The concept of ISO 15 189

The above inspection also includes the operation of judging, measuring or describing the existence of various substances or microorganisms. What institutions collect or prepare specimens, specimen mailing or distribution centers, although they may be part of a larger laboratory network or laboratory system, cannot be regarded as medical or clinical laboratories. According to this definition, we think that the clinical laboratory of hospitals (health institutions) at all levels in China is the medical laboratory or clinical laboratory mentioned in ISO 15 189, so the clinical laboratory of medical institutions at all levels in China should take ISO 15 189 as the quality management standard.