Category Archives: ISO 15189

What are the Requirements to Get ISO 15189 Certification for Medical Laboratory?

To demonstrate the quality and reliability of services, Medical laboratories can seek ISO 15189 Certification, Medical laboratories – Particular requirements for quality and competence, an internationally recognised standard that contains the requirements necessary for diagnostic laboratories to demonstrate their competence to deliver reliable services. ISO 15189 Certification involves the independent assessment of a laboratory to determine competence, impartiality and consistency.

Principles of ISO 15189

  • ISO 15189 Certification for Laboratory Management has a responsibility to manage
  • The laboratory must know who are its users (customers) and meet their requirement
  • The physical laboratory should not interfere with laboratory workers or laboratory samples

Requirements for ISO 15189 Certification

Management Requirements

The following are management requirements for ISO 15189 Certification:

  • Organization and management 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 action Preventive action
  • Continual improvement Control of records Evaluation and Audits Management review.

Technical Requirements

The following are technical requirements for ISO 15189 Certification:

  • Personnel
  • Accommodation and environmental conditions
  • Laboratory equipment, reagents, and consumables
  • Pre-examination processes
  • Examination processes
  • Ensuring quality of examination results
  • Post-examination processes
  • Reporting of results Release of results
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Posted by on November 11, 2017 in ISO 15189


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ISO 15189 Certification – Medical Laboratory Accreditation

The ISO 15189 standard is closely based on the accreditation of laboratories ISO 17025 system, but incorporates essential components for medical laboratories. This standard focuses on the needs of patients and is focused on the clinical roles staff, responsibilities and needs. It addresses issues specific to medical laboratory that include the provision of advisory services to clinicians , collection of patient samples, providing tests in a medical emergency and the contribution of medical laboratory services to patient care . The standard is applicable to private laboratories and laboratories from both public and private hospitals.

ISO 15189 system provides an effective quality management and technical competence framework that enables medical laboratories to meet international standards of patient care and laboratory responsibility. The ISO 15189 Certification, when carefully planned to meet the laboratory requirements, can also improve laboratory services, products and business processes.

Medical laboratories can also benefit from the automation of business processes and controls that achieve or maintain permanently ISO 15189 certification. Automation also helps with standard inspections.

For medical laboratory, ISO 15189 audit is taken by combination of technical experts and medically qualified assessors from the accreditation bodies that have significant experience in medical laboratory accreditation. The concept of laboratory accreditation is defined by the ISO / IEC standard that formal recognition that the testing laboratory is competent to perform specific tests or specific types of tests. The test is defined as a technical operation of determining one or more characteristics of a product, process, or service according to a specified procedure.

Benefits of Medical Laboratory Accreditation:

Medical Laboratory Accreditation – ISO 15189 demonstrates the competence of a laboratory to manage and perform activities defined by the scope of its specific accreditation program. With accreditation of medical laboratories, laboratories are able to obtain an independent third party, the results credible trials for them and for their customers.

ISO 15189 accreditation of medical laboratories helps laboratories deliver services with confidence and attract new customers. A major benefit of accreditation to ISO 15189 is that it is recognized worldwide. Medical laboratories also experience many benefits in becoming accredited.

In addition to reducing the risks Accreditation encourages sharing of best practices and stimulates innovation. Undergoing accreditation process can also have a positive effect on laboratory results because it is accurate and standardized clinical trials directly contributes to the control of all health care costs . This cost control is mainly achieved by targeting accurately all treatment modalities once an accurate diagnosis is reached.

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Posted by on August 5, 2015 in ISO 15189


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