Example

Sample1 Manufacturing process flow.

Seep Description Seep Description
Receive raw material 1. Incoming material QC
from supplier and test （Visual Inspection） Mfg.
Sterilization (EOG） 9. Sterilization
Mfg. (Quality conformance inspection) DEF
STU (BI testing)
Assembly 2. Assembly 1 (Determination of
（Injection molding process） residual ethylene
oxide)

Test 3. Test１
（Visual Inspection) Test 10. Test4
(Electric resistance measurement ) (Visual Inspection)
Mfg.
Mfg. ISO Class 7 GHI
ABC Assembly 4. Assembly 2
（Welding process） Storage
（Coating）
Cleaning 5. Cleaning
Test 11. Test 5
6. Test 2 （Visual Inspection）
Test
（Visual Inspection)
(Leakage current measure) Mfg. Packaging / Labeling 12. Outer containers
JKL
Cleaning / Packaging /
7. Cleaning/Packaging/Labeling 13.Final Inspection
Labeling Final Inspection
（Cleaning） （Visual Inspection）
（Sterilized packaging process）
Test 8. Test 3 Decision on whether the
（Visual Inspection） products an be shipped
（Bio burden testing） Registration
0
 Example
Sample2 Mutual relations of QMS

Marketing Authorization
Holder（JKL, Ltd.） Agreement QMS(ABC, Co.）
実地調査

MNO, Co.(Registration)
Design facility
GHI Distribution Center
（Inspection・Storage）
ABC Mfg. site
STU, Mfg. site.
(Registration)
Assembling plant
Main assembling plant

Agreement
JKL Distribution Center
QMS(DEF, Co.) ：Same QMS
(Registration)
（Distribution Center）
DEF, Mfg. site(Registration)
（Sterilizer） ：Information
exchange

1
 Example
Form2 Outline of MAH/RMS (1/2)
Outline of manufacturing site As of DD/MM/YY

Name of mfg . site

Address of mfg. site
Registration number Date of initial registration
Registration period
Numbers of employees (including part time employees)
Total: Mfg. department : QA/QC department :
Number of mfg. products (Number of products exported to Japan should be described in parenthesis.)
Class I Class II Class III Class IV
Number of products

Product utilizing
medicine/cellular and
tissue-based product
Specified biological product

Product utilizing nano

materials
Micro machine

Product absorbed into

human body
Special designated medical
device
2
 Example
Form2 Outline of RMS (2/2)
If export , please describe your export destination and trade name of the products except Japan.

Export destination Trade name of the product

Changes history of mfg. site  Changes of product / mfg. process (if important)
(please select items, and specify  Changes of QMS organization
details.)  Changes of top management or management representative
 Others ( )
 No Change
Details

Not applied article 4 and article 83 of QMS ordinance (MHLW Ministerial Ordinance No.169 in 2004)

History of QMS inspections by regulatory authorities and registered certification body over the past 5 years.

Name regulatory Inspection date The products subject to Inspection results Type of Inspection
authorities/registered the inspection (On-site or Desk-top)
certification body

Name, address, and applicable mfg. process of critical suppliers

Name Address Applicable mfg. process

3
 Example
Form3 Products list for application

No. Product Generic Trade Approval classification Date of Expiry * Mfg. site
family name name (certification) approval date registration
No. (Certification)

* If sterilizer or distribution center are different, write these mfg. site’s name.
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 Example
Sample3 Layout of RMS

Location map of RMS

Aerial photograph
Site boundary of or location map of
RMS RMS.
S Building
Distinguish a
Q Building building affecting a
subject of product.

T Building

R Building

Medical devices mfg. building

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 Example
Sample4 Floor plan of RMS(1/2)

ISO Class 7
a passage way differential
pressure
Manufacturing Manufacturing (>10Pa)

Sterilizer

Receiving People flow

Packaging Material flow

Shipping
Warehouse Sterilization

Sterilizer 1 Sterilizer 2

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 Example
Sample4 Floor plan of RMS(2/2)

Representative list of mfg. equipment

No. Manufacturing Equipment Model
１ Injection Molding Equipment SK-123
２ Welding Equipment Ly-222
３ Autoclave ST999
・・・ ・・・ ・・・

Representative list of inspection equipment

No. Inspection Equipment Model
１ Gage Blocks 123F
２ Microscope F111
３ Electronic scale SEW124
・・・ ・・・ ・・・
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 Example
Sample5 organization chart

ABC company Organization Chart

PMDA TARO
President and CEO
Top Management

KIKOU JIRO
Human Quality & Regulatory Affairs Finance Global
Resource Reconstruction operation
Management Representative

Regulatory Mfg QA
Affairs department department
department

Mfg. site A QC
department

Mfg. site B Purchasing

department
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 Sample6 Example

List of documents identified with QMS

Control of
Documents identified with the Retention
QMS Article documents
QMS period
Name Number
Section 2
QMS
Article 5
General equirements for
QMS
Article 6 6.1.1 Quality policy
Documentation of QMS 6.1.1 Quality objectives
6.1.2 The quality manual
Any other documentation
6.1.5 specified by the laws, others and
ordinances related to the PMD Act.
6.2 Seihin hyojun syo
Article 7
Quality Manual
Article 8 Procedure about control of
8.2
Control of Documents documents
Article 9 Procedure about control of
9.2
Control of Records records

・*************** *** ***************

9

Sample7 Seihin Hyojyun Syo
Requirements
1.Product family, Generic name
(common name), Proprietary name
2.The date of number of approval
3.Specifications
4.Operating methods and procedure
5.Product design, drawings and
specifications or composition and
content
6.Mfg methods and procedure
***************
8.Labeling and packaging
***************
Example
Reference documents(name, number, etc) Location
(sites)
Copy of marketing approval
Copy of marketing approval
Product Specification
(P2/D2 DMF1 device requirement spec 73345)
Product Manual 7233
Mechanical Specification 7810
(Spec-controlled environment area)
Test specification T78910
(Electrical test specification, IPG)
Product Specification P78910
(DMF1 RV2 product configuration)
Mfg procedure(MT123, SOP04, SOP05)
***************
Product Specification 1234
(P2/D2 DMF1 device requirement spec)
***************
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 Sample8 Example

Implementation of validation status

Mfg Validation date Mfg.

Reasons Mfg equipment
process IQ OQ PQ site
Injection N/A N/A 1/3/2014 ABC Re-Validation Injection molding
molding machine A-01

Soldering 1/1/2014 1/2/2014 1/3/2014 ABC Repairing Soldering Soldering iron D-01,
iron D-01, D-02 D-02

Welding 1/1/2014 1/2/2014 1/3/2014 ABC Change equipment Ultrasonic welding

machine M-01

Sterilization 1/1/2014 1/2/2014 1/3/2014 DEF Purchase new Sterilizer P-04

sterilizer(EOG)

Packing N/A 1/2/2014 1/3/2014 ABC Change setting value Heat Sealer P-01
（Temp:105℃→110℃）

*** *** *** *** *** *** ***

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