Medical Device Quality Management System Certification (ISO 13485)
ISO 13485 is an international standard based on ISO 9001 that incorporates specific requirements for medical devices as well as legal regulatory requirements and preferences of each country.
It is a fundamental quality certification for medical device manufacturers, contract manufacturers, service providers, and distributors.
It is a standard that specifies the requirements for a quality management system of organizations involved in the design, development, production, installation, and servicing of medical devices.
The medical equipment industry must establish a system that ensures the safety of medical devices in accordance with national regulations, international standards, and other applicable requirements.
The necessity of a quality management system for medical devices
ISO 13485, the certification for medical devices, is essential in most cases for medical device companies exporting products to overseas markets and offers significant advantages. In the European Union, meeting EU directives means that the free trade of medical devices is permitted. The most crucial aspect of complying with EU directive requirements is the establishment of a quality system and its independent assessment. When manufacturers operate in the global market, focusing on global or international standards (e.g., ISO) not only provides various benefits but is also legally mandated in some countries.
Expected effects of a quality management system for medical devices
- Obtaining certification for a medical device quality management system helps enhance competitiveness with other companies and improves corporate image.
- Enables the sharing of evolving international experiences through professional managers.
- Demonstrates quality assurance through certification acquisition.
- Generates overall profit through continuous system improvement by establishing a medical device quality management system.
Components of a Medical Device Quality Management System (ISO 13485:2016)
| Requirement number | Title | |
|---|---|---|
| 4. Context of the Organization | 4.1 | General requirements |
| 4.2 | Documentation requirements | |
| 5. Leadership | 5.1 | Management commitment |
| 5.2 | Customer focus | |
| 5.3 | Quality policy | |
| 5.4 | Planning | |
| 5.5 | Responsibility, authority, and communication | |
| 5.6 | Management review | |
| 6. Resource Management | 6.1 | Provision of resources |
| 6.2 | Human resources | |
| 6.3 | Infrastructure | |
| 6.4 | Work environment and contamination control | |
| 7. Product Realization | 7.1 | Planning of product realization |
| 7.2 | Customer-related processes | |
| 7.3 | Design and development | |
| 7.4 | Purchasing | |
| 7.5 | Production and service provision | |
| 7.6 | Control of monitoring and measuring equipment | |
| 8. Measurement, Analysis, and Improvement | 8.1 | General requirements |
| 8.2 | Monitoring and measurement | |
| 8.3 | Control of nonconforming product | |
| 8.4 | Data analysis | |
| 8.5 | Improvement | |