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2
Medical Device Quality
Management Systems
By Gert Bos, MSc, PhD, FRAPS
Introduction
A quality management system (QMS) is one of the five
medical device conformity assessment elements.1
Manufacturers of medical devices are expected
to implement, document, and maintain a QMS that
“ensures the medical devices it designs, manufac-
tures and supplies to the market are safe, perform as
intended, and comply with the relevant provisions of
the regulations in the countries where the product is
made available.”2
Today, a QMS is seen as a set of interrelated or
interacting processes to establish policy and objectives
and to achieve those objectives regarding quality. See
the process flow diagram in Figure 2-1..3
The recognized international standard for medical
device quality management systems (MDQMS) is ISO
13485:2016—Medical devices—Quality management
systems—Requirements for regulatory purposes. In
some jurisdictions, the previous version of the standard
(ISO 13485:2003) also is accepted.
The 2016 version of the standard has to date nearly
reached a globally implemented status. At first glance,
the structure of the new version of the standard has
remained the same, and hence has not been restruc-
tured like most quality management system standards.
The key objectives in the update focus on bringing the
requirements closer to the state of art expectations in
the global regulatory environment. Many elements from
the US FDA Quality System Regulations (QSR) that did
not make it into the previous version of the standard are
now included. Also, key concepts from the global audit
model MDSAP (IMDRF’s Medical Device Single
Audit Program) have been integrated, as well as changes
resulting from the new European Medical Devices
Regulation (EU MDR). These additional elements
include the following:
• Increased focus on compliance with regulatory
requirements
• Process controls based on risk management
• Increased requirements for design and develop-
ment, including considerations of usability, use of
standards, verification and validation, design and
development transfer, and design records
• Increased controls for outsourced processes and
suppliers
• Increased requirements for process validation
• Increased requirements for “feedback,” including
complaint handling
• Introduction of statistical techniques for data
analysis
QMS Versus Good Manufacturing
Practice (GMP)
It is important to understand how QMS (and quality
requirements in regulations and standards) can relate to
several, if not all, processes within an organization that
can impact at least one medical device lifecycle phase.4
Companies or organizations can be involved in one
or more lifecycle stages, including medical device design
and development, production, storage and distribution,
installation or servicing, changes and updates, and asso-
ciated activities (e.g., technical support).
When applied to the manufacturing process,
QMS requirements impose strict controls to create a
controlled manufacturing system, sometimes referred
to as good manufacturing practice (GMP). The
objective is to reduce the likelihood of a nonconform-
ing product reaching the market, or, even better, not
produced at all, thus ensuring products’ ultimate safety
and effectiveness.5
2
Medical Device Quality
Management Systems
By Gert Bos, MSc, PhD, FRAPS
Introduction
A quality management system (QMS) is one of the five
medical device conformity assessment elements.1
Manufacturers of medical devices are expected
to implement, document, and maintain a QMS that
“ensures the medical devices it designs, manufac-
tures and supplies to the market are safe, perform as
intended, and comply with the relevant provisions of
the regulations in the countries where the product is
made available.”2
Today, a QMS is seen as a set of interrelated or
interacting processes to establish policy and objectives
and to achieve those objectives regarding quality. See
the process flow diagram in Figure 2-1..3
The recognized international standard for medical
device quality management systems (MDQMS) is ISO
13485:2016—Medical devices—Quality management
systems—Requirements for regulatory purposes. In
some jurisdictions, the previous version of the standard
(ISO 13485:2003) also is accepted.
The 2016 version of the standard has to date nearly
reached a globally implemented status. At first glance,
the structure of the new version of the standard has
remained the same, and hence has not been restruc-
tured like most quality management system standards.
The key objectives in the update focus on bringing the
requirements closer to the state of art expectations in
the global regulatory environment. Many elements from
the US FDA Quality System Regulations (QSR) that did
not make it into the previous version of the standard are
now included. Also, key concepts from the global audit
model MDSAP (IMDRF’s Medical Device Single
Audit Program) have been integrated, as well as changes
resulting from the new European Medical Devices
Regulation (EU MDR). These additional elements
include the following:
• Increased focus on compliance with regulatory
requirements
• Process controls based on risk management
• Increased requirements for design and develop-
ment, including considerations of usability, use of
standards, verification and validation, design and
development transfer, and design records
• Increased controls for outsourced processes and
suppliers
• Increased requirements for process validation
• Increased requirements for “feedback,” including
complaint handling
• Introduction of statistical techniques for data
analysis
QMS Versus Good Manufacturing
Practice (GMP)
It is important to understand how QMS (and quality
requirements in regulations and standards) can relate to
several, if not all, processes within an organization that
can impact at least one medical device lifecycle phase.4
Companies or organizations can be involved in one
or more lifecycle stages, including medical device design
and development, production, storage and distribution,
installation or servicing, changes and updates, and asso-
ciated activities (e.g., technical support).
When applied to the manufacturing process,
QMS requirements impose strict controls to create a
controlled manufacturing system, sometimes referred
to as good manufacturing practice (GMP). The
objective is to reduce the likelihood of a nonconform-
ing product reaching the market, or, even better, not
produced at all, thus ensuring products’ ultimate safety
and effectiveness.5