Published initially in 1987, ISO 9001 is the first international management system standard (MSS) that specifies the requirements for the establishment, implementation, operation, maintenance, and continual improvement of a quality management system (QMS) in an organization.
ISO 9001 is based on seven quality management principles and it aims to help organizations be more efficient and improve customer satisfaction. A common misconception is that ISO 9001 is intended for larger companies and manufacturers. However, the requirements of ISO 9001 are generic and applicable to any organization, regardless of its type, size, or the products or services it provides.
By the end of this training course, the participant will be able to:
- Explain the fundamental concepts and principles of a quality management system (QMS) based on ISO 9001
- Interpret the ISO 9001 requirements for a QMS from the perspective of an auditor
- Evaluate the QMS conformity to ISO 9001 requirements, in accordance with the fundamental audit concepts and principles
- Plan, conduct, and close an ISO 9001 compliance audit, in accordance with ISO/IEC 17021-1 requirements, ISO 19011 guidelines, and other best practices of auditing
- Manage an ISO 9001 audit program
Why should you attend?
The PECB ISO 9001 Lead Auditor training course enables you to develop the necessary competence to perform quality management system (QMS) audits by applying widely recognized audit principles, procedures, and techniques. This training course combines the requirements of ISO/IEC 17021-1, the recommendations of ISO 19011, and other good practices of auditing and integrates them into a comprehensive methodology which enables you to successfully plan, conduct, and close ISO 9001 conformity assessment audits.
Apart from a theoretical basis, the training course also provides examples, exercises, and quizzes to help you practice the most important aspects of conformity assessment audits: interpretation of ISO 9001 requirements in the context of an audit, principles of auditing, application of audit methods, approaches to evidence collection and verification, leading an audit team, drafting nonconformity reports, and preparing the final audit report.
The successful completion of the training course is followed by an exam. If you successfully pass the exam, you can apply for the “PECB Certified ISO 9001 Lead Auditor” credential. An UKAS accredited and internationally recognized “PECB ISO 9001 Lead Auditor” certificate validates your professional capabilities and demonstrates that you have the knowledge and skills to audit a QMS based on ISO 9001.
Who should attend?
The ISO 9001 Lead Auditor training course is intended for:
- Auditors seeking to perform and lead QMS audits in 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
This training course is participant centered and contains:
- Theories, approaches, and best practices used in ISO management system audits
- Lecture sessions illustrated with examples based on case studies
- Practical exercises based on a case study
- Interaction between participants by means of questions and suggestions
- Stand-alone and scenario-based quizzes, tailored to prepare the participants for the certification exam
The main requirements for participating in this training course are a fundamental understanding of ISO 9001 requirements for a QMS and a comprehensive knowledge of audit principles
Training course structure
Introduction to Quality Management Systems (QMS) and ISO 9001
- Course objectives and structure
- Standards and regulatory frameworks
- Certification process
- Fundamental concepts and principles of quality management
- Quality Management System (QMS)
Audit principles, preparation and launching of an audit
- Fundamental audit concepts and principles
- Audit approach based on evidence and risk
- Initiating the audit
- Stage 1 audit
- Preparing the stage 2 audit (on-site audit)
On-site audit activities
- Stage 2 audit
- Communication during the audit
- Audit procedures
- Creating audit test plans
- Drafting audit findings and nonconformity reports
Closing the audit
- Audit documentation and quality review
- Closing the audit
- Evaluation of action plans by the auditor
- Beyond the initial audit
- Managing an internal audit program
- Competence, evaluation and closing the training
- Exam Duration : 3 hours
The “PECB Certified ISO 9001 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Program (ECP). It covers the following competency domains:
- Domain 1: Fundamental principles and concepts of a quality management system
- Domain 2: Quality management system (QMS) requirements
- Domain 3: Fundamental audit concepts and principles
- Domain 4: Preparing an ISO 9001 audit
- Domain 5: Conducting an ISO 9001 audit
- Domain 6: Closing an ISO 9001 audit
- Domain 7: Managing an ISO 9001 audit program
After successfully completing the exam, you can apply for one of the credentials shown on the table below. You will receive a certificate once you comply with all the requirements related to the selected credential.
For more information about the ISO 9001 certifications and the PECB certification process, please refer to the Certification Rules and Policies.
The requirements for PECB ISO 9001 Auditor certifications are as shown in the table below:
Note: PECB certified individuals who possess both the Lead Implementer and Lead Auditor credentials are qualified for the respective PECB Master Credential, given they have taken 4 additional Foundation Exams related to this scheme. For more information about the Foundation Exams and the overall Master Requirements, please go to PECB Master Credentials.
To be considered valid, the audit activities should follow best audit practices and include the following:
- Planning an audit
- Managing an audit program
- Drafting audit reports
- Drafting nonconformity reports
- Drafting audit work documents
- Reviewing documented information
- Conducting on-site audit
- Following up on nonconformities
- Leading an audit team
Benefits of ISO 9001 for organizations