- Category: Monthly Member Profile
- Published: 02 March 2017
- Hits: 348
The publication of the document CWA 15793: Laboratory Biorisk Management in 2008, had a great impact in the community who work with biological risk management. Since the first International Symposium on Biosafety and Biocustody organized by AMEXBIO in 2009, we have had speakers who have made known the content and scope of this document. In June 2014, AMEXBIO convened its Founding Members, Titular Members and Honorary Members to form a Working Group for the elaboration of its own guidelines for biological risk management, based on the CWA15793. The first meeting took place at the VI International Symposium on Biosafety and Biocustody. The meeting drew up the work plan to be followed. It then began an arduous confidential process, first from CWA's professional translation into Spanish, followed by a technical review before submitting the document to the Working Group in February 2015. The Working Group members made more than 200 comments on the document, which were based about the translation and about the content of the document itself.
It became evident that the AMEXBIO guidelines required a different structure and a thorough revision of the concepts, due to two fundamental reasons: to clearly separate and reinforce the stages of the Deming cycle; and on the other hand to integrate particular requirements from the Mexican regulation. This last important point would allow a simpler implementation at local organizations. One of the goals of the Working Group was to generate an understandable document for people with little experience in management systems. A greater emphasis was also placed on the responsibilities and interrelations of the members of the organization with the biological risk management system, and on setting targets and indicators as part of the biological risk management system. After 45 virtual meetings, one presential meeting and 18 months of work by the Working Group, a draft was reached and released for a "public discussion" in the social networks of the Association during 45 days, between May and July 2016. At the final stage, the AMEXBIO participated in the discussions to homologate a series of words for the Spanish translation of the Professional Certification Exam in Biorisk Management of the IFBA, particularly with the Subcommission on Biosafety and Biocustody of the Association of Microbiology from Argenina (AAM) and with the Spanish Association of Biosafety (AEBioS). Such effort was also incorporated into the AMEXBIO Guidelines with the aim of reducing confusion and facilitating communication between Spanish speakers.
The AMEXBIO Guidelines for Biorisk Management is based on CWA15793, but at no time does it seek to infringe the copyright of CEN. A thorough process has been taken to check what is conducive to it. The Working Group considers that the Guidelines are a logical evolution in time and place from CWA15793, which are non-profit, but pursues the same purposes: to control the biological risks of an organization.
Laboratorio Estatal de Salud Pública de Michoacán
Michoacán, Morelia, Mexico