Guidance on Auditing Climate Change issues in ISO 9001
Climate change issues are one of many issues that organizations are to consider when analysing their internal and external context and determining requirements from customers and other relevant interested parties.
As part of ISO’s commitment to action on climate change, amendments to over 30 of ISO’s Management System Standards, including ISO 9001, have now been issued to include climate change considerations and the same is published on 23 February 2024.
Key points are given below:
The amendments include the determination of whether climate change is a relevant issue for the organization and the consideration of interested parties’ requirements related to climate change.
Emphasizes the need for auditors to maintain objectivity and neutrality when auditing climate change issues, focusing on assessing how organizations address climate change within their quality management systems
Provides guidance for auditing climate change issues impacting the quality management system and its intended results, outlining specific considerations and examples for auditors to evaluate
Furthermore, the document highlights the importance of addressing issues determined as relevant by the organization within the quality management system.
Presents non-exhaustive examples of questions and related aspects for auditors to assess how organizations are addressing climate change issues, including determining the scope of the quality management system, actions to address risks and opportunities, changes, resources, operations, and performance evaluation and improvement.
Underscores the need for auditors to evaluate if organisations have identified contractually agreed customer requirements or statutory and regulatory requqirements with climate change relevance and whether these are being acted upon.
Awareness programme on Good Clinical Practice Professional Certification Scheme (GCPPCS)
Translational Health Sciences and Technology Institute (THSTI), an autonomous institution under the Department of Biotechnology, Ministry of Science and Technology, Government of India announces the rollout of the Good Clinical Practice Professional Certification Scheme (GCPPCS) awareness webinar series.
Good Clinical Practice Professional Certification Scheme (GCPPCS) is first of its kind based on the International Personnel Certification Standard (ISO 17024:2012). GCPPCS is aimed to achieve an uniform, competence standard using internationally accepted best practice for assessment and certification.
GCPPCS has two aspects – a system of accreditation of Training Institutions to ensure standardised, high-quality GCP training and certification (by Third-Party Certification) to promote certification of GCP professionals both within the country and across the globe.
There is an ever-growing demand for trained and certified Good Clinical Practice (GCP) professionals in the clinical research arena both in academia and in industry. THSTI as the Scheme Owner believes that GCPPCS will help in achieving a benchmark in the competence requirements.
When?
Date : March 21,2024 Time : 3pm to 5 pm IST
Who Should Attend?
All Interested professionals – ethics committee members, clinical researchers or clinical trial team members, investigators involved in clinical research or trial, personnel working in the area of regulatory affairs, pharma, biotech, research institutes, academia, and other personnel working in this area can register for the webinar
The registered participants will receive e-Certificates (Certificate of attendance)
Fee ?
There is NO Fee for attending this webinar
Last Date for Registration is March 20,2024 till 6 pm IST
Biomedical Research Courseby ICMR-National Institute of Epidemiology
The National Medical Commission (NMC) has mandated a uniform research methodology course called ‘Basic Course in Biomedical Research’ in order to improve the research skills of Indian medical postgraduates (PG) and teachers in medical institutions.
The course will be offered in online mode by ICMR-National Institute of Epidemiology (ICMR-NIE), Chennai and will explain the fundamental concepts of research methodology in health. It will be delivered through video lectures and reading materials. The students will be awarded with a certificate based on their evaluation of the lecture wise assignments and a final proctored exam.
The enrollment for the course is open throughout the year. There is no deadline for enrolment into the course or for submission of assignments
The participants can learn on their own pace and schedule. They will be eligible for exam registration once they secure the cut off scores in assignments. The students are required to score at least 50 per cent in every assignment for 23 lectures. The candidates can then register for the proctored exam for the upcoming schedule.
The exam registration link for the next available date will be provided as the participant successfully secures a minimum score of 50 per cent in every assignment for 23 lectures.
To register for examination, the participant will have to fill-up an online form and pay the examination fees of ₹ 1,000 online. The city-wise list of examination centres will be made available at the time of registration.
The next exam date for the course is set for February 25, 2024
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.
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 :-
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 🆓
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).
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
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”.
