The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, an...

The International Standard Organization (ISO) 15189 accreditation has raised new enthusiasm among laboratory professionals. On the one hand, it satisfies the desire to undertake a pathway attesting the high degree of quality of laboratory performance measured according to the important role of Laboratory Medicine throughout patient care. On the other hand, it allows demonstrating how the compet...

BACKGROUND The present study was designed in quasi-experiment to assess adoption of the essential clauses of particular clinical laboratory quality management requirements based on international organization for standardization (ISO 15189) in hospital laboratories and to evaluate the cost effectiveness of compliance to ISO 15189. METHODS The quality management intervention based on ISO 15189 ...

INTRODUCTION ISO 15189 was a new standard published in 2003 for accrediting medical laboratories. We believe that some requirements of the ISO 15189 standard are especially difficult to meet for majority of laboratories. The aim of this article was to present the frequency of nonconformities to requirements of the ISO 15189 accreditation standard, encountered during the assessments of medical l...

BACKGROUND Accreditation is a valuable resource for medical laboratories. The development of quality systems based on ISO 15189 has taken place in many laboratories in the European countries but data about accreditation remain scarce. The EFLM Working Group "Accreditation and ISO/CEN standards" conducted a survey that reviews the current state of the accreditation process in European countries....

the present study was designed in quasi-experiment to assess adoption of the essential clauses of particular clinical laboratory quality management requirements based on international organization for standardization (iso 15189) in hospital laboratories and to evaluate the cost effectiveness of compliance to iso 15189.the quality management intervention based on iso 15189 was conceded through t...

ISO/IEC 17025:2017 and ISO 15189:2012 specify the requirements for competence of laboratories. The former refers to laboratories in general, whose activities include testing, calibration sampling followed by testing or while latter medical Despite differences between two standards reflecting specific needs each them is addressing, development these documents has, until now, similar paths. In th...