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SYSTEM REGULATION
VERSUS ISO 13485:2016
QUALITY MANAGEMENT
SYSTEM REQUIREMENTS
NSF INTERNATIONAL 21 CFR § 820 &
ISO 13485:2016 ALIGNMENT CHART
Author: Robert Ruff, Executive Director, NSF International
Researcher: Samuel Brown, Research Associate, NSF International
This tool clarifies the corresponding relationships between the US FDA Quality System Regulation and ISO 13485:2016
– Medical devices – Quality management systems – Requirements for regulatory purposes clauses. Use this tool to
ensure your quality management system meets applicable requirements of both US FDA and ISO 13485:2016
21 CFR § 820 US FDA QUALITY SYSTEM REGULATION ISO 13485:2016 SPECIFIC DIFFERENCES
820.1 Scope 1 Scope
Each manufacturer shall establish a quality ISO 13485:2016 specifies 5.4.2 Top
plan which defines the quality practices, management shall ensure that: b) The
5.4.2 Quality
820.20(d) resources, and activities relevant to devices integrity of the quality management
Management
Quality Planning that are designed and manufactured. system is maintained when changes to the
System Planning
The manufacturer shall establish how the quality management system are planned
requirements for quality will be met. and implemented.
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21 CFR § 820 US FDA QUALITY SYSTEM REGULATION ISO 13485:2016 SPECIFIC DIFFERENCES
(1) Each manufacturer of any class III or
class II device, and the class I devices
listed in paragraph (a)(2) of this section,
shall establish and maintain procedures
to control the design of the device in
order to ensure that specified design
requirements are met.
(2) The following class I devices are subject
to design controls:
(i) Devices automated with computer
software; and 21 CFR § 820 specifies exclusions from
820.30(a)
design control requirements based on the
Design Controls, (ii) The devices listed in the following 7.3.1 General
risk of the device (i.e. class I devices other
General chart. than those cited).
Section Device
868.6810 Catheter, Tracheobronchial
Suction.
878.4460 Glove, Surgeon’s.
880.6760 Restraint, Protective.
892.5650 System, Applicator, Radionuclide,
Manual.
892.5740 Source, Radionuclide Teletherapy.
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21 CFR § 820 US FDA QUALITY SYSTEM REGULATION ISO 13485:2016 SPECIFIC DIFFERENCES
ISO 13485:2016 specifies written quality
agreements between the organization and
Each manufacturer shall establish and 4.1.5 QMS General suppliers.
820.50 maintain procedures to ensure that all Requirements 21 CFR § 820 requires “... purchased or
Purchasing purchased or otherwise received product
7.4.1 Purchasing otherwise received product” to be included
Controls and services conform to specified
process in the Purchasing Controls procedures.
requirements.
ISO 13485:2016 limits its requirement to
purchased product.
Each manufacturer shall establish and ISO 13485:2016 specifies more detailed
maintain procedures for identifying product requirements including the documentation
820.60
during all stages of receipt, production, 7.5.8 Identification of procedures to ensure medical devices
Identification
distribution, and installation to prevent returned to the organization are identified
mix-ups. and distinguished from conforming product.
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21 CFR § 820 US FDA QUALITY SYSTEM REGULATION ISO 13485:2016 SPECIFIC DIFFERENCES
Each manufacturer shall develop, conduct,
control, and monitor production processes
to ensure that a device conforms to its
specifications. Where deviations from device
specifications could occur as a result of the
manufacturing process, the manufacturer
shall establish and maintain process control
procedures that describe any process
controls necessary to ensure conformance
to specifications. Where process controls are
needed they shall include: In this clause, ISO 13485:2016 specifies
(1) Documented instructions, standard requirement that may align with other
820.70(a)
operating procedures (SOP’s), and 21 CFR § 820.70 requirements beyond
Production 7.5.1 Control of
methods that define and control the 21 CR 820.70(a). For example, in clause
and Process Production and
manner of production; 7.5.1, ISO 13485:2016 specifies "b)
Controls, Service Provision
qualification of infrastructure"; whereas,
General (2) Monitoring and control of process this requirement appears in "820.70(f)
parameters and component and device Buildings" of 21 CFR § 820.
characteristics during production;
(3) Compliance with specified reference
standards or codes;
(4) The approval of processes and process
equipment; and
(5) Criteria for workmanship which shall
be expressed in documented standards
or by means of identified and approved
representative samples.
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21 CFR § 820 US FDA QUALITY SYSTEM REGULATION ISO 13485:2016 SPECIFIC DIFFERENCES
ISO 13485:2016's specified requirements
are "as appropriate" unless relative to sterile
medical devices. However, as stated in ISO
13485:2016 0.2 Clarification of concepts,
when a requirement is qualified by the
Each manufacturer shall establish and maintain phrase "as appropriate", it is deemed to
820.70(e) procedures to prevent contamination of 6.4.2 be appropriate unless the organization can
Contamination equipment or product by substances that could Contamination justify otherwise.
Control reasonably be expected to have an adverse control For sterile devices, ISO 13485:2016 specifies
effect on product quality. "... the organization shall document
requirements for control of contamination
with microorganisms or particulate matter
and maintain the required cleanliness during
assembly or packaging processes." 21 CFR §
820 is not this specific.
7.5.6 Validation
Where the results of a process cannot be fully of processes for
verified by subsequent inspection and test, the production and
process shall be validated with a high degree service provision
820.75(a) of assurance and approved according to 7.5.7 Particular 21 CFR § 820 specifies the documentation
Process established procedures. The validation activities requirements of the date and signature of the individual(s)
Validation and results, including the date and signature for validation approving the validation.
of the individual(s) approving the validation of processes for
and where appropriate the major equipment sterilization and
validated, shall be documented. sterile barrier
systems
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21 CFR § 820 US FDA QUALITY SYSTEM REGULATION ISO 13485:2016 SPECIFIC DIFFERENCES
Each manufacturer shall establish and maintain
procedures for monitoring and control of
process parameters for validated processes to
ensure that the specified requirements continue ISO 13485:2016 clause 8.2.5 specifies
to be met. the expectations for monitoring and
measurement of processes.
820.75(b) (1) Each manufacturer shall ensure that 8.2.5 Monitoring
Process validated processes are performed by and measurement 21 CFR § 820 specifies that the monitoring
Validation qualified individual(s). of processes and control methods and data, the date
performed, and individual(s) performing
(2) For validated processes, the monitoring the process or the major equipment be
and control methods and data, the date documented.
performed, and, where appropriate, the
individual(s) performing the process or the
major equipment used shall be documented.
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21 CFR § 820 US FDA QUALITY SYSTEM REGULATION ISO 13485:2016 SPECIFIC DIFFERENCES
Labeling shall not be released for storage ISO 13485:2016 does not prescribe
or use until a designated individual(s) has 7.4.3 Verification specific requirements for labeling other
examined the labeling for accuracy including, of purchased than stating that production controls
where applicable, the correct unique device product shall include “implementation of defined
820.120(b) identifier (UDI) or universal product code 7.5.1 Control of operations for labelling and packaging”
Labeling (UPC), expiration date, control number, production and and does not specifically address the
Inspection storage instructions, handling instructions, service provision inspection of labels. However, 8.2.6
and any additional processing instructions. Monitoring and measurement of product
8.2.6 Monitoring
The release, including the date and and 7.4.3 Verification of purchased
and measurement
signature of the individual(s) performing the products should account for the additional
of product
examination, shall be documented in the DHR. activities cited in 21 CFR § 820.120(b).
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21 CFR § 820 US FDA QUALITY SYSTEM REGULATION ISO 13485:2016 SPECIFIC DIFFERENCES
Each manufacturer shall maintain device
history records (DHR’s). Each manufacturer
shall establish and maintain procedures to
ensure that DHR’s for each batch, lot, or unit
are maintained to demonstrate that the device 21 CFR § 820 specifies additional DHR
is manufactured in accordance with the DMR content beyond that specified in ISO
and the requirements of this part. The DHR 13485:2016. (e.g. (a) The dates of
shall include, or refer to the location of, the manufacture;...
following information:
(d) The acceptance records which
(a) The dates of manufacture; demonstrate the device is manufactured
7.5.1 Control of in accordance with the DMR;
820.184 Device (b) The quantity manufactured;
production and
History Record (e) The primary identification label and
(c) The quantity released for distribution; service provision
labeling used for each production unit;
(d) The acceptance records which demonstrate and
the device is manufactured in accordance
with the DMR; (f) Any unique device identifier (UDI) or
universal product code (UPC), and any
(e) The primary identification label and labeling other device identification(s) and control
used for each production unit; and number(s) used.)
(f) Any unique device identifier (UDI) or
universal product code (UPC), and any
other device identification(s) and control
number(s) used.
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21 CFR § 820 US FDA QUALITY SYSTEM REGULATION ISO 13485:2016 SPECIFIC DIFFERENCES
Any complaint involving the possible failure of
ISO 13485:2016 does not specify that an
a device, labeling, or packaging to meet any of
investigation is not necessary if such an
820.198(c) its specifications shall be reviewed, evaluated, 8.2.2 Complaint
investigation has already been performed for
Complaint Files and investigated, unless such investigation has handling
a similar complaint and another investigation
already been performed for a similar complaint
is not necessary.
and another investigation is not necessary.
7.5.4 Servicing
activities
Each manufacturer shall analyze service reports ISO 13485:2016’s requirement for use of
820.200(b) 8.1 Measurement,
with appropriate statistical methodology in appropriate statistical techniques is found
Servicing analysis, and
accordance with 820.100. in 8.1.
improvement,
General