Workshop on NEC 2023

Two days workshop on National Electrical Code of India

NFE in association with BIS is conducting a 2-Days workshop across multiple locations in India, including Chennai, Mumbai, Bangalore, Hyderabad & Ahmedabad. In Chennai, the workshop is scheduled on 20th & 21st April 2023 at L&T, Manapakkam, Chennai.

Free for the NFE Members and for Non – NFE Members Rs.2500 plus GST

To know more about the workshop and its schedule feel free to connect with NFE at info@nfees.org/nec@nfees.org or visit their website at http://www.nfees.org

Click here to register https://lnkd.in/gJZXxreB

Seminar on Online Reviews by Bureau of Indian Standards

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/

Announcement – Gold Jewellery sale without Six Digit Hallmark to be banned from next month

Gold Jewellery sale without Six Digit Hallmark to be banned from next month

Sale of gold jewellery and gold artefacts hallmarked without six-digit code shall be banned from next month. The Ministry of Consumer Affairs, Food and Public Distribution made an official statement in this regard and said that the decision has been taken to ensure quality culture in micro sale units. The statement made it clear that effective from 1st April 2023, sale of only those gold jewellery and gold artefacts shall be permitted that have been hallmarked with six-digit alphanumeric HUID — unique identification number. The decision was taken after a review meeting of Bureau of Indian Standards (BIS) held on 3rd March 2023 chaired by the union cabinet minister Piyush Goyal.

“Starting from 1st April 2023, the sale of only gold jewellery with HUID shall be permitted,” the official statement of the Ministry of Consumer Affairs, Food and Public Distribution said adding, “In an effort to promote quality culture in micro scale units, BIS is providing an 80% concession on the certification/minimum marking fee across various product certification schemes of BIS. Additionally, units located in the North-East will continue to receive an extra 10% concession.”

Nidhi Khare, Additional Secretary at the Department of Consumer Affairs said that “in consumers interest, it has been decided that after March 31st, sale of gold jewellery and gold artefacts hallmarked without HUID will not be permitted.” She said that currently our digits as well as six-digit HUID are being used.

Here we list out some other important decisions taken at the BIS review meeting:

– BIS shall augment the testing infrastructure in the country.

– It would increase the frequency of product testing and Market Surveillance depending on the criticality of components used for the consumer safety. BIS should also increase the frequency of lab inspection.

– BIS shall enhance Market Surveillance for different products such as Pressure Cooker, Helmets, and other consumer products to ensure product safety and to bring quality consciousness in the country.

– BIS shall map standards against various government schemes and produce booklets in simple and local languages to enhance accessibility and develop a culture of quality consciousness among citizens.

– BIS has proposed Quality Control Orders (QCO) for 663 products in the coming time. Currently, there are 462 products covered under QCOs.

While commenting upon the decisions taken in BIS review meeting, Piyush Goyal said, “We are committed to ensuring that all products in India meet the highest quality and safety standards. These measures shall promote micro scale units, enhance the testing infrastructure, and develop a culture of quality consciousness among citizens.”

Source: https://www.livemint.com/news/india/gold-jewellery-sale-without-six-digit-hallmark-to-be-banned-from-next-month-11677892527916.html

BIS for mandatory hallmarking of gold bullion from July 1

BIS for mandatory hallmarking of gold bullion from July 1

The Bureau of Indian Standards (BIS) has proposed making hallmarking of gold bullion mandatory for approved refiners from July 1, as part of efforts to ensure that consumers don’t face quality issues.


It has also said that all other refiners (those not registered with BIS) manufacturing bullion should compulsorily hallmark their products from January 1, 2024.


India has 44 BIS-approved bullion refineries. They refine “dore” (impure) gold and scrap gold and produce bullion, which is used to manufacture gold jewellery, bars and coins.

The BIS letter says, “Gold bullion is used as raw material for manufacturing jewellery and its purity is paramount for ensuring the desired fineness (995/999) of hallmarked gold jewellery. Hallmarked gold bullion will help in ensuring the desired purity of gold jewellery being manufactured. As such a need has been felt to bring it under mandatory certification.”

Fineness is an indicator of the quantity of pure gold in the gold alloy in parts per thousand. A fineness of 995 indicates 995 parts of gold and five parts of another metal. The highest quality is 999.99.

An advisory committee has been formed under the chairmanship of Pramod Kumar Tiwari, Director general of BIS, to work out the modalities of implementation of hallmarking at the refinery level.

A senior gold industry executive said the BIS’ move to introduce hallmarking at the refinery level is a step towards making gold an asset class in the country.

Consumers, who buy gold bars and coins will benefit from the move. Of India’s total annual gold consumption of 850 tonnes, nearly 20% is in the form of bars and coins. In 2022, the demand for gold coins and bars was 173 tonnes

Source: https://m.economictimes.com/news/india/bis-for-mandatory-hallmarking-of-gold-bullion-from-july-1/articleshow/98283768.cms

World Standards Day 2022 Program

Webinar – World Standards Day (WSD) 2022 Program on Role of Sustainability Standards in International Trade on Oct 14, 2022 – 4 30 pm – 6 00 pm

Sustainable Trade Development and Voluntary Sustainable Standards

Sustainable Development defines international trade as “an engine for inclusive economic growth and poverty reduction, that contributes to the promotion of sustainable development”.

The exponential increase in global trade has enabled many developing countries to pursue economic development through export and export diversification. On the other hand, the nature of trade has changed and that products are now made by bringing parts together from different parts of the world.

Although the expansion of international trade, in the last decade, has brought economic and societal benefits across the globe, it resulted in failing to address the adverse social and environmental and even economic impacts.

Hence, in order for trade to become a ‘sustainable engine’, one approach that seems to be increasingly used is to internalize social, economic and environmental concerns in international trade.

Sustainability Standards play a central role in global trade, and greatly contribute to the improvement of  environmental and social compliance in supply chains. They represent guidelines used by producers, manufacturers, traders, retailers, and service providers to develop good environmental, social, ethical, and food safety practices.

Sustainability standards can unlock new markets for developing countries.

Go Green, Go Sustainable

More and more countries are pursuing green, social and/or sustainable public procurement, therefore standards can play an important role in identifying which products are sustainable.

Adhering to sustainable trade standards can enhance opportunities for market access to retail, corporate and government consumers who are concerned about the sustainability of the products they purchase and the resources they consume in production, use and disposal.

Program Objective

Consultants Consortium of Chennai is organising a Knowledge Session, on the occasion of World Standards Day (WSD), on October 14th 2022.

The program is designed on the topic Sustainability Standards based on the WSD Theme.

Objective of the program is to create awareness to businesses about various National and International Sustainability Standards and hoe implementing the same would increase trade and business opportunities across the globe.

Program Details

Topic – Role of Sustainability Standards in International Trade

Date : October 14th 2022 – Friday

Time : 04 30 pm – 06 00 pm

Meeting Mode – Online / Virtual

Meeting Platform – Zoom

Fee : No Registration Fee.

Program Open for industry and all stakeholders in Conformity Assessment. However, prior registration is a must.

Registration Link

Click the button below for registration

Upon registration, registered delegates will receive meeting link.

Contact

For enquiries, pls email to

contact@ccc-consultants.org

secretariat@ccc-consultants.org

Advisory for Minimum Essentials Fire Safety Measures

NABH – Advisory for Minimum Essential Fire Safety Measures for All Healthcare Facilities

NABH (National Accreditation Board for Hospitals And Healthcare Providers) has issued an advisory recently on Minimum Essential Fire Safety Measures to be followed by healthcare organizations in the country.

This was the advisory for Minimum Essential Fire Safety Measures applicable to Healthcare Units under all schemes of Certification and Accreditation offered by NABH. These guidelines are meant to ensure patient safety and in no way absolves the organization of fulfilling its statutory obligations with regard to fire safety while implementing Certification, Accreditation Programs in the country.

The Advisory has listed out the scenarios where a Healthcare Organisation has Fire NOC, has No Fire NOC in place. The content of the advisory released by NABH is shared below for information purposes :

Advisory Content :

When the Healthcare Facility has Fire NOC in place, advisory calls for health facilities to check on the compliance to the minimum essential home Act/DHO fire safety measures are in place and or functioning.

Advisory says when the Healthcare facilities don’t have Fire NOC , following steps have to be addressed by a healthcare organisation :

  • Approval/Registration from local health authority Eg: Nursing home Act/DHO
  • If Fire NOC is not applicable, organisation has to provide valid justification for the same.
  • If Fire NOC is applicable, confirm that the organization has applied for fire NOC and there is regular correspondence (at least once in three months) with fire department which is acknowledged. Any correspondence received from the fire department has to be submitted.
  • In the absence of Fire NOC, Third Party Inspection Certificate should be made available.
  • The third-party audit should provide evidence to suggest that statutory norms are adhered to Any Observation by the third party should have been addressed.
  • The third-party inspection certificate is valid for a maximum period of one year
  • Head of the organization/Promoter to give an undertaking on the organization’s letter-head stating that fire safety measures are in place and adhered to at all times.
  • During assessment, verify that the points in the checklist are in place and are functioning

*NABH prescribes that Fire & Life Safety Inspection Certificates under NABCB accreditation issued by NABCB accredited Type ‘A’ Inspection Bodies for Fire & Life Safety Inspections of hospitals/health care providers shall be in accordance with the following:
a. National Building Code of India
b. Model Bill to provide for the maintenance of Fire and Emergency service for the state (2019)
c. Respective State Fire Safety Rules
d. NABH accreditation requirements for fire safety and applicable statutes
e. Any other applicable statutes.

Such Fire & Life Safety Inspection Certificates shall be accepted in lieu of statutory Fire NOC, only for consideration for the purpose of NABH accreditation. This does not absolve the hospitals/health care providers from complying to Fire NOC requirements/any other extent applicable statutes. It shall be sole responsibility of hospitals/health care providers to obtain Fire NOC, as applicable.

NABCB accredited Inspection Bodies shall be required to issue a final Fire & Life Safety Inspection certificate under NABCB accreditation bearing NABCB Accreditation Mark after the inspection is carried out and satisfactory corrective action and resolution of non-conformities, if any.

NABH accreditation requirements for Fire & Life Safety : (in addition to above)

  1. Firefighting equipment like wet riser, hydrants, auto sprinkler, fire alarm system, fire extinguishers of all types and sizes should be available as per table below (adapted from NBC 2016).
  2. Operational and maintenance plan for firefighting equipment including refilling of extinguishers.
  3. Up to date fire drawings to be available. Where applicable, the fire drawings should also specify the location of fire dampers.
  4. Fire detection and smoke detectors exist across all floors. The detectors shall be tested for functionality at regular intervals, and records maintained.
  5. Central fire alarm system is installed at a location which is staffed 24/7.
  6. Fire exit plan for each floor. Exit door should be openable and free from any materials which will obstruct way.
  7. Fire Exit signage on all floors well illuminated/ self-glowing, as per NBC guidelines.
  8. Emergency illumination system in case power goes.
  9. Designated place for assembly of patients and staff in case of fire.
  10. Mock fire drill records and schedule of conduct of drills.

Minimum Requirements for Fire Fighting Installations

Advisory can be downloaded by clicking on the link below.

Source of the Information :
https://nabh.co/Announcement/Revised%20Advisory%20for%20Minimum%20Essential%20Fire%20Safety%20Measures%20-20.09.2022.pdf

Above advisory says that Healthcare organisations need to obtain a Fire and Life Safety Inspection Certificates from Third Parties – Type A accredited Inspection Agencies accredited by NABCB in accordance with NBC 2016 and various other Regulations as mandated under various statutes, Rules, laws of centre , state etc

Hospitals , Healthcare Institutions have to look out for Type A Inspection Bodies (IBs) accredited by NABCB if they don’t have Fire NOC to seek Fire and Life Safety Inspections. Type A IBs have to obtain necessary accreditation scope as per various regulatory requirements, standards in the country. These IBs may have to seek accreditation as per IAF Code 34 ; NACE Code 71 which addresses the Inspection of Buildings activities

At the moment NABCB Accredited IBs with above IAF Scope are not found NABCB Registry. Few IBs may seek Accreditation under above scope to cater to the requirement specified by NABH in future. Healthcare organisations have to refer NABCB’s Registry for more updates on the accredited IBs list.

It’s a good move to encourage healthcare businesses to show compliance and adherence to Regulatory, Statutory requirements by offering Safety and Assurance to the users of healthcare facilities and Employees as well.

Advisory on Medical device Standards

Public Notice on Medical Devices Standards from Department of Pharmaceuticals

Public notice on Medical Devices from Department of Pharmaceuticals on what Standards industry and stakeholders have to follow, refer while dealing with Medical Devices.

Medical Device Sector is brought under 100% Regulation which means that it’s well defined framework , structure and has well established regulatory protocols .

Healthcare Services should understand more about the Supply Chain Quality – understand the Regulations, Standards , Certifications , Testing , Inspection norms that are prescribed for the market players.

Unless the supply chain quality is understood correctly, Service providers delivery can’t have the necessary assurance to users .

Procurement teams, QA teams in healthcare services should know about National, International Conformity Assessment practices, norms for Healthcare Products.

Since Users, Patients, stakeholders etc are always seeing Global Quality Campaigns while introducing, prescribing Products, it’s important to respond to queries on the same when asked.

Source: Public Notice No.31026/83-2021-MD dt. 01.02.2022 issued by Department of Pharmaceutical

Consumers to ensure they purchase Products bearing ISI Mark

Over 450 products under the ambit of mandatory certification

For a number of products, compliance to Indian Standards is made compulsory by the Government of India taking into cognizance various considerations viz. public interest, protection of human, animal or plant health, safety of environment, prevention of unfair trade practices and national security.

As on date, over 450 products are under the ambit of mandatory certification.

Consumers must ensure that they purchase these products bearing ISI Mark.

The key consumer products under mandatory certification include Cement, Electric iron, Electric immersion water heater, Domestic Food Mixer, Switches, Helmets, Domestic Pressure Cookers, Automotive tyres, Tubes, Packaged drinking water, LPG stoves, LPG cylinders, Toys etc. The key consumer electronic products under compulsory certification include Mobile phones, Laptops, TV, Power adapters, Power banks, Digital camera etc.

For these products, the Government makes it mandatory for manufacturers to follow Indian Standards and obtain BIS certification. The Indian Standards formulated by BIS form the basis for Product Certification Schemes, which provide Third Party Assurance of Quality of products to consumers.

BIS implements Quality Control Orders (QCOs) issued by the Government which ensure that the notified products conform to the requirements of the relevant Indian Standard(s).

The information on QCOs issued by the Central Government can be obtained from BIS website (www.bis.gov.in) under the following link Conformity Assessment -> Product Certification -> Products under Compulsory Certification.

After the date of commencement of the QCO, no person can manufacture, import, distribute, sell, hire, lease, store or exhibit for sale any product(s) covered under the QCO without a Standard Mark except under a valid certification from BIS. As the QCOs are equally applicable to Indian manufacturers as well as foreign manufacturers, the Indian consumers are assured of the quality of such products manufactured in India as well as imported to the country.

QCOs are issued by various Line Ministries (Regulators) under the Central Government depending upon the product(s)/ product categories being regulated through the Order, after having stakeholder consultations. Any person who contravenes the provisions of the Order shall be punishable under the provisions of sub-section (3) of section 29 of the BIS Act, 2016 with imprisonment or with fine or with both.

Source: https://pib.gov.in/PressReleasePage.aspx?PRID=1847501
Posted On: 02 AUG 2022 5:57PM by PIB Delhi

MDR 17 – An Interactive Session with Regulators

Industry, Startups & Innovators Support Session with Regulators on Licensing Requirements for Medical Device Manufacturers, Startups & Innovators in Tamilnadu – MDR 17

Session Topic : Ease Of Doing Business – Industry & Startups Support Session on Licensing Requirements – MDR 17

Date : 23rd July 2022 Saturday
Time : 3 pm – 5 pm
Meeting : Online Meeting

Program Objective:
Medical Device Industry in India is brought under full regulatory purview and industry has to show compliance to the Regulatory announcements made to this effect, from time to time.

Operators dealing with Risk Category Class A and B devices come under the purview of State Licensing Authorities and those dealing with Risk Category Class C & D devices come under the purview of Central Licensing Authority.

Medical Device Manufacturers, Innovators, Startups of Tamilnadu have requested for interactive sessions with Central and State Licensing Authorities and other stakeholders like BIS etc to guide them to implement the regulatory requirements better.

AIMED which is the voice for Indian Medical Device Manufacturers in the country and NHHID – Anna University , a National Hub for Healthcare Instrumentation Development, and Bureau of Indian Standards have collectively agreed to organize periodical sessions for the benefit of the industry and startups, innovators of Tamilnadu.

Target Audience

Medical Device Manufacturers, Innovators, Startups in Medical Device, MedTech space, Academia, Technology Business Incubators, Innovation Hubs, Medical Device Testing Laboratories, Healthcare services organisations – Hospitals, Diagnostics Centers , and other healthcare businesses, stakeholders to Conformity Assessment, Government organizations etc from Tamilnadu

Program Details:

Session would be conducted as Online Meeting, an interactive engagement with Manufacturers, Innovators, Startups .

There is NO REGISTRATION FEE. However , prior registration is a must.

For Enquiries about the Program :
Ms Rama Venugopal, Jt Coordinator,
AIMED – South India
jt.coordinator.south@aimedindia.com

Hub Co-ordinator
NHHID Hub, Anna University, Chennai
au.nhhid@gmail.com
For more details about the NHHID, Anna University , pls visit – https://www.nhhid.org

Webinar for Med Tech Startups

Webinar with Medical Technology Start-ups on 26 Oct 2021 – Invitation 

Program Announcement from BIS for Med Tech Startups
Webinar with Medical Technology Start-ups on 26 Oct 2021 – Invitation 

Bureau of Indian Standards (BIS), the National Standards body of India, is formulating Indian Standards in various fields. In the field of medical devices and related aspects, BIS has formulated around 1450 standards under its Medical Equipment and Hospital Planning Division Council(MHDC).

With an objective to impart awareness regarding existing Indian Standards on medical devices among the Medtech Start-ups community as well as to explore the feasibility of formulating standards on the novel medical devices developed/being developed by them, the Medical Equipment and Hospital Planning Department (MHD) of BIS is organizing a Webinar with Medical Technology Start-ups on 26 October 2021 from 1400-1700 hrs.

The details of the link for joining the webinar are as follows:

Date26 Oct 2021 (Tuesday)
Time1400 h to 1700 h
Link to joinhttps://bisindia.webex.com/bisindia/j.php?MTID=mec53359b4f7429c481f7ef5c5ec97ebd
Meeting No.2513 899 2572
PasswordBIS@2021

You are cordially invited to participate in the webinar. There is no registration/participation fee. 

Please click on the link below to register :

Contact :
Medical Equipment & Hospital Planning Department
Bureau of Indian Standards
Manak Bhavan
9, Bahadur Shah Zafar Marg
New Delhi – 110 002
Ph : 011-23230910