ISO 13485 in Indonesia

ISO 13485 in Indonesia - Medical Devices : Quality Management System

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

Medical devices are required to meet certain regulations to be distributed to medical industries of Indonesia. 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 Indonesia 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 in Indonesia helps laboratories to develop or upgrade their Quality Management Systems in Indonesia. 

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

ISO 13485 in Indonesia

BENEFITS OF ISO 13485 in Indonesia

  • 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