Certified ISO 9001 Lead Auditor

This course provides comprehensive training for performing quality management system (QMS) audits using recognised audit principles, procedures, and techniques. It covers the requirements of ISO/IEC 17021-1, recommendations of ISO 19011, and best practices for auditing. Delegates gain practical skills in planning, conducting, and closing ISO 9001 conformity assessment audits, including interpreting requirements, collecting evidence, leading audit teams, and preparing audit reports. The course includes examples, exercises, and quizzes to reinforce learning and prepare participants for certification.

Prerequisites

A fundamental understanding of ISO 9001 requirements for a QMS and a comprehensive knowledge of audit principles.

Target audience

• Auditors seeking to perform and lead QMS audits on behalf of certification bodies
• Professionals wishing to adopt PECB’s AMS2 Methodology for conducting audits
• Individuals responsible for maintaining conformity to the requirements of ISO 9001
• Technical experts seeking to prepare for a QMS audit
• Professionals wanting to pursue a career in conformity assessment

Delegates will learn how to:

• Explain the fundamental concepts and principles of a quality management system based on ISO 9001
• Interpret ISO 9001 requirements for a QMS from the perspective of an auditor
• Evaluate QMS conformity to ISO 9001 requirements, in accordance with audit concepts and principles
• Plan, conduct, and close an ISO 9001 compliance audit, following ISO/IEC 17021-1 requirements, ISO 19011 guidelines, and best practices
• Manage an ISO 9001 audit programme

Introduction to quality management systems and ISO 9001

• Introduction to quality management
• Purpose and benefits of a QMS
• Quality management principles
• Process approach
• Risk-based thinking
• PDCA cycle
• Relationship between organisational objectives and the QMS
• Role of leadership in quality management
• Continual improvement

Understanding ISO 9001

• Structure and purpose of ISO 9001
• Context of the organisation
• Interested parties
• Scope of the QMS
• Leadership and commitment
• Quality policy
• Roles, responsibilities, and authorities
• Planning and quality objectives
• Risks and opportunities
• Support and resources
• Competence and awareness
• Documented information

ISO 9001 requirements — auditor perspective

• Operational planning and control
• Customer requirements
• Design and development
• Control of externally provided processes
• Production and service provision
• Release of products and services
• Nonconforming outputs
• Performance evaluation
• Monitoring and measurement
• Internal audit
• Management review
• Corrective action
• Continual improvement

Fundamental audit concepts and principles

• Purpose of management system auditing
• Audit principles
• Integrity and professional conduct
• Fair presentation
• Due professional care
• Confidentiality
• Independence
• Evidence-based approach
• Risk-based approach
• Auditor competence
• Objectivity and impartiality

Audit programme management

• Establishing an audit programme
• Audit objectives
• Audit scope and criteria
• Audit frequency
• Audit resources
• Auditor competence
• Audit team selection
• Managing audit risks
• Monitoring and reviewing the audit programme

Preparing an ISO 9001 audit

• Initial contact with the auditee
• Determining audit objectives
• Defining audit scope
• Determining audit criteria
• Reviewing documented information
• Developing the audit plan
• Allocating responsibilities
• Preparing working documents
• Preparing checklists and audit trails
• Logistics and communication arrangements

Initiating the audit

• Opening meeting
• Confirming audit objectives, scope, and criteria
• Introducing the audit team
• Establishing communication channels
• Confirming access to people and information
• Confirming audit arrangements
• Handling changes to the audit plan

Conducting an ISO 9001 audit

• Evidence-based auditing
• Audit trails
• Sampling
• Interviews
• Observation
• Document and record review
• Process evaluation
• Verification of information
• Following objective evidence
• Maintaining audit notes
• Time management during an audit

Interviewing and communication

• Effective auditor questioning
• Open and closed questions
• Follow-up questions
• Active listening
• Interview techniques
• Dealing with difficult situations
• Maintaining auditor objectivity
• Communication with process owners
• Managing disagreements

Evaluating audit evidence

• Objective evidence
• Sufficiency and appropriateness of evidence
• Verification and corroboration
• Sampling
• Comparing evidence against audit criteria
• Determining conformity
• Identifying potential nonconformities
• Distinguishing observations from nonconformities

Audit findings and nonconformities

• Classification of findings
• Major and minor nonconformities
• Writing clear findings
• Linking findings to audit criteria
• Recording objective evidence
• Avoiding subjective statements
• Root cause considerations
• Corrective action expectations

Completing the audit

• Reviewing audit evidence
• Consolidating findings
• Evaluating audit conclusions
• Reviewing audit objectives and scope
• Preparing audit conclusions
• Preparing for the closing meeting

Closing meeting

• Purpose of the closing meeting
• Presenting audit findings
• Explaining nonconformities
• Presenting audit conclusions
• Handling disagreements
• Agreeing follow-up arrangements
• Maintaining professional communication

Audit reporting

• Structure of an audit report
• Audit objectives and scope
• Audit criteria
• Audit team
• Summary of audit activities
• Positive findings
• Nonconformities
• Audit conclusions
• Opportunities for improvement, where applicable
• Distribution and control of the audit report

Follow-up activities

• Corrective action review
• Verification of corrections
• Verification of corrective action
• Follow-up audits
• Closure of nonconformities
• Maintaining audit records

Leading an audit team

• Role of the lead auditor
• Team coordination
• Allocation of audit responsibilities
• Monitoring audit progress
• Managing audit time
• Resolving team issues
• Maintaining consistency between auditors
• Communicating with the auditee's management

Managing an ISO 9001 audit programme

• Audit programme objectives
• Planning multiple audits
• Auditor competence
• Resource management
• Programme monitoring
• Audit programme evaluation
• Continual improvement of the audit programme

Exams and assessments

The course includes the “PECB Certified ISO 9001 Lead Auditor” exam, which covers competency domains related to quality management systems and ISO 9001.

Hands-on learning

The course features practical exercises, case studies, and quizzes. Participants engage in simulated audits, evidence collection, drafting reports, and audit planning to reinforce skills and prepare for real-world audit scenarios.