ISO 13485 LEAD AUDITOR

Master the Audit of Medical Devices Quality Management Systems (MDQMS) based on ISO 13485

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.

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

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