ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques.
Why You Should Attend
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 the 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?
This training course is intended for auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits; managers or consultants seeking to master a Medical Devices Quality Management System audit process; individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements; technical experts seeking to prepare for a Medical Devices Quality Management System audit; and expert advisors in Medical Devices Quality Management.
Learning Objectives
Participants will understand the operations of a Medical Devices Quality Management System based on ISO 13485; acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks; understand an auditor’s role to plan, lead, and follow up on a management system audit in accordance with ISO 19011; learn how to lead an audit and audit team; learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit; and acquire the competencies of an auditor to plan an audit, lead an audit, draft reports, and follow up on an audit in compliance with ISO 19011.
Educational Approach
This training is based on both theory and best practices used in MDQMS audits. Lecture sessions are illustrated with examples based on case studies. Practical exercises are based on a case study which includes role playing and discussions. Practice tests are similar to the Certification Exam.
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles are required.
The course covers five days of content, with the certification exam on the fifth day, and carries 31 CPD credits. In the self-study format you cover the same material at your own pace.
Yes. The course fee includes the PECB certification and examination fees. If you do not pass, one complimentary retake is available within 12 months of your first attempt.
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles are required.
It is available as self-study (English). Choose the format and language before adding the course to your cart.
There is no scheduled live class for this course at the moment. Organizations that want a dedicated live session can contact us at [email protected].
PECB issues the certificate. After passing the exam you can apply for the “PECB Certified ISO 13485 Lead Auditor” credential. Horus Academy is a PECB Authorized Silver Partner and does not issue the certificate itself.
The “PECB Certified ISO 13485 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency domains:
Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
Domain 2: Medical Devices Quality Management System (MDQMS)
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
After successfully completing the exam, you can apply for the credentials shown on the table below. You will receive a certificate once you comply with all the requirements related to the selected credential.
The requirements for PECB Auditor Certifications are:
| 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.
To be considered valid, these audits should follow best audit practices and include the following activities:
Course agenda
Day 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
Day 2: Audit principles, preparation and launching of an audit
Day 3: On-site audit activities
Day 4: Closing the audit
Day 5: Certification Exam
