Lead Auditor ISO 9001 – QMS

About ISO 9001:

The ISO 9001 Quality Management System Auditor course aims to qualify participants to understand the system standards and implement internal audit processes that support quality and continuous improvement of the organization according to this standard. The course includes the following topics:

1. Understanding the Standard Requirements:

This section aims to provide a comprehensive understanding of the standards to be audited:

• Define the scope and importance of the standard within the context of a quality management system.
• Detailed explanation of the standard’s requirements (e.g., context, leadership, planning, support, operation, performance evaluation, and improvement).
• The structure and objectives of the standard.
• Identify risks and opportunities and the actions required to address them.
• Control processes, preparation, and response to emergencies.
• The high-level structure (HLS) of all management system specifications and how to apply them.
• Understand risk-based thinking and processes.
• Focus on leadership requirements, QMS planning, process support, and performance evaluation.
• The seven quality management principles (QMPs): Analyze how quality principles relate to the standard’s requirements and apply them in auditing.
• Regulatory and legislative references: Understand the importance of identifying applicable laws and regulations related to an organization’s products and services and auditing compliance with them.

2. Implementing a Quality Management System:

• Identifying internal and external issues, stakeholders, their requirements, and the scope of the quality management system.
• Adhering to the quality policy and defining the roles and responsibilities of senior management.
• Managing risks and opportunities (risk-based thinking) and their impact on action plans.
• Setting objectives and programs for achieving them.
• Planning and controlling resource operations, competencies, awareness, communication, and document control.
• Monitoring, measurement, analysis, evaluation, and management review.
• Nonconformities, corrective actions, and continuous improvement.

3. Audit Principles and Guidelines

This section focuses on the methodological foundations of the audit process:

• Audit principles according to the International Standard (19011) Guidelines for Auditing Management Systems.
• The role and responsibilities of the internal auditor according to the standard.
• The competencies and personal characteristics required for the auditor.
• Auditing the Quality management system
• Assessing and analyzing threats and risks and selecting audit processes.

4. Auditor Competency and Requirements:

• Preparing the annual audit program for the quality management system.
• Determining the scope and objectives of the audit.
• Preparing checklists.
• Evaluating and analyzing threats and risks and selecting audit engagements.
• Define and define the objectives of the lead auditor.
• Types of audits (system, process, compliance).
• The seven principles of auditing according to ISO 19011.
• Auditor roles and responsibilities.
• Audit ethics (neutrality, objectivity, confidentiality).
• Qualities of a successful auditor.
• Ethical behavior during the audit.
• Managing opening and closing meetings.
• Dealing with difficult cases during the audit.

5. Case Studies and Practical Exercises:

• Analyzing Real Scenarios.
• Simulating Audits.
• Discussing Potential Nonconformities.

6. Preparing for the Final Exam

• Comprehensive Review of the Material.
• Sample Questions.
• Exam Passing Strategies.