Tag: Guidance Document

Industry Update – Guidance Document

Posted on by Leave a comment

GUIDANCE DOCUMENT – VALIDATION OF RAPID DIAGNOSTICS FOR PATHOGEN IDENTIFICATION AND ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST)

Indian Council of Medical Research (ICMR) in coordination with Central Drugs Standard Control Organisation (CDSCO) has published a Guidance Document on Validation of Rapid Diagnostics for Pathogen Identification and Antimicrobial Susceptibility Testing (AST)

This document provides guidance for innovators and testing laboratories on validating diagnostics for pathogen identification and antimicrobial susceptibility testing.

It outlines a systematic framework to evaluate diagnostic performance, focusing on precision, accuracy, reproducibility, and the ability to detect target pathogens or their genetic materials (e.g., DNA, RNA, toxins, or antigens).

It also includes methods for antimicrobial susceptibility testing and prepares developers for the validation process by detailing evidence requirements and regulatory approval pathways.

Prepared by the AMR Coordination Unit of ICMR, this third draft incorporates expert feedback and inputs from the Central Drugs Standard Control Organization (CDSCO).

The document is designed to evolve with advancements in technology and methodologies, ensuring reliable diagnostics for clinical decision-making.

Click here to Download the Guidance Document

Source: https://www.icmr.gov.in/icmrobject/uploads/Guidelines/1736941384_guidancedocument_amrdiagnostics_revised.pdf

Industry update : NABL 112A & NABL 112B

Posted on by Leave a comment

Industry update : NABL 112A & NABL 112B

National Accreditation Board for Testing and Calibration Laboratories (NABL) is an accreditation body that provides accreditation service to Conformity Assessment Bodies including medical testing laboratories. On December 18,2024, the following documents were issued by NABL.

1 – NABL 112A – Specific Criteria for Accreditation of Medical Laboratories

NABL 112 is a Specific Criteria for Accreditation of Medical Laboratories, prepared by a Technical Committee, which is aligned as per ISO 15189

NABL documents are updated at regular intervals to keep pace with the latest technical developments and to synchronize with the International Standards.

NABL has released NABL 112A which elaborates the requirements of International Standard ISO 15189:2022 as applicable to Indian setting. The document has been designed to make it user friendly for both NABL assessors and laboratories

This document specifies the criteria for the medical testing laboratories for obtaining NABL accreditation. Medical testing laboratory shall fulfill the requirements of this document in addition to the requirements of the ISO 15189:2022 – “Medical laboratories –Requirements for quality and competence”. This specific criteria document shall be used in conjunction with ISO 15189:2022..

2 – NABL 112 B – Guidance document for Medical Laboratories

NABL has issued 112B Document on 18th December 2024. This document shall provide guidance to medical testing laboratories for the following aspects:

– Operation of sample collection centres / facilities
– Sample format for preparing the scope of accreditation
– Lot verification
– Algorithm for Automated Selection and Reporting of Results
– Sample format for competency assessment
– Examples for the type of sample and their stability for Clinical Biochemistry parameters

Click the buttons given below to read the documents in detail.

NABL 112A Document
NABL 112B – Guidance Document

Source: https://nabl-india.org/




Guidance on Auditing Climate Change issues in ISO 9001

Posted on by Leave a comment

Guidance on Auditing Climate Change issues in ISO 9001

Climate change issues are one of many issues that organizations are to consider when analysing their internal and external context and determining requirements from customers and other relevant interested parties.

As part of ISO’s commitment to action on climate change, amendments to over 30 of ISO’s Management System Standards, including ISO 9001, have now been issued to include climate change considerations and the same is published on 23 February 2024.

Key points are given below:

The amendments include the determination of whether climate change is a relevant issue for the organization and the consideration of interested parties’ requirements related to climate change.

Emphasizes the need for auditors to maintain objectivity and neutrality when auditing climate change issues, focusing on assessing how organizations address climate change within their quality management systems

Provides guidance for auditing climate change issues impacting the quality management system and its intended results, outlining specific considerations and examples for auditors to evaluate

Furthermore, the document highlights the importance of addressing issues determined as relevant by the organization within the quality management system.

Presents non-exhaustive examples of questions and related aspects for auditors to assess how organizations are addressing climate change issues, including determining the scope of the quality management system, actions to address risks and opportunities, changes, resources, operations, and performance evaluation and improvement.

Underscores the need for auditors to evaluate if organisations have identified contractually agreed customer requirements or statutory and regulatory requqirements with climate change relevance and whether these are being acted upon.

Click here to read the document

Source: https://committee.iso.org/home/tc176/iso-9001-auditing-practices-group.html

Share