Internal auditor of quality management systems for medical device manufacturers (ISO 13485, ISO 19011)
Participants will gain knowledge into various QMS components, including: leadership, risk management, required procedures, documentation, performance measurement, management analysis and continuous improvement, roles and responsibilities of internal auditors in planning and conducting audits, reporting, planning and monitoring of actions and measures based on audit results.
To enhance understanding, all course slides are voiced. Real-life cases will help participants better apply theory in practice. Structured information is divided into modules, making the learning process even more efficient.
In accordance with ISO 13485:2016 requirements, every company engaged in the production of medical devices is obligated to conduct regular internal audits to ensure product quality and safety. The presence of a qualified internal auditor is crucial to comply with these requirements and maintain the quality management system.
This course is an essenntial step for those aspiring to become highly qualified auditors and make a significant contribution to improving their company’s quality management system.
Duration
36 hours
Language
English/Ukrainian
Format
100% online
Course objective
The objective of the course ” Internal Auditor of the Quality Management Systems for Medical Device Manufacturers (ISO 13485, ISO 19011)” is to provide participants with the necessary knowledge and skills to conduct internal audits of quality management systems, with a specific focus on medical devices. The course covers the fundamental principles, methods, and tools of auditing, as well as the specific requirements for medical device manufacturers, which are critically important for ensuring the safety and effectiveness of medical devices.
Internal auditors verify whether the quality management system complies with the requirements of the ISO 13485 standard and specific normative requirements for medical devices.
Target audience
• Internal auditors
• Project managers and consultants who wish to learn the quality management system audit process for medical device manufacturers
• Members of the QMS implementation team for medical device manufacturers at the enterprise
• Professionals who want to gain in-depth knowledge of QMS for medical device manufacturers
• Specialists involved in daily support of QMS processes
• Students of specialized faculties
Document on completion
QMS internal auditor certificate for manufacturers of medical devices, listed in the SIC international register
Thematic plan
The course program includes 2 modules:
1. Quality management system for medical device manufacturers (ISO 13485)
2. Internal audit (ISO 19011)
The program is designed for 36 hours, including time for studying theoretical material and taking tests.
Objectives
Module 1 Quality Management System for Medical Device Manufacturers (ISO 13485)
Number of hours
| 1.1 | Introduction | 1,5 |
| 1.2 | General provisions of the standard | 2 |
| 1.3 | Organization context | 2 |
| 1.4 | Leadership | 2 |
| 1.5 | Planning | 2 |
| 1.6 | Provision (resource) | 1,5 |
| 1.7 | Functioning | 5 |
| 1.8 | Performance evaluation | 2,5 |
| 1.9 | Improvement | 1 |
| Testing | 1 |
Module 2 Internal audit (ISO 19011)
Number of hours
| 2.1 | Introduction | 1 |
| 2.2 | General provisions of the standard | 1,5 |
| 2.3 | Audit program management | 5 |
| 2.4 | Performing an audit | 5 |
| 2.5 | Auditor competence | 2 |
| Testing | 1 |