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ISO 15189:2012 Accreditation Requirements for Quality and Competence of Medical laboratories

Author: John Mills
by John Mills
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

    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

Author Bio:

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.

About the Author

We are ISO consultants and industry leader in the global market for selling online ISO documentation kits as well as ISO system awareness and auditor training kits. With a presence in more than 36 countries,

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Author: John Mills

John Mills

Member since: Aug 30, 2013
Published articles: 42

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