Quality Management

The aim and purpose of our QM system is consistently high quality. The accreditation according to DIN EN ISO 17025:2018, the recognition of the accreditation by the Central Office of the Federal States for Health Protection for Drugs and Medical Devices (ZLG) and the confirmation of Good Manufacturing Practice (GMP) by the Regional Council of Tübingen prove the success of our approach.

QM Reinraum
Working in the clean room

Accreditation

SAS Hagmann GmbH & Co.KG is accredited by DAkks (the only German accreditation body) according to what is currently the world`s highest quality standard for analytical laboratories.

The unlimited accreditation certificate according to DIN EN ISO 17025:2018 can be found under the following link.

An extension audit to include further methods in the accredited area (ICP-MS, liquid chromatography) was completed in October 2021 without any critical deviations.

 

The new accreditation certificate will be integrated into this homepage as soon as we have it.

Accreditation for physico-chemical and chemical investigations

Frequently asked questions about the extension of time limits for accreditation certificates are answered here:

Accreditation for medical devices (declaration of the DakkS on the extension period)

ZLG Recognition

SAS Hagmann GmbH & Co. KG is recognized by the Central Office of the Federal States for Health-Protection for Drugs and Medical Devices (ZLG) for the examination of medical devices.

Unlike, for example, in the USA (Federal Authority FDA), in Germany the responsibilities for medical devices are a matter for the federal states and are bundled in a separate state authority. However, since there is only one national accreditation body (DAkks), the ZLG carries out assessments and monitoring in the field of medical devices on behalf of the DAkks, in particular to check the high requirements for independence and impartiality in the field of medical devices.

The recognition of these competences by the USA is regulated in an agreement with the European Community (OJ L 31 of 4 Feb 1999; agreement section 7. Medical devices).

ZLG-Anerkennung als Prüflabor für Medizinprodukte und für chem. und physikalisch-chemische Prüfungen von Medizinprodukten für SAS Hagmann

 

An extension audit to include additional methods in the recognized area (ICP-MS, liquid chromatography) was completed in January 2022 without any critical deviations.

 

The new certificate of recognition will be integrated into this homepage as soon as we have it.

ZLG-notification and scope
Document
ZLG Anerkennung.pdf (899.83 KB)
ZLG recognition

                                                                                                                                                                                                                                                                                                                                                                                           

GMP Confirmation

In Germany, the monitoring of medicinal products is a matter of the federal states. The respective regional councils are responsible for monitoring the quality. SAS Hagmann GmbH & Co. KG`s compliance with the principles of good manufacturing practice (GMP) is confirmed by the regional council of Tübingen.

The recognition of these competences by the USA is regulated in an agreement with the European Community (OJ L 31 of Feb 1999; Agreement Section 6. Good Manufacturing Practice for Drugs (GMP)).

A routine inspection by the regional council took place in March 2022. Please find our current GMP confirmation below.

Document
GMP-confirmation