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ISO 13485 Lead Auditor Brochure
Learning Objectives
- 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
- 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
Why should you attend?
ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System audit by applying widely recognized audit principles, procedures and techniques. During this training course, you will acquire the necessary knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and the certification process according to ISO/IEC 17021-1.
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?
- Auditors seeking to perform and lead MDQMS certification audits
- Managers or consultants seeking to master a MDQMS audit process
- Individuals responsible for maintaining conformance with MDQMS requirements
- Technical experts seeking to prepare for a MDQMS audit
- Expert advisors in Medical Devices Quality Management
Course Overview
The “PECB Certified ISO 13485 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Program. The exam covers the following competency domains:
- Fundamental principles and concepts of a MDQMS
- Fundamental audit concepts and principles
- Preparation of an ISO 13485 audit
- Conducting an ISO 13485 audit
- Closing an ISO 13485 audit
- Managing an ISO 13485 audit program
This course is expected to take an estimated 5 days, including examination day, to complete.
For more information about exam details, please visit Examination Rules and Policies.
Certification
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.
For more information about ISO 13485 certifications and the PECB certification process, please refer to the
Certification Rules and Policies.
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.
General Information
- Certification and examination fees are included in the price of the training course
- Training material containing over 450 pages of information and practical examples will be distributed
- A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued
- In case of exam failure, you can retake the exam within 12 months for free
