QMI ISO 13485 provides a comprehensive framework for medical device manufacturers to ensure product quality and regulatory compliance.

ISO 13485 is an internationally published standard that defines requirements within quality management systems for manufacturers of medical devices and equipment. The main objective of the standard is to facilitate harmonised quality management system requirements for regulatory purposes within the medical devices sector.

How is ISO 13485 structured?

ISO 13485 has been based on the requirements of ISO 9001 and has the same structure in terms of clauses. The ISO 13485 standard, medical devices – quality management systems – requirements for regulatory purposes, is the basis for regulatory compliance in local and most export markets. Having certification demonstrates your commitment to meeting your customer requirements.

Who can apply for ISO 13485 certification?

ISO 13485 is applicable to all manufacturers and suppliers of medical devices, components, contract services and distributors of medical devices. For a number of markets ISO 13485 certification is not sufficient on its own and the appropriate local regulatory certification is also required to legally manufacture and sell medical devices.

Requirements of the ISO 13485 standard

The ISO 13485 standard contains specific requirements for manufacture, installation and servicing and requires:

- Risk management approach to product development and product realisation

- Validation of processes

- Compliance with statutory and regulatory requirements

- Effective product traceability and recall systems

- Implementation of a quality management system with several enhancements

Certification Process Requirements Online Registration
Benefits of ISO 13485 certification to your organization:

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

- Increase access to more markets worldwide with certification

- Outline how to review and improve processes across your organization

- Increase efficiency, cut costs and monitor supply chain performance

- Demonstrate that you produce safer and more effective medical devices

- Meet regulatory requirements and customer expectations


PT.Quality Management Indonesia focuses on several scopes according to the competency standards of our experts and auditors. We will continue to improve our personnel competency standard to expand the scope of our certification.

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