Tristel maintains a single Quality Management System conforming to ISO 13485:2016, Medical Devices Regulations – Part 1 – SOP98/282 and 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D, and are audited by MDSAP Medical Device Single Audit Program, as the minimum standard for medical devices to ensure the maintenance of regulatory requirements. Tristel also conforms to ISO 9001:2015 for non-medical products to ensure continual improvement to achieve customer satisfaction. The principles and guidelines of GMP are implemented in the facility with reference to Rules and Guidance for Pharmaceutical Manufacturers and Distributors (‘The Orange Guide’).
To provide customers with effective products for infection and prevention control, a comprehensive service is offered, which includes formulation, design and development through to scaled-up manufacture used in the application of disinfection and cleaning products.
All Tristel products conform to the requirements as applicable to the countries in which the device is intended to be offered for sale as well as to meet the requirements of the customer and patient.
Certificate of Registration MDSAP 703572
ISO 9001:2015 Certificate 553285
EC Certificate – Full Quality Assurance System CE 544967