Category: Certifications

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/

Launch of Healthcare textiles processing facility certification Scheme

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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

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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)

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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/

Proposal for a Directive on Green Claims

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Proposal for a Directive on substantiation and communication of explicit environmental claims (Green Claims Directive)

On 22nd of March 2023 a proposal of the Directive of the European Parliament and of the Council on substantiation and communication of explicit environmental claims (Green Claims Directive) has been published by the European Commission.

This proposal is based on Article 114 of the Treaty of the Functioning of the European Union (TFEU), which applies to measures that aim to establish or ensure the functioning of the internal market, while taking as a base a high level of environmental protection

The proposal aims to ensure the functioning of the internal market for economic actors operating in the internal market and consumers relying on environmental claims. The measures proposed in this Directive will increase the level of environmental protection, while leading to further harmonisation regarding the regulation of environmental claims, and would avoid market fragmentation due to diverging national approaches that were introduced or would be introduced in the absence of rules at EU level.

The Proposal of the Directive states that penalties can be imposed: Member States shall ensure that when penalties are to be imposed in accordance with Article 21 of Regulation (EU) 2017/239449, the maximum amount of such fines being at least at 4 % of the trader’s annual turnover in the Member State or Member States concerned.

The Directive shall not apply to sustainability information involving messages or representations that may be either mandatory or voluntary pursuant to the Union or national rules for financial services, such as rules relating to banking, credit, insurance and re-insurance, occupational or personal pensions, securities, investment funds, investment firms, payment, portfolio management and investment advice

Click here to read the proposal

Source:https://environment.ec.europa.eu/publications/proposal-directive-green-claims_en

Seminar on Online Reviews by Bureau of Indian Standards

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BIS Seminar on IS 19000: 2022, ‘Online Consumer Reviews Principles and Requirements for the Collection, Moderation, and Publication for Online Reviews’ 

BIS is organizing a seminar on IS 19000: 2022, ‘Online Consumer Reviews Principles and Requirements for the Collection, Moderation, and Publication for Online Reviews’ on 24th March 2023 from 10:30 AM onwards at Dr. Lal C. Verman Hall, BIS Headquarters, New Delhi.

The objective of the seminar is to create awareness about fake online reviews impacting businesses and customer’s purchasing decisions. 


Registration link: https://lnkd.in/dXG3syCU

To join online, click on the link: https://lnkd.in/dg4cVURf

Seminar No. 2514 493 0188
Password: 12345

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

CAHO Webinars

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Webinar on Understanding Technical Regulations and Standards

Healthcare services rely on a number of products – from drugs to medical devices to food to electronic items. Many of these items not only need to be of high quality but also safe to use.

Since many products have health and safety implications, they are or should be regulated while others may not need to be regulated but quality needs to be assured.It is therefore necessary for healthcare industry to understand the world of what are called technical regulations and standards, how it should go about procurement of products it needs and what kind of certificates it should rely on

CAHO is hosting a webinar on the topic Understanding Technical Regulations and Standards by Mr.Anil Jauhri , (Former CEO,National Accreditation Board for Certification Bodies (NABCB)) on 23rd March 2023 between 4.00 to 5.30 pm.

Click here for Registration

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