scope:

This document is intended for sterile processing personnel and specifies minimum requirements for a quality management system (QMS) in a health care organization to effectively, efficiently, and consistently process medical devices to prevent adverse patient events and non-manufacturer-related device failures.

Inclusions

This standard addresses the major elements of a quality management system as it applies to the processing of health care products performed in a sterile processing area or similar location with the same responsibility. The major elements of a quality management system are as follows:

a) General objectives and documentation requirements

b) Management responsibility

c) Resource management

d) Product realization

e) Measurement, analysis, and improvement

Exclusions

This standard does not cover

a) the implementation of any specific AAMI standard, recommended practice, or guideline supporting a particular process;

b) the development or implementation of any specific system instruction, work instruction, or policy supporting a particular process and/or piece of equipment;

c) the development or implementation of any specific education, training, or competency test supporting a particular process and/or piece of equipment;

d) the development or implementation of any specific audit process or tool supporting a particular process and/or piece of equipment; or

e) the reprocessing of single-use devices by a health care facility.