Our ISO Certificates

As Amatis we care about international rules and quality management.
We are continuously working on the future, the quality and safety requirements.

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ISO 9001:2015
Quality Management

ISO 9001 is a recognized standard, with requirements in the field of quality management and sets a benchmark for transparency and reliability in the market. Quality management is reflected in all parts of the process in our organization.

Quality management ensures that our products and services meet the needs, requirements, wishes, and specifications of customers, as well as other stakeholders. With ISO 9001 Quality Management we guarantee continuous improvement of quality so that we can better meet the needs of our customers.

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ISO 27001:2013
Information Security

ISO 27001 is about information security. The NEN-ISO / IEC 27001 standard specifies requirements for the implementation, maintenance, and improvement of measures in the field of information security. The standard also contains the regulations for the assessment and treatment of safety risks.

This means that we not only believe that safety is high on the agenda, but that an independent external party can confirm this (TÜV). The ISO certificate is not awarded because it is now in order, but because the processes are designed in such a way that we are continuously working on the future and the quality and safety requirements of tomorrow are taken into account.

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ISO 13485:2016
Medical Services

ISO 13485 certificate is used by organizations involved in the design, production, installation, and servicing of medical devices and related services. It is a standard for quality management. ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices. It is also an effective solution to meet the comprehensive requirements for a QMS in the medical device industry.

This certificate means that we provide quality management, management responsibility, resource management, product realization, and we can do measurements, analysis on our products and improve them simultaneously.