Written by Addendum to NABL 112 document in respect of ISO 15189:2022 version
ISO 15189:2022 is an international standard that specifies the requirements for quality and competence in medical lab environments. It is a standard that requires labs to develop a robust, reliable quality management system (QMS) to establish their competence.
This standard promotes the welfare of patients and satisfaction of laboratory users.
NABL 112 is a Specific Criteria for Accreditation of Medical Laboratories, prepared by a Technical Committee, which is aligned as per ISO 15189: Medical laboratories- Requirements for Quality & Competence
NABl has released the addendum document to NABL 112. Table specifying the applicability of this document to different clauses of ISO 15189:2022 are given below
| ISO 15189: 2022 Requirement | Refer NABL 112 Issue No. 4 Requirements |
| 5.1 Legal entity 5.2 Laboratory Director | Page No. 10 – Organization and management responsibility |
| 6.7 Service agreements Agreement with laboratory users Agreement with POCT operators | Page No. 11 – Service Agreements |
| 6.8.2 Referral laboratories and consultants 6.8.3 Review and approval of externally provided products and services | Page No. 11 – 4 Examination by referral laboratories |
| 5.3.3 Advisory activities | Page No. 12 – Advisory services |
| 8.4 Control of records Creation of records Amendment of records Retention of records | Page No. 13 – Control of records |
| 8.8 Evaluations | Page No. 14 – Evaluation and audits |
| 6.2 Personnel | 5.1 Personnel |
| 6.3 Facilities and environmental conditions | 5.2 Accommodation and environmental conditions |
| 6.4 Equipment Equipment requirements Equipment acceptance procedure Equipment instructions for use Equipment adverse incident reporting Equipment records 6.5 Equipment calibration and Metrological traceability 6.5.2 Equipment Calibration 6.6 Reagents and consumables Receipt and storage Acceptance testing Inventory Management Instructions for use Adverse Incident Reporting | 5.3 Laboratory equipment, reagents and consumables |
| 7.2 Pre-examination processes Primary Sample collection and handling Sample transportation Sample receipt Pre-examination handling, preparation and storage | 5.4 Pre-examination processes |
| 7.2 Examination processes Verification of examination methods Validation of examination methods Evaluation of Measurement Uncertainty Biological reference interval and clinical decision limits Documentation of examination procedures | 5.5 Examination processes |
| 7.3.7 Ensuring the validity of examination results Internal quality Control External quality assessment Comparability of examination results | 5.6 Ensuring quality of examination results |
| 7.3 Post examination processes Reporting of results Post-examination handling of samples | 5.7 Post examination processes |
| 7.4.1 Reporting of results Critical result reports Special considerations for results Automated selection, review, release and reporting of results Requirements of reports Amendments to reported results | 5.8 Reporting of results |
| 7.4.1.2 Result review and release | 5.9 Release of results |
| 7.6 Control of data and information management Authorities and responsibilities for Information management Information Systems management Downtime plans Off site management | 5.10 Laboratory information management |
Source: https://nabl-india.org/