ISO 13485 Lead Auditor
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.
Who Should Attend?
- 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
Learning Objective
Upon successfully completing the training course, participants 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
Educational Approach
This training course is participant centered and:
- 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
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
Course Agenda
Day 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
- Course objectives and structure
- Standards and regulatory frameworks
- Certification process
- Fundamental principles of Medical Devices Quality Management Systems
- Medical Devices Quality Management System (QMS)
Day 2: Audit principles, preparation and launching of an audit
- - Fundamental audit concepts and principles
- - Audit approach based on evidence and risk
- - Initiating the audit
- - Stage 1 audit
- - Preparing the stage 2 audit (on-site audit)
- - Stage 2 audit (Part 1)
Day 3 On-site audit activities
- - Stage 2 audit (Part 2)
- - Communication during the audit
- - Audit procedures
- - Creating audit test plans
- - Drafting audit findings and non-conformity reports
Day 4 Closing the audit
- - Documentation of the audit and its review
- - Closing the audit
- - Evaluating action plans by the auditor
- - Beyond the initial audit
- - Managing an internal audit programme
- - Competence and evaluation of auditors
- - Closing the training
Day 5 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
