Our management system is continually monitored and improved, and is subject to regular internal audit by trained management system auditors as well as independent external audits by certification and accreditation bodies.
Certified by BSI since June 2010, ISO 9001:2015 certification of our quality management system demonstrates our commitment to the delivery of products and services of the highest quality. OGT maintains systems that enable us to meet expectations as well as continually improve our business practices in a changing world.
Certificate No. FS 593863
ISO 27001:2013 certification acknowledges that ‘information’ (in all forms; written, verbal, electronic, personnel and materials) is of highest value to OGT’s stakeholders and clients, demonstrating that we have put systems in place to protect information that we have been entrusted to use.
The OGT information security management system, certified by BSI since August 2010, ensures that formalised procedures are in place for the protection of all types of information, as a matter of course. Should problems occur, business continuity procedures and disaster recovery plans ensure that information is protected, while priority services and access to information are maintained.
Certificate No. IS 593864
Certified by BSI Group The Netherlands B.V. (EU Notified Body No. 2797) in accordance with IVDR Annex IX Chapter I and III, Cytocell Ltd's EU Quality Management System (QMS) Certificate demonstrates that our QMS and a representative selection of our IVDR Technical Documentation meet the requirements of the Regulation.
The scope of the EU QMS Certificate is applicable to Class C in vitro diagnostic (IVD) medical devices that fall under EMDN W0106 (Genetic testing) and IVP3004 (IVD devices which require knowledge of chromosomal analysis), with the following Intended Purposes:
Certificate no. IVDR 747622
Developed by the International Medical Device Regulators Forum (IMDRF), the MDSAP enables medical device manufacturers to fulfil the requirements of multiple participating regulatory authorities through a single QMS audit.
The certification from BSI is for the full MDSAP audit criteria, which is based on ISO 13485:2016 with additional country-specific requirements for the US FDA, Health Canada, TGA (Australia), ANVISA (Brazil), MHLW and PMDA (Japan).
The scope of the approval is applicable to the design, development and manufacture of DNA FISH probes, ancillary products, in vitro diagnostic kits and reagents for the detection of chromosomal abnormalities in life science research and diagnostic use.
Certificate No. MDSAP 736531
Certified since October 1999, the ISO 9001 and ISO 13485 certification of our Management System demonstrates CytoCell's commitment to the delivery of products and services of the highest quality.
For this management system certification the scope of the approval is applicable to the design, development and manufacture of DNA FISH probes, ancillary products, in vitro diagnostic kits and reagents for the detection of chromosomal abnormalities in life science research and diagnostic use.
Certificate no. FM 723073
Certificate no. MD 722804