ISO 9001 Lead Auditor Course

• Educational Background: No formal prerequisites are required; however, prior knowledge of ISO 9001 standards or QMS is recommended. 

• Professional Experience: Experience in quality management, auditing, or compliance roles is beneficial for understanding the course content. 

• Language Proficiency: A good command of English is essential, as all course materials and assessments are conducted in English. 

• Master ISO 9001 Standards: Gain a comprehensive understanding of ISO 9001 requirements and principles. 

• Conduct Effective QMS Audits: Develop the skills to plan, execute, and manage quality audits. 

• Enhance Auditing Techniques: Learn advanced methods, including interviewing and evidence verification. 

• Ensure Compliance and Improvement: Gain expertise in identifying non-conformities and implementing corrective actions. 

The ISO 9001 Lead Auditor Course is tailored for professionals responsible for auditing Quality Management Systems (QMS). It provides advanced knowledge of ISO 9001 standards and equips learners with the tools to lead effective and compliant audit processes. Below are the individuals who will benefit from this course:

• Quality Managers
• Internal Auditors
• Compliance Officers
• Risk Management Professionals
• Consultants specialising in QMS
• Third-Party Auditors
• Operations Managers 

Module 1: Definition and Fundamentals

• International Organisation for Standardisation (ISO)
• Introduction to ISO 9001
• Basic Terminology of Quality Management System (QMS)
• Principles of Quality Management System (QMS)
• ISO 9001 Family of Standards and Versions
• ISO 19011:2018
• Fundamentals of ISO 9001:2015

Module 2: Structure

• ISO 9001:2015 and its Clauses     
• Process Approach
• PDCA Cycle
• Layout Standards that Follow the PDCA
• Scope and Limitations
• Limitations of ISO 9001
• Benefits of ISO 9001

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
• Responsibilities
• Leadership Skills

Module 5: Audit Programme

• Audit Programme
• Process Audit Checklist

Module 6: Audit Report

• Audit Reports
• Audit Findings
• Follow-Ups

Module 7: Procedures

• Procedures in Reference to the 9001:2015
• Scope of QMS
• Objectives of a QMS
• Policies of a QMS

Module 8: Methods to Operate a QMS Efficiently

• Challenges Faced During Implementation
• Methods to Operate a QMS Efficiently
• Implementation Process

Module 9: Risk Management

• Risk and Opportunity
• Risk-Based Thinking
• Conducting Risk Assessments
• Risk Assessment Methodology
• Risk Assessment Implementation
• Risk Register

Module 10: Roles and Responsibilities of a Lead Implementer and Quality Team

• Roles and Responsibilities of a Lead Implementer and Quality Team
• How to Maintain QMS Structure?
• Corrective Actions
• Records
• Sequential Operation Process
• Measurement and Monitoring of Processes
• Controlling of Errors

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
• Tips for Lead Auditors
• Report Preparation, Findings, Reconciliation, and Conclusions

Module 12: Audit Activities and Techniques

• Opening Meetings
• Daily Discussion Meetings
• Closing Meeting
• Presentation of Reports
• Non-Conformance Report
• Tools and Techniques

Module 13: Methods of Collecting Information

• Visual Observation
• Examination of Records
• Employee Interviews

Module 14: Certification

• Certification Process for Organisations
• Selecting an ISO 9001 Registrar
• Steps to Certification
• Prepare for the Certification Audits
• Stage 1 Audit
• Stage 2 Audit
• Re-Certification Audit