Category: Certifications

Medical Textiles (Quality Control) Order, 2023

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Medical Textiles (Quality Control) Order, 2023

The Union Ministry of Textiles has introduced Quality Control Orders (QCOs) for six medical- textile products that will come into effect from April 1, 2024.

Medical textiles QCO encompass a range of products vital to healthcare and hygiene. The products covered under this QCO include Sanitary Napkins, Medical textiles -Shoe covers, Medical textiles -Dental bib/Napkins, Disposable baby diaper, Reusable sanitary pad/ sanitarynapkin/ period panties andMedical textiles -Bed sheet and pillow cover

In mass consumption items of Medical textiles like Sanitary Pads and baby diapers, self help groups are exempted from QCO while Micro and Small units are given relaxation for 1 year so as facilitate penetration without affecting availability.

The conformity assessment requirements specified in these QCOs are equally applicable to domestic manufacturers as well as foreign manufacturers who intend to export their products to India.

The Bureau of Indian Standards shall be the certifying and enforcing authority. All Medical Textiles shall bear the Standard Mark under a license from the Bureau of Indian Standards

Any person, who contravenes the provisions of this Order, shall be punishable in accordance with the provisions of the Bureau of Indian Standards Act, 2016. Products covered under the order are given below:

For the purposes of the Schedule – A and Schedule – B, it is clarified that the latest version of Indian Standards established and published by the Bureau of Indian Standards from time to time in accordance with the  provisions of clause (17) of section 2 of the Bureau of Indian Standards Act, 2016 (11 of 2016), shall apply from the date of such publication.

Click here to read the Notification

Source – https://texmin.gov.in/quality-control-orders-qco

Awareness and Implementation Webinar

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Awareness and Implementation Webinar on QCOs on Identified Indian Standards under Medical Textiles -20 November 2023 (1430 onwards)

BIS, the National Standards Body of India was established for harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. BIS has been providing traceability and tangibility benefits to the national economy in a number of ways, i.e., providing safe reliable quality goods; minimizing health hazards to consumers; promoting exports and imports substitute; control over proliferation of varieties, etc.

The Textiles Department, Bureau of Indian Standards is organizing an “Awareness and Implementation Webinar on QCOs on Identified Indian Standards under Medical Textiles” on Monday, 20 November, 2023  at 1430 hrs onwards. 

The main objective of the webinar is to spread awareness on product standards on Medical Textiles e.g.  Sanitary Pad (Disposable and reusable), Baby Diaper, Bedsheet and Pillow Cover, Shoe Covers, Dental Bib, Coveralls, Facemask etc.

Webinar will not only talk about the salient features and importance of these standards but also disseminate valuable information on BIS conformity assessment/certification process for implementation of standards. 

Through this webinar, it is envisaged to bring the manufacturers/stakeholders of Medical Textiles and BIS to a common platform for discussion on standards which are brought under Quality Control Order(QCO’s)  by Ministry of Textiles (MoT) as well as its implementation related issues. 

Considering the importance of the event we hope that you would make it convenient to participate in the above webinar. It is requested to confirm your participation by return e-mail.

Please note that there is NO REGISTRATION FEE for this webinar.  You can join directly from the following link :-

Webinar Link: https://bismanak.webex.com/bismanak/j.php?MTID=m50648bf361e4ac4891d7924144944c69

Webinar ID: 2516 299 4441
Webinar Password: Txd36@123

Program schedule is given below for your kind reference

World Standards Day 2023

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Invitation to All to join WSD 2023 Celebrations

Oct 14th is Celebrated World over as World Standards Day.🎊

CCC(Consultants Consortium of Chennai) and MSCC(Management Systems Consultants Consortium) are organising a webinar on Oct 14th 2023 from 4 pm–5 pm.🗓️

WSD Theme this year : Shared Vision for a better World – Incorporating SDG 3

SDG 3 is all about Good Health and Wellbeing 👩🏻‍⚕️

In alignment with Global Theme,we have scheduled a webinar on the following topic:

Healthcare Quality Assurance – Standards ✅

ISO has released a Healthcare QMS Std – ISO 7101, for the first time globally.🏥
Pharma Sector is witnessing Global MS Standards in Pharma Manufacturing as well💊
Medical Devices Sector is racing towards implementing MDQMS 🩺

Session on Healthcare Quality Assurance is designed to Educate Healthcare Sector – be it Services or Products , and various other stakeholders, about various Healthcare Quality Assurance Standards which are introduced globally to improve the Healthcare Quality Focus across the globe.

Healthcare Services can’t offer Assurance on its Quality when its Supply Chain, Value Chain Quality is not in alignment with its Quality Assurance Framework.

Time to LEARN, UNLEARN and RELEARN 🧑‍🎓

Prog Info :

Date : Oct 14, 2023
Time : 4 pm – 5 pm
Meeting Mode : Zoom Meeting
Fee – No Fee. Free for all 🆓

Registration Link :https://us02web.zoom.us/meeting/register/tZwsd-uhrD8rHdXTn3awk0eCxcSxAzqqSg20

Prior registration is a must. All registered delegates will receive direct mail from ZOOM, CCC Secretariat and also a SMS.

For Prog info, updates, visit – https://ccc-consultants.org/world-standards-day-2023/

For queries , pls mail :

CCC – contact@ccc-consultants.org
MSCC – info@msccglobal.com

World Standards Day (WSD)

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World Standards Day (WSD) -14 October 2023 – Session by QAI

World Standards Day is celebrated globally on Oct 14 every year.

Global Theme for this year is on: Shared vision for better world: Incorporating SDG 3 (Good Health and Well Being)

Quality and Accreditation Institute (QAI) is Celebrating WSD 2023 by organising a one Hour Session based on the Global Theme on 14 October 2023 between 11 AM to 12 PM.

The session will be held in Virtual Mode (Webinar).

Registration Link: https://us02web.zoom.us/meeting/register/tZ0vceGhrzwqHdRVwoCTgdFgh559fLKH8pVN

After registering, you will receive a confirmation email containing information about joining the meeting.

Join hands to celebrate the day.

INTERNAL AUDITOR TRAINING PROGRAM

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Internal Auditor Training Program As Per Iso 13485:2016 Standard

IBSC (Indian Biomedical Skill Consortium) is conducting Internal Auditor Training Program on ISO 13485:2016 – Medical Device Quality Management System

COURSE OUTCOMES:

a. Use of ISO13485:2016 as the basis for a QMS for medical device manufacturers
b. Ways to increase effective manufacturing of medical devices and cost savings through quality management
c. Supply chain monitoring to achieve continuous improvement·  
d. Understanding how to meet regulatory requirements leading to increased patient safety

Duration: 3 Days (12th, 13th & 14th October 2023)
Mode: Online (Hybrid mode)
Eligibility: Any (Working Professionals & Interested Student

Discount: 25% to AMTZ Manufactures; AiMeD Members, IBSC Partners
For quotation send email to n.nareshkumar@ibsc-amtz.in

Program Details: https://www.ibsc-amtz.in/coursedetails/30

Last Date for Registration: 7th October 2023

For more information, please contact :
Mr. Nitturi Naresh Kumar
WhatsApp: 918897330990
n.nareshkumar@ibsc-amtz.in

Industry Information update

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Commerce ministry authorises EPCMD to issue registration-cum-membership certificates for exporters

The Commerce Ministry has authorized the newly-established Export Promotion Council for Medical Devices (EPCMD) to issue registration-cum-membership certificates for exporters of specific medical items. These items include bandages, first-aid boxes, hot water bottles, ice bags, gloves, surgical garments, syringes, and stethoscopes.

A Registration-cum-Membership Certificate (RCMC) is required for exporters to avail benefits under the foreign trade policy, as well as customs and excise benefits

Holding the certificate can also help exporters in availing benefits with respect to customs and excise.

These items also include hot water bottles, ice bags, gloves, personal protective garments for surgical/medical use, surgical gowns and drapes, syringes, with or without needles, and stethoscopes.

The directorate general of foreign trade (DGFT) in a public notice stated that the council has been included in FTP for “issuing RCMC for specific items”.

Click here to read the Notification

source: https://economictimes.indiatimes.com/news/economy/foreign-trade/commerce-ministry-authorises-epcmd-to-issue-registration-cum-membership-certificates-for-exporters/articleshow/101386747.cms

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/

BSI Launch Event: Antimicrobial Resistance (AMR) certification

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BSI Antimicrobial Resistance (AMR) Certification – Launch event on Monday, 26th June 2023 between 15:00 hrs – 16:30hrs (IST)

According to the World Health Organization, antimicrobial resistance (AMR) has been declared a top 10 global public health threat and is expected to get worse unless action is taken. It threatens to undermine the basis of modern medicine by rendering the antibiotics used to treat and prevent infections ineffective.

Resistance can come from many sources – BSI is working with the pharmaceutical industry to focus on the evolution of responsible manufacturing of antibiotics. Manufacturing waste from the production of antibiotics may contribute to the development of AMR in the environment unless emissions from waste streams are effectively controlled

BSI, in collaboration with the AMR Industry Alliance, will launch an industry antibiotic manufacturing certification scheme on 26 June 2023

This independent and impartial certification program is perfectly situated to serve as a mechanism for antibiotic manufacturers to demonstrate evolving best practice and compliance to the Antibiotic Manufacturing Standard. While government regulators have a role to play in promoting responsible manufacturing, the industry has shown its willingness to self-regulate by developing this manufacturing standard and independent certification scheme.

Companies including Centrient, Roche, Pfizer, Teva, Viatris, and Sandoz were participants in the pilot program and have helped provide technical expertise to shape the certification program.

  • Provide independent third-party assurance that your organization is minimizing the risk of waste emissions from manufacturing 
  • Prove that the industry can self-regulate the antimicrobial resistance topic through certification and external third-party independent assessments
  • Differentiate yourselves in healthcare systems tenders by showing your antibiotic products are independently certified by a trusted organization with a recognizable Mark of Trust

Who should attend?

  • Pharmaceutical manufacturers
  • Regulators
  • Government policy makers
  • Trade associations
  • Contract manufacturers
  • Hospital / healthcare systems sustainability procurement
Click here to Register
Click here for speaker details

NABH – LATEST NOTIFICATIONS

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Latest Notifications Issued by NABH on Hospital Accreditation Standards

NOTIFICATION FOR SMALL HEALTH CARE ORGANIZATIONS

NABH has started implementation of 3rdedition accreditation standards for SHCOs w.e.f. 1st March 2023.

In view of multiple representations received from various stakeholders and our endeavour to continue conducting comprehensive assessments of SHCOs, NABH has decided to increase number of man-days for conducting the mid-term surveillance assessments of SHCOs under 3rd edition, from current 1*1 (1 assessor for 1 day) to 2* 2 (2 assessors for 2 days) with immediate effect.

There shall be no change in the number of man-days for final and re-assessments of SHCOs.

Source: https://nabh.co/Announcement/Notification%20for%20Change%20in%20Man-days%20for%20Surveillance%20assessment%20of%20SHCOs.pdf

NOTIFICATION FOR FEEDBACK ON 5th EDITION ACCREDITATION STANDARDS FOR HOSPITALS

NABH will soon be initiating drafting of 6th edition of Hospital Accreditation Standards in accordance with ISQua EEA Guidelines. You are requested to give feedback on the current NABH Standards i.e. 5th Edition. Your feedback/ inputs will add value in developing new edition of Hospitals standards.

The comments are invited on the following link.

Feedback form: https://forms.gle/5TXp5PsymacUR3Mu8

The last date for receiving feedback is 15th May, 2023.

Source: https://nabh.co/Announcement/Notification%20for%20Feedback%20on%205th%20Edition%20Standard.pdf

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/

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