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SZU‘s measures in connection with Covid-19

We are constantly monitoring and evaluating the COVID-19 situation. We have taken a number of measures to help minimize the risk of infection. We do everything we can to ensure that these measures have the least impact on the operation of our business and on running orders. Our main goal in this situation is to protect the health of our employees and customers.

More information: https://www.szutest.cz/en/news/szu-s-measures-in-connection-with-covid-19


ČSN EN ISO 13485 ed. 2:2016

THE STANDARD PRINCIPLE

The Standard defines the requirements for quality management system in production and distribution of medical devices and establishes specific requirements in areas specific to this field, e.g. sterilisation, technical documentation, traceability). In its structure it follows up the requirements of ISO 9001.

HISTORY

Due to the growing emphasis on quality management systems of manufacturers and suppliers of medical devices, in 2001 the Standard ISO 13485 was compiled, which extended on the original Standard ISO 9001 specifying the requirements for production of medical devices.

BENEFITS FOR ORGANIZATIONS

OUR EVALUATION OF THE STANDARD

The Standard joins the advantages of the general Standard ISO 9001 and of the requirements for a specific field. It is a quality tool serving as the basis for demonstration of product conformity with EU directives.

 

 

 

Who can you reach out to?

Jana Servusová

Jana Servusová

QMS, EMS, OHSAS

servusova@szutest.cz
+420 541 120 541
+420 602 439 403

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