In July 2018, IBBL (Integrated BioBank of Luxembourg) successfully passed the audit to become certified according to the latest version of the ISO 9001 norm, specifying the requirements of Quality Management Systems.
The audit further confirmed the rigour and strength of IBBL’s Quality Management System (QMS). Indeed, no nonconformities were identified throughout the certification audit, while a number of positive findings were highlighted.
Notably, from a management perspective, IBBL was found to have a very detailed management review and thorough strategic vision, practically translated into concrete objectives and Key Performance Indicators (KPIs). In terms of quality, the comprehensive crisis management plan was particularly appreciated. Finally, the audit acknowledged the implication, commitment and competence of the staff: the seamless move to the new facilities in Dudelange was particularly praised.
“The certification is the official demonstration of our ability to consistently provide products and services that meet or exceed customer and regulatory expectations. It further affirms our dedication to quality and strengthens our reputation as a client-oriented organisation”, states Dr. Sabine Lehmann, Quality Manager at IBBL. “The passion and unwavering commitment of our staff have significantly contributed to the outcome of the audit”.
The ISO 9001:2015 certification comes shortly after the confirmation of the prolongation of IBBL’s ISO 17025:2005 accreditation in May 2018. The accreditation, which had been voluntarily suspended after the move, specifies the general requirements for the competence of testing and calibration laboratories for the following methods:
• Complete Blood Count with ABX Micros CRP 200;
• DNA Quantification by Spectrofluorometry;
• Nucleic Acid Quantification by Spectrophotometry;
• RNA Integrity Measurement;
• DNA Cross-Linking Assessment by PCR;
• Long-Range PCR;
• Human sCD40L Quantification in Serum;
• 16s rRNA Gene Sequencing.
IBBL’s ISO 9001:2015 certification was issued by TŰV Rheinland and is valid until 2020, while the ISO 17025 accreditation was issued by OLAS (Office Luxembourgeois d’Accreditation et de Surveillance) and is valid until 2023.