Quality is an important value for VisMederi. It is the core of a trust-based relationship with clients, partners and employees and is an integral part of business culture.
VisMederi conducts all of its activities in compliance with the European system of certification UNI EN ISO 9001 : 2015. This entails continually working on improving the internal management system by getting the entire company involved in the optimization of services and performance. In order to satisfy the needs and expectations of the forefront of international research, VisMederi’s quality policy prioritizes the creation of an elevated, qualitative level of analysis and the continual improvement of methods, technical facilities and instruments, searching for the full involvement of its own personnel. The staff is its most important resource for reaching quality objectives.
At VisMederi, objectives and suitability with quality policy are constantly re-examined and adjusted for the development of scientific research, assuring continual attention towards the client.
Quality Management System Certificate
UNI EN ISO 9001 : 2015
In 2010, VisMederi obtained certification for the UNI EN ISO 9001 : 2008 standard. The Quality Management System ensures the requisites of management systems for quality that a company must meet in order to show its capability to provide products and services that meet the requisites of the client in regulated areas. Quality is defined by the ISO 9001:2008 as the level in which a series of intrinsic characteristics meet the requisites in a process of continual improvement. Since 2018 VisMederi has adapted to the new edition of UNI EN ISO 9001 : 2015 standard.
Accreditation for medical laboratories
UNI EN ISO 15189 : 2013
In May 2015, the company obtained accreditation as an operating laboratory in compliance with the UN CEI EN ISO/IEC 15189 : 2007 standards for the medical sector through Accredia (Italian governmental body of accreditation). The management system requirements in ISO 15189 : 2013 are written in a language relevant to a medical laboratories operations and meet the principles of ISO 9001 : 2008 Quality management systems – Requirements and are aligned with it pertinent requirements.
Information Security Management System Certificate
EN ISO 27001 : 2013
EN ISO 27001 : 2013 is an international standard that provides the requirements of an Information Security Management System – ISMS. The Standard includes people, processes and IT systems by applying a risk management process.
During the year 2019 VisMederi obtained this prestigious certification in order to meet the contractual requirements of the Customers and to demonstrate impartiality of compliance with laws and regulations. VisMederi also intends to guarantee constant monitoring of company performance and therefore activate the necessary improvement actions.
Accreditation Good Clinical Laboratory Practice (GCLP)
In January 2017 VisMederi obtained from the British independent consultancy company Qualogy the accreditation as a serological laboratory that operates in compliance with the international Good Clinical Laboratory Practice Guidelines (GCLP, ISBN 978-1-904610-00-7). The GCLP guidelines, adopted by the World Health Organization (WHO), identify the necessary requirements and the procedures to be followed in the laboratories that conduct analyses of samples from clinical trials.