Tag: NABL

HOSPEX Healthcare Expo 2023

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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.

For more information about Expo, visit – https://hospex.in/

All Conference details are available at – https://hospex.in/hospex-2023-conference/

Contact :

T S Soumya, Hospex
+91 9080078447
Email – reach@hospex.in

Hospex Conferences

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

Program Brochure
Registration

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
  • Post Market Surveillance of Medical Devices
  • Biomedical Engineers Skill Certification Program, Scheme Details, Benefits 
Program Brochure
Registration

Contact Details :

For more information about Conference, visit – https://hospex.in/hospex-2023-conference/

For more information about Expo, visit – https://hospex.in/

For support in registration, reach out to :

Ms Soumya – 9080078447 

Email – reach@hospex.in

NABL Document Review Checklist

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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’.

Click here to read the Document

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

Procedure for submission of cough syrups for Testing

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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 :

  1. Covering letter from the Manufacturer / Exporter on Letterhead addressed to concerned Laboratory
  2. Manufacturing License of the product for Export purpose
  3. Export Order
  4. Representative sample from the export consignment
  5. Thrice the quantity required for performing complete analysis of the sample
  6. Qualitative composition of product including excipients
  7. Certificate of analysis by the manufacturer of the particular batch and method of analysis (STP)
  8. Reference / Working standard (with traceability certificate) and placebo as applicable
Click here to read the Notification

Source: https://www.dgft.gov.in/CP/?opt=notification

QCI’s Virtual Trainings

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QCI’s Virtual Trainings on NABCB Accreditation – ISO/IEC 17020, ISO/IEC 17065 & ISO/IEC 17021

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:

Source: https://tcb.qcin.org/

One Person Company (OPC)

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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

click here to read the Notification

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

Health Ministry to rope in State Governments to establish Medical Devices Testing Laboratories

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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.

Click here to read more
Click here to read Notification

Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=156725&sid=1

GCLP Workshop @ Chennai

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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

Click here to register
Click to Download Brochure

Training Program on ISO 15189:2022 Standard

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Medical Education and Learning Point (MELAP) is conducting the following Training programs in Chennai

4 days Onsite Training program on IA&QMS as per ISO 15189:2022 standard

Medical Education and Learning Point (MELAP) in collaboration with Dept of Biochemistry – Madras Medical College ( MMC ) is conducting 4 Day IA & QMS / QC training program as per the New version of standard ISO 15189 : 2022. This course is Accredited by NBQP, Division of QCI

Program Details are given below:

Date & Time    : 27th – 30th March  2023  9.30 am to 4.00 pm

Venue              : Madras Medical college – Chennai

Regn Fee         : For Doctors / Senior Resident – Rs.11000 (incl of tax)

                          For Technical staff / PG Students – Rs.9000 (incl of tax)

For Registration/Query : kindly contact

Mr .Anil Saini #7042949292 &9899869683

Ksaini.anil@gmail.com

Ms.Tripti Madan – 9958697309

Onsite 2 day Refresher course as per ISO 15189:2022  Standard for those who have already done 2012 version (Accredited by NBQP, Division of QCI)

Medical Education and Learning Point (MELAP) in collaboration with Department of Regenerative Medicine & Research, Govt Stanley Hospital Chennai is conducting a 2 day refresher course as per ISO 15189:2022  Standard

Program details are given below

Date                :           24th & 25th March2023

Venue             :           Department of Regenerative Medicine & Research, Govt Stanley

Hospital Chennai

Regn fee          :           Rs.6500 (incl of tax)

For Registration/Query : kindly contact

Mr .Anil Saini #7042949292 &9899869683

Ksaini.anil@gmail.com

Ms.Tripti Madan – 9958697309

Seats are limited & available on first come basis only

ISO 15189:2022 FOR MEDICAL LABS PUBLISHED

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ISO 15189:2022 – Medical laboratories — Requirements for quality and competence

This document specifies requirements for quality and competence in medical laboratories.

This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.

This document is also applicable to point-of-care testing (POCT).

NOTE : International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This fourth edition cancels and replaces the third edition (ISO 15189:2012), which has been technically revised. It also replaces ISO 22870:2016.

The main changes are as follows:

  • Alignment with ISO/IEC 17025:2017 resulted in the management requirements now appearing at the end of the document;
  • Requirements for point-of-care testing (POCT), previously in ISO 22870, have been incorporated;
  • Increased emphasis on risk management.

Introduction

The objective of this document is to promote the welfare of patients and satisfaction of laboratory users through confidence in the quality and competence of medical laboratories.

This document contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities for improvement. Benefits of this approach include: increasing the effectiveness of the management system, decreasing probability of invalid results, and reducing potential harm to patients, laboratory personnel, the public and the environment.

The requirements for risk management are aligned with the principles of ISO 22367.

The requirements for laboratory safety are aligned with the principles of ISO 15190.

The requirements for sample collection and transport are aligned with ISO 20658.1

This document contains the requirements for point-of-care testing (POCT) and supersedes ISO 22870, which will be withdrawn upon publication of this document.

The format of this document is based on ISO/IEC 17025:2017.

The medical laboratory is essential to patient care; activities are provided within an ethical and governance framework, that recognizes the obligations of healthcare providers to the patient. These activities are undertaken in a timely manner to meet the needs of all patients and the personnel responsible for the care of those patients. Activities include arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, processing of patient samples, selection of examinations that are fit for intended use, examination of samples, sample storage, as well as subsequent interpretation, result reporting and advice to laboratory users. This may also include the provision of results to the patient, arrangements for urgent testing and the notification of critical results.

While this document is intended for use throughout the currently recognized medical laboratory disciplines, it can effectively be applied to other healthcare services, such as diagnostic imaging, respiratory therapy, physiological sciences, blood banks and transfusion services.

The use of this document facilitates cooperation between medical laboratories and other healthcare services, assists in the exchange of information, and in the harmonization of methods and procedures.

The comparability of patient examination results between medical laboratories, regardless of city or country, is facilitated when medical laboratories conform to this document.

When a laboratory seeks accreditation, it should select an accreditation body which operates in accordance with ISO/IEC 17011, and which takes into account the particular requirements of medical laboratories.

Comparisons between this document, ISO 9001:2015 and ISO/IEC 17025:2017 are in Annex B. The comparison of ISO 15189:2012 to ISO 15189:2022 (this document) is in Annex C.

Source : https://www.iso.org/standard/76677.html

Transition Timeline Announcement

ILAC Announcement – 8th

ISO 15189:2022 Medical Laboratories – Requirements for quality and competence has now been published.

Further a resolution was endorsed at the ILAC General Assembly to allow a 3-year implementation period from the date of publication of this revised standard (ie now December 2025) as shown below:

ILAC Resolution GA 26.08

As the revised version of ISO 15189 is scheduled for publication in 2022 or early 2023, the General Assembly endorses the recommendation of the AIC that a transition period of 3 years from the date of publication be adopted. 

Noting that the requirements for Point of Care Testing (POCT) contained in ISO 22870:2016 have been incorporated into the revised ISO 15189, ISO 22870:2016 in conjunction with ISO15189:2012 will still be recognised as a Level 4 standard for POCT for the duration of the transition period. 

At the end of the transition period, accreditation of a medical laboratory to ISO 15189:2012 and accreditation of POCT to ISO 22870:2016 in conjunction with ISO15189:2012 will not be recognised under the ILAC Arrangement.

The implementation of this transition period for ISO 15189:2022 by the signatories to the ILAC MRA for the accreditation of medical laboratories will be monitored by the ILAC AMC to ensure the deadline is achieved. The process used by the AMC to monitor this implementation of the revised standard will be similar to that used during the implementation of ISO/IEC 17025:2017

Posted on 08th December 2022

Source :https://ilac.org/latest_ilac_news/iso-151892022-for-medical-labs-published/

Transition Timeline Announcement of NABL

NABL has released transition announcement for Accredited Medical Testing Labs in the country

Click here to read Transition Announcement

Pathcon & Lab Expo 2022

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6th Annual Conference of the Association of Practising Pathologists, India
(PATHCON & Lab Expo 2022)

Pleasure to invite you all to “6th Annual Conference of the Association of Practising Pathologists, India (PATHCON & Lab Expo 2022), which is going to be held virtually on 17th (Saturday) December 2022 &  in Hybrid mode at The Hotel Vivanta by Taj, Dwarka, New Delhi on 18th (Sunday) December 2022. This conference will bring together all of us who have put in a lifetime of effort to bring this association to this landmark event.

Date: 17th (Saturday) December 2022 – Virtual Mode
Date: 18th (Sunday) December 2022 – Hybrid Mode

Participants will learn of the rapid development and spread of technical advancement in recent years, the people who made this possible and the necessary equipment, regulations and other requirements for setting up new centres. The scientific program will cover the latest developments in all disciplines of Lab medicine. The emphasis will be on interactive sessions and panel discussions with clinical colleagues to encourage active participation of all delegates. We hope the students and residents will benefit from the experience of their colleagues and teachers and gather encouragement from the pioneers in research. Several well renowned speakers have confirmed their active participation, and this will add to the academic benefits of this conference. Save the dates in your diary today. We look forward to greeting you in what promises to be an exciting and fruitful meeting with a high scientific standard.

Keeping in mind the interest of our young participants, we shall be inviting posters and abstracts for oral presentation from all across the country and details are available on the website.

This year the venue which we have finalised is situated in Dwarka, New Delhi which is well connected all across Delhi & NCR through Delhi metro and other modes of transportation. It is just 3.5 Kms away from the IGI Airport. Delhi has a wide choice of hotel accommodation for different budgets. Kindly make your arrangements for travel and stay well in advance. The weather in Delhi in December is cool and pleasant, though light jackets may be required in the evenings. The organising committee welcomes all delegates to avail the discounted early registration rates and actively participate in this landmark event in the history of our Association.

Delhi is a historical city & always been a centre of power with many monument, multiple cuisine restaurants & it is a shoppers’ paradise and very well connected by road, rail and air to all major cities of India.

Conference Registration Fee mentioned below in Brochure Please check

Download Program Registration Form Here
Download Program Brochure Here

ABSTRACT SUBMISSION GUIDELINES

> Abstracts for Oral Presentation/Poster Presentation are to be submitted online through the conference website only.
> You need to register yourself on the online portal for submission of the abstract. You can make the registration payment later, but submission of relevant information is must.
> The presenting author MUST be registered for the conference.
> The number of papers to be accommodated are limited. You can indicate your preference during submission (oral/poster). Some abstract requests for Oral presentations will be shifted to the poster section. Case reports, unless carrying a very novel message, will not be considered for oral presentations.
> It is mandatory that the Presenting author is registered for the conference to be eligible for presentation and for awards.
> The cut-off date will be 31 Oct 2022 by 1700 hrs. No abstracts will be considered after this Deadline.
> Abstracts will be listed on the conference website by 10 Nov 2022. The abstract is restricted to a maximum of 300 words. It should include: Objectives, Methods, Results, Conclusions, and Keywords.
> One participant may submit upto 3 abstracts, and only one abstract would be considered for Oral Presentation.

Conference Manager

Mr. Saurabh Sharma
Phone: +91 9871799136
Email: secretariat.pathcon@gmail.com

Conference Secretariat
Tripti : +91 – 9958697309
Dr Neeraj Jain : +91 – 9810492621
Dr Rajan Verma : +91 – 9999138158

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