CEN WORKSHOP AGREEMENT CWA 15793

CWA 15793:2011 (E)
3.9
biorisk management system (adapted from OHSAS 18001:2007)
part of an organization’s management system used to develop and implement its biorisk policy and manage
its biorisks
NOTE 1 A management system is a set of interrelated elements used to establish policy and objectives and to achieve
those objectives.
NOTE 2 A management system includes organizational structure, planning activities (including for example, risk
assessment and the setting of objectives), responsibilities, practices, procedures, processes and resources.
3.10
biorisk management advisor
individual who has expertise in the biohazards encountered in the organization and is competent to advise top
management and staff on biorisk management issues
NOTE Depending on national guidelines and institutional traditions the role of a biorisk management advisor may be
differently named e.g. biosafety officer, biosecurity officer, biorisk manager or biorisk management officer.
3.11
biosafety (adapted from: WHO/CDS/EPR/2006.6)
laboratory biosafety describes the containment principles, technologies and practices that are implemented to
prevent the unintentional exposure to biological agents and toxins, or their accidental release
3.12
biosecurity (adapted from: WHO/CDS/EPR/2006.6)
laboratory biosecurity describes the protection, control and accountability for biological agents and toxins
within laboratories, in order to prevent their loss, theft, misuse, diversion of, unauthorized access or intentional
unauthorized release
NOTE In the context of this agreement biosecurity is restricted to laboratory biosecurity; laboratory includes animal and
manufacturing facilities, and does not include all aspects of biosecurity in the sense of national or regional control
measures to prevent the dissemination of alien species and pathogens.
3.13
calibration (ISO 17025:1999)
correlation of the performance of equipment (e.g. readings of an instrument) to a standard
3.14
certification
systematic, documented process to ensure systems perform in accordance with available certification
standards or applicable validation guidance
3.15
community
people outside the workplace potentially affected by the activities of the facility
3.16
competence (ISO 9000:2005)
appropriate education, training, skills and experience
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