Quality management

Quality management or QM is the indication for all organized measures for an improvement of products, processes, or services. Quality management is the core task of the management and a central criterion for the company’s success. The quality management system is obligatory in many branches of the life sciences, among others medical technology, in many fields of healthcare, medical rehabilitation, or the production of medical products.

We offer the following services:

General quality management and performance concepts
e.g. CAPA and the customer-specific performance.

Quality management for hospitals
Comparison of central quality models such as Total Quality Management (TQM), DIN EN ISO 9000ff, European Foundation for Quality Management (EFQM), Kooperation für Transparenz und Qualität im Gesundheitswesen (KTQ), proCum Cert (pCC), Joint Commission International (JCI), and the respective implementation.

Application, performance, and validation as well as placing different knowledge of the GxP standards
Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Good Laboratory Practice (GLP), Good Automated Manufacturing Practice (GAMP), Good Documentation Practice (GDP), Good Engineering Practice (GEP), Good Pharmacovigilance Practice (GpvP).

Providing Standard Operating Procedures (SOP)
Concepts and regular updates of standardized instructions of use for the performance of, among others, scientific, epidemiological, and clinical trials.

Working according to the SOPs shall enable our customers to comply, especially in regard to investigator initiated trials (IIT), with the legal requirements such as AMG, MPG, or European Directive 2001/20/EC and international requirements such as ICH-GCP.