How To Implement The Dossier “of Quality Assurance In Testing”
Quality assurance records are the most important one in quality management. Based on criteria 2429 and ISO 15189: 2021 times ago. The dossier set includes:
The main process consists of
Internal testing (IQC):
The following contents should be presented: when it is needed for internal inspection, which tests need to be tested, the time for conducting the inspection, what steps to take in the internal inspection, what results should be recorded, if If the results are not satisfactory, what should we do and overcome errors?
Present all 8 items according to Decision 5530.
External testing procedure (EQA):
Need to do as follows: General diagram to conduct external inspection, where to register to participate in external inspection, how to handle samples, where to write results, how to return results, how to keep samples, analyzing and evaluating how external samples
Present all 8 items according to Decision 5530.
Inter room procedure (if applicable)
The content is similar to EQA but it is necessary to specify which lab to compare and which tests to participate.
The laboratory depends on the characteristics and nature of the testing group to perform, which requires a suitable form
Internal inspection form: A form to record the results of internal inspection The forms are divided into: Internal tests for biochemistry, hematology, immunology, microbiology, coagulation, etc. Depending on what laboratory you are testing.
. Content of the form to be performed: Type of material used for inspection, number of inscriptions, expiry date, control result limit, date of internal inspection implementation, results of each day, and person performing.
Standard calendar tracking form: Typically applicable to biochemical, immunological and coagulation tests.
Levey-Jennings Chart: Printed from machine, hand-painted, drawn on Excel or it is best to use IQC internal data analysis and analysis software.
Evaluation form of QC results periodically.
New QC control value setting form: Rebuild new QC limit to suit your laboratory
External inspection result form: Usually in the form of an external control organization
Book of monitoring external test results: Record the results of external control performed.
Minutes of laboratory / laboratory staff meeting / reviewing and evaluating EQA results monthly.
Instructions for performing internal inspection, external testing, guidance and preparation of calibration samples.
The original data of internal control, external control, inter-room comparison: This original data is extremely important, it proves the realistic results that the laboratory performs. These results should be printed directly from the testing machine.
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