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ISO 13485 Lead Auditor: Medical Device Quality Management
Medical device quality requires consistent, traceable processes. Use ISO 13485 to structure audit investigations, assess evidence and substantiate conclusions. Make your findings useful to audited managers and improvement decisions.
- Duration
- 4.5 days 31 hours
- Code
- ISO13485LA Code
- Certification
- ISO 13485: Medical devices quality management Certification
Accredited training for the ISO 13485: Medical devices quality management certification.
Presentation
ISO 13485 is an international standard for the medical device industry. It addresses the medical device lifecycle, from production to post-production, including decommissioning and disposal. This quality standard also applies to other parties, including certification bodies involved in approval procedures. ISO 13485 gives management professionals a tool for developing and maintaining effective processes.
The ISO 13485 Lead Auditor course develops the skills needed to audit quality management systems for medical devices (MDQMS) under ISO 13485. You will learn recognised auditing principles, procedures and techniques for these systems.
You will also gain the knowledge to plan, conduct and manage internal and external audit programmes in accordance with ISO 19011 and the ISO 13485 certification process.
At the end of this 5-day course, you can take the certification exam and obtain the PECB Certified ISO 13485 Lead Auditor designation. This certificate demonstrates the skills needed to conduct organisational audits using auditing best practices.
Objectives
By the end of the ISO 13485 Lead Auditor course, you will be able to:
- Understand and explain how a medical device quality management system (MDQMS) operates.
- Describe key ISO 13485:2016 requirements in an audit context.
- Understand the relationship between ISO 13485 and other standards and regulations.
- Understand an auditor's responsibilities for planning, conducting and following up a management system audit under ISO 19011.
- Lead an audit and an audit team.
- Master audit planning, execution, reporting and follow-up under ISO 19011.
- Pass the ISO 13485 Lead Auditor exam and obtain one of its 4 associated PECB certifications.
Program
Day 1: Introduction to an MDQMS and ISO 13485
- The standards, regulatory and legal framework for medical device quality management.
- Fundamental medical device quality management system (MDQMS) principles.
- The ISO 13485:2016 certification process.
- Operation of a medical device quality management system.
- Key aspects of ISO 13485:2016.
Day 2: Audit principles, preparation and initiation
- Fundamental audit concepts and principles.
- The evidence-based audit approach.
- Audit initiation.
- Audit stages (part 1).
- Prepare an on-site audit (parts 1 and 2).
Day 3: On-site audit activities
- Audit stages (part 2).
- Communication during the audit.
- Audit procedures: observation, document review, interviews, sampling, technical verification, collaboration and evaluation.
- Write audit test plans.
- Formulate audit conclusions.
- Write audit findings and nonconformities.
Day 4: Closing the audit
- Audit documentation.
- Quality review.
- The audit closing meeting.
- Assessment of action plans by the auditor.
- Surveillance audits.
- Benefits of a pre-audit.
- Manage an internal audit programme.
Final half-day:
- Take the ISO 13485 Lead Auditor certification exam (duration: 3 hours).
Please note: the PECB ISO 13485 Lead Auditor exam and course materials are available in English only.
Audience
This course is intended for:
- Auditors seeking to conduct and lead medical device quality management system certification audits.
- Managers and consultants wishing to manage an MDQMS audit process.
- Medical device compliance managers and technical experts preparing for an MDQMS audit.
- Consultants specialising in medical device quality management.
Prerequisites
The ISO 13485 Lead Auditor course requires:
- Sound general knowledge of ISO 13485 and management system auditing principles.
Teaching and assessment methods
- Initial skills assessment
- Training materials provided to participants
- Continuous assessment throughout the course
- End-of-course feedback questionnaire
- Combination of theory and practical application
- Attendance records
- Post-course follow-up evaluation
- Quiz / multiple-choice questions
- Practical exercises
Course highlights
Practical exercises based on real cases, with 450 pages of documentation; 31 CPD credits; PECB certification exam included in the course price; if you do not pass, retake it free of charge within 12 months.
Dates and sessions
Choose the date and delivery format that suit you.
No upcoming sessions are currently available.
Training content provided in partnership with PECB