ISO 15189 Certification

What Is ISO 15189 Certification?

ISO 15189 is a Medical Laboratory Accreditation Particular requirements for the quality and competence. This covers the most essential elements for every medical laboratories to demonstrate and the quality and competence of the services they provide.

As well as to consistently to deliver technically and valid test or “examination” results as they are known in the standard. The standard which has been clearly developed with strong involvement and expertise from the medical, scientific and clinical community, is for the usabilty of medical laboratories in developing their company management systems and maintaining their own competence.

For  accreditation bodies to confirm or recognize the competence of the registered laboratories through accreditation. Medical laboratory services are very essential in the diagnosis and assessment of health of the patients.

Their services encompasses arrangements for

  • requisition,
  • patient preparation,
  • patient identification,
  • collection of samples,
  • transportation,
  • storage,
  • Processing and examination of clinical samples,

Together with subsequent of the result validation, interpretation, reporting and advice. The Medical laboratory services are and should therefore meet all the needs of all patients, clinical personnel responsible for patient care and any other interested parties.

The laboratories main aim is not just only to provide accurate results. But also to do so for the right patient and within a appropriate meaningful time frame as regards with the clinical management, using appropriate laboratory procedures and with a respect for ethics, confidentiality and the safety of the patient.

At present, the 2012 version is in the implementation.

How It Can Help

The certification in provides guidelines for establishing an effective (QMS) quality management system. Following are the guidelines and leads to the assurance of best accurate test results, and a significant reductions in errors and mistakes, and the increase of confidence of patients, external stakeholders, clinicians, and in the value of your laboratory testing.

When In a laboratory environment, the safety rules must all be established to reduce the risks to staff, visitors, and customers. Developing a (QMS) quality management system which is based on the will helps laboratories t achieve the highest level of safety and security, consistency, and performance.

Who should take Certification

The certification in ISO 15189 was first launched in 2003. It was then revised in 2007 and then again in 2012. The ISO 15189 standard establishes a unique stringent set of (QMS) quality management requirements specifically for all laboratories when at every level of health care system.

Some of the best standard’s objectives for the lab operations which include the ensuring of quality and traceability of patients’ information, maintaining all the safety and integrity of laboratory materials, monitoring the facility’s environmental conditions, and supporting public health decision-making.

Why is Certification Necessary

  • Global standard for the accreditation in medical laboratory results.
  • It is Based on good laboratory practices and engagements
  • It is primarily Focused on technical specifications in medical laboratory.
  • Process approach matching is the pre-analytical, analytical, and post-analytical phases.
  • It is Oriented to support the accurate clinical decisions.
  • It helps in Identification and traceability information of different phases of the medical laboratory processes.
  • It helps in Monitoring and measuring of devices, that significantly helps contribute to the trueness with uncertainty of the reported results;
  • Training and competence assessment of this will help the staff which is critical to good management and good laboratory practices.
  • Infrastructure to correctly support the operation practices.

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