Manager of the quality management system for medical device manufacturers
(ISO 13485)
This online course allows you to acquire the necessary knowledge and skills to implement and maintain the quality management system for medical device manufacturers (QMS) based on the ISO 13485:2016 standard.
Training participants will acquire knowledge about various components of the QMS for medical device manufacturers, including the following: leadership, risk management, necessary procedures, documentation, performance evaluation, management review, and continuous development and improvement of the QMS.
Duration
21 hours
Language
English/Ukrainian
Format
100% online
Objectives
• Understand the implementation principles of the QMS for medical device manufacturers in accordance with the requirements of ISO 13485
• Get a complete understanding of the concepts, approaches, methods and techniques necessary for effective management of the QMS
• Acquire knowledge in identifying risks and opportunities related to the QMS
• Understand the linkage between the QMS and meeting the requirements of various stakeholders of the organization
• Develop the knowledge and skills necessary to advise organizations on best practices of the quality management for medical device manufacturers
• Get information about the organization and carrying out an internal audit
• Understand the operation of the QMS in accordance with ISO 13485
• Improve the ability to analyze the internal and external environment of the organization and decision-making in the context of the quality management system for medical device manufacturers
Target audience
• Heads of departments
• Project managers and consultants who wish to become familiar with the process of implementing and functioning of the quality management system for medical device manufacturers
• Members of the QMS for medical device manufacturers implementation team at the enterprise
• Professionals who wish to gain in-depth knowledge of the QMS for medical device manufacturers
• Specialists involved in daily support of the QMS processes
• Students of specialized faculties
Document on completion
Certificate of the QMS manager for medical device manufacturers, listed in the SIC international register
Evaluation scale
60.0-100.0
0.0-59.9
Complies
Does not comply
Thematic plan
The course program includes:
1. «Quality management system for manufacturers of medical device (ISO 13485)» module
The program is designed for 21 hours, including time for studying theoretical material and taking tests.
Objectives
Module 1 Quality management system for manufacturers of medical device (ISO 13485)
Number of hours
|
1 |
Introduction |
1,5 |
|
2 |
Scope |
0,5 |
|
3 |
Terms and definitions |
3 |
|
4 |
Quality management system |
2 |
|
5 |
Management responsibility |
2 |
|
6 |
Resource management |
2 |
|
7 |
Product realization |
6 |
|
8 |
Measurement, analysis and improvement |
3 |
|
|
Testing |
1 |
Detailed content of the program Module 1 Quality management system for manufacturers of medical device (ISO 13485)
|
1 |
Introduction: – General provisions: – Concept – Process approach – Connection with ISO 9001 |
|
2 |
Scope |
|
3 |
Terms and definitions |
|
4 |
Quality management system: – General provisions – Documentation requirements: – A) Control of documents – B) Control of records |
|
5
|
Management responsibility: – Management commitment – Customer focus – Quality policy – Planning. Quality objectives – Responsibility and authority – Management review |
|
6 |
Resource management: – Provision of resources – Human resources – Infrastructure – Work environment – Contamination control |
|
7 |
Product realization: – Planning of product realization – Determination and review of requirements related to product – Communication with customers – Design and development – Purchasing – Production and service provision – Control of monitoring and measuring equipment |
|
8 |
Measurement, analysis and improvement: – Monitoring and measurement – Internal audit – Monitoring and measurement of processes and product – Control of nonconforming product – Analysis of data – Improvement – Corrective and preventive action |