ISO 13485 Lead Auditor Training

Live Online & Classroom Enterprise Certification Training

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.

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What is ISO 13485 Lead Auditor Certification Training about?

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.

What are the objectives of ISO 13485 Lead Auditor Certification Training ?

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

Who is ISO 13485 Lead Auditor Certification Training 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
Expert advisors in Medical Devices Quality Management

What are the prerequisites for ISO 13485 Lead Auditor Certification Training?

A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.

Available Training Modes

Live Online Training

30 Hours

Classroom Training

5 Days

Course Outline Expand All

Expand All

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

Who is the instructor for this training?

The Trainer is PECB certified Instructor with extensive domain experience, including years of experience training & mentoring professionals in the industry.

ISO 13485 Lead Auditor Certification Training - Certification & Exam

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

For any queries; feel free to reach us at pecb@springpeople.com.

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