Certified ISO 9001 Lead Auditor Training in Denmark

What Can You Achieve with This Training?

• Learn to plan and conduct ISO 9001 Quality Management System (QMS) audits using internationally recognised audit principles and methods.

• Develop auditing competencies aligned with ISO 19011 guidelines and ISO/IEC 17021-1 requirements.

• Apply audit evidence collection, interviewing, sampling, and process evaluation techniques.

• Strengthen your ability to identify nonconformities, document audit findings, and follow up corrective actions.

• Learn to coordinate audit teams, allocate responsibilities, and complete audits effectively as a Lead Auditor.

• Build the knowledge needed to manage ISO 9001 audit programmes and prepare for the PECB Certified ISO 9001 Lead Auditor certification process.

The Certified ISO 9001 Lead Auditor Training provides comprehensive knowledge and practical skills for planning, conducting, and completing audits that assess conformity with ISO 9001 Quality Management System (QMS) requirements.

The programme focuses on established management system auditing principles, procedures, and techniques. Participants examine ISO/IEC 17021-1 requirements, ISO 19011 guidelines, and recognised auditing best practices to understand how ISO 9001 conformity assessment audits are performed.

The course begins with the fundamentals of quality management, the structure of ISO 9001, and the interpretation of QMS requirements from an auditor's perspective. It then addresses audit programme management, audit objectives, scope and criteria, audit planning, and audit team selection.

Practical modules cover collecting objective audit evidence, interviewing, sampling, reviewing documents and records, evaluating processes, and classifying nonconformities.

Participants also explore opening and closing meetings, audit report preparation, verification of corrective actions, and follow-up audits.

The final modules focus on the responsibilities of a lead auditor, coordination of audit teams, and management of audit programmes involving multiple audits.

Throughout the course, examples, exercises, and quizzes help reinforce the concepts and support preparation for the certification examination.

Exams and Certification

The course includes the PECB Certified ISO 9001 Lead Auditor examination.

The examination covers competency domains related to ISO 9001 Quality Management Systems and auditing.

The examples, practical exercises, and quizzes included in the course support examination preparation.

Candidates who pass the examination may apply for the PECB Certified ISO 9001 Lead Auditor credential, subject to meeting the applicable certification requirements.

Participants should have:

• A fundamental understanding of ISO 9001 Quality Management System requirements

• Comprehensive knowledge of auditing principles

This course is designed for professionals who want to conduct or lead ISO 9001 QMS audits or develop a career in conformity assessment.

It is particularly suitable for:

• Auditors seeking to conduct and lead QMS audits on behalf of certification bodies

• Professionals interested in using PECB's AMS2 Methodology for auditing

• Individuals responsible for maintaining conformity with ISO 9001 requirements

• Technical experts preparing for a QMS audit

• Professionals pursuing a career in conformity assessment

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

• Explain the fundamental concepts and principles of an ISO 9001-based Quality Management System.

• Interpret ISO 9001 requirements from an auditor's perspective.

• Evaluate QMS conformity with ISO 9001 using established audit concepts and principles.

• Plan, conduct, and close ISO 9001 conformity audits in line with ISO/IEC 17021-1, ISO 19011, and recognised auditing practices.

• Define audit programme objectives, scope, criteria, and resources.

• Prepare audit plans, checklists, and working documents.

• Conduct professional opening and closing meetings.

• Collect objective evidence through interviews, observation, sampling, and document review.

• Compare audit evidence against ISO 9001 requirements to determine conformity.

• Identify, classify, and document major and minor nonconformities.

• Prepare audit reports and communicate findings to relevant stakeholders.

• Verify corrections and corrective actions and support follow-up audits.

• Coordinate audit teams and fulfil the responsibilities of a Lead Auditor.

• Plan, monitor, evaluate, and continually improve ISO 9001 audit programmes.

1. Introduction to Quality Management Systems and ISO 9001

• Introducing quality management

• Understanding the purpose and benefits of a QMS

• Reviewing quality management principles

• Exploring the process approach

• Understanding risk-based thinking

• Examining the Plan-Do-Check-Act (PDCA) cycle

• Relating organisational objectives to the QMS

• Understanding the role of leadership in quality management

• Introducing continual improvement

2. Understanding ISO 9001

• Reviewing the structure and purpose of ISO 9001

• Examining the context of the organisation

• Identifying interested parties

• Defining the scope of the QMS

• Understanding leadership and commitment

• Reviewing the quality policy

• Establishing roles, responsibilities, and authorities

• Examining planning and quality objectives

• Assessing risks and opportunities

• Reviewing support and resources

• Understanding competence and awareness

• Managing documented information

3. ISO 9001 Requirements — Auditor Perspective

• Evaluating operational planning and control

• Reviewing customer requirements

• Assessing design and development

• Examining the control of externally provided processes

• Reviewing production and service provision

• Evaluating the release of products and services

• Assessing nonconforming outputs

• Reviewing performance evaluation

• Examining monitoring and measurement

• Evaluating internal audits

• Reviewing management review

• Assessing corrective action

• Examining continual improvement

4. Fundamental Audit Concepts and Principles

• Understanding the purpose of management system auditing

• Reviewing fundamental audit principles

• Applying integrity and professional conduct

• Understanding fair presentation

• Demonstrating due professional care

• Maintaining confidentiality

• Ensuring independence

• Applying an evidence-based approach

• Using a risk-based approach

• Evaluating auditor competence

• Maintaining objectivity and impartiality

5. Audit Programme Management

• Establishing an audit programme

• Defining audit objectives

• Determining audit scope and criteria

• Planning audit frequency

• Identifying audit resources

• Evaluating auditor competence

• Selecting the audit team

• Managing audit risks

• Monitoring and reviewing the audit programme

6. Preparing an ISO 9001 Audit

• Establishing initial contact with the auditee

• Determining audit objectives

• Defining the audit scope

• Establishing audit criteria

• Reviewing documented information

• Developing the audit plan

• Allocating audit responsibilities

• Preparing working documents

• Creating checklists and audit trails

• Arranging logistics and communication

7. Initiating the Audit

• Conducting the opening meeting

• Confirming audit objectives, scope, and criteria

• Introducing the audit team

• Establishing communication channels

• Confirming access to people and information

• Verifying audit arrangements

• Managing changes to the audit plan

8. Conducting an ISO 9001 Audit

• Applying evidence-based auditing

• Following audit trails

• Using sampling techniques

• Conducting interviews

• Applying observation techniques

• Reviewing documents and records

• Evaluating processes

• Verifying information

• Following objective evidence

• Maintaining audit notes

• Managing audit time

9. Interviewing and Communication

• Developing effective auditor questions

• Using open and closed questions

• Asking follow-up questions

• Practising active listening

• Applying interview techniques

• Managing difficult situations

• Maintaining auditor objectivity

• Communicating with process owners

• Managing disagreements

10. Evaluating Audit Evidence

• Understanding objective evidence

• Assessing the sufficiency and appropriateness of evidence

• Applying verification and corroboration

• Using sampling

• Comparing evidence against audit criteria

• Determining conformity

• Identifying potential nonconformities

• Distinguishing observations from nonconformities

11. Audit Findings and Nonconformities

• Classifying audit findings

• Distinguishing major and minor nonconformities

• Writing clear audit findings

• Linking findings to audit criteria

• Recording objective evidence

• Avoiding subjective statements

• Considering root causes

• Establishing corrective action expectations

12. Completing the Audit

• Reviewing audit evidence

• Consolidating findings

• Evaluating audit conclusions

• Reviewing audit objectives and scope

• Preparing audit conclusions

• Preparing for the closing meeting

13. Closing Meeting

• Understanding the purpose of the closing meeting

• Presenting audit findings

• Explaining nonconformities

• Communicating audit conclusions

• Handling disagreements

• Agreeing follow-up arrangements

• Maintaining professional communication

14. Audit Reporting

• Understanding the structure of an audit report

• Documenting audit objectives and scope

• Recording audit criteria

• Identifying the audit team

• Summarising audit activities

• Documenting positive findings

• Reporting nonconformities

• Presenting audit conclusions

• Including opportunities for improvement, where applicable

• Managing audit report distribution and control

15. Follow-Up Activities

• Reviewing corrective actions

• Verifying corrections

• Verifying corrective actions

• Conducting follow-up audits

• Confirming the closure of nonconformities

• Maintaining audit records

16. Leading an Audit Team

• Understanding the role of the Lead Auditor

• Coordinating the audit team

• Allocating audit responsibilities

• Monitoring audit progress

• Managing audit time

• Resolving team issues

• Maintaining consistency between auditors

• Communicating with the auditee's management

17. Managing an ISO 9001 Audit Programme

• Establishing audit programme objectives

• Planning multiple audits

• Managing auditor competence

• Coordinating resources

• Monitoring the programme

• Evaluating audit programme performance

• Applying continual improvement to the audit programme