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Date: 09-Sep-2024 Category: Extra Ordinary State: Union Government Country: India

In pursuance of Sub rule 1 of Rule 15 of the Bureau of Indian Standards Rules, 2018, the Bureau of Indian Standards hereby notifies that Indian standards

Issued by Bureau of Indian Standards · Not Applicable

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Executive Summary & Key Takeaways

Gazette Notification Description

  • This gazette notification from the Bureau of Indian Standards (BIS) announces the establishment of a new Indian Standard (IS/ISO/IEC TS 17021-15:2023). This standard pertains to conformity assessment, specifically outlining requirements for bodies providing audit and certification of management systems, focusing on quality management systems in healthcare organizations.

Key Changes

  • A new Indian Standard, IS/ISO/IEC TS 17021-15:2023, concerning conformity assessment and auditing/certification of management systems in healthcare organizations, was established on August 31, 2024.
  • No existing standards were withdrawn as a result of this notification.
  • The standard specifies competence requirements for auditing and certification of management systems for quality in healthcare organizations.

Impact Analysis

Impact on Healthcare Organizations

  • Compliance with this standard could enhance the credibility and quality of healthcare services provided.

Impact on Certification Bodies

  • The standard provides a framework for consistent and reliable certification of healthcare quality management systems.

Impact on Government and Regulatory Bodies

  • Enforcement of this standard may require inspection and monitoring activities.

Suggested Action Items

  • Government agencies should develop enforcement strategies for the new standard.

Key Entities Referenced

Bureau of Indian Standards (BIS): The issuing authority of the gazette notification. Responsible for developing and implementing Indian standards. Bureau of Indian Standards Rules, 2018: The legal framework under which the notification was issued. Rule 15, sub-rule (1) specifically governs the establishment and withdrawal of Indian Standards. IS/ISO/IEC TS 17021-15:2023: The newly established Indian Standard concerning conformity assessment and auditing/certification of management systems in healthcare organizations. Department of Consumer Affairs: The department under which the BIS operates.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 xxxGIDHxxx सी.जी.-डी.एल.-अ.-09092024-257013 xxxGIDExxx CG-DL-E-09092024-257013 असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 702] नई दिल्ली, सोम ार, जसतम्ब र 9, 2024/भाद्र 18 1946 No. 702] NEW DELHI, MONDAY, SEPTEMBER 9, 2024/BHADRA 18, 1946 भारतीय मानक ब्य रू ो (उपभोक्त ा मामल ेज भाग) अजधसचू ना नई दिल्ली, 3 जसतम्बर, 2024 सिं भ:भ HQ-PUB013/1/2020-PUB-BIS (1022).—भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के उपजनयम (1) के अनुसरण में भारतीय मानक ब्यूरो एति्द्वारा अजधसूजचत करता ह ै की जिन भारतीय मानकों के ज रण इसमें संलग्न अनूसूची के जद्वतीय स्ट्तंभ में दिये गये ह,ैं तीसरे स्ट्तभं में इंजगत जतजि को स्ट्िाजपत हो गये ह|ैं चौिे स्ट्तंभ में दिय े गय े मानकों के ज रण, यदि कोई हो तो े भी साि-साि लाग ू रहगें े िब तक े पााँच ें स्ट्तंभ में इंजगत जतजि को ापस जलए िाने ह|ैं अनसु चू ी क्रम स्ट्िाजपत भारतीय मानकों की सख्ं या, प्रजतस्ट्िापन जतजि भारतीय मानकों, यदि ापस जलए ापस होन ेकी स.ं जतजि र् भतिा िीर्कभ िान ेह,ैं की सख्ं या, र् भतिा िीर्कभ (1) (2) (3) (4) (5) 1 आई एस/आई एस ओ/आई ई सी टी 31 अगस्ट्त 2024 लाग ू नहीं लाग ू नहीं एस 17021-15 : 2023 5771 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] अनुरूपता जनधारभ ण — प्रबंधन प्रणाजलयों के ऑजडट ए ं प्रमाणन उपलब्ध करान े हते ु जनकायों के जलए अपेक्षाएाँ भाग 15 स्ट् ास्ट््य से ा संगठनों में गुण त्ता के जलए प्रबंधन प्रणाली के ऑजडटटंग ए ं प्रमाणन हते ु सक्षम अपेक्षाए ाँ पी. रािेि, ैज्ञाजनक िी ए ं उप महाजनिेिक (आई टी एस, पी आर टी ए ं टी एन एम) [ज ज्ञापन-III/4/असा./475/2024-25] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 3rd September, 2024 Ref: HQ-PUB013/1/2020-PUB-BIS (1022).—In pursuance of Sub-rule (1) of Rule (15) of the Bureau of Indian Standards Rules, 2018, the Bureau of Indian Standards hereby notifies that Indian standards, particulars of which are given in the second column of the schedule hereto annexed have been established on the date indicated against it in third column. The particulars of the standards, if any which are given in the fourth column shall also remain in force concurrently till they are withdrawn on the date indicated against them in the fifth column. SCHEDULE Sl No., Year & Title of the Indian Date of No. , Year & Title of the Date of No. Standards Established Establishment Indian Standards to be Withdrawal Withdrawn, if any (1) (2) (3) (4) (5) IS/ISO/IEC TS 17021-15 : 2023 31 August 2024 Conformity Assessment — NA NA Requirements for Bodies Providing Audit and Certification of Management 1 Systems Part 15 Competence Requirements for Auditing and Certification of Management Systems for Quality in Healthcare Organizations P. RAJESH, Scientist G & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./475/2024-25] Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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