ISO 13485 is a global standard certificate that specifies requirements for a quality management system. Using the certificate, the organization must demonstrate its ability to consistently provide medical devices and related services that meet customer and applicable regulatory requirements.

The ISO 13485 standard is an efficient way to meet all of the requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address regulations and responsibilities while also demonstrating a commitment to medical device safety and quality.

Who Should Apply for ISO 13485?

Organizations involved in one or more stages of the life-cycle of a medical device, such as design and development, production, storage and distribution, installation, or servicing, as well as design and development or provision of associated activities (e.g., technical support) can apply for the certificate.

ISO 13485 can also be used by suppliers or external parties who provide products to such organizations, including quality management system-related services.

The Benefits of ISO 13485

  • • Rapid and consistent cycle
  • • Reduced waste
  • • Process improvement as a system
  • • Increased customer satisfaction
  • • Greater credibility and prestige
  • • Increase the reliability and image of your company


How Can QACA Help You?

A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for ISO 13485. In addition, our certified certification body conducts audits that follow the ISO 13485. 

QACA helps achieve certification that can demonstrate to potential clients that they adhere to best practices and regulatory requirements. We help the company benefit from improved process control and continuous improvement, resulting in continuous ROI.

You can request a certificate from us to evaluate your organization's performance based on ISO 13485.