ISO 13485:2016 - Medical

Devices: Quality EXERGEN

Clause Management Systems - QSR Sub Part Section QSR Sub Section Doc #
Requirements for
Sort # Regulatory Purposes

1 Scope § 820.1 - Scope.

1
2 2 Normative references

3 Terms and definitions § 820.3 - Definitions.

Quality Management
4 System
4
4.1 General requirements
Document QMS and
4.1.1 maintain effectiveness § 820.5 - Quality system. Quality system

§ 820.20 - Management
responsibility. (b) Organization

(e) Quality system

procedures
Organization determines § 820.20 - Management
4.1.2 processes needed responsibility. (a) Quality policy
7
(b) Organization

(d) Quality planning

Organization determines § 820.20 - Management

4.1.3 criteria for proceses to be responsibility. (b)(2) Resources
8 effective
(b)(3) Management
representative

(c) Management
review

(e) Quality system

procedures

Processes evaluated for § 820.70 - Production and (b) Production and

4.1.4 impacts … process controls. process control
9

§ 820.75 - Process validation. (c) Process changes

Outsourced processes
4.1.5 controlled … § 820.50 - Purchasing controls. Establish procedures
10
 (a) Evaluation of
Suppliers, Contractors,
and Consultants

4.1.6 Computer software § 820.25 - Personnel. (b) Training

validated …

§ 820.70 - Production and (i) Automated

process controls. processes

Documentation
4.2 requirements
§ 820.20 - Management
4.2.1 General responsibility. (a) Quality policy
13
(e) Quality system
procedures
§ 820.20 - Management (e) Quality system
4.2.2 Quality manual responsibility. procedures
14
§ 820.181 - Device master
4.2.3 Medical device file record.
15

Establish and maintain

4.2.4 Control of documents § 820.40 - Document controls. procedures
16

(a) Document approval

and distribution

(b) Document changes

§ 820.180 - General (b) Record retention

requirements. period

Establish and maintain

4.2.5 Control of records § 820.40 - Document controls. procedures
17

§ 820.72 - Inspection,
measuring, and test equipment. (b) Calibration
 § 820.80 - Receiving, in-process,
and finished device acceptance. (e) Acceptance records

§ 820.180 - General
18 requirements.
(a) Confidentiality
(b) Record retention
period

(c) Exceptions

§ 820.181 - Device master

record.

§ 820.184 - Device history

record.
19

§ 820.186 - Quality system

record.

§ 820.198 - Complaint files. (d) MDRs

(e) Records

(f) Complaint unit

separate from
manufacturer

(g) Complaint unit OUS

§ 820.200 - Servicing. (d) Documentation

Management
5 Responsibility
20
 § 820.20 - Management
5.1 Management commitment responsibility. (a) Quality policy
21
(b)(2) Resources

(c) Management
review
§ 820.20 - Management (c) Management
5.2 Customer focus responsibility. review
22

§ 820.30 - Design controls. (a) General

§ 820.100 - Corrective and (a) Establish

preventive action. procedures that
include

(c) Complaint
§ 820.198 - Complaint files. investigation

5.3 Quality policy § 820.20 - Management (a) Quality policy

responsibility.
23
24 5.4 Planning

5.4.1 Quality objectives § 820.20 - Management (a) Quality policy

responsibility.
25
(d) Quality planning

5.4.2 Quality management § 820.20 - Management (d) Quality planning

system planning responsibility.

26
Responsibility, authority
5.5 and communication
27
§ 820.20 - Management
5.5.1 Responsibility and authority responsibility. (b) Organization
28
(b)(1) Responsibility
and authority

5.5.2 Management § 820.20 - Management (b)(3) Management

representative responsibility. representative

29

5.5.3 Internal communication § 820.20 - Management (b)(1) Responsibility

responsibility. and authority

30

§ 820.25 - Personnel. (b) Training

 5.6 Management review
31

5.6.1 General § 820.20 - Management (c) Management

responsibility. review
32

§ 820.20 - Management (c) Management

5.6.2 Review input responsibility. review

33
§ 820.100 - Corrective and (a)(7) Management
preventive action. review

§ 820.20 - Management (c) Management

5.6.3 Review output responsibility. review

34

35 6 Resource Management

§ 820.20 - Management
6.1 Provision of resources responsibility. (b)(2) Resources

36

6.2 Human Resources § 820.25 - Personnel. (a) General

37
(b) Training

§ 820.70 - Production and (d) Personnel

process controls.

6.3 Infrastructure § 820.70 - Production and (f) Buildings

38 process controls.

(g) Equipment

(h) Manufacturing
material
 (i) Automated
processes

Work environment and

6.4 contamination control
39

6.4.1 Work environment § 820.25 - Personnel. (b) Training

40
§ 820.70 - Production and (c) Environmental
process controls. control

(d) Personnel

(e) Contamination

(f) Buildings

6.4.2 Contamination control § 820.70 - Production and (a) General

process controls.

41

(e) Contamination

7 Product Realization
42

Planning of product (b) Design and

7.1 realization § 820.30 - Design controls. development planning
43

§ 820.80 - Receiving, in-process,

and finished device acceptance. (a) General

(c) In-process
acceptance activities

(d) Final acceptance

activities

(e) Acceptance records

§ 820.140 - Handling.
 (a) Establish
§ 820.150 - Storage. procedures

(b) Receipt/dispatch

(a) Establish
§ 820.160 - Distribution. procedures

(b) Distribution
records

§ 820.180 - General
requirements.

§ 820.184 - Device history

record.

§ 820.186 - Quality system

record.

§ 820.200 - Servicing. (a) Establish

procedures

(b) Analyze reports

(c) MDR evaluation

(d) Documentation
Customer related
7.2 processes
44
Determination of
7.2.1 requirements related to § 820.30 - Design controls. (c) Design input
45 product
(a) Establish
§ 820.160 - Distribution. procedures

Review of requirements
7.2.2 related to product § 820.30 - Design controls. (c) Design input
46

(d) Design output

(e) Design review

 (b) Distribution
§ 820.160 - Distribution. records

§ 820.100 - Corrective and (a)(5) Implement

7.2.3 Communication preventive action. action
47
(a) Establish
§ 820.160 - Distribution. procedures
(a) Maintain files and
§ 820.198 - Complaint files. procedures

(e) Records

§ 7.46 - Firm initiated recall

§ 806.10 - Reports of corrections

and removals

§ 803.50 - Manufacturer
reporting requirements

7.3 Design and development

48

7.3.1 General § 820.30 - Design controls. (a) General

49

Design and development (b) Design and

7.3.2 planning development planning
50

Design and development

7.3.3 inputs (c) Design input
51
Design and development
7.3.4 outputs (d) Design output
52

7.3.5 Design and development (e) Design review

review

53

7.3.6 Design of development (f) Design verification

verification

54
 Design of development
7.3.7 validation (g) Design validation

55
Design and development
7.3.8 transfer (h) Design transfer
56

7.3.9 Control of design and (i) Design changes

development changes

57
Design and development
7.3.10 files (j) Design history file
58
7.4 Purchasing
59
7.4.1 Purchasing process § 820.50 - Purchasing controls. Establish procedures
60

(a) Evaluation of
Suppliers, Contractors,
and Consultants

7.4.2 Purchasing information § 820.50 - Purchasing controls. (b) Purchasing data

61
Verification of purchased
7.4.3 product § 820.50 - Purchasing controls. Establish procedures
62

(a) Evaluation of
Suppliers, Contractors,
and Consultants

§ 820.80 - Receiving, in-process,

and finished device acceptance. (a) General

(b) Receiving
acceptance activities

Production and service

7.5 provision
63

7.5.1 Control of production and § 820.70 - Production and (a) General

service provision process controls.
64
 (g) Equipment

§ 820.120 - Device labeling.

(a) Label integrity

(b) labeling inspection

(c) Labeling storage

(d) Labeling operations

(e) Control number

§ 820.130 - Device packaging.

(a) Establish
§ 820.160 - Distribution. procedures
 § 820.184 - Device history
record.

§ 820.70 - Production and (c) Environmental

7.5.2 Cleanliness of product process controls. control
65
(e) Contamination

(h) Manufacturing
material
(a) Establish
7.5.3 Installation activities § 820.170 - Installation. instructions and
66 procedures

(b) Person installing

(a) Establish
7.5.4 Servicing activities § 820.200 - Servicing. procedures
67

(b) Analyze reports

(c) MDR evaluation

(d) Documentation
 7.5.5 Particular requirements for § 820.70 - Production and (c) Environmental
sterile medical devices process controls. control

68

(e) Contamination

§ 820.184 - Device history

record.

Validation of processes for § 820.70 - Production and (b) Production and

7.5.6 production and service process controls. process control
provision
69

(i) Automated
processes

§ 820.75 - Process validation. (a) When to validate

(b) Establish
procedures

(c) Process changes

Particular requirements for

validation of processes for § 820.70 - Production and (i) Automated
7.5.7 sterilization and sterile process controls. processes
70 barrier systems

§ 820.75 - Process validation. (a) When to validate

(b) Establish
procedures

§ 820.130 - Device packaging.

7.5.8 Identification § 820.60 - Identification.

72

§ 820.86 - Acceptance status.

 § 820.120 - Device labeling. (e) Control number

§ 820.140 - Handling.

§ 820.150 - Storage. (a) Establish

procedures

(b) Distribution
§ 820.160 - Distribution. records

§ 820.184 - Device history

record.

7.5.9 Traceability
73

[Link] General § 820.65 - Traceability.

76

§ 820.160 - Distribution. (b) Distribution

records

Particular requirements for

[Link] implantable medical § 820.65 - Traceability.
devices
77

7.5.10 Customer property § 820.50 - Purchasing controls. Establish procedures

78

§ 820.180 - General (a) Confidentiality

requirements.

§ 820.70 - Production and (c) Environmental

7.5.11 Preservation of product process controls. control
79
 (e) Contamination
80
(h) Manufacturing
81 material

§ 820.120 - Device labeling. (a) Label integrity

82
§ 820.130 - Device packaging.

§ 820.140 - Handling.

(a) Establish
§ 820.150 - Storage. procedures

Control of monitoring and § 820.70 - Production and (i) Automated

7.6 measuring equipment process controls. processes
83

§ 820.72 - Inspection, (a) Control

measuring, and test equipment.

(b) Calibration

Measurement, Analysis,
8 and Improvement
84
§ 820.100 - Corrective and (a)(1) Analyze quality
8.1 General preventive action. data
85
§ 820.250 - Statistical (a) Establish
techniques. procedures

(b) Sampling plans

based on valid
statistical rationale
Monitoring and
8.2 measurement
86

§ 820.20 - Management (c) Management

8.2.1 Feedback responsibility. review
87
§ 820.100 - Corrective and (a)(1) Analyze quality
preventive action. data

(a) Maintain files and

§ 820.198 - Complaint files. procedures
(a) Maintain files and
8.2.2 Complaint handling § 820.198 - Complaint files. procedures
88

(b) Review and

evaluate complaints

(c) Complaint
investigation
(d) MDRs
 (e) Records

(f) Complaint unit

separate from
manufacturer

(g) Complaint unit OUS

Reporting to regulatory
8.2.3 authorities § 820.198 - Complaint files. (d) MDRs
89

§ 803.17 - requirements for

developing, maintaining, and
implementing written MDR
procedures
 8.2.4 Internal audit § 820.22 - Quality audit.

90

Monitoring and § 820.70 - Production and

8.2.5 measurement of processes process controls. (a) General
91
§ 820.75 - Process validation. (c) Process changes

Monitoring and § 820.80 - Receiving, in-process,

8.2.6 measurement of product and finished device acceptance. (a) General
92

(b) Receiving
acceptance activities

(c) In-process
acceptance activities

(d) Final acceptance

activities

(e) Acceptance records

Control of nonconforming
8.3 product
93

§ 820.90 - Nonconforming
8.3.1 General product. (a) Control
94
(b) Review and
dispostion
Actions in response to § 820.90 - Nonconforming
8.3.2 nonconforming product product. (a) Control
95 detected before delivery
(b) Review and
dispostion
Actions in response to § 820.90 - Nonconforming
8.3.3 nonconforming product product. (a) Control
96 detected after delivery
(b) Review and
dispostion

§ 7.46 - Firm initiated recall

8.3.4 Rework § 820.90 - Nonconforming (b) Review and

97 product. dispostion
§ 820.100 - Corrective and (a)(1) Analyze quality
8.4 Analysis of data preventive action. data
98
8.5 Improvement
100
 (a) Establish
8.5.1 General § 820.100 - Corrective and procedures that
preventive action. include
101

§ 820.100 - Corrective and (a) Establish

8.5.2 Corrective action preventive action. procedures that
102 include
(a)(1) Analyze quality
data
(a)(2) Investigate
nonconformity

(a)(3) Indentify action

(a)(4) Verify or
validate action
(a)(5) Implement
action

(a)(6) Information
dissemination

(a)(7) Management
review

(b) documentation

§ 820.100 - Corrective and (a) Establish

8.5.3 Preventive action preventive action. procedures that
103 include
(a)(1) Analyze quality
data
(a)(2) Investigate
nonconformity

(a)(3) Indentify action

(a)(4) Verify or
validate action
(a)(5) Implement
action

(a)(6) Information
dissemination
(a)(7) Management
review

(b) documentation
Update this Section
with EXERGEN Doc Differences ISO, QSR or Similar
Title

QSRs are regulations applicable to finished

Quality Manual medical devices while ISO 13485 is an
international standard for all organzations
involved in the life cycle of a medical
device. Similar. Required by Both
Quality Manual Similar. Required by Both

QSRs have 34 definitions with legal

Quality Manual implications while ISO 14835 has 20
explanatory definitions. Note slight
differences in complaints and
manufacturer Similar. Required by Both

Quality Management
System Flowchart

Quality Manual
Similar Similar. Required by Both

organization shall document the role(s)

undertaken by the organization under the
applicable regulatory requirements Similar. Required by Both

Similar Similar. Required by Both

Management 4.1.2. a) determines processes needed for
Review Procedure the quality management system Similar. Required by Both
Organizational Chart 4.1.2.b) Apply risk based approach for
processes needed ISO Requirement only

4.1.2 c) determine the sequence and

interaction of these processes. Similar. Required by Both

Management
Review Procedure
4.1.3 b) Ensure availability of resources Similar. Required by Both
Organizational Chart
4.1.3 c) maintain effectiveness Similar. Required by Both
4.1.3 c) maintain effectiveness
4.1.3 d) monitor, measure, analyze
processes Similar. Required by Both
4.1.3 a) determine criteria and methods
needed to ensure that both the operation
and control Similar. Required by Both

Similar Similar. Required by Both

Similar Similar. Required by Both

Similar Similar. Required by Both

 Controls proportionate to risk
ISO Requirement only

Personnel who perform verification and

validation activities shall be made aware of
defects and errors that may be
encountered as part of their job functions
QSR Requirement only

ISO specifies software used in QMS and

proportionate to the risk of the software Similar. Required by Both

Similar Similar. Required by Both

QSRs call for an outline Similar. Required by Both

Quality Manual
ISO specifies quality manual ISO Requirement only

Similar Similar. Required by Both

Document control
Similar Similar. Required by Both

Document control ISO 4.2.4 f) requires documents of external

origin needed by the QMS be controlled.
820.40 requires documentation of
approval date and signature Similar. Required by Both

Approved changes shall be communicated

Document control to the appropriate personnel in a timely
manner.
Change records shall include a description
of the change, identification of the
affected documents, the signature of the
approving individual(s), the approval date,
and when the change becomes effective QSR Requirement only
Control of quality
records Similar Similar. Required by Both

Document control
Similar Similar. Required by Both

equipment identification, calibration

Equipment Control dates, the individual performing each
calibration, and the next calibration date
shall be documented. QSR Requirement only
 (1) The acceptance activities performed;
Receiving & (2) the dates acceptance activities are
Incoming Inspection performed;
(3) the results;
(4) the signature of the individual(s)
conducting the acceptance activities; and
(5) where appropriate the equipment
used. These records shall be part of the
DHR. QSR Requirement only
Control of quality Accessible to FDA. Electronic records
records backed up. QSR Requirement only
Control of quality ISO specifies protecting health
records information, QSRs note FOI Similar. Required by Both
Control of quality
records Similar Similar. Required by Both
does not apply to the reports required by
Control of quality 820.20(c) Management review, 820.22
records Quality audits, and supplier audit reports
used to meet the requirements of
820.50(a)

Control of quality Records shall remain legible, readily

records identifiable and retrievable. Changes to a
record shall remain identifiable. Record
retention.
Control of quality
records Records shall be maintained to provide
evidence of conformity to requirements. Similar. Required by Both
Quality System Record shall include, or
Control of quality refer to the location of, procedures and
records the documentation of activities required
by this part that are not specific to a
particular type of device(s) QSR Requirement only
Control of quality
records
Specific requirements QSR Requirement only

Control of quality Records shall be maintained to provide

records evidence of conformity to requirements
and of the effective
ISO Requirement only

Control of quality Records shall remain legible, readily

records identifiable and retrievable.
ISO Requirement only

Control of quality Records shall remain legible, readily

records identifiable and retrievable.
ISO Requirement only
Records shall be maintained to provide
N/A evidence of conformity to requirements
and of the effective ISO Requirement only
Management
Review Procedure Similar Similar. Required by Both
Management
Review Procedure Similar Similar. Required by Both
Management
Review Procedure Similar Similar. Required by Both
Management
Review Procedure Similar Similar. Required by Both

Design Control
Similar Similar. Required by Both

Corrective and
Preventive Actions
Similar Similar. Required by Both

Record Keeping
Similar Similar. Required by Both
5.3 includes a commitment to comply with
Management requirements and to maintain the
Review Procedure effectiveness of the quality management
system Similar. Required by Both

Management
Review Procedure
5.4.1 Quality objectives measurable ISO Requirement only
Management
Review Procedure Similar Similar. Required by Both

Management 5.4.2 b) integrity of the quality

Review Procedure management system is maintained when
changes to the quality management
system are planned and implemented. ISO Requirement only

Management
Review Procedure Similar Similar. Required by Both
Management
Review Procedure

5.5.2 c) ensuring the promotion of

Management awareness of applicable regulatory
Review Procedure requirements and quality management
system requirements throughout the
organization. Similar. Required by Both
Top management shall ensure that
appropriate communication processes are
Management established within
Review Procedure the organization and that communication
takes place regarding the effectiveness of
the quality management system. ISO Requirement only
Top management shall ensure that
appropriate communication processes are
Management established within the organization and
Review Procedure that communication takes place regarding
the effectiveness of the quality
management system. ISO Requirement only
Management 5.6.1 includes assessing opportunities for
Review Procedure improvement and the need for changes to
the quality management system Similar. Required by Both

a) feedback;
b) complaint handling;
c) reporting to regulatory authorities;
d) audits;
e) monitoring and measurement of
processes;
f) monitoring and measurement of
Management product;
Review Procedure g) corrective action;
h) preventive action;
i) follow-up actions from previous
management reviews;
j) changes that could affect the quality
management system;
k) recommendations for improvement;
l) applicable new or revised regulatory
requirements.
ISO Requirement only
Corrective and
Preventive Actions Similar Similar. Required by Both

a) improvement needed to maintain the

suitability, adequacy, and effectiveness of
the quality
management system and its processes;
Management b) improvement of product related to
Review Procedure customer requirements;
c) changes needed to respond to
applicable new or revised regulatory
requirements;
d) resource needs.
ISO Requirement only

Management
Review Procedure
Similar Similar. Required by Both
Competence,
awareness and
training Similar Similar. Required by Both
Competence,
awareness and
training Similar Similar. Required by Both
Competence,
awareness and
training Similar Similar. Required by Both

Equipment Control
Similar Similar. Required by Both

Equipment Control
Similar Similar. Required by Both

Material Control
Similar Similar. Required by Both
Verification,
Validation &
Qualification
Similar Similar. Required by Both
Work environment
and contamination
control Similar. Required by Both
Competence,
awareness and
training Similar Similar. Required by Both
Work environment
and contamination
control Similar Similar. Required by Both

Similar Similar. Required by Both

Work environment
and contamination
control Similar Similar. Required by Both

Similar Similar. Required by Both

Requirements for sterile devices for

Work environment control of contamination with
and contamination microorganisms or particulate matter and
control maintain the required cleanliness during
assembly or packaging processes.
ISO Requirement only

Similar Similar. Required by Both

Planning of product Plan and develop processes including risk

realization processes management
ISO Requirement only

Receiving &
Incoming Inspection
7.1 c) Criteria for product acceptance Similar. Required by Both

7.1 d) records needed to provide evidence

that the realization processes and resulting
product meet requirements Similar. Required by Both

QC Inspection and 7.1 d) records needed to provide evidence

Positive Lot Release that the realization processes and resulting
product meet requirements Similar. Required by Both

7.1 d) records needed to provide evidence

that the realization processes and resulting
product meet requirements Similar. Required by Both

7.1 c) Criteria for product acceptance Similar. Required by Both

 7.1 c) Criteria for product acceptance Similar. Required by Both

Similar Similar. Required by Both

7.1 c) Criteria for product acceptance Similar. Required by Both

Records include or refer to the location of:

(1) The name and address of the initial
consignee;
(2) The identification and quantity of
devices shipped;
(3) The date shipped; and
(4) Any control number(s) used

QSR Requirement only

7.1 d) records needed to provide evidence

that the realization processes and resulting
product meet requirements Similar. Required by Both

records needed to provide evidence that

the realization processes and resulting
product meet
requirements Similar. Required by Both

records needed to provide evidence that

the realization processes and resulting
product meet requirements Similar. Required by Both
records needed to provide evidence that
the realization processes and resulting
product meet
requirements Similar. Required by Both

Similar Similar. Required by Both

Similar Similar. Required by Both

Similar Similar. Required by Both

Customer related
processes
7.2.1 d) User training needed to ensure
Design Control specified performance and safe use of the
medical device ISO Requirement only

Similar Similar. Required by Both

7.2.2 d) User training needed to ensure
Design Control specified performance and safe use of the
medical device ISO Requirement only
7.2.2 d) User training needed to ensure
Design Control specified performance and safe use of the
medical device ISO Requirement only
Design Control Similar Similar. Required by Both
 Similar Similar. Required by Both
Corrective and
Preventive Actions 7.2.3 d) advisory notices to customers
ISO Requirement only

7.2.3 b) order handling Similar. Required by Both

Record Keeping
7.2.3 c) complaints Similar. Required by Both
7.2.3 c) complaints and 820.198(e)(8) any
reply to complainant Similar. Required by Both

Adverse Event A firm may decide of its own volition and

Reporting under any circumstances to remove or
correct a distributed product. QSR Requirement only
Submit writen report to FDA of any
correction or removal initated to reduce
risk to health or remedy a violation of the
Act QSR Requirement only
Report information that a device may have
coaused or contributed to a serious injury
MDR WI or has malfunctioned and the device
would likely cuase or contribute to a death
or serious injury if malfunction recurred.
QSR Requirement only

Applicable to Class II and III devices.

Design Control Excludes Class I devices except those
automated with software and 5 other
specific devices QSR Requirement only
7.3.2 specifies documentation of each
Design Control element of the plan while 820.30 (b)
require a documented plan Similar. Required by Both

7.3.3 c) specifies output of risk

Design Control management. 820.30 c) requires design
inputs documented by approval signature
and date Similar. Required by Both
Design Control 7.3.4 b) specifies purchasing and servicing
information Similar. Required by Both

Design Control 7.3.5 b) specifies to identify and ppropose

actions. 820.3(e) requires individual(s)
who does not have direct responsibility for
the design stage being reviewed. Similar. Required by Both

Design Control 7.3.6 specifies verifcation of connectivity

or interfacing with other medical devices.
820.30(f) requires individual conducting
verifcation be documented. Similar. Required by Both
 7.3.7 specifies validation of interfaces,
clinical studies, performance evaluation to
Design Control regulatory standards. 820.30 (g) requires
documentation of individual conducting
the validation. The results of the design
validation, including identification of the
design, method(s), the date, and the
individual(s) performing the validation,
shall be documented in the DHF. Similar. Required by Both
Design Control
Similar Similar. Required by Both

7.3.9 specifies to determine the

Design Control significance of the change to function,
performance, usability, safety, and
applicable regulatory requirements, and
effect of change on constituent parts on in
process and distributed product. Similar. Required by Both
Design Control
Similar Similar. Required by Both

Purchasing
Similar Similar. Required by Both

7.4.1 d) proportionate to the risk

associated with the medical device.
Purchasing Non-fulfilment of purchasing requirements
shall be addressed with the supplier
proportionate to the risk associated with
the purchased product Similar. Required by Both
Purchasing 7.4.2 c) requirements for qualification of
supplier personnel Similar. Required by Both
Purchasing
Similar Similar. Required by Both

Purchasing 7.4.3 specifies activites proportionate to

risk and provisions for on site supplier
verification Similar. Required by Both

7.4.3 specifies the activities are

proportionate to risk Similar. Required by Both
7.4.3 specifies to determine if any changes
Receiveing to the purchased product affect the
realization process Similar. Required by Both

Production
Procedure
Similar, 7.5.1 a)-c) Similar. Required by Both
Equipment Control

Similar, 7.5.1 d) Similar. Required by Both

Similar, 7.5.1 e) Similar. Required by Both

Labels shall be printed and applied so as to

remain legible and affixed during the
customary conditions of processing,
storage, handling, distribution, and where
appropriate use.
QSR Requirement only

Labeling shall not be released for storage

or use until a designated individual(s) has
examined the labeling for accuracy
including, where applicable, the correct
unique device identifier (UDI) or universal
product code (UPC), expiration date,
control number, storage instructions,
handling instructions, and any additional
processing instructions. The release,
including the date and signature of the
individual(s) performing the examination,
shall be documented in the DHR

QSR Requirement only

Each manufacturer shall store labeling in a

manner that provides proper identification
and is designed to prevent mixups.
QSR Requirement only

Each manufacturer shall control labeling

and packaging operations to prevent
labeling mixups. The label and labeling
used for each production unit, lot, or batch
shall be documented in the DHR
QSR Requirement only
Where a control number is required by
820.65, that control number shall be on or
shall accompany the device through
distribution. QSR Requirement only

Similar, 7.5.1 e) Similar. Required by Both

Distribution Similar, 7.5.1 f) Similar. Required by Both

 820.184 - DHR shall include
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which
demonstrate the device is manufactured in
accordance with the DMR;
(e) The primary identification label and
labeling used for each production unit; and
(f) Any unique device identifier (UDI) or
universal product code (UPC), and any
other device identification(s) and control
number(s) used.

QSR Requirement only

Similar, 7.5.2 a) - d) Similar. Required by Both

Similar, 7.5.2 a) - d) Similar. Required by Both

Similar, 7.5.2 e) Similar. Required by Both

Similar Similar. Required by Both N/A

Similar Similar. Required by Both

N/A
Similar Similar. Required by Both N/A

7.5.4 b) specifes to use analysis as input to

improvement. 820.250 b) requires the use
of statisical methodology Similar. Required by Both

7.5.4 a) specifies to evaluate if a

complaint; 820.200(c) requires that an
MDR event shall be processed as a
complaint Similar. Required by Both

Requires
(1) The name of the device serviced;
(2) Any unique device identifier (UDI) or
universal product code (UPC), and any
other device identification(s) and control
number(s) used;
(3) The date of service;
(4) The individual(s) servicing the device;
(5) The service performed; and
(6) The test and inspection data.
QSR Requirement only
 EtO Sterilization, QC
Inspection and maintain records of the sterilization
Postive Lot Release, process parameters used for each
Microbial Testing, sterilization batch
Load Configuration
ISO Requirement only
maintain records of the sterilization
process parameters used for each
sterilization batch ISO Requirement only

Sterilization records shall be traceable to

each production batch of medical devices
ISO Requirement only
Verification,
Validation &
Qualification, Risk
Manament Similar Similar. Required by Both
Verification,
Validation &
Qualification, Risk
Manament Similar Similar. Required by Both
Verification,
Validation &
Qualification, Risk
Manament Similar Similar. Required by Both

Similar, 7.5.6 d) specifies statistical

techniques; 820.75 requires specific
documentation and the use of qualified
personnel Similar. Required by Both

Similar, 7.5.6 f) Similar. Required by Both

Verification,
Validation & Validate sterile processes and sterile
Qualification, Risk barrier systems
Manament ISO Requirement only
Verification,
Validation & Validate sterile processes and sterile
Qualification, Risk barrier systems
Manament ISO Requirement only

Validate sterile processes and sterile

barrier systems
ISO Requirement only

Validate sterile processes and sterile

barrier systems
ISO Requirement only

Materials Control,
Receiving and
Incoming Inspection,
Returned Goods
Similar Similar. Required by Both

Similar Similar. Required by Both

 Similar Similar. Required by Both

The organization shall document

procedures to ensure that medical devices
returned to the
organization are identified and
distinguished from conforming product. Similar. Required by Both

The organization shall document

procedures to ensure that medical devices
returned to the
organization are identified and
distinguished from conforming product. Similar. Required by Both

The organization shall document

procedures to ensure that medical devices
returned to the
organization are identified and
Distribution distinguished from conforming product. Similar. Required by Both

Similar Similar. Required by Both

Materials Control

820.65 includes life sustaining devices

QSR Requirement only

Similar Similar. Required by Both

Materials Control,
Distibution Control,
Environmental
Control
Similar Similar. Required by Both
The organization shall identify, verify,
protect, and safeguard customer property
Clinical Trials Data provided for use or incorporation into the
Monitoring product while it is under
the organization’s control or being used by
the organization. ISO Requirement only

The organization shall identify, verify,

protect, and safeguard customer property
provided for use or incorporation into the
product while it is under
the organization’s control or being used by
the organization.
ISO Requirement only

Product Distribution
Procedure
Similar Similar. Required by Both
 Similar Similar. Required by Both

Similar Similar. Required by Both

Similar Similar. Required by Both

Similar Similar. Required by Both

Similar Similar. Required by Both

Similar Similar. Required by Both

Verification
Similar, proportionate to risk Similar. Required by Both

Similar Similar. Required by Both

Equipment Control
Similar Similar. Required by Both
Risk Management
Similar. Required by Both
Corrective and
Preventive Actions
Similar Similar. Required by Both
Statistical
Techniques &
Applications Similar Similar. Required by Both
Statistical
Techniques &
Applications Similar Similar. Required by Both

The information gathered in the feedback

Management review process shall serve as potential input into
risk management ISO Requirement only
This feedback process shall include
provisions to gather data from production
as well as post-production activities. ISO Requirement only
Complaint gather and monitor information relating to
Evaluations whether the organization has met
customer requirements ISO Requirement only
Complaint Similar, 820.198(a) requires a formally
Evaluations designated unit Similar. Required by Both
820.198(b) requires the name of the
individual who made the decision to not
investigate. Similar. Required by Both

Similar Similar. Required by Both

MDRs QSR Requirement only
Records shall include:
(1) The name of the device;
(2) The date the complaint was received;
(3) Any unique device identifier (UDI) or
universal product code (UPC), and any
other device identification(s) and control
number(s) used;
(4) The name, address, and phone number
of the complainant;
(5) The nature and details of the
complaint;
(6) The dates and results of the
investigation;
(7) Any corrective action taken; and
(8) Any reply to the complainant.

QSR Requirement only

When the manufacturer's formally

designated complaint unit is located at a
site separate from the manufacturing
establishment, the investigated
complaint(s) and the record(s) of
investigation shall be reasonably accessible
to the manufacturing establishment
QSR Requirement only

If a manufacturer's formally designated

complaint unit is located outside of the
United States, records required by this
section shall be reasonably accessible in
the United States at either:
(1) A location in the United States where
the manufacturer's records are regularly
kept; or
(2) The location of the initial distributor.

QSR Requirement only

MDRs
QSR Requirement only

Develop, maintain, and implement written

MDR procedures for (1) Timely and
effective identification, communication,
and evaluation of events that may be
subject to MDR requirements;(2) A
standardized review process or procedure
for determining when an event meets the
criteria for reporting under this part; and
(3) Timely transmission of complete
medical device reports to manufacturers
or to us, or to both if required.

QSR Requirement only

 Similar, 8.2.4 specifies management take
Internal audit corrective and proventive actions without
delay. 820.22 requires management
review the report and the dates of the
audit. Similar. Required by Both

Similar Similar. Required by Both

Similar Similar. Required by Both

Receiving, IN process
and finished device
acceptance
Similar Similar. Required by Both

Similar Similar. Required by Both

Similar Similar. Required by Both

Similar Similar. Required by Both

Similar Similar. Required by Both

Control of
nonconforming
product
Control of
nonconforming
product Similar Similar. Required by Both

Similar Similar. Required by Both

Control of
nonconforming
product Similar Similar. Required by Both

Similar Similar. Required by Both

Advisory Notice
Similar Similar. Required by Both

Similar Similar. Required by Both

Issue advisory notices
ISO Requirement only

Similar Similar. Required by Both

Statistical techniques
Similar Similar. Required by Both
Corrective and
Preventive Actions

Similar Similar. Required by Both

Corrective and Actions taken with undue delay and

Preventive Actions proportionate to the effect of the
nonconformance ISO Requirement only
Corrective and
Preventive Actions Similar Similar. Required by Both
Corrective and
Preventive Actions Similar Similar. Required by Both
Corrective and
Preventive Actions Similar Similar. Required by Both
Corrective and
Preventive Actions Similar Similar. Required by Both
Corrective and
Preventive Actions Similar Similar. Required by Both

820.100(a)(6) - Ensuring that information

related to quality problems or
Corrective and nonconforming product is disseminated to
Preventive Actions those directly responsible for assuring the
quality of such product or the prevention
of such problems
QSR Requirement only
Submitting relevant information on
Corrective and identified quality problems, as well as
Preventive Actions corrective and preventive actions, for
management review. QSR Requirement only
Corrective and
Preventive Actions Similar Similar. Required by Both

Corrective and Actions taken proportionate to the effect

Preventive Actions of the potential problem
ISO Requirement only
Corrective and
Preventive Actions Similar Similar. Required by Both
Corrective and
Preventive Actions Similar Similar. Required by Both
Corrective and
Preventive Actions Similar Similar. Required by Both
Corrective and
Preventive Actions Similar Similar. Required by Both
Corrective and
Preventive Actions Similar Similar. Required by Both

820.100(a)(6) - Ensuring that information

related to quality problems or
Corrective and nonconforming product is disseminated to
Preventive Actions those directly responsible for assuring the
quality of such product or the prevention
of such problems
QSR Requirement only
 Submitting relevant information on
Corrective and identified quality problems, as well as
Preventive Actions corrective and preventive actions, for
management review. QSR Requirement only
Corrective and
Preventive Actions Similar Similar. Required by Both