Quality & Compliance
Our business is built on quality control and continuous improvement. Our facilities are certified by all the relevant quality management organisations and adhere to the highest standards.
Quality
Across Unilabs, our quality programmes aim to meet and surpass both regulatory requirements and our clients’ expectations – and to promote a culture of quality. This allows us to deliver consistent, high-quality, cost-effective services.
We double-check our results continuously to ensure our tests are accurate through peer review among our expert staff, and by participating in proficiency testing programmes. Every day, more than 13,500 Unilabs staff work to meet industry-leading quality standards.
Our goal is simple – to provide fast and reliable data.
Location: York Bioanalytical Solutions
Quality is built into all of our systems and procedures, with our dedicated independent QA team ensuring that exacting standards are maintained.
We employ a ratio of one expert QA auditor for every 5 scientists. This enables us to audit data virtually contemporaneously, where required, to fulfil our delivery promises on each and every study.
The YBS standard products are QA audited electronic data and audited draft reports, delivered to, or ahead of, timelines agreed for each study.
Below are the dates of the most recent inspections by the various regulatory authorities:
Location: York, UK
- FDA remote record review - September 2021
- MHRA GCP inspection - November 2022
- MHRA GLP inspection - March 2024
Location: Unilabs Copenhagen
Unilabs Copenhagen has one of the oldest accreditations in Denmark.
Unilabs is regularly subjected to audits by Sponsors and regulatory authorities.
QMS:
- The Unilabs Quality Management System will ensure that your project will be performed and reported in accordance with Good Clinical Practice (GCP), Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples, and ISO/IEC 15189:2022 as applicable.
Certificates:
- ISO 15189:2022 accredited by DANAK under registration number 160 to medical examination.
- CLIA Certificate of registration no. 99D2280741, by CMS.
Other Unilabs locations:
Our laboratories are accredited to the internationally recognised ISO 15189 Medical Laboratories: Requirements for Quality and Competence standard.
We are accredited by:
• COFRAC (France) • IPAC (Portugal) • SAS (Switzerland)
• SWEDAC (Sweden) • Norwegian accreditation (Norway)
• UKAS (UK) • DANAK (Denmark) • ENAC (Spain and Peru)
• SNAS (Slovakia) • CAI & NASKL (Czech Republic) • EIAC (UAE)
We have additional accreditations for our pharma activities in Denmark, such as Good Clinical Practices.
Many of our imaging institutes are certified to ISO 9001 or accredited to ISO 17025 (SWEDAC). Our teleradiology services, provided through our radiology business Telemedicine Clinic, have multiple certifications, such as ISO 9001:2015, 27001:2013 and QSI.