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)
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.