scope:

General

This Standard is intended to form the basis of a QMS within a health care or home setting for the purpose of providing safe, reliable kidney dialysis treatments.

Note: A comprehensive QMS can be achieved when this Standard is used in combination with the following related Standards:

a) CAN/CSA-C22.2 No. 60601-1;

b) CAN/CSA-C22.2 No. 60601-2-16;

c) CAN/CSA-C22.2 No. 60601-2-39;

d) CSA ISO 8637-1;

e) CSA ISO 8637-2;

f) CSA Z23500-1;

g) CSA Z23500-2;

h) CSA Z23500-3;

i) CSA Z23500-4;

j) CSA Z23500-5;

k) CSA Z364.2.1;

l) CSA Z364.5; and

m) CSA Z8000.

Supplemental requirements

As part of a QMS, this Standard includes requirements for

a) quality management, including

i) policies and procedures;

ii) documentation;

iii) roles and responsibilities;

iv) management review;

v) personnel qualifications and training; and

vi) adverse event management (e.g., recalls);

b) occupational health and safety;

c) evaluation and purchase of dialysis equipment and medical devices;

d) infection prevention and control;

e) work areas and equipment;

f) environmental conditions; and

g) utilities (e.g., power supply and water quality).

Applicable health care facilities (HCFs)

This Standard applies to health care or home settings where kidney dialysis therapies occur, including, but not limited to,

a) hospital dialysis centres;

b) regional dialysis clinics;

c) trauma centres;

d) emergency care facilities;

e) medical clinics, with or without overnight stay or observation;

f) nursing homes;

g) long-term care facilities;

h) assisted-living facilities;

i) mental health facilities;

j) rehabilitation facilities;

k) chronic care facilities;

l) group homes;

m) hospice care facilities;

n) stand-alone dialysis clinics; and

o) client homes.

Terminology

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.