

During this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process.
Based on practical exercises, you will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution.
After acquiring the necessary expertise to perform this audit, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Auditor” credential. By holding a PECB Lead Auditor Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices.
Who should attend?
Learning Objectives
Educational approach
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
Day 4: Closing the audit
Day 5: Certification Exam
Domain 3: Fundamental audit concepts and principles
Domain 4: Preparation of an ISO 13485 audit
Domain 5: Conducting an ISO 13485 audit
Domain 6: Closing an ISO 13485 audit
Domain 7: Managing an ISO 13485 audit program
For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.
| Credential | Exam | Professional experience | MS audit/assessment experience | Other requirements |
| PECB Certified ISO 13485 Provisional Auditor | PECB Certified ISO 13483 Lead Auditor Exam or equivalent | None | None | Signing the PECB Code of Ethics |
| PECB Certified ISO 13485 Auditor | PECB Certified ISO 13483 Lead Auditor Exam or equivalent | Two years: One year of work experience in Medical Devices Quality Management | Audit activities: a total of 200 hours | Signing the PECB Code of Ethics |
| PECB Certified ISO 13485 Lead Auditor | PECB Certified ISO 13483 Lead Auditor Exam or equivalent | Five years: Two years of work experience in Medical Devices Quality Management | Audit activities: a total of 300 hours | Signing the PECB Code of Ethics |
| PECB Certified ISO 13485 Senior Lead Auditor | PECB Certified ISO 13483 Lead Auditor Exam or equivalent | Ten years: Seven years of work experience in Medical Devices Quality Management | Audit activities: a total of 1,000 hours | Signing the PECB Code of Ethics |
Note: PECB Certified Individuals who do possess the Lead Implementer and Lead Auditor Credentials are qualified for the respective PECB Master Credential, given they have taken 4 additional Foundation Exams which are related to this scheme. For more detailed information about the Foundation Exams and the overall Master Requirements, please go to the following link: https://pecb.com/en/master-credentials.
To be considered valid, these audits should follow best audit practices and include the following activities:
Audit planning
Audit interview
Managing an audit program
Drafting audit reports
Drafting non-conformity reports
Drafting audit working documents
Documentation review
On-site audit
Follow-up on non-conformities
Leading an audit team
During this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process.
Based on practical exercises, you will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution.
After acquiring the necessary expertise to perform this audit, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Auditor” credential. By holding a PECB Lead Auditor Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices.
Who should attend?
Learning Objectives
Educational approach
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
Day 4: Closing the audit
Day 5: Certification Exam
Domain 3: Fundamental audit concepts and principles
Domain 4: Preparation of an ISO 13485 audit
Domain 5: Conducting an ISO 13485 audit
Domain 6: Closing an ISO 13485 audit
Domain 7: Managing an ISO 13485 audit program
For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.
| Credential | Exam | Professional experience | MS audit/assessment experience | Other requirements |
| PECB Certified ISO 13485 Provisional Auditor | PECB Certified ISO 13483 Lead Auditor Exam or equivalent | None | None | Signing the PECB Code of Ethics |
| PECB Certified ISO 13485 Auditor | PECB Certified ISO 13483 Lead Auditor Exam or equivalent | Two years: One year of work experience in Medical Devices Quality Management | Audit activities: a total of 200 hours | Signing the PECB Code of Ethics |
| PECB Certified ISO 13485 Lead Auditor | PECB Certified ISO 13483 Lead Auditor Exam or equivalent | Five years: Two years of work experience in Medical Devices Quality Management | Audit activities: a total of 300 hours | Signing the PECB Code of Ethics |
| PECB Certified ISO 13485 Senior Lead Auditor | PECB Certified ISO 13483 Lead Auditor Exam or equivalent | Ten years: Seven years of work experience in Medical Devices Quality Management | Audit activities: a total of 1,000 hours | Signing the PECB Code of Ethics |
Note: PECB Certified Individuals who do possess the Lead Implementer and Lead Auditor Credentials are qualified for the respective PECB Master Credential, given they have taken 4 additional Foundation Exams which are related to this scheme. For more detailed information about the Foundation Exams and the overall Master Requirements, please go to the following link: https://pecb.com/en/master-credentials.
To be considered valid, these audits should follow best audit practices and include the following activities:
Audit planning
Audit interview
Managing an audit program
Drafting audit reports
Drafting non-conformity reports
Drafting audit working documents
Documentation review
On-site audit
Follow-up on non-conformities
Leading an audit team

| Credential | Exam | Professional experience | MS audit/assessment experience | Other requirements |
| PECB Certified Management Systems Provisional Internal Auditor | PECB Certified Management Systems Internal Auditor exam | None | None | Signing the PECB Code of Ethics |
| PECB Certified Management Systems Internal Auditor | PECB Certified Management Systems Internal Auditor exam | Two years of general work experience; At least one year in the implementation, operation and/or auditing of management systems | At least 200 hours | Signing the PECB Code of Ethics |
| Credential | Exam | Professional experience | MS audit/assessment experience | Other requirements |
| PECB Certified Management Systems Provisional Internal Auditor | PECB Certified Management Systems Internal Auditor exam | None | None | Signing the PECB Code of Ethics |
| PECB Certified Management Systems Internal Auditor | PECB Certified Management Systems Internal Auditor exam | Two years of general work experience; At least one year in the implementation, operation and/or auditing of management systems | At least 200 hours | Signing the PECB Code of Ethics |

| Credential | Exam | Professional experience | EnMMS project experience | Other requirements |
| PECB Certified ISO 50001 Provisional Implementer | PECB Certified ISO 50001 Lead Implementer Exam or equivalent | None | None | Signing the PECB Code of Ethics |
| PECB Certified ISO 50001 Implementer | PECB Certified ISO 50001 Lead Implementer Exam or equivalent | Two years: One year of work experience in Energy Management | Project activities: a total of 200 hours | Signing the PECB Code of Ethics |
| PECB Certified ISO 50001 Lead Implementer | PECB Certified ISO 50001 Lead Implementer Exam or equivalent | Five years: Two years of work experience in Energy Management | Project activities: a total of 300 hours | Signing the PECB Code of Ethics |
| PECB Certified ISO 50001 Senior Lead Implementer | PECB Certified ISO 50001 Lead Implementer Exam or equivalent | Ten years: Seven years of work experience in Energy Management | Project activities: a total of 1,000 hours | Signing the PECB Code of Ethics |
| Credential | Exam | Professional experience | EnMMS project experience | Other requirements |
| PECB Certified ISO 50001 Provisional Implementer | PECB Certified ISO 50001 Lead Implementer Exam or equivalent | None | None | Signing the PECB Code of Ethics |
| PECB Certified ISO 50001 Implementer | PECB Certified ISO 50001 Lead Implementer Exam or equivalent | Two years: One year of work experience in Energy Management | Project activities: a total of 200 hours | Signing the PECB Code of Ethics |
| PECB Certified ISO 50001 Lead Implementer | PECB Certified ISO 50001 Lead Implementer Exam or equivalent | Five years: Two years of work experience in Energy Management | Project activities: a total of 300 hours | Signing the PECB Code of Ethics |
| PECB Certified ISO 50001 Senior Lead Implementer | PECB Certified ISO 50001 Lead Implementer Exam or equivalent | Ten years: Seven years of work experience in Energy Management | Project activities: a total of 1,000 hours | Signing the PECB Code of Ethics |

| Designation | Exam | Professional experience | MS audit/assessment experience | EnMMS project experience | Other requirements |
| PECB Certificate Holder in ISO 50001 Foundation | Pass the PECB ISO 50001 Foundation Exam | None | None | None | Signing the PECB Code of Ethics |
| Designation | Exam | Professional experience | MS audit/assessment experience | EnMMS project experience | Other requirements |
| PECB Certificate Holder in ISO 50001 Foundation | Pass the PECB ISO 50001 Foundation Exam | None | None | None | Signing the PECB Code of Ethics |

| Credential | Exam | Professional experience | SOMMS project experience | Other requirements |
| PECB Certified ISO 18788 Provisional Implementer | PECB Certified ISO 18788 Lead Implementer Exam or equivalent | None | None | Signing the PECB Code of Ethics |
| PECB Certified ISO 18788 Implementer | PECB Certified ISO 18788 Lead Implementer Exam or equivalent | Two years: One year of work experience in Security Operations Management | Project activities: a total of 200 hours | Signing the PECB Code of Ethics |
| PECB Certified ISO 18788 Lead Implementer | PECB Certified ISO 18788 Lead Implementer Exam or equivalent | Five years: Two years of work experience in Security Operations Management | Project activities: a total of 300 hours | Signing the PECB Code of Ethics |
| PECB Certified ISO 18788 Senior Lead Implementer | PECB Certified ISO 18788 Lead Implementer Exam or equivalent | Ten years: Seven years of work experience in Security Operations Management | Project activities: a total of 1,000 hours | Signing the PECB Code of Ethics |
| Credential | Exam | Professional experience | SOMMS project experience | Other requirements |
| PECB Certified ISO 18788 Provisional Implementer | PECB Certified ISO 18788 Lead Implementer Exam or equivalent | None | None | Signing the PECB Code of Ethics |
| PECB Certified ISO 18788 Implementer | PECB Certified ISO 18788 Lead Implementer Exam or equivalent | Two years: One year of work experience in Security Operations Management | Project activities: a total of 200 hours | Signing the PECB Code of Ethics |
| PECB Certified ISO 18788 Lead Implementer | PECB Certified ISO 18788 Lead Implementer Exam or equivalent | Five years: Two years of work experience in Security Operations Management | Project activities: a total of 300 hours | Signing the PECB Code of Ethics |
| PECB Certified ISO 18788 Senior Lead Implementer | PECB Certified ISO 18788 Lead Implementer Exam or equivalent | Ten years: Seven years of work experience in Security Operations Management | Project activities: a total of 1,000 hours | Signing the PECB Code of Ethics |