Accreditation Schemes >
Medical Testing Laboratories (ISO 15189)
Overview
NABL grants accreditation to medical testing laboratories in accordance with ISO 15189 “Medical laboratories- requirements for quality and competence”
NABL grants accreditation services to Medical Laboratories in following disciplines:
- Clinical Biochemistry
- Clinical Pathology
- Haematology & Immunohaematology
- Microbiology & Infectious disease serology
- Histopathology
- Cytopathology
- Flow Cytometry
- Cytogenetics
- Molecular Diagnostics
- Histocompatibility and Immunogenetics
- Medical Imaging
- NABL 112 A “Specific Criteria for Accreditation of Medical Laboratories”
- NABL 112 B “Guidance document: Medical Laboratories”
Benefits of Laboratory Accreditation
Formal recognition of competence of a laboratory by NABL in accordance with international criteria has many advantages:
- A ready means for customers to identify and select reliable testing, measurement and calibration services that are able to meet their needs.
- Increased confidence in Testing/ Calibration Reports issued by the testing calibration and medical testing laboratories which emphasise on accuracy and reliable results.
- The results from accredited laboratories are used extensively by regulators for the public benefit in the provision of services that promote an unpolluted environment, safe food, clean water, energy, health and social care services.
- Better control of laboratory operations and feedback to laboratories as to whether they have a sound Quality Assurance System and are technically competent.
- Helpful in participating in tenders that require independently verified laboratories.
- Potential increase in business due to enhanced customer confidence and satisfaction: Accredited laboratories receive a form of international recognition, which allows their data and results to be more readily accepted in overseas markets. Accreditation helps to reduce costs for manufacturers and exporters who have their products or materials tested in accredited laboratories, by reducing or eliminating the need for retesting in another country.
- Users of accredited laboratories enjoy greater access for their products, in both domestic and international markets.
- Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.
Eligibility
The CABs should be legally identifiable & appropriately registered. They can be a part of a big organization or an independent entity. NABL can provide accreditation to:
- CABs undertaking any sort of medical laboratory in the specified fields.
- Private or government CABs.
- Small operations to large multi-field CABs.
- Site facilities and mobile laboratories.
- Inhouse/ Open to others/ partially Open to others
- Laboratories of Educational Institutes
- Research and Development laboratory
Fee Structure
| Medical Laboratories (covering all disciplines) & Associated Sample Collection Centre/ Facility (SCF) | ||
| Micro Laboratories1 (Up to 25 patients/ day) (Applicable for two disciplines only) | ₹ 6,000 + ₹ 200 per SCF | |
| Mini Laboratories2 (26 – 50 patients/ day) (Applicable for two disciplines only) | ₹ 10,000 + ₹ 200 per SCF | |
| 1,2 Laboratories with more than two disciplines shall apply for at least small category | ||
| Small Laboratories (51 – 100 patients/ day) | ₹ 18,700 + 200 per SCF | |
| Medium Laboratories (101-400 patients/ day) | ₹ 44,000 + ₹ 200 per SCF | |
| Large Laboratories (401-1000 patients/ day) | ₹ 1,10,000 + ₹ 200 per SCF | |
| Very Large Laboratories (above 1000 patients/ day) | ₹ 2,20,000 + ₹ 200 per SCF | |
| Medical Imaging- Conformity Assessment Bodies (MI-CAB): For 01 group/ modality (e.g., Computed Tomography, Ultrasound and Colour Doppler) | ₹ 11,000 | |
| Application Fee (non-refundable, to be paid along with the application) Please note that the details mentioned above relate only to the application fee. For information on other applicable fees, including the annual accreditation fee, mid-cycle assessment fee, scope extension fee, change of premises fee, etc., kindly refer to NABL 100A. |
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Relevant Documents
| Document No. | Document Title | View Document |
|---|---|---|
| NABL 100A | General Information Brochure | View / Download |
| NABL 100B | Accreditation Process & Procedure | View / Download |
| NABL 111 | Procedure for Recognition of Sample Collection Centre/ Facility declared by Medical Laboratories (CABs) | View / Download |
| NABL 112 A | Specific Criteria for Accreditation of Medical Laboratories | View / Download |
| NABL 112B | Guidance document: Medical Laboratories | View / Download |
| NABL 131 | Terms & Conditions for Obtaining and Maintaining NABL Accreditation | View / Download |
| NABL 133 | Policy for Use of NABL Symbol and / or Claim of Accreditation by Accredited Conformity Assessment Bodies (CAB) & NABL Accredited CAB Combined ILAC MRA Mark | View / Download |
| NABL 134 | Procedure for Dealing with Appeals against Adverse Decisions Taken by NABL | View / Download |
| NABL 135 | Specific Criteria for Accreditation of Medical Imaging – Conformity Assessment Bodies | View / Download |
| NABL 153 | Application Form for Medical Testing Laboratories | View / Download |
| NABL 208A | Pre-Assessment Guidelines and Forms (based on ISO 15189:2022) | View / Download |
| NABL 218 | Desktop Surveillance | View / Download |
| NABL 218A | Checklist for Annual Surveillance | View / Download |
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