Chapter 1: Setting up a Quality Management System
24
• In 1911, adulterating foods or drugs was made
illegal.
• In 1938, the Federal Food, Drug, and Cosmetic Act
was enacted, making it illegal to sell unsafe drugs.24
• The law was amended in 1962 to include drug
effectiveness, following the Thalidomide scandal in
Europe.
• In 1963, the first drug Good Manufacturing
Practices (GMPs) were adopted.25
• The Medical Device Amendments began in 1976 and
were published in 1978.26
• The Safe Medical Devices Act was enacted in 1990.27
• In 1996, the Quality System Regulation was
published, incorporating most ISO principles,
becoming effective in June 1997. The design control
requirements took effect in June 1998, replacing
the 1978 GMP requirements and based on ISO
13485:1996. These changes focused on ensuring
safe and effective drugs and medical devices to
ensure they caused no harm.
The QSR requires all manufacturers to develop and
follow procedures and fill in the details that are
appropriate to a given device according to the current
state-of-the-art manufacturing for that specific device.
While the QSR provides the framework for manu-
facturers, the manufacturer is responsible for determining
how it will meet the requirements. This enables both large
and small organizations to meet the requirements and
covers the broad and diverse range of medical devices,
technologies and manufacturing processes.
Among other factors, the QMS should be devel-
oped to accommodate the risk of devices of any
complexity, taking into account relevant manufacturing
processes and organizational complexity and size. The
QSR outlines basic elements for inclusion. Additional
details may be required as device complexity and poten-
tial risk increase.
Subsystems of a Quality System
As in ISO 13485, QSR requirements can be segmented
around subsystems.
Management
An organization’s management needs to demonstrate
its understanding, support and leadership for imple-
menting and maintaining a QMS that complies with
QSR requirements. This should be demonstrated by a
QSR assessment.
The organization’s quality policy outlines its
aims and how they are fulfilled regarding regulatory
requirements as defined by management. It is import-
ant to include FDA quality system requirements as
part of the policy.
The organizational structure has to be defined. The
independence of those responsible for product quality
(the quality unit) and product release to customers
must be defined clearly they must be autonomous from
influence by those in the organization not responsible
for product quality. Typically, product quality responsi-
bility within an organization is a different reporting line
from that of those responsible for product research and
development, manufacturing, sales and/or marketing.
Management review is the opportunity for exec-
utive management to confirm the quality system
remains effective. Clearly defined inputs, usually in the
form of metrics for each subsystem, should assess how
the system is functioning while ensuring the metrics
demonstrate products remain safe and effective. It is
important to follow through on any actions (e.g., via the
CAPA system) resulting from the management review.
The intervals at which management review occurs must
be defined and scheduled on a regular basis. The review
must take place annually, at a minimum however,
reviews typically are quarterly. Annual reviews are not
sufficient to ensure quality system effectiveness.
The management representative’s role is key within
the organization. Executive management appoints the
management representative and documents it in writ-
ing. The QSR defines the management representative’s
responsibilities in ensuring the QMS is established and
maintained effectively and requires the representative to
report on QMS performance to executive management.
This is done primarily through regular management
review meetings.
24
• In 1911, adulterating foods or drugs was made
illegal.
• In 1938, the Federal Food, Drug, and Cosmetic Act
was enacted, making it illegal to sell unsafe drugs.24
• The law was amended in 1962 to include drug
effectiveness, following the Thalidomide scandal in
Europe.
• In 1963, the first drug Good Manufacturing
Practices (GMPs) were adopted.25
• The Medical Device Amendments began in 1976 and
were published in 1978.26
• The Safe Medical Devices Act was enacted in 1990.27
• In 1996, the Quality System Regulation was
published, incorporating most ISO principles,
becoming effective in June 1997. The design control
requirements took effect in June 1998, replacing
the 1978 GMP requirements and based on ISO
13485:1996. These changes focused on ensuring
safe and effective drugs and medical devices to
ensure they caused no harm.
The QSR requires all manufacturers to develop and
follow procedures and fill in the details that are
appropriate to a given device according to the current
state-of-the-art manufacturing for that specific device.
While the QSR provides the framework for manu-
facturers, the manufacturer is responsible for determining
how it will meet the requirements. This enables both large
and small organizations to meet the requirements and
covers the broad and diverse range of medical devices,
technologies and manufacturing processes.
Among other factors, the QMS should be devel-
oped to accommodate the risk of devices of any
complexity, taking into account relevant manufacturing
processes and organizational complexity and size. The
QSR outlines basic elements for inclusion. Additional
details may be required as device complexity and poten-
tial risk increase.
Subsystems of a Quality System
As in ISO 13485, QSR requirements can be segmented
around subsystems.
Management
An organization’s management needs to demonstrate
its understanding, support and leadership for imple-
menting and maintaining a QMS that complies with
QSR requirements. This should be demonstrated by a
QSR assessment.
The organization’s quality policy outlines its
aims and how they are fulfilled regarding regulatory
requirements as defined by management. It is import-
ant to include FDA quality system requirements as
part of the policy.
The organizational structure has to be defined. The
independence of those responsible for product quality
(the quality unit) and product release to customers
must be defined clearly they must be autonomous from
influence by those in the organization not responsible
for product quality. Typically, product quality responsi-
bility within an organization is a different reporting line
from that of those responsible for product research and
development, manufacturing, sales and/or marketing.
Management review is the opportunity for exec-
utive management to confirm the quality system
remains effective. Clearly defined inputs, usually in the
form of metrics for each subsystem, should assess how
the system is functioning while ensuring the metrics
demonstrate products remain safe and effective. It is
important to follow through on any actions (e.g., via the
CAPA system) resulting from the management review.
The intervals at which management review occurs must
be defined and scheduled on a regular basis. The review
must take place annually, at a minimum however,
reviews typically are quarterly. Annual reviews are not
sufficient to ensure quality system effectiveness.
The management representative’s role is key within
the organization. Executive management appoints the
management representative and documents it in writ-
ing. The QSR defines the management representative’s
responsibilities in ensuring the QMS is established and
maintained effectively and requires the representative to
report on QMS performance to executive management.
This is done primarily through regular management
review meetings.