ISO 15189:2012 Accreditation Requirements for Quality and Competence of Medical laboratories
Posted: Jun 23, 2017
ISO 15189 is a global initiative that aims to create a measure of quality in medical laboratories. The standard has developed initiatives to promote competence and responsibility in medical laboratory processes, equipments and outcomes.
ISO 15189:2012 accreditation specifies requirements for quality and competence in medical laboratories. ISO 15189 will be utilized by medical laboratories to develop their own quality management systems and appraise their ability. It can also be used to confirm or declare the competence of medical laboratories by laboratory customers, regulators and accreditation bodies.
Requirements of Medical Laboratories for quality and competence
Personnel qualifications documentation, job descriptions, personal introduction to the organizational environment program, training provision, competence assessment per person, reviews of staff performance, continuing education and professional development, and personal records of relevant skills.
- Accommodation and environmental conditions
Laboratory and office facilities to provide an environment appropriate for the duties to be undertaken, storage facilities, staff services, patient sample collection facilities, facility maintenance and environmental conditions.
- Laboratory equipment, reagents, and consumables
Equipment: Documented procedure, acceptance testing, user manual, calibration and metrological traceability, maintenance and repair, adverse indented reporting, and records.
Reagents and consumables: Documented procedure, reception and storage, acceptance testing, inventory management, instructions for use, adverse incident reporting, and records.
- Pre-examination processes
Documented procedures, information for patients and users, information on application forms, first sample collection and handling, sample transportation, sample reception, pre-examination handling, preparation, and storage.
- Examination processes
Examination procedure selection which has been validated for their intended use, verification of analysis procedures, validation of test methods, measurement uncertainty of measured quantity values, biological reference intervals or clinical decision values, and documentation of testing procedures.
- Ensuring quality of examination results
Quality control procedures to verify the design to achieve expected quality of results, quality control materials, quality control data, inter-laboratory comparisons, analysis of inter-laboratory comparison samples, evaluation of laboratory performance, and comparability of examination results.
- Post-examination processes
Review of results, storage, retention, and disposal of clinical samples.
- Reporting of results
Reports of examination results, the report attributes, and content.
- Release of results
Documented procedures, automatic selection and reporting of results, and revised reports.
- Laboratory information management
Authorities, responsibilities and information system management
My name is John, I have written many articles and blogs about ISO 15189 certification and other international standards. Recently I have written article on ISO 15189 Certification requirements for medical laboratories. I have also worked for many years as an ISO consultant with leading Consultancy Company in USA.
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