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ISO 13485 Lead Auditor
Duration
5 Days
Course
PECB-ISO13485LA
Available Formats
Classroom Training, Online Training
Course Description
Overview
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 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.
Educational approach:
- This training is based on both theory and best practices used in MDQMS audits
- Lecture sessions are illustrated with examples based on case studies
- Practical exercises are based on a case study which includes role playing and discussions
- Practice tests are similar to the Certification Exam
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
- 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
Objectives
By the end of this training course, students will be able to:
- 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
Audience
- 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
Prerequisites
-
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
Topics
- 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
- 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
Related Courses
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ISO 9001 Lead Auditor
PECB-ISO9001LA- Duration: 5 Days
- Delivery Format: Classroom Training, Online Training
- Price: 2,650.00 USD
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ISO 9001 Lead Implementer
PECB-ISO9001LI- Duration: 5 Days
- Delivery Format: Classroom Training, Online Training
- Price: 2,650.00 USD
Self-Paced Training Info
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- Same in-demand topics as instructor-led public and private classes.
- Standalone learning or supplemental reinforcement.
- e-Learning content varies by course and technology.
- View the Self-Paced version of this outline and what is included in the SPVC course.
- Learn more about e-Learning
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