Certification statement

≪1≫ Certification certificate etc.

1 Application book
 

Manufacture of designated managed medical equipment, etc. Book of certification (No. 64 (1))

(Foreign companies should use this method No. 64 (3))

〇Key points〇
 

・Attached documents (draft) including the citations for the application and whether or not the book is correct or not.
 

・Whether the applicant's information (named Japanese location) and the information on the registration record are correct or not are the same.
 

・Please note the circumstances regarding the application of the Meals on Wheels 0128 No. 6, and the notes on whether or not they apply. ``Based on January 22, 1, No. 28 No. 0128 of the Meals on Wheels, 6.''
 

・Whether it's right or wrong, it includes extra resources or extra resources in terms of quantity demanded.

2 Supporting materials fee (STED)
 

① Overview

② Compatibility with basic requirements standards

③ Equipment information

④Confirm the effectiveness of the design and provide a written summary.

⑤ Attachment (draft)

⑥ Wind management

⑦Manufacturing information

〇Key points〇
 

・Created 0210 no.
 

・Conforms to JIS requirements in the usage description.
 

Whether or not it is included, please refer to the 0210 No. 1, 1st column of events (including the information, signatures, etc.).
 

・Please clearly indicate whether or not you agree to the terms and conditions.
 

・Personal corporate representative's signature or name seal (corporate representative's seal).

3 Permissible stamps
 

Manufacturer's license, manufacturing license, foreign manufacturer, renewal registration book or partner industry license, etc.

〇Key points〇
 

・Results omitted QMS compliance check, demand provision standard compliance confirmation. A certified book is required.
 

・The latest version of the book.
 

・As a result of any changes or updates, please confirm the latest information on the book, etc., and confirm the location of the production and sales records in the register.

≪2≫Compatibility test book

1 Application book
 

Applicability of designated managed medical equipment, etc. certification book (formula 67 (1))

(Foreign companies should use this method 67 (2))

〇Key points〇
 

・If there is a "standard match" in the original application, and if the match is omitted, the confirmation of the existence of the item is required, and the request is made and the "child item list" is submitted.
 

・Review of the property including whether or not the property is installed or not is included in the report.
 

・Whether it's right or wrong, it includes extra resources or extra resources in terms of quantity demanded.

2 Supplementary materials
 

・Quality control system standard specification record stamp

・Management document clarity

・Custom diagram design structure

・Customer's construction site

・Production method flow chart

・Combination test report

*References about how many changes have been made to Nyoka Sengoku, and how many changes have been made.

※Regular check-up information and demand declaration book

*Specific content of the basic training plan and other necessary text

〇Key points〇
 

・The latest version of the quality management system standard specification book (quality manual) confirms whether or not it can be included in the certification page.
 

・You are a foreign manufacturer, the language you use is Japanese or English, and the translated version is included.
 

・Confirm the location of each factory, manufacturing area, etc. from the geographical area of ​​the site and the layout of the manufacturing facility.
 

・Information regarding the name and department of the management supervisor, manager, and responsible engineer.
 

・Information on the manufacturing process (determining whether or not to purchase or sell to the market) and the specific process details of each individual's installation.
 

・Outline of manufacturing process for specific products.Please refer to the October 26, 10 event report "Required QMS compatibility training report request."
 

・Easy to understand the pros and cons of detailed production process activity monitoring system for each individual quality control system.
 

・Confirm whether or not it is possible to manage production, sales, etc. with a quality management system based on individual production bases.

3 Attached documents
 

・Results of QMS monitoring results or ISO nuclear reports for the past three years

・Product title or DMR

・Combination test book and report book

・Design and development report

*Contents of the basic report, contents of the report, and other necessary text.

〇Key points〇
 

・Articles that are not in demand and are cited in the standard book of the standard.
 

・Is the stamp of the product label correct or not? 0827 No. 4 Chapter 6 Chapter 36. Article 6 (5) Comparative contents.
 

・The latest version of the ISO13485 certification book. (Wakasaki Mae previously provided this request was not provided)
 

・Results may be omitted from QMS compliance check, demand provision standard compliance confirmation. A certified book is required.
 

・Confirmation of company name, location, changes in supply and demand, updates, etc., and confirmation of the latest documents. (Not inclusive)
 

・Demand supply, testing schedule, etc., each production facility (inclusive storage)) application item, time of implementation of playing, playing method or person expression (样style).
 

・The amount of work required to meet the standards for a group of different products, and to reduce the amount of work required to adjust the current requirements in this next application.
 

・Demand and supply matching conditions are not included in the result report.