Explanation of this Cross Reference Table:

ISO 13485:2003 and FDA 21 CFR Part 820 served as "Master" (similar requirements of the other regulations are shown in "Italics ").
There are / might be additional requirements which are not reflected in this Cross Reference Table.

CMDR JPAL
QSReg MDD
ANVISA
Canadian Medical Devices Japan’s Pharmaceutical Affairs Quality System
ISO 13485:2003 Quality System Regulation Medical Devices Directive Resolution No. 59
Regulations Law Element
21 CFR Part 820 93/42/EEC (27-Jun-2000)
SOR/98-282 MHLW Ministerial Ordinance
(01-Apr-2012) incl. 2007/47/EC
(31-Oct-2011) No. 169, 2004
Chapter 1 General Provisions ATTACHMENT I
1 - Scope 820.1 Scope Section 2 Application Article 1 Definitions, scope Section 1 General Rules Part A – Miscellaneous ./.
(Scope) Article 3 1. Scope

Article 3
2 - Normative references 820.1 (b) ./. Article 5 - Reference to standards ./. ./.
(Scope)

ATTACHMENT I
Article 2
3 - Terms and definitions 820.3 Definitions Section 1 Interpretation Article 1 - Definitions, scope Part A – Miscellaneous ./.
(Definitions)
2. Definitions

Annex II, 1
820.5 - Quality Systems Section 32 (2) (f) - Class II devices
Annex II, 3.2 Quality System ATTACHMENT I
820.20 (b) Organization Section 32 (3) (j) - Class III devices Part A – Miscellaneous
Chapter 2
Annex V, 1 3. Quality System
4 - Quality management system Article 5
820.20 (b) (2) Resources Section 32 (4) (e) - Class IV devices Management Controls
4.1 - General requirements (General Requirements for Quality
Annex V, 3.2 Quality System Part B – Quality System Requirements
Management System)
820.20 (d) Quality planning Section 32 (4) (p) - Class IV devices 1. Management responsibility
Annex VI, 1 (b) Organization
820.20(e) Quality System Procedures Section 43.1
Annex VI, 3.2 Quality System

820.3 (u) Definitions ATTACHMENT I

Annex II, 3.2, 6.1 Part A – Miscellaneous
820.20 (a) Quality Policy 3. Quality System
Annex V, 3.2, 5 Chapter 2
4.2 - Documentation Requirements
820.20(e) Quality System Procedures Section 32 (4) (f), (g), (o) - Class IV devices Article 6 (Documentation of Quality Part B – Quality System Requirements Management Controls
4.2.1 – General
Annex VI, 3.2, 5 Management System) 1. Management responsibility
820.40 Document Controls (a) Quality Policy
Annex VII, 2
820.181 Device Master Record Part D – Documents and Record Controls

820.3 (v) Definitions

ATTACHMENT I
Section 32 (2) (f) - Class II devices Annex II, 3.2 Quality System
Part A – Miscellaneous
820.5 Quality Systems
Chapter 2 2. Definitions (bb)
4.2.2 - Quality Manual Section 32 (3) (j) - Class III devices Annex V, 3.2 Quality System Management Controls
Article 7 (Quality Manual)
820.20 (e) Management Responsibility
Part A – Miscellaneous
Section 32 (4) (p) - Class IV devices Annex VI, 3.2 Quality System
3. Quality System
820.186 Quality System Record

Annex II, 3.2 Quality System

Annex II, 6.1

Annex V, 3.2 Quality System Chapter 2 ATTACHMENT I

4.2.3 – Control of Documents 820.40 Document Controls ./. Document Controls
Annex V, 5 Article 8 (Control of Documents) Part D – Documents and Record Controls

Annex VI, 3.2 Quality System

Annex VI, 5

Annex II, 3.2 Quality System

Annex II, 6.1
820.180 – General Requirements Records
Annex V, 3.2 Quality System ATTACHMENT I
820.184 – Device History Record
Annex V, 5 Chapter 2 Part D – Documents and Record Controls DHRs
4.2.4 - Control of Records Sections 52, 53, 54, 55, 56, 66, 67, 68
Article 9 (Control of Records)
820.186 – Quality System Record
Annex VI, 3.2 Quality System Part M – Records Electronic Records & Electronic
Annex VI, 5 Signatures
820.30 (j) – Design History File
Annex VII, 2

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ATTACHMENT I
820.20 (a) Quality Policy Annex II, 3.1 Quality System
Part B – Quality System Requirements
5 - Management Responsibility Chapter 2 1. Management responsibility
820.20 (b) (2) Resources ./. Annex V, 3.1 Quality System Management Controls
5.1 - Management Commitment Article 10 (Management Commitment) (a) Quality Policy
(b) (1) Responsibility and Authority
820.20 (c) Management Review Annex VI, 3.1 Quality System
(c) Management review

Chapter 2
5.2 - Customer Focus ./. ./. ./. ./. Management Controls
Article 11 (Customer Focus)

ATTACHMENT I
Chapter 2 Part B – Quality System Requirements
5.3 - Quality Policy 820.20 (a) Quality Policy ./. ./. Management Controls
Article 12 (Quality Policy) 1. Management responsibility
(a) Quality Policy

Annex II, 3.2 (a)

ATTACHMENT I
5.4 – Planning Chapter 2 Part B – Quality System Requirements
820.20 (a) Quality Policy ./. Annex V, 3.2 (a) Management Controls
5.4.1 - Quality Objectives Article 13 (Quality Objectives) 1. Management responsibility
(a) Quality Policy
Annex VI, 3.2

Annex II, 3.2

Chapter 2
5.4.2 - Quality Management System
820.20 (e) Quality System Procedures ./. Annex V, 3.2 Article 14 (Quality Management System ./. Management Controls
Planning
Planning)
Annex VI, 3.2

Annex II, 3.2 (b)

ATTACHMENT I
5.5 - Responsibility, Authority &
Chapter 2 Part B – Quality System Requirements
Communication 820.20 (b) (1) Responsibility and authority ./. Annex V, 3.2 (b) Management Controls
Article 15 (Responsibility and Authority) 1. Management responsibility
5.5.1 - Responsibility and Authority
(b) (1) Responsibility and Authority
Annex VI, 3.2

ATTACHMENT I
Chapter 2
Part B – Quality System Requirements
5.5.2 - Management Representative 820.20 (b) (3) Management Representative ./. ./. Article 16 (Responsible Engineering Management Controls
1. Management responsibility
Manager)
(b) (3) Management representative

Chapter 2
5.5.3 - Internal Communication ./. ./. ./. ./. Management Controls
Article 17 (Internal Communication)

Annex II, 3.2 (b)

ATTACHMENT I
5.6 - Management Review Chapter 2 Part B – Quality System Requirements
820.20 ( c ) Management Review ./. Annex V, 3.2 (b) Management Controls
5.6.1 - General Article 18 (Management review) 1. Management responsibility
(c) Management review
Annex VI, 3.2

Annex II, 3.2 (b)

Chapter 2
5.6.2 - Review Input ./. ./. ./. Management Controls
Article 19 (Review Input)
Annex V, 3.2 (b)

Chapter 2
5.6.3 - Review Output ./. ./. ./. ./. Management Controls
Article 20 (Review Output)

6 - Resource Management Chapter 2

820.20 (b) (2) Resources ./. ./. ./. Management Controls
6.1 - Provision of resources Article 21 (Provision of Resources)

ATTACHMENT I
Part B – Quality System Requirements
1. Management responsibility
6.2 - Human Resources Chapter 2 (b) (2) Resources and personnel for
820.25 (a) General ./. ./. Management Controls
6.2.1 – General Article 22 (Personnel) verification

3. Personnel
(a) General Instructions

ATTACHMENT I
Chapter 2
Part B – Quality System Requirements
6.2.2 - Competence, Awareness & Training 820.25 Personnel ./. ./. Article 23 (Competence, Awareness and Training
3. Personnel
Training)
(a) General Instructions

ATTACHMENT I
820.70 (f) Buildings
Chapter 2 Part G – Process and Production Controls
6.3 – Infrastructure Section 14 ./. Facility and Environmental Controls
Article 24 (Infrastructure) 1. Process and production controls
820.70 (g) Equipment
(g) Equipment

ATTACHMENT I
820.70 (c) Environment
Part G – Process and Production Controls
1. Process and production controls
820.70 (d) Personnel
Chapter 2 (b) Environmental control
6.4 - Work Environment Section 14 Annex I, 8 Facility and Environmental Controls
Article 25 (Work Environment) (c) Cleaning and sanitation
820.70 (e) Contamination control
(d) Personal health and care
(e) Contamination control
820.70 (h) Manufacturing material
(f) Removal of trash and chemical sewage

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ATTACHMENT I
Part C – Design Controls
820.20 (d) Quality planning
(a) General Instructions
(g) Design transference
820.30 (a) General
(h) Design release
820.30 (h) Design Transfer Section 9 (2)
Part H – Inspection and Tests
Annex II, 3.2
1. Inspection and tests
820.80 Receiving, in-process, and finished Section 10 Design Controls
7 - Product Realization Chapter 2 (a) General instructions
device acceptance Annex V, 3.2
7.1 - Planning of Product Realization Article 26 (Planning of Product Realization)
(a) General Section 32 (3) (e) - Class III devices Risk Management
Part K – Handling, Storage, Distribution
Annex VI, 3.2
and Installation
820.170 Installation Section 32 (4) (d), (e),(g) - Class IV devices
4. Installation
820.181 Device master record
Part M – Records
2. Product master record (PMR)
820.200 (a) Servicing
Part N – Technical Assistance

Section 9
ATTACHMENT I
Article 11 Conformity assessment Part C – Design Controls
7.2 - Customer-related Processes 820.30 ( c ) Design Input Section 32 (2) - Class II devices Design Controls
procedures Article 27 (Determination of Requirements (c) Design input data
7.2.1 - Determination of Requirements
Related to the Products)
related to the Product 820.50 (b) Purchasing data Section 32 (3) - Class III devices Market Authorization
Annex II, 3.2 ( c ) Part E – Purchase Controls
(b) Purchase forms
Section 32 (4) - Class IV devices

ATTACHMENT I
Chapter 2
7.2.2 - Review of Requirements related to Part K – Handling, Storage, Distribution
820.160 Distribution ./. ./. Article 28 (Review of Requirements Order Management
the Product and Installation
Related to Products)
3. Distribution
Order Management
ATTACHMENT I
Chapter 2
7.2.3 - Customer Communication 820.198 – Complaint Files ./. ./. Part M – Records
Article 29 (Customer Communication) Complaint Handling and Vigilance
4. Complaints file
Reporting

ATTACHMENT I
820.30 (a) General Chapter 2
7.3 - Design and Development Part C – Design Controls
820.30 (b) Design and Development ./. ./. Article 30 (Design and Development Design Controls
7.3.1 - Design and Development Planning (a) General Instructions
Planning Planning)
(b) Design planning and development

Section 9

Section 32 (2) - Class II devices Chapter 2 ATTACHMENT I

7.3.2 - Design and Development Inputs 820.30 ( c ) Design Input Annex II, 3.2 ( c ) Article 31 (Design and Development Part C – Design Controls Design Controls
Section 32 (3) - Class III devices Inputs) (c) Design input data

Section 32 (4) - Class IV devices

Chapter 2 ATTACHMENT I
7.3.3 - Design and Development Outputs 820.30 (d) Design Output ./. ./. Article 32 (Design and Development Part C – Design Controls Design Controls
Outputs) (f) Design output data

Chapter 2 ATTACHMENT I
7.3.4 - Design and Development Review 820.30 (e) Design Review ./. Annex II, 3.2 ( c ) Article 33 (Design and Development Part C – Design Controls Design Controls
Review) (e) Design Review

Section 32 (2) (c) - Class II devices

Chapter 2 ATTACHMENT I
7.3.5 - Design and Development
820.30 (f) Design Verification Section 32 (3) (f) - Class III devices Annex II, 3.2 ( c ) Article 34 (Design and Development Part C – Design Controls Design Controls
Verification
Verification) (d) Design verification
Section 32 (4) (i) - Class IV devices

Section 20

Section 32 (2) (c) - Class II devices Chapter 2 ATTACHMENT I

7.3.6 - Design and Development Validation 820.30 (g) Design Validation Annex II, 3.2 ( c ) Article 35 (Design and Development Part C – Design Controls Design Controls
Section 32 (3) (f) - Class III devices Validation) (g) Design transference

Section 32 (4) (i) - Class IV devices

ATTACHMENT I
7.3.1 - Design and Development Planning Part C – Design Controls
Note Design transfer
820.30 (h) Design transfer ./. ./. ./.
(g) Design transference
Design Controls
(h) Design release

Chapter 2 ATTACHMENT I
7.3.7 - Control of Design and Development
820.30 (i) Design Changes Section 34 Annex II, 3.2 ( c ) Article 36 (Control of Design and Part C – Design Controls Design Controls
Changes
Development Changes) (i) Design changes

4.2.4 - Control of Records Chapter 2

2nd paragraph Article 9 (Control of Records) ATTACHMENT I
820.30 (j) Design history file ./. ./. Part C – Design Controls Design Controls
7.3.7 - Control of Design and Development Article 36 (Control of Design and (j) Design background record
Changes Development Changes)

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ATTACHMENT I
Part E – Purchase Controls
820.50 Purchasing Controls
7.4 – Purchasing Chapter 2 (a) Evaluation of suppliers and contractors
./. Annex II, 3.2 (d) Purchasing Controls
7.4.1 - Purchasing Process 820.50 (a) Evaluation of suppliers, Article 37 (Purchasing Process)
contractors and consultants Part B – Quality System Requirements
3. Personnel
(c) Consultants

Annex II, 3.2 (d)

Section 32 (3) (a) - Class III devices ATTACHMENT I
Chapter 2
7.4.2 - Purchasing Information 820.50 (b) Purchasing data Annex V, 3.2 (c) Part E – Purchase Controls Purchasing Controls
Article 38 (Purchasing Information)
Section 32 (4) (a), (f) - Class IV devices (b) Purchase forms
Annex VI, 3.2

ATTACHMENT I
820.80 Receiving, in-process, and finished Annex II, 3.2 (d)
Part H – Inspection and Tests
device acceptance Chapter 2
1. Inspection and tests
7.4.3 - Verification of Purchased Product (a) General ./. Annex V, 3.2 (c) Article 39 (Verification of Purchased Purchasing Controls
(a) General instructions
Products)
(b) Receiving inspection and tests
820.80 (b) Receiving acceptance activities Annex VI, 3.2
(e) Inspections and tests records

ATTACHMENT I
Part G – Process and Production Controls
820.70 Production and process controls
1. Process and production controls
(a) General Annex I, 13 Production and Process Controls
(a) General instructions
(g) Equipment
820.70 (g) Equipment Annex II, 3.2 (d) Facility and Environmental Controls
7.5 - Production and Service Provision
Section 32 (2) (d) - Class II devices
Part H – Inspection and Tests
820.72 (a) Control of inspection, Annex III, 3 Chapter 2
7.5.1 - Control of Production and Service 1. Inspection and tests Labeling
measuring, and test equipment. Section 32 (3) (g) - Class III devices Article 40 (Control of Production and
Provision (a) General instructions
Annex IV, 2 Service Provision)
2. Inspection, measuring and testing Handling, Storage, Distribution, &
820.120 Device Labeling Section 32 (4) (f) (g) (o) - Class IV devices
[Link] - General Requirements equipment Installation
Annex V, 3.2 (c) (d)
820.130 Device packaging
Part L – Packaging and Labeling Controls
Annex VI, 3.2 DHRs
820.184 Device History record
Part M – Records
3. Product background record

Article 12

Annex I, 8

[Link] - Control of Production and Service Annex II, 3.2 (d)

ATTACHMENT I
Provision - Specific Requirements Section 17 Chapter 2
Part G – Process and Production Controls
820.70 (e) Contamination control Annex III, 3 Article 41 (Cleanliness of Products and Production and Process Controls
1. Process and production controls
[Link].1 - Cleanliness of Product and Section 32 (3) (e) - Class III devices Contamination Control)
(e) Contamination control
Contamination Control Annex IV, 2

Annex V, 3.2 (c)

Annex VI, 1

ATTACHMENT I
Chapter 2 Part K – Handling, Storage, Distribution Handling, Storage, Distribution, &
[Link].2 - Installation Activities 820.170 Installation Section 45 (i) Annex I, 13.6 (d)
Article 42 (Installation Activities) and Installation Installation
4. Installation

Chapter 2 ATTACHMENT I
[Link].3 - Servicing Activities 820.200 Servicing Section 45 (i) ./. Servicing
Article 43 (Servicing Activities) Part N – Technical Assistance

Article 12

Section 17 Annex I, 8 Chapter 2 ATTACHMENT I Production and Process Controls

[Link] - Particular Requirements for Sterile
820.75 (b) Process validation Article 44 (Manufacturing Control of Sterile Part G – Process and Production Controls
Medical Devices
Section 32 (3) (e) - Class III devices Annex II, 3.2 (d) Medical Devices) 2. Special processes (a) (2) (3); (b) Sterilization

Annex IV, 2

ATTACHMENT I
7.5.2 - Validation of Processes for Part G – Process and Production Controls
820.70 (i) Automated Processes Section 20 Chapter 2
Production and Service Provision 1. Process and production controls
Annex I, 12.1 (a) Article 45 (Validation of Processes for Production and Process Controls
(h) Automated processes
820.75 Process validation Section 32 (4) (i) - Class IV devices Production and Service Provision)
[Link] - General Requirements
2. Special processes

820.3 (o) Definitions Section 17 Annex I, 8.4 Chapter 2 ATTACHMENT I

[Link] - Particular Requirements for Sterile
Article 46 (Validation of Sterilisation Part G – Process and Production Controls Sterilization
Medical Devices
820.75 Process validation Section 32 (3) (e) - Class III devices Annex VII, 3 Process) 2. Special processes

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Article 14
Section 21

Annex I, 13
Section 32 (1)

Annex II, 2
Section 66 (2) (a) - Implants
7.5.3 - Identification and Traceability 820.60 Identification Annex II, 3.2 (d)
Chapter 2 ATTACHMENT I
Section 71 (2) (a) - PART 2 CUSTOM-
Identification and Traceability
Article 47 (Identification) Part F – Identification and Trackability
[Link] – Identification 820.80 (b) Receiving acceptance activities Annex V, 2
MADE DEVICES
Annex V, 3.2 (c)
Section 81 (b) - PART 3 MEDICAL
Annex VI, 2
DEVICES FOR INVESTIGATIONAL
TESTING
Annex VIII, 2

Section 32 (3) (c) - Class III devices

Section 32 (4) (c), (f) - Class IV devices

Chapter 2
Sections 52 to 56
[Link] - Traceability Article 48 (Traceability)
ATTACHMENT I
820.65 – Traceability
Section 71 (2) - PART 2 CUSTOM-MADE
./. Identification and Traceability
Part F – Identification and Trackability
[Link].1 – General Article 49 (Traceability of Specially
DEVICES
Designated Medical Devices)
Section 81 - PART 3 MEDICAL DEVICES
FOR INVESTIGATIONAL
TESTING

ATTACHMENT I
Part F – Identification and Trackability
[Link].2 – Particular Requirements for Section 54 (1), (2) Chapter 2 2. High risk products (class III or IV)
Active Implantable Medical Devices and ./. ./. Article 49 (Traceability of Specially Identification and Traceability
Implantable Medical Devices Section 66 Designated Medical Devices) Part L – Packaging and Labeling Controls
3. High risk products labeling (class III or
IV)

Annex II, 3.2 (e)

820.60 Identification ATTACHMENT I Identification and Traceability
Chapter 2
[Link] - Status Identification ./. Annex V, 3.2 (d) Part H – Inspection and Tests
Article 50 (Status Identification)
820.86 Acceptance Status 1. Inspection and tests Acceptance Activities
Annex VI, 3.2

Chapter 2
7.5.4 - Customer Property ./. Section 67 (2), (3) Article 20 ./. Production and Process Controls
Article 51 (Customer Property)

820.120 Device Labeling ATTACHMENT I

Part K – Handling, Storage, Distribution
820.130 Device packaging and Installation
1. Handling Labeling
820.140 Handling 2. Storage
Chapter 2
7.5.5 - Preservation of Product Section 14 Annex I, 5 3. Distribution
Article 52 (Preservation of Products) Handling, Storage, Distribution, &
820.150 Storage 4. Installation
Installation
820.160 Distribution Part L – Packaging and Labeling Controls
1. Products packaging
820.170 Installation 2. Products labeling

ATTACHMENT I
Part G – Process and Production Controls
1. Process and production controls
(b) Environmental control
820.70 ( c ) Environmental control
Annex II, 3.2 (e)
Chapter 2 Part H – Inspection and Tests
7.6 - Control of Monitoring and Measuring 820.72 Inspection, measuring and test Inspection, Measuring, and Test
./. Annex V, 3.2 (d) Article 53 (Control of Monitoring and 1. Inspection and tests
Devices equipment Equipment
Measuring Devices) 2. Inspection, measuring and testing
Annex VI, 3.2 equipment
820.70 (i) Automated processes
Part G – Process and Production Controls
1. Process and production controls
(h) Automated processes

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ATTACHMENT I
820.80 Receiving, in-process, and finished
8 - Measurement, Analysis and Part H – Inspection and Tests
device acceptance Chapter 2 Management Controls
Improvement 1. Inspection and tests
(a) General ./. ./. Article 54 (Measurement, Analysis and
(a) General instructions
Improvement) Statistical Techniques
8.1 – General
820.250 Statistical Techniques
Part O – Statistic Techniques

Annex II, 3.1

Annex IV, 3

8.2 - Monitoring and Measurement 820.198 Complaint Files Section 57 (1) (a) Annex V, 3.1 ATTACHMENT I
Chapter 2 Complaint Handling and Vigilance
Part M – Records
Article 55 (Feedback) Reporting
8.2.1 – Feedback 21 CFR Part 822 Postmarket Surveillance Section 61 (2) (c) (i) Annex VI, 3.1 4. Complaints file

Annex VII, 4

Annex VIII, 5

An obligation to keep the QMS effective

and to monitor the QMS: ATTACHMENT I
Chapter 2
8.2.2 - Internal Audit 820.22 Quality Audit ./. Annex II, 3.2 (b) Part B – Quality System Requirements Management Controls
Article 56 (Internal Audit)
Annex V, 3.2 (b) 2. Quality audit
Annex VI, 3.2

An obligation to keep the QMS effective ATTACHMENT I

820.22 Quality Audit and to monitor the QMS: Chapter 2 Part B – Quality System Requirements Management Controls
8.2.3 - Monitoring and Measurement of
./. Annex II, 3.2 (b) Article 57 (Monitoring and Measurement of 2. Quality audit
Processes
820.250 Statistical Techniques Annex V, 3.2 (b) Processes) Statistical Techniques
Annex VI, 3.2 Part O – Statistic Techniques

Annex II, 3.1

ATTACHMENT I
Annex IV, 3
Part C – Design Controls Management Controls
8.2.4 - Monitoring and Measurement of 820.80 Receiving, in-process, and finished (h) Design release
Annex V, 3.1 Chapter 2
Product device acceptance
Section 57 (1) (a) Article 58 (Monitoring and Measurement of Statistical Techniques
Part H – Inspection and Tests
Annex VI, 3.1 Products)
[Link] - General Requirements 820.250 Statistical Techniques 1. Inspection and tests
Acceptance Activities
Annex VII, 4
Part O – Statistic Techniques
Annex VIII, 5

ATTACHMENT I
[Link] - Particular Requirement for Active Chapter 2
Part H – Inspection and Tests
Implantable Medical Devices and 820.80 (e) – Acceptance records ./. ./. Article 59 (Monitoring and Measurement of Acceptance Activities
1. Inspection and tests
Implantable Medical Devices Specially Designated Medical Devices)
(e) Inspections and tests records

Annex II, 3.2 (b) Chapter 2 ATTACHMENT I

8.3 - Control of Non-conforming Product 820.90 – Non-conforming product ./. Article 60 (Control of Nonconforming Part i – Noncompliant Components and Nonconforming Product
Annex V, 3.2 (b) Products) Products

Chapter 2 ATTACHMENT I
8.4 - Analysis of Data 820.250 Statistical Techniques ./. ./. Statistical Techniques
Article 61 (Analysis of Data) Part O – Statistic Techniques

Recall Reporting:
820.20 ( c ) Management review
Annex II, 3.1 ATTACHMENT I Management Controls
820.100 Corrective and Preventive Action Part B – Quality System Requirements
Section 57
Annex IV, 3 1. Management responsibility CAPA
8.5 – Improvement 820.198 Complaint Files (c) Management review
Section 58 Chapter 2
Annex V, 3.1
Article 62 (Improvement) Complaint Handling and Vigilance
8.5.1 – General 21 CFR Part 803 - Medical Device Part J – Corrective Measure
Sections 59 to 65.1 - Mandatory Problem Reporting
Reporting Annex VI, 3.1
Reporting
Part M – Records
21 CFR Part 806 - Medical Devices; Annex VII, 4 4. Complaints file Statistical Techniques
Reports of Corrections and Removals
Annex VIII, 5

Corrective Action:

Annex II, 3.1

Annex IV, 3
820.100 – Corrective and Preventive Chapter 2 ATTACHMENT I
8.5.2 - Corrective Action Annex V, 3.1 CAPA
Action Article 63 (Corrective Actions) Part J – Corrective Measure
Annex VI, 3.1

Annex VII, 4

Annex VIII, 5

820.100 – Corrective and Preventive Chapter 2

8.5.3 - Preventive Action ./. ./. ./. CAPA
Action Article 64 (Preventive Actions)

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