2016! Laboratory qualification requirements for testing personnel - Database & Sql Blog Articles

Testing is a very professional job, so different testing laboratories have different qualification requirements for testing personnel. Shanghai Jinma This paper summarizes the requirements of various testing laboratories for the qualification of testing personnel for your reference. If you need to consult the elisa kit laboratory preparation and requirements, please call our sales staff.

The general requirements for laboratory accreditation are a major focus.

According to Shanghai Jinma Bio, I learned:

Laboratory managers should ensure that all operational equipment, testing and/or

calibration

The ability of the person to evaluate the results, sign the test report and calibrate the certificate. When using employees, they should be properly supervised. Personnel performing specific tasks should be qualified as required based on appropriate education, training, experience and/or provable skills.

Note: (1) Certain technical fields (such as

Nondestructive testing

) Personnel performing certain tasks may be required to hold a personal qualification certificate, and the laboratory is responsible for meeting the requirements for the appointment of these designated personnel. The requirements for personnel to be certified may be legal, special technical field standards, or customer requirements.

(2) In addition to having sufficient qualifications, training, experience, and sufficient knowledge of the tests performed, the personnel responsible for the opinions and explanations contained in the test report must also have:

- knowledge of the relevant technical knowledge used to manufacture the tested items, materials, products, etc., knowledge of the methods used or intended to be used, and possible defects or degradation during use;

- knowledge of the general requirements set forth in the regulations and standards;

- An understanding of the extent to which deviations are found in the normal use of items, materials and products.

2. General requirements for laboratory qualification

The laboratory shall have professional technicians and managers appropriate to its testing and/or calibration activities. The laboratory should use formal or contract personnel. When using contracted personnel and other technical personnel and key support personnel, the laboratory shall ensure that these personnel are competent and supervised and work in accordance with the requirements of the laboratory management system.

For all sampling, testing and/or

calibration

Personnel who have issued inspection/calibration reports and operating equipment shall be qualified and certified according to the relevant education, training, experience and/or provable skills as required. The laboratories and managers of laboratories engaged in the testing and/or calibration activities of special products shall also comply with the requirements of relevant laws and administrative regulations.

The laboratory technical supervisor and authorized signatory shall have the technical title of engineer (including engineer), be familiar with the business, and pass the examination. (This article is mandatory).

The quality supervision and inspection institution set up according to law and authorized by law, its authorized signatory shall have the technical title of engineer (including engineer), be familiar with the business, and have been engaged in the professional field for more than 3 years. (This article is mandatory).

3. Medical laboratory

1. The laboratory management shall have an organizational plan, a personnel policy, and a job description that stipulates the qualifications and responsibilities of all personnel.

2. The laboratory management shall maintain a record of the educational background, professional qualifications, training, experience and ability of all personnel, and relevant personnel shall be able to use relevant information at any time, including:

a) certificate or license (when required);

b) previous work materials;

c) job description;

d) continuing education and performance records;

e) competency assessment;

f) Special provisions for reporting adverse events or accidents.

Other records related to the personal health of the authorized person may include occupational hazard exposure records and immune status records.

3. The laboratory shall be headed by one or more persons with negative management responsibilities and the ability to be responsible for the services provided by the laboratory.

Note: The abilities here should be understood as having a background in basic education, postgraduate education, continuing education, and several years of medical laboratory training or work experience.

4. Microbiology Testing Laboratory

When using personnel in the laboratory, the following conditions should be considered:

a) Persons with color vision disorders are unable to perform certain tests involving color discrimination.

b) Laboratory personnel should be familiar with biosafety safe handling knowledge and disinfection knowledge.

c) The laboratory shall implement effective supervision of the personnel in the training.

d) The laboratory should train new employees in testing skills and confirm the testing skills of new employees.

5. Chemical Testing Laboratory

(1) The authorized signatory of the laboratory shall have a bachelor's degree or above in chemistry and have more than three years of relevant technical work experience. If the above conditions are not met, there should be sufficient chemical-related field testing experience (at least ten years).

(2) Laboratory personnel should receive training on chemical safety and protection, and ambulance knowledge. Key testers (persons familiar with the various test methods, procedures, objectives, and results evaluation) should have a method for evaluating the uncertainty of chemical analysis measurements.
In the new year, let us work together for life sciences. In 2016, I wish you good health and work well!