Page 50 - Safety Risk Management for Medical Devices

CHAPTER 7

Quality Management System

Abstract
Your Quality Management System (QMS) is the internal reflection of the external standards. Your
SOPs bring the standards to life within your company. A clear, organized, and well-written SOP
sends a message to regulatory bodies that your QMS is consistent and compliant to applicable
standards. More importantly, well-written SOPs ensure that your personnel can faithfully and accu-
rately follow your internal processes resulting in proper outcomes and quality work. On the other
hand, a poorly written confusing SOP could result in noncompliance, which could lead to observa-
tions and warnings from regulatory bodies at best and in some cases, severe penalties including
consent decrees and shut down of the company.
Keywords: Quality Management System; risk management; SOP

Your Quality Management System (QMS) is the internal reflection of the external
standards. Your SOPs bring the standards to life within your company. A clear, orga-
nized, and well-written SOP sends a message to regulatory bodies that your QMS is
consistent and compliant to applicable standards. More importantly, well-written
SOPs ensure that your personnel can faithfully and accurately follow your internal
processes resulting in proper outcomes and quality work. On the other hand, a poorly
written confusing SOP could result in noncompliance, which could lead to observa-
tions and warnings from regulatory bodies at best and in some cases, severe penalties
including consent decrees and shut down of the company.
In addition to SOPs, many companies employ templates and work instructions to
assist in the quality execution of the risk management work. While SOPs are more
high level and designed to ensure compliance to applicable standards, work instruc-
tions provide detailed guidance on how to do the work.
As with all other controlled documents, risk management artifacts must be
controlled per the methods that are stipulated in your QMS. Absent this strict
control, it would be easy for analyses and their targets to go out of sync. That in
turn could lead into unwanted outcomes like missed Hazards, injured patient, audit
findings, etc.
One of the great benefits of a good risk management process is the ability to
provide safety impact analysis of proposed changes. In any good QMS, an impact

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00007-6 All rights reserved. 29