PECB Certified ISO 13485 Lead Auditor Training

Live Online & Classroom Enterprise Certification Training

The PECB Certified ISO 13485 Lead Auditor course equips participants with the expertise to plan, conduct, and manage audits of Medical Devices Quality Management Systems (MDQMS) based on ISO 13485. It enables professionals to assess compliance, improve system performance, and ensure the safety and quality of medical devices.

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What is PECB Certified ISO 13485 Lead Auditor Certification Training about?

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. 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.

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

None.

Available Training Modes

Live Online Training

Course Outline Expand All

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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

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Who is the instructor for this training?

The trainer for this PECB Certified ISO 13485 Lead Auditor Training has extensive experience in this domain, including years of experience training & mentoring professionals.

PECB Certified ISO 13485 Lead Auditor Certification Training - Certification & Exam

SpringPeople is the Authorized Training Partner of PECB.
The training fees is exclusive of exam cost.
For any queries, feel free to reach us at PECB@springpeople.com

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