General requirements for quality management and safety in perioperative settings

1.1

This Standard includes requirements for establishing a quality management system (QMS) that addresses safety of patients, personnel, families, vendors, third parties, and visitors in a perioperative environment including requirements for

a) establishing a QMS;

b) occupational health and safety (OHS);

c) policies and standard operating procedures (SOPs), clinical practice standards, and documentation;

d) personnel qualifications and training;

e) work areas and equipment;

f) infection prevention and control;

g) evaluation and purchase of medical devices; and

h) management and prevention of patient safety incidents.

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 (non-mandatory) to define their application.