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
ISO 14001: Environmental Management System
ISO 14001 is an internationally accepted specification for an environmental management system (EMS). It specifies requirements for establishing an environmental policy, determining environmental aspects and impacts of products/activities/services, planning environmental objectives and measurable targets, implementation and operation of programs to meet objectives and targets, checking and corrective action, and management review.
ISO 14001: Environmental Management System
ISO 50001: 2018: Energy Management System
The management of energy consumption in the provision of the design, production and distribution of in vitro diagnostics and bio chemicals, distribution and service of laboratory equipment. Operating from Head Office in Brno, including all buildings and processes operated on this site. All significant energy uses relate to the operation of the buildings and facilities with the main sources of energy being electricity and gas.
ISO 50001: 2018: Energy management