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

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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

E-Compliance Co., Ltd. sells and consults "QMS" models (samples) in accordance with the new QMS ministry ordinance.

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.


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