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OGT management system

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.

 

Independent certifications & accreditations

 

Oxford Gene Technology Ltd

ISO 9001:2015

ISO 9001Certified 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

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ISO 27001:2013

ISO/IEC 27001ISO 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 formalized 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

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Cytocell Ltd

Medical Device Single Audit Program (MDSAP) Certification

MDSAP CertificationDeveloped by the International Medical Device Regulators Forum (IMDRF), the MDSAP enables medical device manufacturers to fulfill the requirements of multiple participating regulatory authorities through a single QMS audit.

The certification from Lloyd’s Register (LR) 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.

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ISO 9001:2015 and ISO 13485:2016 Certification

ISO 9001:2015 and ISO 13485Certified by Lloyd’s Register 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.

View ISO 9001:2015 Certificate

View ISO 13485:2016 Certificate