It is based on both ISO Standard for Medical laboratories - Medical laboratories — Particular requirements for quality and competence - and CLSI GPA4 documents - Quality Management System: A Model for Laboratory Services; Approved guideline 4th edition -, and provides information and examples to assist with writing a quality manual that addresses all . We provide medical laboratories with ISO implementation packages including quality manual, procedures and records to aid in meeting the ISO accreditation requirements. ISO was prepared by Technical Committee ISO/TC , Clinical laboratory testing and in vitro diagnostic test systems. This third edition cancels and replaces the second edition (ISO ), which has been technically revised.
It is based on both ISO Standard for Medical laboratories - Medical laboratories — Particular requirements for quality and competence - and CLSI GPA4 documents - Quality Management System: A Model for Laboratory Services; Approved guideline 4th edition -, and provides information and examples to assist with writing a quality manual that addresses all quality system essentials (QSE) that are critical for quality management. health or clinical laboratory. They are based on both ISO and CLSI GPA3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the “12 Quality System Essentials”. A diagram representing these 12 essentials is shown below. Organization Personnel Equipment Purchasing. It is recommended to read ISO article or ISO article as these provide a clear explanation on the quality manual and its required contents. The WHO Laboratory Quality Management System (LQMS) handbook also contains information on the quality manual which is provided in the right-hand column.
Special thanks to the members of the Quality Manual Working Group for their contributions to this publication. Name Laboratory Position. Quality manual based on current ISO Adherence to contents of quality manual. 5. Legal entity. The laboratory or the organization of which the. It has been compiled to meet the requirements of ISO adhere to the same QMS and this quality manual is common to all specialities.
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