المتطلبات الدولية لاعتماد المختبرات الطبية وفق المواصفة القياسية ISO 15189:2012

الوصف
الفئات المستهدفة

ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies. 

ISO 15189-What the Standard Requires:

  • Management requirements and responsibility;
  • Quality management system;
  • Document control;
  • Service agreements;
  • Examination by referral laboratories;
  • External services and supplies;
  • Advisory services;
  • Resolution of complaints;
  • Identification and control of nonconformities;
  • Corrective and preventive action;
  • Continual improvement;
  • Control of records;
  • Evaluation and audits;
  • Management review;
  • Technical requirements;
  • Personnel;
  • Accommodation and environmental conditions;
  • Laboratory equipment, reagents, and consumables;
  • Pre-examination, examination and post-examination processes;
  • Ensuring quality of examination results;
  • Reporting and release of results; and
  • Laboratory information management.

 


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