説明
Education and training rules, procedure manuals, and formats
【Amendment QMS ministry ordinance commentary video included】
On March 26, 2021, the Ministry of Health, Labor and Welfare issued the "Ministerial Ordinance for Partial Revision of the Ministerial Ordinance on Manufacturing Control and Quality Control Standards for Medical Devices and In Vitro Diagnostic Drugs" (Ministry of Health, Labor and Welfare Ordinance No. 60, 3rd year of Ordinance). Promulgated.
The transitional period is three years, and the new QMS Ministerial Ordinance must be complied with on March 26, 2024 (the day three years have passed since the date of enforcement of the revised Ministerial Ordinance).
The purpose of this amendment is to be consistent with the QMS ministry ordinance and ISO 13485: 2016, the international standard for quality management systems for medical devices.
The pre-amendment QMS ministry ordinance was consistent with the ISO 13485: 2003 edition, lagging behind the latest international standards.
The Ministry of Health, Labor and Welfare also published an article-by-article commentary on the new QMS ministry ordinance on March 26, 2021. "Partial Amendment of Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Drugs" (Yakusei Hatsu 0326 No. 10)
E-Compliance creates and distributes the following useful materials.
・ Amendment QMS Ministerial Ordinance (text)
・ Comparison table between the revised QMS ministerial ordinance and the current QMS ministerial ordinance
・ Amendment QMS ministry ordinance commentary
・ Quality manual (corresponding to QMS ministry ordinance 2021 version)
・ Amendment QMS ministry ordinance procedure request difference distribution
・ Distribution of old and new product standard correspondence table
If you wish, please download from here.
Those who have already built a QMS that complies with the current QMS ministry ordinance and need to respond to revisions
Those who will enter the medical device from now on
It is a recommended model for.
Since it is in MS-Word format, you can freely add or modify it.
【For those who wish to purchase from Rakuten Ichiba】
You can access the Rakuten Ichiba purchase page by clicking the product title below.
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File list
* When you place an order, the following files will be delivered by email in Word file format.
* For the commentary video, we will send you the URL to download by email.
【Education and training management rules, procedure manuals, styles】
・ MD-QMS-K3 Education and Training Management Regulations
・ MD-QMS-S301 Educational Training Management Manual
・ MD-QMS-F301 Education and Training Qualification Certificate
・ MD-QMS-F302 deployment-specific strength meter（Skill Map）
・ MD-QMS-F303 Individual strength meter
・ MD-QMS-F304 Education and training Karima
・ MD-QMS-F305 Educational Training Yearly Plan and Report
・ MD-QMS-F306 Education and training plan and report
・ MD-QMS-F307 Education and training attendee list
・ MD-QMS-F308 Individual education and training experience
table of contents
Education and training management regulations
1.Purpose
2.Scope of application
3.Definition of terms
4.Purpose of education and training
5.Responsibility system
5.1 Education and training manager
5.2 Matters concerning education and training practitioners
5.2.1 Certification of education and training practitioners
5.2.2 Ability of education and training practitioners
6.Contents of education and training
6.1 Education
6.2 Training
7.Competence management
8.Education and training planning and implementation
9.Numbering of education and training management numbers
10.Creation and storage of education and training implementation records
10.1 Creating education and training implementation records and reporting to the quality assurance department
10.2 Keeping records
11.Reference
12.Supplementary Provisions
Education and training management procedure manual
1.Purpose
2.Scope of application
3.Definition of terms
4.Roles and responsibilities
5.Qualification of education and training practitioners
6.Creating a competence table
6.1 Creating a competence table for each department
6.2 Creating an individual competence table
7.Creating a curriculum
8.Formulation of education and training plan
8.1 Creation of an annual education and training plan
8.2 Creating an individual education and training plan
9.Implementation of education and training
10.Creating personalized education and training records
11.Preparation of education and training report
12.Evaluation of competence
12.1 Evaluation of individual competence
12.2 Evaluation of competence (skill map) by department
13.Preparation of annual education and training report
14.Keeping records
15.Style
16.Reference
17.Supplementary Provisions
Our features include not only the sale of templates, but also the provision of consultations according to the class of medical equipment, the provision of QMS templates related to software development, and support for inspections.
In addition, our QMS template can be changed to support FDA QSR if desired.
In particular, it is possible to support at the FDA level even for requirements that are not so strict under the QMS ministry ordinance, such as medical device design and development and risk analysis.
Click here for requests, questions, and inquiries regarding our consultation and products
