ISO 15189:2022 Medical Laboratory Accreditation Consultant in India

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. The fourth edition of the ISO 15189 standard with some revised requirements was published by the ISO in December 2022. The revision ensures compliance with the ISO/IEC 17025 standard in the ISO 15189:2022 standard revised edition. In addition to other significant improvements including the increased emphasis on risk throughout the standard, the most current amended standard now includes the point of care testing (POCT) requirements that were originally defined in the ISO 22870 standard. 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 2022 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:

  1. Clinical Biochemistry
  2. Clinical Pathology
  3. Haematology and Immunohaematology
  4. Microbiology and Serology
  5. Histopathology
  6. Cytopathology
  7. Genetics
  8. Nuclear medicine (in-vitro tests only)

ISO 15189:2022 Certification Consultancy, a leading ISO and accreditation consultant in India, provides consultancy for ISO 15189:2022 Certification. The ISO 15189 certificate for accreditation is issued by accreditation bodies, such as NABL for India. and others. The ISO 15189:2022 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.

Steps of ISO 15189 Accreditation Consultancy by, a leading ISO 15189 Consultancy in India, is having vast industrial experience in the implementation of ISO 15189:2022 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:

  1. Micro-level survey for each and every test parameter of the laboratory and preparation of detailed Gap Analysis report,
  2. Preparation of applicable documents required by ISO 15189:2022 based on detailed study of all activities of the laboratory, such as;
    • ISO15189 Quality Manual,
    • Quality Procedures (Mandatory procedures required by the ISO 15189 standard),
    • Standard Operating Procedures (SOPs) to control identified activities having risk potential to the test parameter,
    • Formats to establish the objective evidence of implementation and to ensure control over all the activities,
    • Sample Risk Assessment and Opportunity Sheet
  3. ISO 15189 awareness training to all levels of employees within the laboratory,
  4. Help in effective implementation of system by periodic visit till accreditation,
  5. Conduct internal audit to check readiness for the accreditation,
  6. Conduct management review meeting in presence of Top Management to guide the laboratory for effective implementation on all the issues related to management requirements and technical requirements.

Benefits of ISO 15189 Accreditation

Accreditation to this standard is patient-focused, impartial, objective, and operates within a good system. It provides many benefits such as those detailed below:

  1. For Healthcare Regulators
    • provides an independent assurance of quality and safety,
    • provides a mechanism for measuring quality improvement,
    • supports consistency in the quality of care,
    • encourages innovation
  2. For Patients
    • consistency in the quality of care,
    • up-to-date technologies and its procedures and techniques reflect current best practice,
    • Staff providing the service is competent to undertake the tasks they perform.
  3. For Medical Laboratories
    • provides an opportunity for external perspectives on the laboratory's practice,
    • can prevent the unnecessary duplication of information gathering on performance often required by regulatory bodies,
    • encourages the sharing of best practice,
    • reduces risk, and
    • Provides international recognition.

Technical Requirements for ISO 15189 System

Laboratories have to identify the following technical requirements during ISO 15189 system implementation:

  1. Nominate one person as Quality Manager for establishing, implementation and monitoring of effective implementation of the management requirements, and one person as Technical Manager for control, supervision and monitoring of the technical requirements,
  2. Define the test parameters, range of detection, and limit of detection, % C.V. or MU,
  3. Establishing quality assurance procedures and examination procedures, etc.

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