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IS/ISO 15189 : 2022

IS/ISO 15189 : 2022 — Medical Laboratories Requirements for Quality and Competence Third Revision

IS/ISO 15189 : 2022 is an Indian Standard titled Medical Laboratories Requirements for Quality and Competence Third Revision, classified under Medical and Hospital Equipments. Certification is voluntary.

IS Number
IS/ISO 15189 : 2022
Status
0
Certification
Voluntary
Committee
Hospital Planning
Type
System Standard

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What is IS/ISO 15189 : 2022?

IS/ISO 15189 : 2022 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Medical Laboratories Requirements for Quality and Competence Third Revision. It falls under the <strong>Medical and Hospital Equipments</strong> group. Certification under this standard is voluntary.

How to get certified for IS/ISO 15189 : 2022

  1. 1
    Apply online — Submit the BIS portal application with product details, factory information, and test reports.
  2. 2
    Lab testing — Submit product samples to a BIS-recognised testing laboratory for evaluation against the standard.
  3. 3
    Factory inspection — A BIS officer visits your manufacturing facility to verify quality control systems.
  4. 4
    Licence grant — On approval, BIS issues the licence. You may then affix the ISI Mark on compliant products.
View official document on bis.gov.in →

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