Z7000-18

Preface
0 Introduction
1 Scope
2 Reference publications
3 Definitions and abbreviations
4 QMS principles in the perioperative environment
5 Respectful workplace dynamics
6 Quality management systems (QMS)
7 Evaluation and purchase of medical devices and equipment
   used in a perioperative environment
8 Personnel
9 OHS
10 Infection prevention and control
11 Area design and use

Preface This is the first edition of CSA Z7000, General requirements for quality management and safety in perioperative settings. This Standard replaces CSA Z305.0-13, Safety of personnel in perioperative environments. CSA acknowledges that the development of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH). This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope 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.

Preface This is the first edition of CSA Z7000, General requirements for quality management and safety in perioperative settings. This Standard replaces CSA Z305.0-13, Safety of personnel in perioperative environments. CSA acknowledges that the development of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH). This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope 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.