ISO 15189

MEDICAL LABORATORIES- PARTICULAR REQUIREMENT FOR QUALITY AND COMPETENCE

There is a growing demand and also a requirement in medical and clinical laboratories in USA and abroad for this international standard. This standard is a product of ISO9001:2000 and ISO/IEC 17025 with medical/clinical laboratory emphasis. This standard replaces international standard ISO/IEC guide 58 and ISO/IEC 17011.

Medical Laboratories and essential to patient care and demand competent personal to perform activities.

QSE's 10 step approach covers:

Laboratory personal competence

Patient preparation

Identification

Collection, transportation, storage, processing and examination of samples

Validation and interpretation of reporting and advice

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