ISO 13485 Quality Management System for Medical Devices

What is ISO 13485

ISO 13485 Standard includes the requirements for the implementation of a Quality Management System for medical devices. The structure of the Standard and the requirements are like those of international Quality Standard ISO 9001. Their main differences are the requirements for monitoring records for each product, the risk management in all process stages, the monitoring of infrastructure maintenance, the documented procedures for the work environment, the service provision, the customer feedback as well as keeping interested parties informed.

 ISO 13485 Quality Management System for Medical Devices

Target Audience

The Standard can be applied by Organizations involved in one or more stages of the life cycle of a medical device, including design and development, production, storage and distribution, installation, repair and provision of corresponding activities (eg. technical support). ISO 13485 can also be used by suppliers or external parties that provide medical devices. The requirements of ISO 13485 Standard are applicable to Organizations, regardless of their size and type.

ISO 13485
Quality Management System
for Medical Devices

The Benefits:

The implementation and certification against ISO 13485 Standard have advantages such as:

  • Safe Products
  • Meeting legislative requirements
  • Improved quality of services / products
  • Satisfied customers
  • Better management control

Certification Process / Required Documents

The Organization interested to achieve certification against ISO 13485 Standard requirements contacts ISC Control and fills in the certification application.

An initial audit is conducted and if successful, a certificate of compliance is issued that is valid for 3 years, provided that the organization undergoes an annual audit.

Why Choose ISC Control as Your Certification Body?

Global Recognition

Selecting the right organization or certification body that offers qualitative and credible training and certification services can be a challenge. However, by choosing an accredited certification body, such as ISC Control, proves that you follow best practices, up to speed, and trustworthy.

Professionals who pursue a ISC Control con certification credential will benefit from the recognition in domestic and overseas markets. Being accredited by some of the strictest and most reputable accreditation bodies in the world gives us global recognition.