TOP Management – Practices for supporting and improving quality management systems for manufacturers of medical devices (ISO 13485)
This online course will provide top management of organizations with the necessary knowledge and skills to use the full capabilities of the quality management system for medical device manufacturers that meets the requirements of ISO 13485:2016, which allows them to manage the quality of manufactured medical devices efficiently and effectively.
The course also contains an array of practical instruments that will help your management system work like a charm and continuously improve the management system, processes, products and services, increase competitiveness and customer loyalty.
Duration
42 hours
Language
English/Ukrainian/Russian
Format
100% online
Objectives
• Successfully implement a systematic approach to the enterprise’s business processes
• Apply effective business-planning instruments
• Accurately identify processes, measure their performance, and manage them efficiently
• Effectively allocate responsibilities and authorities
• Correctly formulate the policy and strategy of your business
• Develop risk-based thinking
• Develop objectives at the strategic, tactical, and operational level
• Build a stable team, determine and maintain competence of each employee, build a motivation system at your company
• Carry out regular reviews of your management system
• Get the maximum benefit from the implementation of the “improvement” principle
Target audience
• Successful managers and leaders who wish to achieve maximum results
• Managers of all levels – to develop their own leadership and managerial abilities, as well as to develop their own team and business
• Specialists who plan to take up managerial posts – to gain self-confidence and deep understanding of the specifics of future work
• Quality directors and managers
Document on completion
Top manager qualification certificate, specialization «Best business management practices in accordance with the requirements of the international standard ISO 13485:2016», listed in the SIC international register
Thematic plan
The course program includes two modules.
The program is designed for 42 hours, including time for studying theoretical material and taking tests.
After completion of each module, the listener is being tested.
Objectives
Module 1 The practice of implementing, maintaining and improving the quality management system for medical device manufacturers in accordance with the requirements of ISO 13485:2016
Number of hours
|
1.1 1.2 |
Introduction Scope |
1 0.5 |
|
1.3 |
Terms and definitions |
1,5 |
|
1.4 |
Quality management system |
1,5 |
|
1.5 |
Management commitment |
2 |
|
1.6 |
Resource management |
2.5 |
|
1.7 |
Product realization |
6 |
|
1.8 |
Measurement, analysis and improvement |
3 |
|
|
Testing |
1 |
Module 2 Tools and approaches for the development and continuous improvement of the business management system
Number of hours
| 1.1 | Understanding the organization and its context. Auxiliary tools | 3 |
| 1.2 | Understanding the needs and expectations of stakeholders | 1 |
| 1.3 | FSMS scope and processes | 0,5 |
| 1.4 | Leadership in business | 2 |
| 1.5 | Policy and strategy | 1 |
| 1.6 | Functions, responsibilities, and authorities | 1 |
| 1.7 | Actions to treat risks and implement opportunities | 2 |
| 1.8 | FSMS objectives | 1 |
| 1.9 | Planning changes | 1 |
| 1.10 | Resources. Efficient use | 1,5 |
| 1.11 | Documentation | 1 |
| 1.12 | Operational planning and control over current activities | 1 |
| 1.13 | Internal audits | 1 |
| 1.14 | Management systems analysis | 2 |
| 1.15 | Nonconformities and corrective actions | 1 |
| 1.16 | Improvement | 2 |
| Testing | 1 |