Quality management in a high-containment laboratory

Abstract

The National Biosafety Laboratory level 4 in Wuhan was accredited according to the Guo Biao (National standard) 19489:2008 standard in 2017 by the China National Accreditation Service for Conformity Assessment and was then licensed to store and handle microorganisms of risk group 4. The current aim of laboratory management is to accredit this high-containment laboratory according to the ISO/IEC 17025:2017 standard to set up a quality management system. To complement this standard, the Comité Européen de Normalisation (CEN, i.e., European Committee for Standardization) Working Agreement 15793:2011 is also used for safety and security against biorisks. The Chinese Guo Biao 19489:2008 standard is also taken into account to achieve two aims: to comply with Chinese legislation and to improve the level of detail in the laboratory’s documentation. Furthermore, the management proposes to apply Good Research Laboratory Practices (published by the China National Accreditation Service for Conformity Assessment), in which ethical rules are laid down. Only a well-integrated and well-managed quality management system can master the implementation of all these different guidelines. Nonetheless, it would be better if all the requirements were combined into one standard. Therefore, there is a real need for drafting a new standard or guideline specifically for containment laboratories. Keywords: Biocontainment, Biosecurity, Bbiosafety, BSL4, Accreditation