QMS compatibility test report

Specified text of the notification

1. The application for the purpose of manufacture of the requested product, the application for approval, or the approval for the modification of the parts of the approval section.

2. Partial changes have been approved since our own training, and some changes have been made.

〇Key points〇

At the time of application for approval of partial change, since the next meeting of the demand coordination machine or the prefecture, the purpose of approval of the application for partial change has been approved, and the proposal for the change is to be printed under the terms of the exchange. The stamp of the record book.

Three.ISO13485 Please note that the program will be implemented within three years of the launch of the program, and that the program will be implemented within 3 years. Partner country's certification book or report on foreign countries Approval of certification by the relevant authorities

〇Key points〇

Required statement in the lower column of supply and demand

①ISO13485 Certification book

②Third-party certification mechanism external foreign authority's actual ground report report

③Basic MOU Confirmation book or report on achievement of successive countries etc.

4Approval certification book for foreign authorities

4. Outline of the manufacturing process for the purpose of the training

〇Key points〇

・Ensurement of guaranteed property with no parts received and quality judgment

・Record of detailed work contents

5. An overview of the operational activities of each program, as well as mutually interactive resources for the quality management and management system of each program.

〇Key points〇

・Manufacture owned and developed production facility

・Activity overview

Compatible Tuning Practitioner's Fees

1. Tuning test design support fee

(1) Outline of the training program

(2) The layout of the training program

(3) Plane design for the design of the program, cleaning of the main equipment for the design and construction, and cleaning of the main equipment for the design and construction, and the cleaning of the main equipment for the design

〇Key points〇

(XNUMX) Overview

・Manufacturers, etc., selected foreign manufacturers of medical equipment, etc., and proprietary manufacturing facilities.

・Contents available in English for overseas manufacturing facilities

・Manufacturers and manufacturers are all under the same manufacturing conditions, and their releases are recorded once they originate.

(2) Cloth Bureau Encyclopedia

・Other proprietary manufacturing facilities

・Encyclopedia is available.

(3) Plane image

・Clearly defined construction area, formal room, etc.

Two.QMS Relevant information

(1) Tunnel diagram structure

(2) Quality management system standard book

(3) Management sentence string table

〇Key points〇

(1) Organization

The manufacturer, the safety management department, or the safety management department.
(2) Quality management system standard book

Original seal

(3) Management sentence string table

If the results are met, the quality and quality of the materials required will be provided.

3. Item matching fees
(1) Compatibility of requested item and child item details

(2) Outline of the product standard
(3) Materials for a clear record of accompanying documents, etc., outlining the purpose of the product.

(4) Implementation information during the manufacturing process

〇Key points〇

(2) Overview
Under the circumstances of each item, we will assist you in the design of each item, and we will provide you with the appropriate information for each item in the catalog, so that you can clearly understand the information.

(3) Additional materials, etc., including an outline of the purpose of the item and a clear record of the progress.

Please check the details of the actual implementation process, process name, implementation date, and date of implementation (date of approval of the final report).

Four.QMS Ministerial Ordinance No. 3 Chapter fees

(1) Comprehensive operating procedures for notifying customers of the progress of manufacturing, purchasing, selling, etc.

(2) Attestation document requiring compliance with domestic quality industry operations

(3) Domestic product quality operations management procedures
(4) Yojuji Seisakusho, etc.’s reading book
(5) Notification from a self-repair business or second-hand purchase business or purchase supplier, quality operating procedures for a medical equipment sales business or purchase supplier

〇Key points〇

(3) Operating instructions

① Overview of domestic quality management operations

② Market purchase decision

③ Comprehensive information on product quality, etc. (comprehensive product quality changes, etc.) and reporting on the actions of personnel in charge of management.

④Recovery of goods

⑤ Safety management and control department will report on the safety information after the market launch.

(4) Reading book

Manufacturers who sell customary manufacturing facilities may not directly access the manufacturing facility, and may contact other commercial manufacturing facilities under the circumstances of collection of information.

Specified text of the notification

1. Partial changes have been approved since our own training, and some changes have been made.

Two.ISO13485 Please note that the program will be implemented within three years of the launch of the program, and that the program will be implemented within 3 years. Partner country's certification book or report on foreign countries Approval of certification by the relevant authorities

〇Key points〇

Required statement in the lower column of supply and demand

①ISO13485 Certification book

②Third-party certification mechanism external foreign authority's actual ground report report

③Basic MOU Confirmation book or report on achievement of successive countries etc.

4Approval certification book for foreign authorities

3. Outline of the manufacturing process for the purpose of the training

〇Key points〇

・Ensurement of guaranteed property with no parts received and quality judgment

・Record of detailed work contents

4. An overview of the operational activities of each program, as well as mutually interactive resources for the quality management and management system of each program.

〇Key points〇

・Manufacture owned and developed production facility

・Activity overview

5. Summary of the recovery since our own regular meeting performance (as we proceed)

〇Key points〇

Date of start of recycling, product name, contents of recycling, separate classification of recycling, name of manufacturing company, etc.

6. oath book

Tunnel Requirements Notification Table 4-2.(6) “Suitable Tuning Practitioner’s Fees”

1. Tuning test design support fee

(1) Outline of the training program

(2) The layout of the training program

(3) Plane design for the design of the program, cleaning of the main equipment for the design and construction, and cleaning of the main equipment for the design and construction, and the cleaning of the main equipment for the design

〇Key points〇

(XNUMX) Overview

・Manufacturers, etc., selected foreign manufacturers of medical equipment, etc., and proprietary manufacturing facilities.

・Contents available in English for overseas manufacturing facilities

・Manufacturers and manufacturers are all under the same manufacturing conditions, and their releases are recorded once they originate.

(2) Cloth Bureau Encyclopedia

・Other proprietary manufacturing facilities

・Encyclopedia is available.

(3) Plane image

・Clearly defined construction area, formal room, etc.

Two.QMS Relevant information

(1) Tunnel diagram structure

(2) Quality management system standard book

(3) Management sentence string table

3. Item matching fees

(3) Compatibility of the requested item with the confirmation of the original item (formula XNUMX) and standard compliance.

(2) Outline of the product standard

(3) Accompanying documents, etc., and a clear record of the purpose of the product.

(4) Implementation information during the manufacturing process

(3) Annual production volume for the past three years

(6) Should the use of biologically derived raw materials, etc. in the medical equipment, or the safety aspects of the safety measures, be made without the presence of quality materials?

〇Key points〇

(2) Overview
Under the circumstances of each item in the catalogue, we will provide you with the appropriate information for each item in the catalogue, so that you can clearly understand the information.

(3) Additional materials, etc., including an outline of the purpose of the product and a clear record of its progress.

Please check the details of the actual implementation process, process name, implementation date, and date of implementation (date of approval of the final report).

Four.QMS Ministerial Ordinance No. 3 Chapter fees

(1) Comprehensive operating procedures for notifying customers of the progress of manufacturing, purchasing, selling, etc.

(2) Attestation document requiring compliance with domestic quality industry operations

(3) Domestic product quality operations management procedures

(4) Yojuji Seisakusho, etc.’s reading book

(5) Notification from a self-repair business or second-hand purchase business or purchase supplier, quality operating procedures for a medical equipment sales business or purchase supplier

〇Key points〇

(3) Operating instructions

① Overview of domestic quality management operations

② Market purchase decision

③ Comprehensive information on product quality, etc. (comprehensive product quality changes, etc.) and reporting on the actions of personnel in charge of management.

④Recovery of goods

⑤ Post-launch safety information report, etc. by the Safety Management and Pipeline Department

(4) Reading book

Manufacturers who sell customary manufacturing facilities may not directly access the manufacturing facility, and may contact other commercial manufacturing facilities under the circumstances of collection of information.