World Standards Day 2023

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)

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.

DRAFT FRAME WORK FOR ACCREDITATION AND RANKING OF COLLEGES REGULATED BY NMC

Starting from the 2024-25 academic session, all medical colleges in the country, both private and public, will mandatorily be rated and ranked. The move follows a Memorandum of Understanding (MoU) signed by the National Medical Commission (NMC) with the Quality Council of India (QCI) to rate medical institutions.

An MoU between the NMC, the medical education regulator, and the QCI was signed recently to this effect

NABL Document Review Checklist

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’.

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

NABH – LATEST NOTIFICATIONS

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

NABH Notification

NABH – DIGITAL HEALTH ACCREDITATION STANDARDS – (DRAFT)

NABH has released the Draft standard – Digital Health Accreditation Standards – 1st Edition.

NABH invites comments, suggestions and feedback in the draft document from public at large, including the stakeholders like hospitals the other clinical establishments, industry, consumer groups etc.

The comments may be shared on the form within 20 days of publication of this notice on the website.

Please find the Link for google form link to submit the feedback.

https://forms.gle/wSCKTJnfbDwvnase7

The last date for receiving comments is 2nd May 2023

Source:https://nabh.co/Announcement/Public%20Notice%20for%20Digital%20Health%20Standard%201st%20Edition.pdf

QCI’s Virtual Trainings

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/

Launch of Healthcare textiles processing facility certification Scheme

Healthcare Textiles Processing Facility Certification Scheme Launched in India

On the occasion of World Health Day on 7 April, the triple A partnership of AMTZ LTD, Association of Healthcare Providers – AHPI (India) and Association of Indian Medical Device Industry – Aimed India, launched Healthcare Textiles Processing Facility Certification Scheme (HTPFCS) to ensure the quality of healthcare textiles, including personal protective equipment (PPE), by certifying the facilities or laundries that process them for reuse

While the Covid-19 pandemic has highlighted the importance of healthcare textiles and PPE in protecting healthcare workers and patients from infection, the quality of these products depends not only on the materials used but also on the processing facilities where they are sterilized, cleaned, and packaged.

The Healthcare Textiles Processing Facility Certification Scheme will help ensure that these facilities meet international standards for quality and safety. It aligns with international standards and guidelines, including those of the World Health Organization (WHO) and the International Organization for Standardization (ISO).

Under the scheme, healthcare textiles processing facilities can apply for certification by undergoing a rigorous evaluation process that includes site visits, documentation reviews, and testing of samples.The certification will be valid for three years, after which the facility will need to undergo a recertification process.

The Certification would be carried out by independent third party certifying agencies to be accredited as per applicable international standard, ISO 17065, and approved by AMTZ to assure their competence, impartiality and consistent implementation of certification process.

The Healthcare Textiles Processing Facility Certification Scheme is open for applications from healthcare textiles processing facilities in India and abroad.

source:http://www.pharmabiz.com/NewsDetails.aspx?aid=157437&sid=1#:~:text=The%20Healthcare%20Textiles%20Processing%20Facility%20Certification%20Scheme%20is%20a%20welcome,of%20healthcare%20textiles%20and%20PPE.

IAF CertSearch

IAF CertSearch Team Identifies 20,000 Fake or Fraudulent ISO QMS Certs

As of 2023, more than 27,000 medical device QMS certificates have been issued worldwide

On Feb. 13, 2023, 33 nations sent their medical device regulators to Riyadh, Saudi Arabia, to participate in the Global Harmonization Working Party. The GHWP is a nonprofit organization that studies and recommends ways to harmonize global medical device regulations

The IAF was asked to participate and provide an update on the IAF CertSearch database, a global database where users can search and validate the status of accredited certificates issued by a certification body that has itself been accredited by an IAF-recognized accreditation body. The IAF presentation was provided by Nigel Johnston, who developed the database.

The presentation given to the GHWP members focused attention on the use of ISO 13485 and how the IAF CertSearch database is helping regulators to verify the credibility of these certificates. Johnston’s presentation raised alarms. He noted that the IAF CertSearch team had identified 20,000 fake or fraudulent certificates in the last year alone.

Although it isn’t fully populated (the database represents about 44% of all ISO QMS certificates included in the ISO Survey), it is now mandatory that accredited certification bodies upload them. Because of this requirement, this percentage is expected to increase significantly.

Source: https://www.qualitydigest.com/inside/fda-compliance-article/iaf-certsearch-team-identifies-20000-fake-or-fraudulent-iso-qms-certs

One Person Company (OPC)

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

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