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GOOD HOSPITAL PRACTICE

GOOD HOSPITAL PRACTICE

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QM according to DIN EN 15224 / ISO 9001

5.2.18 Evaluation of diagnostic tests

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Purpose and goal

The quality characteristics of diagnostic tests (e.g. accuracy, repeatability, sensitivity, specificity) should be determined.

Application

Description of the process

Risks

Resources

Material

Time required

Documentation

Responsibility and qualification

Notes and comments

Applicable documents

Validation documents

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