Chapter 1: Setting up a Quality Management System
26
example, either by having the product under lock and key
or using a stock control system to ensure no one can take
the material and use it as a medical device or component
thereof. If an organization reworks nonconforming mate-
rial, the rework must demonstrate the medical device still
meets the product’s defined specifications. Elements that
need to be included in the control process for noncon-
forming product should be defined. These should include
how the product is identified and controlled, so it is not
used inadvertently. Personnel responsible for deciding
on the disposition of nonconforming product must
be identified and documented. If the nonconformity
is detected during finished medical device testing, the
disposition decision probably would be made by more
senior personnel, so the quality and regulatory impact
can be considered by those with the widest knowledge of
the organization.
A formally designated complaint unit should
be responsible for the specific requirements relating
to complaint files. All complaints have to be docu-
mented, including those received verbally by telephone
or received by other members of the organization
who normally would not receive complaints. There
is a defined timescale for assessing all complaints to
determine whether they are medical events under the
requirements of 21 CFR Part 803 (Medical Device
Reporting).28 The period from receipt of a complaint
to its review must be within the timescale. If a service
report is a medical event, this would be included in the
reporting system the manufacturer must have in place.
In the system, the manufacturer has to ensure service
report review to determine whether they are medi-
cal events. 21 CFR Part 806’s requirements relating
to corrections and removals also must be included in
organization procedures.29 In addition, the organization
must ensure the procedure can be implemented at any
time, even on a public holiday. Medical device tracking
needs to be built into the quality system, and 21 CFR
Part 821 states the manufacturer or importer is respon-
sible for devices that fall under the regulation.30 This
will be covered in an FDA assessment. The organization
must ensure it can locate the device in a timely manner,
so the customer can be contacted in the event the device
is subject to a correction or removal. There should be
procedures in place for any statistical techniques used
in the QMS, manifested in at least quarterly analysis of
quality trending by the quality assurance function.
Design Control
Design and development include all aspects of bringing
the medical device to the customer. This ranges from
determining the design inputs and ensuring they are in
line with the user and regulatory requirements through
product availability and customer service. It also
includes managing design changes. QSR requirements
identify various ways to approach this:
• planning
• inputs
• outputs
• review
• verification
• validation
• transfer
• design changes
• design history file (DHF)
Design control procedures are required, including some
specified in the QSR. Each device must have a DHF.
This may include all the documents relating to the
device’s development and should include any change(s)
made once the device has been placed on the market
and throughout its lifecycle. There should be clear trace-
ability, linking inputs to outputs that demonstrate the
input has been achieved. This usually is managed using
a trace matrix. These matrices often use databases to
ensure clear linkage of the requirements, especially for
a complex device. The DHF also will include evidence
of the design reviews that took place during the device’s
development, and key decisions made. The design
review must include an independent review by some-
one not involved in the device’s development but with
sufficient knowledge to assess the device’s safety and
effectiveness and ensure the design is appropriate for its
intended use. This often occurs at two levels: assessing
26
example, either by having the product under lock and key
or using a stock control system to ensure no one can take
the material and use it as a medical device or component
thereof. If an organization reworks nonconforming mate-
rial, the rework must demonstrate the medical device still
meets the product’s defined specifications. Elements that
need to be included in the control process for noncon-
forming product should be defined. These should include
how the product is identified and controlled, so it is not
used inadvertently. Personnel responsible for deciding
on the disposition of nonconforming product must
be identified and documented. If the nonconformity
is detected during finished medical device testing, the
disposition decision probably would be made by more
senior personnel, so the quality and regulatory impact
can be considered by those with the widest knowledge of
the organization.
A formally designated complaint unit should
be responsible for the specific requirements relating
to complaint files. All complaints have to be docu-
mented, including those received verbally by telephone
or received by other members of the organization
who normally would not receive complaints. There
is a defined timescale for assessing all complaints to
determine whether they are medical events under the
requirements of 21 CFR Part 803 (Medical Device
Reporting).28 The period from receipt of a complaint
to its review must be within the timescale. If a service
report is a medical event, this would be included in the
reporting system the manufacturer must have in place.
In the system, the manufacturer has to ensure service
report review to determine whether they are medi-
cal events. 21 CFR Part 806’s requirements relating
to corrections and removals also must be included in
organization procedures.29 In addition, the organization
must ensure the procedure can be implemented at any
time, even on a public holiday. Medical device tracking
needs to be built into the quality system, and 21 CFR
Part 821 states the manufacturer or importer is respon-
sible for devices that fall under the regulation.30 This
will be covered in an FDA assessment. The organization
must ensure it can locate the device in a timely manner,
so the customer can be contacted in the event the device
is subject to a correction or removal. There should be
procedures in place for any statistical techniques used
in the QMS, manifested in at least quarterly analysis of
quality trending by the quality assurance function.
Design Control
Design and development include all aspects of bringing
the medical device to the customer. This ranges from
determining the design inputs and ensuring they are in
line with the user and regulatory requirements through
product availability and customer service. It also
includes managing design changes. QSR requirements
identify various ways to approach this:
• planning
• inputs
• outputs
• review
• verification
• validation
• transfer
• design changes
• design history file (DHF)
Design control procedures are required, including some
specified in the QSR. Each device must have a DHF.
This may include all the documents relating to the
device’s development and should include any change(s)
made once the device has been placed on the market
and throughout its lifecycle. There should be clear trace-
ability, linking inputs to outputs that demonstrate the
input has been achieved. This usually is managed using
a trace matrix. These matrices often use databases to
ensure clear linkage of the requirements, especially for
a complex device. The DHF also will include evidence
of the design reviews that took place during the device’s
development, and key decisions made. The design
review must include an independent review by some-
one not involved in the device’s development but with
sufficient knowledge to assess the device’s safety and
effectiveness and ensure the design is appropriate for its
intended use. This often occurs at two levels: assessing