ISO 13485: Medical devices - Quality Management System
ISO 13485 is designed to efficiently manage the quality management system of organizations providing medical devices and related services that consistently meets customer and applicable regulatory requirements such as design & development, installation, operation, storage and distribution or servicing of a medical device.
Implementing an ISO 13485 management system helps you gain recognition as a highly reputable organization as well as enabling you to meet the requirements of the standard, applicable legislation and customer needs.
Why choose ISO 13485 certification?
- Improve operational processes and maintain an effective system to ensure compliance with regulatory requirements.
- Demonstrate your organization’s commitment to the safety and quality of medical devices.
- Improve reliability and accountability to both stakeholders and customers.
- Increase efficiency and cut costs.
- Enhance your company’s image and reputation.
Talk to our experts
SOCOTEC Certification Thailand Co., Ltd
Why obtain ISO 13485 certification with SOCOTEC Certification Thailand Co., Ltd?
SOCOTEC Certification Thailand Co., Ltd is an experienced certification body for ISO 13485 certification. Being certified with SOCOTEC Certification (Thailand) Co., Ltd means you benefit from the proximity of our teams.
SOCOTEC Certification Thailand Co., Ltd is an experienced certification body for ISO 13485 certification. Being certified with SOCOTEC Certification (Thailand) Co., Ltd means you benefit from the proximity of our teams.
You want to get certified?
Which complementary certifications do we offer?
SOCOTEC Certification Thailand Co., Ltd
What is an integrated management system?
The specifications of each standard are met by an integrated management system which incorporates several standards. Choosing this integration option eliminates audit duplication. A typical integrated management system might include ISO 9001 Quality Management, ISO 14001 Environmental Management, ISO 45001 Occupational Health and Safety Management and ISO/IEC 27001 Information Security Management. However it is not limited to just these standards.
The specifications of each standard are met by an integrated management system which incorporates several standards. Choosing this integration option eliminates audit duplication. A typical integrated management system might include ISO 9001 Quality Management, ISO 14001 Environmental Management, ISO 45001 Occupational Health and Safety Management and ISO/IEC 27001 Information Security Management. However it is not limited to just these standards.
Want to know more about certification?
