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.
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.
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
HOSPEX Healthcare Expo cum Conferences 2023 – SEP 15-17,2023 at Zamra International Convention Centre, Kochi, Kerala
The “First, Best, and Only Hospital Expo in Kerala” for all your Medical Equipments and Hospital needs.
Experience the Next Generation of Healthcare at HOSPEX Healthcare Expo in Kerala! Join us as we bring together leading manufacturers and suppliers from the medical industry to showcase cutting-edge medical equipment and innovations. From state-of-the-art imaging technology to advanced surgical instruments, explore the latest advancements that are shaping the future of healthcare.
2nd Edition of HOSPEX Healthcare Expo cum Conferences will be held at Kochi, Kerala from Sep 15th – 17th 2023. This is Kerala’s first B2B Medical Expo which will take place at Zamra International Convention and Exhibition Center, Kochi, Kerala.
HOSPEX 2023 Expo is the platform to showcase Technology, Products & Innovations to the healthcare fraternity.
Expo cum Conference Theme this year is on :
Future of Healthcare – Device | Digital | Diagnostics
Don’t miss this exclusive opportunity to witness the forefront of medical technology under one roof at the HOSPEX Healthcare Expo.
HOSPEX Expo has a projected walk-in of 10000+ professionals and entrepreneurs from all over South India including doctors, hospital owners, managers, supply & purchase staff, distributors that are all from the medical industry.
HOSPEX is the Convergence platform where Makers (Medical Device Manufacturers) , Users (Healthcare Establishments) and Innovators (MedTech, HealthTech, Digital Health Innovators, FinTech, Insuretech, CyberTech etc) and Governments , Policy Makers join the connected conversations to strengthen and improve the Healthcare Ecosystem in the country.
The core focus of HOSPEX Healthcare Expo 2023 is medical knowledge dissemination thereby hosts multitude of conferences focused on the futuristic trends in the medical industry. These conferences provide attendees with the opportunity to learn about new products and technologies, network with other professionals in the field, and stay up-to-date on the recent and futuristic developments in the industry.
SMART Hospitals Conference
Date : Sep 16, 2023
Time : 10 00 am to 6 00 pm
Fee : Rs 500 per delegate
SMART Hospitals Conference focus is to enable Micro and Small Hospitals to Go Digital, use various HealthTech and MedTech Solutions – be it for Clinical Decision Support Solutions, Tech Solutions to help Hospitals to streamline their day to day practices, Tech solutions to improve productivity of healthcare workforce, Technologies that facilitate Quality and Safe Patient Care.
Conference will connect SMART Technologies, Solutions that are needed in healthcare settings as Future of Healthcare will be driven by Practitioners , Healthcare Settings using SMART Devices, Diagnostics and Digital Solutions.
Conference Outline :
SMART Medical Technologies help Practitioners to improve service standards
SMART Medical Device for Safe Patient care in Clinical Settings , Home Healthcare Setting
Testing and Certification of SMART Medical Devices – Global Regulations and Certification Requirements
Empowering Practitioners : Virtual Cardiac Care Diagnostic Solutions
Telehealth and Telemedicine – NMC Regulations & Clinical Establishments
SMART Prescription for Prescribers – EHR Solution
SMART Technologies to enable Small Hospitals – Technology Session
SMART HealthTech Ecosystem
Digital Health Apps for Enhancing Patient Satisfaction, Loyalty and Referrals
Digital Ecosystems: Future of Healthcare – The Value for All: Patients, Healthcare organisations and Innovators, Startups
Smart Healthy Aging Tech Solutions
Target Audience :
Medical Professionals, Healthcare Professionals from Hospitals and other Healthcare organisations, HealthTech, MedTech Professionals , Startups, Innovators, Incubation Hubs, Medical Device Industry Representatives, Digital Health Teams, Quality Professionals, Regulatory Affairs Professionals and other stakeholders like Insurers, Governments, Regulators, Corporate Health & Wellness Teams, Corporate Medical Centers, Home Healthcare Service Providers etc
HOSPEX PURCHASE MANAGERS WORKSHOP – FOR BIOMEDICAL TEAMS, PROCUREMENTS TEAMS IN HOSPITALS AND OTHER HEALTHCARE SETTINGS
Venue: Zamra Convention Centre, Kochi, Kerala
Date : September 15, 2023
Time : 2 30 pm – 5 30 pm
Fee – Rs 250 + GST
Target Audience :
Healthcare Professionals Who are incharge of Procurement Practices in Hospitals and other Healthcare Settings
Medical Professionals, Promoters, Management Teams, Administrators, Purchase Teams, Biomedical Engineers, Finance Teams, Quality Teams , other functional heads who are interested in understanding more about Quality and Safety related Regulations of Hospital Supply Chain and Vendors .
Workshop shall cover following items that Hospitals Procure with special reference to:
– Biomedical Equipments
– Consumables and Disposables
– Standalone MedTech or Healthtech Software that is used for clinical decision support purpose
Program Objective :
Since Medical Devices, Health Technologies are part of the Value Chain of Hospital Supplies, its imperative for Procurement Teams, Purchase Managers, Finance Teams, Promoters , Quality Teams to learn more about Regulations and Compliances related to their Supply Chain , Value Chain of Hospitals (Suppliers and Vendors)
Hence HOSPEX has designed an Awareness Session covering the following topics for Hospital Teams who are incharge of Procurement :
Understanding Medical Device Regulations- Laws of the Land
Medical Device Regulations – Role of Bureau of Indian Standards
Foreign Regulations , Quality Specification – How its listed in other Key Global Regulations
Claims of Voluntary Certifications – How Authentic these claims are ?
Materiovigilance Program of India – Regulatory Requirement
NABL Document Review Checklist as per ISO 15189:2022 Standard
National Accreditation Board for Testing and Calibration Laboratories (NABL) has released Document Review Checklist (NABL 220D) based on ISO 15189:2022 Standard
All NABL Lead assessor is required to review the information provided by the laboratory in line with NABL policies relevant to applicant medical testing laboratories and provide their remarks / comments on the overall completeness of the information on the application forms and the management system document in conformance with the requirements of ISO 15189: 2022 standard.
Lead assessor is required to submit the Document Review Report (DRR) directly to NABL within 10 days along with duly filled Form-74 ‘Declaration of Impartiality and Confidentiality’.
Mandatory Testing of Cough Syrup before Export – Procedure for submission of cough syrups for Testing
Cough syrup exporters will have to undertake testing of their products at specified Government Laboratories and obtain Production of Certificate of Analysis with effect from June 1 before getting permission for the outbound shipments
Ministry of Commerce & Industry has issued a Notification No.06/2023 dated 22nd May 2023 permiting export of cough syrups, subject to the export sample being tested and production of Certificate of Analysis (COA) issued by any of the Central Government Laboratories and any NABL Accredited State Drug Testing Laboratory.
The specified Central Government labs include Indian Pharmacopoeia Commission, Regional Drug Testing Lab (RDTL – Chandigarh), Central Drugs Lab (CDL – Kolkata), Central Drug Testing Lab (CDTL – Chennai Hyderabad, Mumbai), RDTL (Guwahati)] and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of State Governments
In order to facilitate the process of testing of cough syrups at the said laboratories, the following are the pre-requisite requirements for submission of samples :
Covering letter from the Manufacturer / Exporter on Letterhead addressed to concerned Laboratory
Manufacturing License of the product for Export purpose
Export Order
Representative sample from the export consignment
Thrice the quantity required for performing complete analysis of the sample
Qualitative composition of product including excipients
Certificate of analysis by the manufacturer of the particular batch and method of analysis (STP)
Reference / Working standard (with traceability certificate) and placebo as applicable
Quality Council of India (QCI) is an autonomous body under the Department for Promotion of Industry & Internal Trade (DPIIT), Ministry of Commerce & Industry, Government of India. QCI is the apex national body and provides accreditation and other related services through its constituent Boards viz. National Accreditation Board for Certification Bodies (NABCB), National Accreditation Board for Testing and Calibration Laboratories (NABL), National Accreditation Board for Hospitals (NABH), National Accreditation Board for Education and Training (NABET), National Board for Quality Promotion (NBQP).
Training and Capacity Building (TCB), an independent Cell under the ambit of QCI has been regularly conducting trainings for the laboratories, TIC Sector, and industries
Latest training program details of TCB are given below:
NABL accepts the “One Person Company (OPC)” as a legal entity of CAB
NABL accepts the “One Person Company (OPC)” as a legal entity of CAB under the Companies Act 2013.
An OPC has features of a Company along with the benefits of a Sole Proprietorship.
An OPC can have just one single member and one Director. The Director and member can also be the same person. OPC of sole-proprietor and company form of business has been provided with concessional /relaxed requirements under the Companies Act, 2013.
The accredited CABS which are under Proprietorship are given a transition period till 31.12.2023 to align with any one of the legal entities specified in the Notification
Health Ministry to rope in State Governments to establish Medical Devices Testing Laboratories
The Ministry of Health and Family Welfare (MoHFW) is planning to rope in state governments also to establish or designate their existing laboratories as state medical devices testing laboratories and bring in enabling rules to support setting up of more testing laboratories for medical devices across the country as the sector is experiencing major regulatory paradigm shift including the introduction of a licensing regime.
A draft rule has been notified by the Ministry, under which it has proposed to insert a new sub-rule to the Rule 19, that the state government may, by notification, establish state medical devices testing laboratory for the purpose of testing and evaluation of medical devices or to carry out any other functions as may be specifically assigned to it.
The State Government may also designate any laboratory having facility for carrying out and evaluation of medical devices as state medical devices testing laboratory for the purpose, with a condition that the laboratory should be accredited by the National Accreditation Body for Testing and Calibration Laboratories (NABL).
It has also added a definition to the state medical devices testing laboratory, stating that it means a laboratory established or designated by the state government under the Rule 19(3), which is the freshly proposed sub-rule. While the Rule 19 was specifically for Central medical devices testing laboratory, it has been proposed for amendment by omitting the word ‘Centre’, this emphasising that the laboratories could be established either by the Central or the state government. The draft amendment is expected to be taken into consideration in seven days from the date of making the draft available to the public.
Good Clinical Laboratory Practices (GCLP)Workshop on International Standards ISO 15189:2022 from 23rd – 25th March 2023
GCLP outline the basic principles and procedures to be followed by clinical/diagnostic laboratories involved in patient care or clinical research so as to provide highly reliable, reproducible and auditable results, which contribute to good patient care and promote a positive attitude from a patient’s perspective.
This GCLP workshop is designed to offer comprehensive guidance for those who are implementing GCLP/ISO 15189:2022 in their medical laboratories and a special session on Quality System and QA/QC in Molecularbiology Laboratory Testing included in this workshop
Only those from accredited (NABL/NABH) medical laboratories or preparing for accreditation or planning to take up a career in medical laboratory accreditation with ISO 15189:2012/2022 and Clinical Research Organization (CRO)’s laboratories (human clinical trials), are encouraged to participate in this workshop
Learning Objectives:
Basic principles of the GCLP and their relation to patient care services or clinical research.
Implementing GCLP essentials to establish a quality system and its maintenance.
Gaps between ISO 15189:2012 and ISO 15189:2022, and implementing new standards
Workshop Scope:
Overview and essentials of ISO 15189:2012.
Overview and essentials of new standard – ISO 15189:2022.
Overview and essentials of NABL-112 guidelines document.
Overview and essentials of ICMR-GCLP 2021 guidelines.
Special reference to the following key components: o Quality System Essentials (QSEs). o Establishment, management and monitoring of quality system. o Quality indicators and continual improvement. o Issues with EQAS/PT, Issues with facility operation. o Internal Quality Audit (IQA) – common NCs and its closures. o Lab accreditation associated challenges and overcoming the challenges. o Biosafety and infection control. o Quality system and basic requirements in Molecularbiology Laboratory Testing/Assays – International standard. Workshop activities include didactic lectures, interactive sessions, group discussions/exercises and case studies. The faculties from national and international settings will facilitate the program.
Registration: The participants can register for the program by paying Rs. 3,500/- and the payment can be done by scanning via net-banking or GooglePay to the following bank account: Account No. 1248135000009037, Account Name: SDC Microbiology CME, Bank: Karur Vysya Bank, IFSC Code: KVBL0001248, Branch: PH Road, Chennai-600077
The workshop is restricted to 60 slots and the registration will be done on “first come-first served basis”. For online registration, the following link has to be used: https://forms.gle/yASYBXXqKnp7NmdN8. Out station participants need to book accommodation on their own
Venue: Decennial Hall, Saveetha Dental College and Hospitals Campus, Saveetha Institute of Medical and Technical Sciences (SIMATS), Deemed University, Chennai-600077.
Contact: Dr. Pachamuthu Balakrishnan, Department of Microbiology, Centre for Infectious Diseases, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences (SIMATS), Deemed University, Chennai-600077. WhatsApp/Mobile: 7667444221, Email: GCLPSAVEETHA@gmail.com
