Z305.0-13

Scope 1.1 This Standard includes requirements for a quality management system (QMS) that addresses safety of personnel in perioperative environments including requirements for a) establishing a QMS; b) OHS; c) policies and SOPs, clinical practice standards, and documentation; d) personnel qualifications and training; e) work areas and equipment; f) infection, prevention, and control; and g) evaluation and purchase of reusable medical devices. 1.2 In this Standard, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; "should" is used to express a recommendation or that which is advised but not required; and "may" is used to express an option or that which is permissible within the limits of the standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (nonmandatory) to define their application.