach
• Preparing audit plans and checklists

Day 4: Conducting and Managing the Audit Process

• Opening and closing meetings
• Conducting interviews and site walkthroughs
• Gathering and verifying audit evidence
• Identifying findings and nonconformities
• Writing objective and concise audit reports

Day 5: Lead Auditor Responsibilities & Final Evaluation

• Roles and responsibilities of a lead auditor
• Managing the audit process and audit team dynamics
• Auditor competence, behavior, and ethical considerations
• Reporting audit findings in line with ISO 19011
• Managing corrective action requests and follow-up procedures
• Preparing for certification and third-party audits