ISO 13485 in Thailand

ISO 13485 Medical Devices – Quality Management System

ISO 13485 specifies requirements in Thailand for a Quality Management System that can be used by an organisation in Thailand involved in one or more stages of the life-cycle of medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning, disposal of medical devices, and provision of associated activities in Thailand.

Medical devices are required to meet certain regulations to be distributed to medical industries of Thailand. A quality certificate that can assure you are producing and selling devices that are safe is the ISO 13485.

Internationally recognized and accepted, the ISO 13485 is a necessary certification in Thailand if you are looking to improve performance and remove any uncertainty in your business. Suitable for medical device industries, this certificate requires you to specific requirements.

ISO 13485:2016 helps laboratories to develop or upgrade their Quality Management Systems in Thailand. 

ISO 13485 is the leading ISO Consultants in Thailand in handling Medical Devices and Quality Management.

ISO 13485 Medical Device

BENEFITS OF ISO 13485 in Thailand

  • Trust in being a safe supplier and producer
  • Likelihood of meeting customer requirements and expectations
  • Reduce operation cost and production loss rate
  • Improve processes based on objective measurement
  • Increase competitive advantage
  • More effective risk management
  • Better definition of roles and key responsibilities for employees