Certifications

Thanks to our consistent application of our quality management system certified to pharmaceutical requirements, which is closely linked to compliance with good manufacturing practice (GMP) guidelines, we guarantee that processes occur under controlled and reproducible conditions at all times.

Röchling Medical has a large number of certifications related to everything from quality management to environmental safety to specific products, and is constantly working on new developments and corresponding certifications.

Everything we do is marked by a strong sense of environmental and energy consciousness, which is reflected in our implementation of certified management systems in accordance with ISO-14001-Environment and ISO 50001-Energy.

Manufacturing products for the pharmaceuticals, life sciences and diagnostics industry entails strict standards, which regards environmental conditions. That is why our production takes place in a controlled environment.

The following table shows an overview of the certifications our individual locations hold:

Zertifizierung

Bereich

Neuhaus, Germany

Brensbach, Germany

Rochester, USA

ISO 9001

Quality Management System

X

X

X

ISO 15387

GMP

X

-

-

ISO 13485

Medical Devices

X

X

X

ISO 16949

Design & Development Management Sytsem

-

-

X

ISO 50001

Energy

X

X

-

ISO 14001

Environment

X

-

-

ISO 8317

Child Resistant Packaging

X

-

-

Drug Master Files

(for selected products)

X

-

-

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