Quality and Qualifications

Reliable test results thanks to continual improvement 

Customer satisfaction and quality are the central factors for the success of our company activities. Expert advice and fulfilling international standards are a matter of course for us.

To monitor these goals, and ensure continual improvement we introduced TOTAL QUALITY MANAGEMENT (TQM) in 1996. In accordance with the philosophy of the European Foundation of Quality Management (EFQM), all quality relevant and business management factors, including all processes are permanently networked together with each other and are sustainably oriented to benefit the success of our customers, the satisfaction of our employees and the progress of the company.

Our processes have been described and regulated in a TQM-/EFQM manual. Included in this manual is the quality manual, in which our standard processes (SOPs) are described so that they are both verifiable and transparent. All quality-relevant processes are defined in detail, for example document management, qualification of devices, validation of methods, procedure in the case of transgression of specifications (OOS, out of specification) and the change control system.  

Accreditation / Certification 

Our quality management system is tested regularly by independent authorities and accredited resp. certified in accordance with the following norms and guidelines: 

• EN ISO/IEC 17025
• Good Manufacturing Practice (GMP)
• FDA

ISO 17025 re-accreditation of UFAG Laboratorien AG (STS 0072) is carried out in 5-year cycles by the Swiss Accreditation Office (SAS). Surveillance audits take place every two years or, if necessary, at more frequent intervals. Internal audits take place annually and are performed by the Quality Management of UFAG LABORATORIEN. 

The GMP status of the laboratory is monitored firstly by regular internal audits by Quality Management, and secondly every two years by the Swiss Regional Drug Inspection Agency (Regionalen Heilmittelinspektorate) on behalf of Swissmedic in multi-day inspections. 

Along with the Swiss authorities, UFAG LABORATORIEN is also registered by the FDA and has been repeatedly and successfully audited many times by auditors from the Foreign Inspection Offices. 

Round robin tests

As part of the state accreditation of test laboratories in accordance with standard EN ISO/IEC 17025, participation in ring (or proficiency) tests is stipulated. In this way, the quality of the work carried out is proven.

For quality assurance in food and feedstuffs analysis, UFAG Laboratorien AG takes part, on a regular basis, in independent ring tests and inter-laboratory comparisons of renowned suppliers (e.g. FAPAS, AAFCO, QS-Deutschland, public authorities).

Trust is good, but control is better

Mutual trust and cGMP quality are the basic prerequisites for a long-term customer relationship in the pharmaceutical sector. In accordance with the GMP guidelines, not only the authorities but also the customers are obliged to test compliance with the guidelines of Good Manufacturing Practice in the laboratories within the framework of an audit.  

These inspections are greatly welcomed as they offer the customer the chance to get to know the laboratory more intensively and to build up the necessary level of trust in UFAG LABORATORIEN as a service providing partner. There is also the chance to exchange information and quality requirements and to experience how other companies interpret and implement the GMP guidelines.  

And last but not least: Our own actions will be questioned by a third party. This helps us to do away with the so-called “business myopia” of having a blinkered attitude to our own work, to test our own processes in a critical manner and to continually improve according to TQM / EFQM principles.