[ What is ISO 15189:2012? ]

Because medical laboratory services are essential to patient care, they must be able to meet the needs of all patients and the clinical personnel responsible for their care.

Also, this requirement includes requesting tests, preparing, and identifying patients, taking and administering samples, testing, and interpreting results, along with safety and ethics in medical laboratories.

ISO 15189:2012 specifies requirements for quality and specific competencies of medical laboratories based on ISO/IEC 17025 and ISO 9001 and can be used by medical laboratories to develop quality management systems and evaluate their own competencies. It can also be used by laboratory customers, regulators, and certification authorities to identify or recognize the competence of a medical laboratory.

Although 15189 is intended for use across the currently accepted field of medical laboratory services, it is also useful and appropriate for stakeholders working in other services and fields such as clinical physiology, medical imaging, and medical physics.

[ Necessity of ISO 15189:2012 ]

• •  Meet the needs of patients and clinical personnel
• •  Helping medical laboratories comply with safety and ethics
• •  Helping active participation in disease prevention as well as diagnosis and patient management
• •  Provide appropriate training opportunities for internal staff

[ ISO 15189:2012 Requirements ]

• Scope
• Normative references
• Terms and definitions
• Management requirements
• Technical requirements

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