QMS systematic construction

Updated: July 2024, 3

We provide medical equipment and other equipment that are compatible with each other and provide support in our business area.

We have been working for a long time to support the production of articles in this category, as well as supporting the long-term development of new business customers and providing customers with support.

In summary, we will take a look at the various business practices associated with the construction of the QMS system for medical equipment manufacturers.

从GQP到QMS

Manufacturing department demand QMS system

Before the implementation of the law on medical equipment, medical equipment, etc. in the country, it was possible to apply for the production of medical equipment, etc. in the country, the demand system GQP quality management procedure, the production process, etc., and the talent available in the receiving prefecture. After the implementation of the law, the QMS ministerial ordinance was established and the QMS system was established, and it was possible to obtain employment.

However, since the construction of QMS (Quality Management System) has given rise to a wide range of medical equipment, it is very difficult to construct a complete QMS.

In this case, the Ministry of Health, Labor and Welfare has issued a Ministerial Ordinance on the Systematic Standards for Production Management and Quality Management of Medical Instruments and In-Body Diagnostic Products in all prefectures. When medical equipment or in vitro diagnostic equipment is available, the first condition is to meet the ministerial requirements.
The Ministerial Ordinance is referred to as the “System Ordinance”.

3 Comprehensive system standards (Article 1, Subsection XNUMX of the Ministerial Ordinance on the Government System)

Manufacturers are responsible for the highest cost during the market distribution of medical equipment, demand development, necessary organization system, ensuring quality management system, ensuring written implementation and effective maintenance, ensuring on-site management and storage quality. The management booklet, and the local management record for safekeeping.

When the application is accepted, the requirements listed below will be met in a systematic manner, and the receipt will be confirmed.

① Specific requirements for quality management system
② Specific requirements for systematic documentation of product quality management
③ Requirements for quality management system standard book
④ Requirements for product quality management and manual management
⑤Requirements for record management

　

3 Standards for staff assignment (Article 2, Subsection XNUMX of the Government Ordinance)

Medical equipment manufacturers, demand allocation management personnel, customer support personnel, and other personnel, which are suitable for local management based on QMS ministerial quality management operations.

At the time of application, please include the details of the request transaction, the responsible person's records, the payment management system, etc., and the reception confirmation.

① Manager
② Manager
③ Manufacturer who purchased the product
④ Japan Quality Service Supervisor

Limited Third-Type Medical Equipment Manufacturer's QMS System Ministerial Regulations

Third-party medical equipment manufacturers limited to general medical equipment equipment, external health management, quality management, and quality management submissions for medical equipment enterprises with special requirements.

Ministerial provisions for the following QMS system for non-qualified third-party medical equipment manufacturers.

	Requirements	System ministerial ordinance article
①	Product quality management systematic documentation requirements	Article 6, Subsection 1, Item 1
②	Requirements for quality management system standard book	Article 7, Subsection 2
③	Cultural management specific requirements	Article 8, Subsection 3
4	Specific requirements such as staff assignment manager	Article 10 items 1 to 3
⑤	Specific requirements such as staff assignment person in charge of management	Article 16:

Licensed medical equipment, approval, approval, etc. are compatible with each other, and we are familiar with the system.

We support and submit legal claims for newly introduced medical equipment businesses, existing manufacturing businesses, production businesses, Japanese machinery businesses, etc.

We provide our customers with new and innovative manufacturing businesses with support and compliance with the QMS system.

Medical equipment has a high level of industry, and its capabilities are perfect, as well as small administrative staff.

Our teams are present in all prefectures across the country. You must receive additional information from our system.