Laboratory Biorisk Management Standard CWA 15793:2008

Laboratory Biorisk Management Standard CWA 15793:2008- International -Laboratory Biorisk ManagementStandardCWA 15793:2008

Laboratory Biorisk Management Standard CWA 157932

Laboratory Biorisk Management Standard CWA 15793:2008Overview• In 2007, the document was adopted, and publishedas CWA 15793:2008 by CEN in 2008– 76 participants from 24 countries developed amanagement system approach to biosafety andbiosecurity in the laboratory– CEN in Brussels facilitated the process with funding bythe European Commission

Laboratory Biorisk Management Standard CWA 15793:2008CWA 15793:2008is aManagement System StandardConsistent with other internationalstandards such as ISO 9001 /14001 and OSHAS18001Contains definitions, requirementsand notes for guidance

Laboratory Biorisk Management Standard CWA 15793:2008A Management System ApproachWhat is a Management System?• A framework that integrates best practices and procedures• Ensures that an organization can effectively achieve all of its objectives• Frequently built around the Plan, Do, Check, Act cycle

Laboratory Biorisk Management Standard CWA 15793:2008What is Biorisk Management?• Biorisk encompasses biosafety andbiosecurity, where the hazards arebiological agents and their products• Establishes systems and policies tomanage the laboratory biorisk• Integral in the day-to-day operations of theinstitute / organization, both in normal timesand times of emergency

Laboratory Biorisk Management Standard CWA 15793:2008Purpose of the CWA 15793:2008The Standard can be used for:• Improving overall laboratory biorisk performance• Increasing awareness of biosafety andbiosecurity risks• Effective management of complex laboratorysafety and security processes• Improving international laboratory collaborationand safety harmonization• Basis for new or revised legislation or regulations• Support laboratory certification/accreditation,audits/inspections

Laboratory Biorisk Management Standard CWA 15793:2008Scope• The Standard is not a technical document• The Standard is performance oriented― Describes what needs to be achieved― How to do it is up to the organization

Laboratory Biorisk Management Standard CWA 15793:2008Scope• The Standard is not intended to replace anynational or sub-national regulatoryrequirements that may apply to thelaboratory/facility• Compliance with regulatory requirements ismandatory

Laboratory Biorisk Management Standard CWA 15793:2008Integration• The standard is designed to complement othermanagement standards– ISO9001 (Quality)– ISO14001 (Environmental)– OHSAS18001 (Occupational Health and Safety)

Laboratory Biorisk Management Standard CWA 15793:2008CWA 15793:2008• Extensive Definition SectionContent• Policy, Planning, Implementation &Operation, Checking and Corrective Action,Review

Laboratory Biorisk Management Standard CWA 15793:2008ContentExamples of topics covered:– Biorisk Management Policy– Hazard Identification, risk assessment, and risk control– Roles, responsibilities, and authorities– Training, awareness and competence– Operational control– Emergency response and contingency plans– Inventory monitoring and control– Accident and incident investigation– Inspection and audit– Biorisk management review

Laboratory Biorisk Management Standard CWA 15793:2008International ApproachLocal solutions for local problems• Not country specific• Based on international, acceptable best practices• Local solutions possible• The Standard is based around the current WHOBiosafety and Biosecurity Guidelines

Laboratory Biorisk Management Standard CWA 15793:2008Risk Assessmenthttp://www.biosafetyriskassessment.org/

Laboratory Biorisk Management Standard CWA 15793:2008Example• Occupational Health4.4.1.6 Occupational healthThe organization shall have access to appropriate occupational health expertise andestablish an occupational health program commensurate with the activities and risk ofthe facility.

Laboratory Biorisk Management Standard CWA 15793:2008CWA 15793BMBL, LBM etc.Management System yes noPolicy yes Generic (if at all)ContinualImprovementRoles &ResponsibilitiesyesyesnosomeDocument Control yes noAuditing yes someObjectives yes noCertification(accredited)yesKey differencesno

Laboratory Biorisk Management Standard CWA 15793:2008SummaryCWA 15793:2008• Comprehensive blueprint for biosafety &biosecurity (biorisk) program

Laboratory Biorisk Management Standard CWA 15793:2008• CWA 15793:2008 has a life-cycle of 3 years– Renewal, change, termination• Learning experience for the community– Implementation by laboratoriesNext Steps

Laboratory Biorisk Management Standard CWA 15793:2008Next Steps…• Document now available on CEN website• New 2010 CEN workshop:“Guidance Document”• Clearinghouse for user experiences• Training and education seminars and workshopshttp://www.cen.eu/cenorm/businessdomains/technicalcommitteesworkshops/workshops/ws31.asp

Laboratory Biorisk Management Standard CWA 15793:2008• CWA 15793:2008 “Guidance Document”1. Meeting in Europe2. Meeting in Africa3. Meeting in North America

Laboratory Biorisk Management Standard CWA 15793:2008Conclusions• The Laboratory Biorisk Management Standard hasbeen developed by the community for thecommunity• Addresses biorisk holistically, and is directlyapplicable for controlling hazardous biologicalagents and toxins in the laboratory

Laboratory Biorisk Management Standard CWA 15793:2008Conclusions…• Adoption and implementation of the CWA 15793:2008 willbe an integral part of the future biorisk managementagenda for laboratories worldwide, and a necessity toprotect people and the environment as well as buildingcommunity confidence

Laboratory Biorisk Management Standard CWA 15793:2008http://www.cen.eu/CENORM/Sectors/technicalcommitteesworkshops/workshops/ws31.asp

Laboratory Biorisk Management Standard CWA 15793:2008WORLD HEALTH ORGANIZATION24

Laboratory Biorisk Management Standard CWA 15793:2008References: Guidelines• Laboratory Biosafety Manual, 3 rd Edition– World Health Organization• Biosafety in Microbiological and Biomedical Laboratories, 5 thEdition,– CDC/NIH: extensive recommendations on biosecurity• Laboratory Biosafety Guidelines, 3 rd Edition– Public Health Agency Canada• Biorisk Management: Laboratory Biosecurity Guidance– WHO/FAO/OIE joint international biosecurity guidelines• Laboratory Biosecurity Handbook– Sandia National Laboratories• Organization for Economic Co-operation and Development(OECD) is establishing biosecurity guidelines