Certificates

Our management system is based on STORZ MEDICAL AG's principles governing quality, safety and environmental protection. It meets the requirements of internationally accepted standards and regulations and includes, inter alia, a certified quality management system in compliance with the EN ISO 13485:2012 and ISO 9001:2015 standards, as well as a certified environmental management system in accordance with the ISO 14001:2015 standard. This system fulfils the requirements set out in Annex II of the Medical Devices Directive (MDD) 93/42/EEC, in addition to other national standards and statutory requirements such as the »Quality System Regulation« (QSR) 21 CFR Part 820 of the U.S. Food and Drug Administration (FDA), the »Conformity Assessment System« (CMDCAS) recognized by relevant Canadian authorities under ISO 13485:2003, and Taiwan's »Technical Cooperation Program« (TCP) under EN ISO 13485:2012.

Our products and services are designed to satisfy all the demands placed on them in relation to quality, safety and environmental protection. This is why product quality control is an essential part of our quality assurance activities, and why the focus of our environmental management measures is on environmental aspects along the life cycle of our products and services. Our goal is to manufacture products in line with market requirements using eco-friendly and resource-saving processes, and to conform to legal and social standards. For the benefit of customers, suppliers and ourselves we want, through continuity, to ensure lasting partnerships and, furthermore, to create long-term competitive advantages, by being a dependable partner in every respect – including quality, sustainability and care for the environment.

Here you will find confirmation of our certification by recognized certification bodies:

pdfMDD certificate
pdfQuality management system for medical devices EN ISO 13485:2012
pdfQuality management system ISO 9001:2015 and environmental management system ISO 14001:2015
pdfQuality management system ISO 9001:2015 and environmental management system ISO 14001:2015 (IQNet Partner Certificate)

 

STORZ MEDICAL AG
Lohstampfestrasse 8
8274 Tägerwilen
Switzerland
Tel.: +41 (0)71 677 45 45
Fax: +41 (0)71 677 45 05

www.storzmedical.com