Certyfikat numer 60107089

Numer Certyfikatu: 60107089
Certyfikowany właściciel: SORIMEX Spolka z ograniczona
odpowiedzialnoscia Sp. k.
ul. Równinna 25
87-100 Torun

(see attachment for scope included)
Design and development, manufacture and distribution
of disposable and reusable SpO2 sensors, disposable
and reusable temperature probes, NIBP cuffs, NIBP cuffs
adapters, SpO2 probes cables, SpO2 probes adapters,
temperature probes cables, ECG electrodes, ECG cables
and wires, ECG adapters and electrocardiographs

Spełnione Standardy: EN ISO 13485:2012
EN ISO 13485:2012/AC:2012
Typ Certyfikatu: QM-System Normenkonf. Medizin

Quality Management System
EN ISO13485 quality management standard for medical devices and related services

The European standard EN ISO 13485 specifies requirements for a quality management system when an organization is required to demonstrate its ability to provide medical devices and related services that constantly meet customer requirements and applicable legal requirements.

Competent auditors analyze and evaluate the customer's quality management system. If all applicable requirements are met, its quality management system is certified according to EN ISO 13485.

The customer's quality management system is subject to regular monitoring.

Certified customers may use the test mark in their communication.

Further information on this service can be found here.