ISO 15189 standard for Medical Laboratories - Particular requirements for quality and competence - covers the essential elements for medical laboratories to demonstrate the quality and competence of their services, as well as to consistently deliver technically valid test or "examination" results as they are known in the standard. The standard, which has been developed with strong involvement from the medical, scientific and clinical community, is for the use of medical laboratories in developing their management systems and maintaining their own competence; and for accreditation bodies to confirm or recognize the competence of these laboratories through accreditation. Medical laboratory services are essential in the diagnosis and assessment of the health of patients. Their services encompass arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent result validation, interpretation, reporting and advice. Medical laboratory services should therefore meet the needs of all patients, clinical personnel responsible for patient care and any other interested parties. The laboratory's aim is not only to provide accurate results, but to do so for the right patient within a meaningful timeframe as regards 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. The standard mainly focuses on quality system requirements and technical requirements covering the quality assurance practices. This standard is applicable to mainly following types of laboratories:
Punyam.com, a leading ISO and accreditation consultant in India, provides consultancy for ISO 15189:2012 Certification. The ISO 15189 certificate for accreditation is issued by accreditation bodies, such as NABL for India. and others. The ISO 15189:2012 certificate is issued for the period of 2 years after successful completion of pre-assessment and registration (final) assessment. Surveillance audit is conducted by the accreditation body after 1 year. Upon completion of 2 years, renewal audit for ISO 15189 systems is done and certificate is issued for 2 more years. After that, at every 2 years the renewal audit for ISO15189 accreditation is conducted without any surveillance.
Punyam.com, a leading ISO 15189 Consultancy in India, is having vast industrial experience in the implementation of ISO 15189:2012 for all types of medical laboratories, such as clinical, pathology, microbiology, etc. Punyam implements the ISO 15189 system for its customers in the following manners:
Accreditation to this standard is patient-focused, impartial, objective, and operates within a good system. It provides many benefits such as those detailed below:
Laboratories have to identify the following technical requirements during ISO 15189 system implementation: