Manufacturing business QMS system construction
Updated: July 2026, 8
The standard conformance of manufacturing management and quality management of medical equipment, etc. has been changed in the past, and now it has been changed, and the quality management of the manufacturer's own manufacturing facility has been completed. A new system with step-by-step system control.
The fundamental changes were made, and the Standard Ministerial Regulations on Production Management and Quality Management for Medical Equipment and In vitro Diagnostics (hereinafter referred to as the "QMS Ministerial Regulations") were modified and new manufacturing operations were implemented.
One of the requirements for the approval of the new medical equipment manufacturing industry, the alternative GQP ministerial ordinance, and the QMS system ministerial ordinance.
In addition, please be aware that the system for managing the quality of products in relation to each other has been changed, the regulations for the procedures of the prefectures and provinces before the cancellation, and the regulations for the procedures of the items that have been approved by the PMDA, and the regulations for the procedures of the items that have been approved by the PMDA.查.
However, please be sure to check the production management and quality management of medical equipment, etc., and the actual implementation of the prefecture.
Quality management system standard book (quality manual) structure
During the production QMS (Quality Management System), the most important quality management system standards are composed of quality management procedure manuals, reviews, production manuals, records, etc.
QMS ministerial ordinance required written provisions
| Terms | QMS ministerial ordinance |
| Clarification of quality policy | Article 6, Subsection 1, Section 1 |
| Specification of quality criteria | Article 6, Subsection 1, Section 1 |
| Quality management system standard book | Article 6, Subsection 1 |
| Materials for quality management procedures | Article 6, Subsection 1, Item 4 |
| Matters related to the written requirements for the law and regulations | Article 6, Subsection 1, Item 5 |
| Product classification book | Article 6, Subsection 2 |
| Responsibilities of the department and its members | Article 15, Subsection 1 |
| Requirements for basic design and maintenance of business operations | Article 24, Subsection 2 |
| Specific requirements such as the health status and cleanliness of the employee | Article 25, Subsection 2 |
| Working environmental conditions and specific requirements | Article 25, Subsection 3 |
| Management requirements for dyed products, etc. | Article 25, Subsection 5 |
| Product wind management requirements | Article 26, Subsection 5 |
| Items related to product requirements | Article 28, Subsection 2 |
| The text of the program to open the program | Article 30, Subsection 5 |
| Record of purchase information | Article 38, Subsection 3 |
| Manufacture kimono service offer specific requirements | Article 40, Subsection 1 |
| Manufacture, supply and delivery operational instructions | Article 40, Subsection 1 |
| Product cleanliness requirements | Article 41 |
| Specific requirements for the security industry | Article 42, Subsection 1 |
| Comprehensive operation command system for the implementation of additional functions | Article 43, Subsection 1 |
| Product preservation operation management command system | Article 52, Subsection 1 |
| Comprehensive operation command system for managing goods with limited expiration dates | Article 52, Subsection 2 |
| New production process | Article 60, Subsection 9 |
| Heavy new production and extinction video | Article 60, Subsection 10 |
| Notice | Article 62, Subsection 2 |
| Literary quality management system | Article 66 |
| 228-20 Clause 2 of the XNUMXnd Section of the XNUMXnd Section of the XNUMXth Section of the ``Enforcement Guide'' where the manufacturing location of the relevant manufacturer is acknowledged and the product is available. | Section 69 |
| Japanese quality industry work manual | Article 72, Subsection 2 |
| Provisions made by the manufacturer and manufacturer | Article 72-2 |
| Procedures for notifying repair personnel | Article 72-2 Subsection 2 Section 1 |
| Guaranteed business or tax guarantee procedures | Article 72-2 Subsection 2 Section 2 |
| The procedure for notifying the purchaser of the two-handed purchase | Article 72-2 Subsection 2 Section 3 |
QMS Ministerial Ordinance Required Process Procedures Enhancement Provisions
| Terms | Procedure example | QMS ministerial ordinance |
| literary management | Literature management specifications | Article 8, Subsection 2 |
| record management | Record management specifications | Article 9, Subsection 2 |
| work environment | Article 25, Subsection 3 | |
| Product design development | Article 30, Subsection 1 | |
| Recruitment process | Purchase management specifications | Article 37, Subsection 1 |
| Manufacturing and service delivery management | Article 40, Subsection 1 | |
| Additional clothing service | Article 45, Subsection 4 | |
| Testimonials for the process of burning bacteria | Article 46, Subsection 1 | |
| Product identification | Article 47, Subsection 2 | |
| Identification of retired goods | Product identification management specifications | Article 47, Subsection 3 |
| Guaranteed product tracking | Product identification management specifications | Article 48, Subsection 1 |
| preservation of goods | Product preservation specifications | Article 52, Subsection 1 |
| Management of goods with limited expiry dates | Product preservation specifications | Article 52, Subsection 2 |
| 监测和测Quantity | Article 53, Subsection 2 | |
| Collection of opinions from product buyers, etc. | Collection of opinions from product receivers, etc. | Article 55, Subsection 3 |
| Establishment and implementation of internal planning, etc. | Internal calculations | Article 56, Subsection 6 |
| Management of accepted and rejected products, etc. | Rejected product placement determination | Article 60, Subsection 2 |
| Numerical analysis, etc. | numerical analysis | Article 61, Subsection 1 |
| Dissemination and implementation of notices | Announcement and implementation instructions | Article 62, Subsection 2 |
| Minister of Health, Labor and Welfare's report on the situation | Quality information, defect reports, recovery management specifications | Article 62, Subsection 6 |
| Amendment measures | Revised Wakazuki Preventive Measures Implementation | Article 63, Subsection 2 |
| Precaution | Revised Wakazuki Preventive Measures Implementation | Article 64, Subsection 2 |
QMS Ministerial Ordinance Requirement Recording Provisions
| Terms | example | QMS ministerial ordinance |
| The result of management | Management record | Article 18, Subsection 2 |
| Educational training, skills and training for young people | Skill provision, skill and cultivation record | Article 23 Section 5 |
| Basic design of insurance industry | Article 24, Subsection 4 | |
| Risk Management | Wind analysis report, wind management confirmation table | Article 26, Subsection 6 |
| Product requirements, basic outcomes and fundamental measures to be taken | Article 28, Subsection 3 | |
| Information on how to proceed with the design process | Article 31, Subsection 1 | |
| Information on how to proceed with the design and development process | Article 32, Subsection 4 | |
| Design development results, etc. | Article 33, Subsection 3 | |
| As a result of the development of the design, the measures taken on this basis have been taken. | Article 34, Subsection 2 | |
| Design development results, etc. | Article 35, Subsection 3 | |
| Design and development changes, core results, etc. | Article 36, Subsection 4 | |
| Purchased goods, commercial results, etc. | Providing business selection table, Providing commercial annual selection table | Article 37, Subsection 5 |
| Purchase information | Purchase information | Article 38, Subsection 3 |
| The basics of purchasing goods | List of purchased items | Article 39, Subsection 3 |
| Records of each product | Article 40, Subsection 2 | |
| Medical equipment safety and certification | Article 42, Subsection 3 | |
| Expanding auxiliary clothing industry | Maintenance, repair work record, auxiliary clothing work work guide | Article 43, Subsection 2 |
| List of instructions for each review | Article 44, Subsection 1 | |
| Manufacturer's certification etc. | Article 45, Subsection 6 | |
| The result of the process of firing | Article 46, Subsection 3 | |
| Guaranteed traceability | Article 48, Subsection 3 | |
| Name and address of person purchasing specific medical equipment and products | Article 49, Subsection 4 | |
| Contents of loss or damage of goods to recipient | Product management table for recipients of goods received | Article 51, Subsection 2 |
| Special storage conditions | Product storage condition management table | Article 52, Subsection 3 |
| Non-existence measurement standard proofreading or proofreading | Article 53, Subsection 3, Section 1 | |
| An effective review of the results of previous studies | Article 53, Subsection 6 | |
| The results of the measurement and equipment calibration process are as follows: | Article 49, Subsection 4 | |
| Internal calculation results | Internal accounting accounting book and notification book, internal accounting list, internal accounting report or request for revision measures, notification of internal accounting revision measures implementation report | Article 56, Subsection 6 |
| Product quality and quantity results | Article 58, Subsection 3 | |
| person who decides the purchase | Article 58, Subsection 4 | |
| Personnel for specific medical equipment related products | Article 59 | |
| Special use rejected quality personnel | Rejected product processing table | Article 60, Subsection 5 |
| Specific circumstances of failure, etc. | Rejected product processing table | Article 60, Subsection 6 |
| Numerical analysis results | Number analysis record book | Article 61, Subsection 3 |
| Purchaser's selection policy | Contribution record book | |
| Reasons for implementing unsettled tax reform measures or enforcement measures | Contribution record book | Article 62, Subsection 5 |
| The results of the revised measures, etc. | Revised car protection measures record book | Article 63 item 5 |
| Results of use of anti-driving measures, etc. | Revised car protection measures record book | Article 64, Subsection 2 |
| A copy of the necessary documents for the purchaser, manager, and other personnel responsible for the purchase of the product. | Technical opinion book | Article 71, Subsection 1, Section 2 |
| Record of each product's purchase decision results, purchase destination, etc. | Purchase record | Article 72, Subsection 2, Section 3 |
| When there is a serious impact on the production of products, such as the manufacturing method, etc., which may be changed, the person in charge of management and the person responsible for the production of medical equipment, etc., shall be reported. | Japan Domestic Quality Management Report | Article 72, Subsection 2, Subsection 4 |
| When receiving relevant information regarding the quality of the product (not passing the quality), the person responsible for management and the person responsible for the production of medical equipment will be notified. | Japan Domestic Quality Management Report | Article 72, Subsection 2, Section 5 |
| A record of the contents of the summoning of distribution products in Japan, as well as a record of the person responsible for the management and the production of medical equipment. | summons record | Article 2, Subsection XNUMX, Section XNUMX, Section XNUMX |
| Article 72, Subsection 2, Sections 3 to 6, except for the contents of the article, where the person in charge of managing the quality control business in Japan shall report the person responsible for the production of medical equipment when necessary. | Japan Domestic Quality Management Report | Article 72, Subsection 2, Section 7 |
| When necessary, correspondence or instructions may be provided by medical equipment manufacturers, foreign manufacturers, etc., medical equipment manufacturers, store boards, clinics, and other Japanese practice quality management businesses. | Book instructions for manufacturers, manufacturers, customers, users, etc. | Article 72, Subsection 2, Section 8 |
| Information regarding the implementation of security measures as stipulated in Article 2, Subsection 2 of the GVP Ministerial Ordinance for Security Management Department | Safety report provided by safety management section | Article 72, Subsection 2, Section 9 |
| If you are responsible for the personnel responsible for handling the Japanese domestic product quality industry, whether or not to create a designated person or not, the designated personnel will be appointed in the market for exporting goods. | decision report | Article 72, Subsection 4 |
关联Notification
| release time | File No | Name |
| August 26, 27 | 药食监ま发0827No.XNUMX | Partial amendments to the U.S. Medical Law, etc., and amendments to the ministerial ordinances for production control and quality control standards for medical instruments and in vitro diagnostic medical products. |
| 26th, April 11 | 药食监监发1119No.1119・药食监监发XNUMXNo.XNUMX | 关于适当证证和QMS适当性调查查请的处億 |
| 26th, April 10 | 药食监ま发1024No.10 | Establishment of QMS requirements |
Licensed medical equipment available, approval and approval etc.For your convenience, please contact us.
We support and submit legal claims for newly introduced medical equipment businesses, existing manufacturing businesses, production businesses, Japanese machinery businesses, etc.
Medical equipment application has high level of industry, ability is perfect, and administrative staff is small.
However, we provide medical equipment, medical equipment, legal services, and other legal services based on the basis of our production, business, and business agents.
Our teams are present in all prefectures across the country. You must receive additional information from our system.
All-Japan project for staff management
Related article
