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Certifications

BioVendor – Laboratorni medicina 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: Quality Management System

ISO 9001:2000 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 13485: 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 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.



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