Quality Control Solution Suppliers in China

Quality Control Solution

Definition

Substance, material, or article intended by its manufacturer to be used to verify the performance characteristics of an IVD medical device.

Performance Characteristics

One of the parameters used to define the analytical or clinical performance of an IVD medical device.

Basic Features of Control Materials

The composition of the quality control product shall be similar or identical to the substrate used to test the patient samples.
Quality control products should be uniform and stable.
Quality control products must be tested in the same manner as the patient sample.

Internal Quality Control

Internal Quality Control (IQC) is a function of quality control to monitor and evaluate the work quality of the laboratory.
A series of inspection and control measures are adopted by each laboratory.
IQC is important for improvement of the laboratory quality management system, as it is a measure of laboratory performance.

External Quality Assessment

External Quality Assessment (EQA) is used to describe a method that allows for comparison of a laboratory's testing to a source outside the laboratory.
Allows comparison of performance and results among different test sites
Provides early warning for systematic problems associated with kits or operation
Provides objective evidence of testing quality
Indicates areas that need improvement
Identifies training needs

QC Rules

Our quality control methods are based on Westgard rules.
Based on this rule system, two kinds of quality control methods are established: L-J quality control and X-B quality control. L-J quality control curve is a straight line in an ideal state, with a fluctuation no more than 2 SD.

Specifications for FIA