Quality and Certification
At Caltag, we're committed to providing products and services that meet the highest standards of quality, safety, and reliability. Our processes are built with precision and compliance in mind, ensuring you can trust what you receive.
ISO 13485 Certification
Caltag Medsystems Ltd. are certified to the ISO 13485:2016 standard due to our unique position as a manufacturer and worldwide exporter of IVD devices, and distributor of life sciences products to the UK and Ireland.
Globally recognised, the ISO 13485 standard defines the Quality Management System (QMS) requirements for the manufacture of medical devices. For Caltag, our ISO 13485 certification incorporates the “manufacture and supply of cellular stabilisation reagents for research and in vitro diagnostic use”.
Our ISO 13485-compliant QMS is implemented across all areas of our business, ensuring excellence is part of our day-to-day routine in supplying all our customers with a range of life science products and medical devices.
ISO 14001 Certification
Caltag Medsystems Ltd. are certified to the ISO 14001:2015 standard.
ISO 14001 is the international Standard for Environmental Management Systems (EMS). For Caltag, our ISO 14001 certification incorporates the “services of sourcing, manufacturing and distribution of life science reagents”.
Our ISO 14001-compliant EMS is utilised in all areas of our business, including monitoring our suppliers’ environmental and sustainability practices, recording our carbon emissions from equipment energy consumption, travel and courier company usage and reducing our landfill waste contributions.
Cyber Essentials
Caltag is Cyber Essentials certified!
Cyber Essentials is a UK government-backed scheme certifying that organisations have secured their IT against common online threats by using firewalls, secure configuration, and user access control.
Ensuring our IT systems adhere to these requirements not only helps protect our business but also provides confidence to our partners and customers that we take the security of confidentiality seriously.
Human Tissue Authority
Caltag Medsystems Ltd. is licensed by the Human Tissue Authority (License Number 12672) to procure, process and store human tissue in the UK.
This license reflects our commitment to sourcing and importing products ethically and adhering to all UK regulations and guidelines.
Read more on our ethical practices here.
British Standards Institution (BSI)
At Caltag, we're delighted to be a BSI committee member!
The British Standards Institution is the national standards body of the United Kingdom, producing technical standards on a wide range of products and services.
Our BSI membership reflects our commitment to maintaining quality across our business. This membership enables us to stay up-to-date with the latest recognised standards and best business practices.
British In Vitro Diagnostics Association (BIVDA)
Caltag is proud to be a BIVDA member!
The British In Vitro Diagnostics Association (BIVDA) is the national industry association for manufacturers and distributors of in vitro diagnostic tests (IVDs) in the UK.
Being a BIVDA member demonstrates our commitment to the life science and diagnostics community to deliver regulatory excellence. As a BIVDA member, we connect with industry experts and stay informed on the latest developments to strengthen our knowledge and ensure the best IVD practices are implemented within our business.