Category: Standards

NABH MITRA PROGRAM – Launch

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LAUNCH OF NABH MITRA EMPANELMENT PROGRAMME (MEP)

The NABH MITRA Empanelment Programme has been officially launched to build a nationwide network of verified professionals and organisations (“MITRAs”) who will support hospitals with NABH Accreditation, Certification, and digital health transformation, especially across Tier 2, 3, and 4 cities in India.

The last date to submit applications for empanelment is October 10,2025

About the Programme

The initiative offers a structured, transparent framework for MITRAs—trusted companions to hospitals—who will guide healthcare organisations through quality improvement and digital enablement in line with NABH standards. Empanelled MITRAs will be listed on the NABH website with verified credentials and areas of expertise.

Categories of MITRAs

Digital MITRA: Supports hospitals in implementing NABH Digital Health Standards and IT enablement through structured digital health consultancy. Digital MITRA category has additional training and experience requirements

Organisational MITRAs: Support hospitals for both Full Accreditation and Entry-Level Certification.

Individual MITRAs: Independently support hospitals mainly for Entry-Level Certification.

Who Can Apply:

Individual MITRAs: Qualified professionals with at least one successful accreditation or certification support project and one NABH-certified professional (current assessors not eligible).

Organisational MITRAs: Registered companies, LLPs, trusts, societies, or proprietorship entities operational for at least one year, with experience supporting minimum three hospitals through accreditation or certification. Must have at least two NABH-certified professionals (current NABH assessors not eligible).

Application Process & Fees

i. Apply via the NABH online portal by October 10, 2025.
ii. Shortlisted candidates will be invited for interviews and required training.
iii.Empanelment fee for a three-year period: ₹20,000 + GST (Individual MITRA), ₹50,000 + GST (Organisational MITRA).
iv.Training program charges: ₹25,000 + GST for MITRA, ₹15,000 + GST for Digital MITRA (paid after selection)

Additional Information

i. MITRAs will play a key role in enabling hospitals to achieve NABH standards and strengthen India’s healthcare quality framework
ii. Empanelment does not imply endorsement or financial association by NABH.
iii.Maintaining high standards, transparency, and ethical conduct is compulsory.

Download NABH Concept Note

Source: https://portal.nabh.co/Announcement/MEP_Concept.pdf

Industry Information update : Sector-wise Compendiums of Indian Standards

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Sector-wise Compendiums of Indian Standards published – BIS

BIS Unveils 130 Sector-wise Compendiums of Indian Standards to Enhance Industry and Consumer Awareness

The Bureau of Indian Standards (BIS) has released a comprehensive collection of 130 sector-specific compendiums of Indian Standards, now accessible on the BIS portal.

Organized by industry sectors and product/service categories, these compendiums serve as consolidated reference guides for a wide range of stakeholders, including regulatory authorities, industry professionals, academic institutions, and consumer organizations.

Stakeholders can access the compendiums at
https://services.bis.gov.in/php/BIS_2.0/bisconnect/compendium_of_indian_standards_dept_wise

Please scan the QR code given below to download :

Source: https://services.bis.gov.in/php/BIS_2.0/bisconnect/compendium_of_indian_standards_dept_wise

Industry Information Update – BIS – Sector wise Calendar for Upcoming Webinars

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BIS – Sector wise Calendar for Upcoming Webinars

Bureau of Indian Standards is organising Sector specific awareness programs

In order to spread the awareness among the concerned stakeholders, manufacturers, importers and common consumers BIS is organising ‘Interactive lecture series and Sector-wise webinar’ on the below mentioned topics.

Manufacturers including MSMEs are requested to attend the above webinars based on their respective business interests for a particular sector.

Participation in these webinars does not require any preregistration and can be joined conveniently and remotely through Computer / Laptops / Mobiles.

The link for joining these webinars are hosted well in advance on BIS Website: www.bis.gov.in

Source: https://www.bis.gov.in/

Industry Update – NABH Notification Reg the Name of Healthcare Organisations

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NABH Notification: Guidelines on Naming of Healthcare Organizations (HCOs)

The National Accreditation Board for Hospitals & Healthcare Providers (NABH) has issued a directive to ensure that the names of Healthcare Organizations (HCOs) accurately reflect the services they provide.

Key Points:

  • HCO names must clearly communicate the nature of services available within the facility.
  • Misleading names suggesting specialized or super-specialty care must be avoided unless those services are actually and verifiably available.
  • Misrepresentation through the name of the facility is strongly discouraged and may lead to adverse decisions.
  • The name used in NABH applications must match the name on the registration certificate.

Purpose:

  • To maintain transparency, trust, and clarity for patients and the general public.

Action Required:

  • HCOs are requested to review and, if necessary, modify their current naming conventions to comply with these guidelines.

NABH Notification is given below :

Source: https://nabh.co/

Industry update – Guidelines for Common Bio Medical Waste Treatment

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Guidelines for Common Bio-medical Waste Treatment and Disposal Facilities

The Guidelines for Common Biomedical Waste Treatment and Disposal Facilities (CBWTFs) were introduced by the Central Pollution Control Board (CPCB) under the Ministry of Environment, Forest and Climate Change (MoEF&CC), Government of India.

These guidelines aim to ensure the safe, scientific, and environmentally sound handling of biomedical waste generated by healthcare facilities.

CBWTF stands for Common Biomedical Waste Treatment and Disposal Facility. It is a centralized facility designed to collect, treat, and dispose of biomedical waste generated from healthcare facilities (such as hospitals, clinics, laboratories, etc.) within a specific region.

As the amount of biomedical waste continues to increase—especially after the COVID-19 pandemic—the need for centralized facilities that can efficiently serve multiple healthcare units has become more urgent. They are especially important for smaller healthcare units that lack the resources to treat waste independently. By standardizing procedures and encouraging centralized treatment, these guidelines help minimize health risks, environmental pollution, and legal non-compliance.

The guidelines establish standards for site selection, infrastructure requirements, waste collection, transportation, treatment, disposal, staff safety, and legal compliance.

Click here to read the Guideline document

Source: https://cpcb.nic.in/openpdffile.php?id=TGF0ZXN0RmlsZS80NDBfMTc0NDgwMDgzMl9tZWRpYXBob3RvMTA1MjUucGRm

Industry Update – Programme on Implementation of NABH 1st Edition Digital Health Standards for Hospitals

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Programme on Implementation of NABH 1st Edition Digital Health Standards for Hospitals

NABH (National Accreditation Board for Hospitals and Health Care Providers) is organizing 2 days training on ” NABH 1st Edition Digital Health Standards for Hospitals” in an online mode

Objective of the Programme: The objective of this programme is to provide guidance to healthcare providers, healthcare administrators and Healthcare IT personnel on implementation of NABH standards

The aim of the programme is to develop Internal Counsellors within the hospitals for helping them to work towards implementation of Digital Health Standards for quality and patient safety, achieving accreditation and maintaining the same.

Who Should attend: Owners of healthcare organization, CTO`s of the Hospitals, Healthcare IT personnel, HMIS and EMR product owners/employees, medical professional, nursing professional, medical administrators, para medical staff, etc. NABH encourage to keep the group a mix of professionals from diverse healthcare background.

Registration: Click the link https://portal.nabh.co/EventDetails.aspx?id=271#gsc.tab=0

Please click on “Click to Register” on the preferred batch. After you register, Login with the registered credentials, go to Education and Training, go to the programme you have registered for and “Click to Register” and pay the registration fees.

Registration fee (non-refundable & non-changeable) is Rs. 8,000/- + GST @ 18% (total Rs. 9,440/).

The fees would include Guidebook of 1st Edition Digital Health Standards for Hospitals course material. It is a nonresidential programme.

Program Schedule : Virtual Mode
Dates – April 26-27, 2025
May 17-18,2025

Limited Seats are available and will be allotted on ‘first cum first serve’ basis

For any queries please contact:

Mr. Vikash Chaudhary
Assistant Director
National Accreditation Board for Hospitals & Healthcare Providers (NABH)
Quality Council of India
ITPI Building, 5th Floor,
4 – A, Ring Road, I P Estate,New Delhi – 110002
Tel: +91 11 42600622
Fax: +91 11 233 23 415
Email: vikash@nabh.co

Source: https://nabh.co/

Industry update : NABH GUIDEBOOK FOR CLIMATE ACTION AND SUSTAINABILITY IN HEALTHCARE

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NABH GUIDEBOOK FOR CLIMATE ACTION AND SUSTAINABILITY IN HEALTHCARE

National Accreditation Board for Hospitals and Healthcare Providers (NABH) has been developing quality healthcare standards . NABH standards have always focused on creating an ecosystem for quality and safety of the services delivered in the healthcare organizations.

As a step towards addressing the biggest challenge of 21st century i.e. climate change and sustainability, NABH has developed a simple checklist to guide NABH accredited and certified healthcare organizations to achieve climate change adaption, resilience and sustainability.

This cohesive document includes essential of concept of sustainability in healthcare, guidance for implementation and strategic framework. To motivate healthcare organizations, industry best practices are also showcased in the document.

This document along with a self-assessment checklist is available for free download in NABH website http://www.nabh.co/

Click here to read the guidebook with a self assessment checklist

Source: http://www.nabh.co/

Industry update : NABL 112A & NABL 112B

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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/




Industry Update – Establishment of the Global Accreditation Cooperation

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Establishment of the Global Accreditation Cooperation (GLOBAC)

The establishment of the Global Accreditation Cooperation (GLOBAC) marks a significant shift in the global accreditation landscape, merging the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC) into a single entity.

This transition, aimed to be operational by January 2026, follows extensive discussions and agreements among IAF and ILAC members in 2024.

Key Developments

Formation of GLOBAC:

In 2019, IAF and ILAC members decided to create GLOBAC, which will take over their existing roles. The formal incorporation process began in New Zealand in October 2024 after the approval of GLOBAC’s Constitution and General Rules.

Mutual Recognition:

GLOBAC aims to enhance international trade by ensuring mutual recognition of accredited services across borders, thereby removing technical barriers. Until GLOBAC becomes operational, IAF and ILAC will continue their normal operations with existing recognition arrangements remaining valid

Transition Plan

Before Transition Date:

Until the Transition Date, IAF and ILAC will maintain their operations, and existing guidance for regulators will remain applicable. The IAF Multilateral Recognition Arrangement (IAF MLA) and ILAC Mutual Recognition Arrangement (ILAC MRA) will continue to function until GLOBAC takes over

After Transition Date:

Following the Transition Date, GLOBAC will assume all responsibilities of IAF and ILAC. Regulations referencing IAF MLA or ILAC MRA will gradually be updated to reflect GLOBAC’s framework. It is anticipated that the use of IAF MLA and ILAC MRA Marks will cease three years post-transition

Recommendations for Regulators:

Regulators are encouraged to collaborate with IAF and ILAC members to prepare for necessary changes in their documentation as GLOBAC becomes operational. This proactive approach will facilitate a smoother transition to the new accreditation framework

For further inquiries regarding this transition, stakeholders can contact the GLOBAC Executive Committee through its Secretary : secretary@globac.org

Click here to read more

Industry update

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Indian Pharmacopoeia Commission – Materiovigilance Programme of India (IPC-MvPI) as Certification Body for ICMED 9000 and ICMED 13485

Indian Pharmacopoeia Commission – Materiovigilance Programme of India (IPC-MvPI) is awarded provisional approval from the Quality Council of India (QCI) to function as a certification body for the ICMED 9000 (ISO 9001 requirements plus additional requirements specified under the scheme) and ICMED 13485 (ISO 13485 requirements plus additional requirements specified under the scheme) certification schemes.

This accreditation will enable IPC-MvPI to assess the quality management systems of medical device industries, ultimately enhancing the quality of medical devices and ensuring consumer protection

To know more, please visit https://ipc.gov.in/news-highlights/1296-indian-pharmacopoeia-commission-%E2%80%93-materiovigilance-programme-of-india-ipc-mvpi-as-certification-body-for-icmed-9000-and-icmed-13485.html

Source: https://www.ipc.gov.in/icmed-certification.html

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