1, with one of the following conditions, can apply for the examination of junior workers:
(1) in the same occupation (type of work) for more than two years or more than four years of continuous work;
(2) after the completion of the training of junior workers.
2. Those who have one of the following conditions can apply for the intermediate trade test:
(1) three years after obtaining the certificate of junior grade of the declared occupation (type of work);
(2) obtaining the certificate of junior grade of the declared occupation (type of work) and completing the intermediate trade training;
(3) graduating from a higher education institution or a secondary specialized school and engaging in the occupation (type of work) corresponding to the specialty of the study. (3) Graduated from higher education institutions or secondary specialized schools and engaged in occupations (job types) corresponding to their majors.
3. Those who have one of the following conditions can apply for the senior worker examination:
(1) Obtaining the intermediate grade certificate of the declared occupation (type of work) for four years;
(2) Obtaining the intermediate grade certificate of the declared occupation (type of work) and completing the training of the senior worker;
(3) Graduating from a higher education institution and obtaining the intermediate grade certificate of the declared occupation (type of work). certificate of intermediate work level of the declared occupation (work type).
Basic Requirements
1 Professional Ethics
1.1 Basic Knowledge of Professional Ethics
1.2 Professional Code of Medical Devices
2 Basic Knowledge
2.1 Knowledge of Laws and Regulations
(1) Basic Knowledge of Laws and Regulations
(2) Product Quality Law
(3) Metrology Law
(4) Knowledge of the Law on Measurement
(5) Basic knowledge of the Law of the People's Republic of China on the Protection of the Rights of Individuals with Disabilities >(iii) Knowledge of Measurement Law
(iv) Knowledge of Administrative Licensing Law
(v) Knowledge of Labor Law
(vi) Knowledge of Consumer Protection Law
2.2 Basic Computer Application
(i) Composition of Computer System
(ii) Basic Knowledge of Windows
(iii) Application of Office Automation Software
(4) Network Fundamentals
2.3 Introduction to some of the basics of certification
(a) Compulsory Product Certification (3C certification) regulations
(b) The first batch of product catalogs for the implementation of the 3C product certification
(c) Introduction to the ISO 9001 certification
() (iv) Introduction to CE certification
(v) Introduction to the establishment of quality management systems and conduct internal audits
(vi) Certification marks and certificates of the basics
2.4 Overview of the ISO 13485 : 2003 standard
(a) The emergence and development of the ISO 13485 standard
(b) ISO 13485: 2003 standard of the basic ideas and characteristics
(C) ISO 13485 standard in China
(D) ISO 13485 : 2003 standard content profile
(E) ISO 13485 and ISO 9000 family of standards relationship
2.5 Introduction to human anatomy
Work requirements
1 Elementary
Occupational
Functions Job content Skill requirements Relevant knowledge
I.
Medical
devices
Regulations (a) Supervision and management regulations
(b) Supervision and management of business licenses
(c) Management of instructions and packaging, etc.
1. be able to. Explain the content of the management of the production, operation and use of medical devices
2. Can explain the conditions and procedures for the license of business enterprises, the main content of supervision and inspection
3. Can explain the requirements for medical device instructions, labels, packaging marking national supervision and management of medical devices, supervision and management of business licensing, instructions, labels and packaging marking
II.
Technical
Standards (a) the content of technical standards
(b) medical device standards commonly used terminology
(c) the basic concept of surface roughness 1. can basically explain the composition and content of the technical standards
2. can basically explain the medical device standards commonly used terminology
3. can be able to describe the basic concept of the surface roughness and its grade
3. can be proficient in the surface The basic concept of surface roughness and its grading The content of technical standards; the common nomenclature in medical device standards; the grading of surface roughness
III.
Merchandise
Acceptance
Procedures (a) Merchandise in and out of the warehouse
(b) Determination of non-conformity
(c) Acceptance formalities and steps
(d) Maintenance in the warehouse
(e) The acceptance and maintenance of goods in the warehouse
(f) The acceptance and maintenance of goods in the warehouse
2. be able to distinguish the difference between defective and non-conforming goods
3. be able to determine the degree of non-conformity of the goods
4. be able to carry out the in-store inspection and maintenance of medical equipment the full range of acceptance procedures; the basic concepts of sampling; the grading of non-conformity; in-store maintenance. Classification of failure; knowledge of in-store maintenance
4.
Medical
devices
classification (a) medical device classification code
(b) the full list of classification of medical devices 1. be able to provide the code of medical devices in China's industrial and agricultural products
2. know the numbering rules of the classification of medical devices
3. understand the list of all classification catalogs of medical devices
4. be able to provide a basic description of the hospital's classification habits of medical devices Knowledge of the rules of classification of medical devices; the hospital's classification habits of medical devices