BioVendor – Laboratorní medicína a.s. is ISO 9001 certified, ISO 13485 certified, and ISO 14001 for the development, production and distribution of in-vitro diagnostics and laboratory chemicals and distribution and service of laboratory instruments (see below).
ISO 9001: 2015: Quality Management System
ISO 9001:2015 Quality management systems – Requirements is intended for use in any organization which designs, develops, manufactures, installs and/or services any product or provides any form of service. It provides a number of requirements which an organization needs to fulfill if it is to achieve customer satisfaction through consistent products and services which meet customer expectations.
ISO 9001: 2015: Quality Management System
ISO 13485: 2016: Medical Devices - Quality Management Systems - Requirements for regulatory purposes
While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained.
ISO 13485: 2016: Medical Devices - Quality Management Systems - Requirements for regulatory purposes