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

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

ISO 13485 in Malaysia

ISO 13485 Medical Devices – Quality Management System

ISO 13485 specifies requirements in Malaysia for a Quality Management System that can be used by an organisation in Malaysia 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 Malaysia.

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

Internationally recognised and accepted, the ISO 13485 is a necessary certification in Malaysia 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 Malaysia. 

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

ISO 13485 Medical Device

BENEFITS OF ISO 13485 in Malaysia

  • 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

Note

ISO 13485 Medical Devices – Quality Management System

ISO 13485 Medical Devices – Quality Management System

ISO 13485 specifies requirements for a Quality Management System that can be used by an organisation 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.

We are a leading ISO Consultants in Singapore in handling Medical Devices and Quality Management.

And our certification on ISO 13485 can also be used by suppliers or other external parties providing product such as raw materials, components, sub assemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services to such organisations.

ISO 13485 also adopts a risk management approach which includes assessment to identify and estimate risk. It uses risk controls and techniques with a view to eliminate hazardous situations throughout product realization.

ISO 13485 Medical Device

BENEFITS OF ISO 13485

  • 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

Note