Live instructor-led training
ISO 13485 Lead Auditor
- CMDBID 100191357
- Course Code ISO 13485 LA
- Duration 5 Days
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Course content
What you will learn
Overview
ISO 13485 Lead Auditor is a practical training course for teams that need structured, instructor-led skills in ISO, Lead Auditor Day, Medical Devices Quality Management.
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 should you 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 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.
Audience
- Managers or consultants involved in Medical Devices Quality Management
- Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
- Individuals responsible for maintaining conformance with MDQMS requirements
- MDQMS team members.
Skills Gained
- 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.
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
Outline
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
Certification
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.
Confirm current exam requirements with CourseMonster vendor-authorised training.
Continue your learning pathway: view all Quality and Management courses or compare related courses and follow-on options.
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LVC = Live Virtual Class
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