ISO 13485 Lead Auditor
Develop the expertise to plan, conduct and close ISO 13485 conformity assessment audits in this five-day PECB certification course. The course applies the requirements of ISO/IEC 17021-1 and the guidelines of ISO 19011 to medical device quality management system audits. Earn the internationally recognized PECB Certified ISO 13485 Lead Auditor credential.
CREDENTIAL
Awarded by PECB. PECB sets and marks the examination and awards the credential. Standards Academy delivers the training and administers the enrolment.
About This Course
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.
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
Course Agenda
Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
Audit principles, preparation and launching of an audit
On-site audit activities
Closing the audit
Certification Exam
Who Should Attend
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
On passing the exam, PECB awards the credential that corresponds to the candidate's professional experience:
| Credential | Experience required |
|---|---|
| PECB Certified ISO 13485 Provisional Auditor | No professional experience required |
| PECB Certified ISO 13485 Auditor | Two years of professional experience, including one year in medical devices quality management200 hours of audit activities |
| PECB Certified ISO 13485 Lead Auditor | Five years of professional experience, including two years in medical devices quality management300 hours of audit activities |
| PECB Certified ISO 13485 Senior Lead Auditor | Ten years of professional experience, including seven years in medical devices quality management1,000 hours of audit activities |
Every credential requires the candidate to sign the PECB Code of Ethics.
Frequently asked questions
Format and price
All taxes included · Includes PECB exam voucher
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Quick Facts
- Duration
- 5 days
- CPD Credits
- 31
- Language
- English
- Provider
- PECB
- Category
- Quality & Management
What's Included
- 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
- An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
- In case of exam failure, you can retake the exam within 12 months for free