ISO 13485 MD QMS Lead Auditor Self-Study Training Course (PECB)
Course Overview
What you'll learn
Upon completion of this course, learners 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
Course Agenda
- Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
- Course objectives and structure
- Standards and regulatory frameworks
- initiating the audit
- Fundamental principles of Medical Devices Quality Management Systems
- Medical Devices Quality Management System (MDQMS)
- 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)
- 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
- 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 program
- Competence and evaluation of auditors
- Closing of the training
Who This Course Is For
This course is designed 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
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
About this course
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.
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.
Certification
After successfully passing the exam, you can apply for one of the following credentials with PECB. You will receive the certificate once you comply with all the requirements related to your selected credential.
- PECB Certified ISO 13485 Provisional Auditor
- PECB Certified ISO 13485 Auditor
- PECB Certified ISO 13485 Lead Auditor
- PECB Certified ISO 13485 Senior Lead Auditor
- PECB Certified ISO 13485 Master
Enrolment information
By enrolling on this course you agree to your personal information being passed to PECB.
Learners enrolling onto this course will receive an email from PECB to set up your Learner Account, course registration, access to the course materials and final exam.
If you have not received this information within 5 working days please contact Global.PECB.Training@sgs.com
General information
PECB will provide training material of over 450 pages of information and practical examples.
Learners may reach out to PECB to request the Attestation of Course Completion as proof of taking the course, this can be requested before taking the exam or after and is worth 16 CPD (Continuing Professional Development) credits.
In case of exam failure, the candidate can retake the exam once for free within 12 months following the initial exam date.
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
The fee for this course covers:
- Course Materials (for lifetime, please note that updated course materials are not included)
- First Exam
- One resit exam (if required)
- PECB Certification Fee
- First Year PECB Annual Maintenance Fee (AMF)
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