NABH – Notification – 3rd Edition of NABH Standard

NOTIFICATION – IMPLEMENTATION PLAN OF 3 rd EDITION OF THE NABH SHCO ACCREDITATION STANDARDS

The 3rd Edition of NABH SHCO Accreditation Standards along with the Guidebook has been released on 31st August 2022

NABH has released notification on Implementation plan of 3rd Edition of the NABH SHCO Accreditation Standard as follows:

• All accredited SHCOs must be in full compliance with third edition by 1st March 2023 and shall submit the documentary compliance for the same by this date.

• All the assessments (Pre, Final, Renewal, Surveillance) shall be based on Third Edition w. e. f. 1st March 2023

• For all the assessments before 1st March, 2023, decision shall be based on Second Edition. However, such SHCOs would require to comply with the Third edition in next six months from the date of accreditation.

• NABH will not accept any application (New as well as Renewal) on Second Edition Standard after 31st December 2022

The whole process of transition will be completed by 1st March, 2023.

source: NABH/Notification/SHCO/3rd Edition/Imp/2022/7379 dt 7.9.22

Frequently Asked Questions ( FAQs) on Medical Device Rules, 2017

CDSCO has released a document on Frequently Asked Questions on Medical Device Rule, 2017

Central Drugs Standard Control Organization (CDSCO) . Directorate General of Health Services, Ministry of Health and Family Welfare, has released a Document on FAQs on Medical Device Rule 2017, to create public awareness about Medical Devices Regulation.

Source : Doc No.: CDSCO/FAQ/MD/01/2018
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadImmunization/FAQmd2018.pdf

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

Social Audit Standards issued by ICAI

Exposure Draft on Compendium of Social Audit Standards issued by ICAI

In order to regulate the profession of Social auditors, the Sustainability Reporting Standards Board of ICAI has developed the draft preface to the social audit standards as specified in the notification dated July 25, 2022 issued by SEBI .

“Securities and Exchange Board of India (Issue of Capital and Disclosure Requirements) (Third Amendment) Regulations, 2022” dated July 25, 2022, has been issued in The Gazette of India regarding formation of Social Stock Exchange . The notification defines Social Stock Exchange as “A separate segment of a recognized stock exchange having nationwide trading terminals permitted to register Not for Profit Organizations and/ or list the securities issued by Not-for-Profit Organizations in accordance with provisions of these regulations.”

As per the above notification, The Institute of Chartered Accountants of India (ICAI) has been entrusted with the responsibility of being Self- Regulatory Organization for regulating the profession of Social auditors

In this regard, Sustainability Reporting Standards Board of ICAI has developed following :

• (i) Draft Preface to the Social Audit Standards
• (ii) Draft Framework for the Social Audit Standards
• (iii) Draft Social Audit Standards (SAS) on all the sixteen thematic areas specified in the above mentioned notification.

The downloadable version of the Exposure Draft is available at: https://resource.cdn.icai.org/71191srsb57193.pdf
Comments on this exposure draft are sought by ICAI latest by August 26, 2022

  1. Electronically Click on https://forms.gle/eFUnUZcXFzJzyCRC7 to submit comment online (Preferred method)
  2. Email: Comments can be sent to: sustainability2022@icai.in

Source: https://www.icai.org/post/srsb-ed-compendium-of-social-audit-standards-for-comments

Notification from NABH – Launching New portal for 5th edition Hospital Accreditation Standards

NABH has released Notification on May 30,2022 on launching its new portal for 5th edition Hospital Accreditation Standards w.e.f. 01.06.2022

The new portal is designed in a manner to ensure objectivity, transparency, seamless functioning and a faster turn-around time. It also incorporates use of mobile applications to ensure real-time assessment process supported by objective evidence.

All the NEW APPLICANTS under the hospital accreditation programme are requested to register on the new portal w.e.f. 01-06-2022 via the link https://hcoaccreditation.nabh.co

The new portal is to be used only for the hospital accreditation programme, the other accreditation programs will continue to run on the existing portal.

WAD 2022 Event Update from CCC

World Accreditation Day Conference – Post Event Update

World Accreditation Day Conference 2022 – Post Event Update

WAD 2022 Conference jointly organised by International Accreditation Services (IAS), USA; Bureau of Indian Standards and Consultants Consortium of Chennai ended on June 10th 2022 with a positive a note.

Two days conference held on June 9th and 10th had eminent speakers from India and abroad , from various sectors , sharing rich insights about Standards, Certifications, Accreditations, Inspections & Regulations related to Sustainability and Environment across the globe.

Two days of intense learning sessions came to an end on June 10th.

Conference had 324 delegates registering for multiple sessions across two days and the feedback received from them is very encouraging.

The conference is supported by many Trade and Industry Platforms as listed below :

Sharing few pictures of the event for reference :

Session Videos are shared here for industry and stakeholders benefit. Please check the links below

INAUGURAL SESSION :
Theme – Sustainability in Economic Growth and the Environment

TECHNICAL SESSION 1:
Theme – Sustainable Standards for a Safer World

TECHNICAL SESSION 2 :
Theme – ESG Rating for Sustainability Initiatives

TECHNICAL SESSION 3 :
Theme – Sustainability Initiatives in Food Sector

TECHNICAL SESSION 4 :
Theme – Sustainable Healthcare Initiatives

TECHNICAL SESSION 5 :
Theme – Incorporating Sustainability in Educational Institutions

Laboratory Director Designation – ISO 15189 Standard Requirement

Designation of Lab Director, a QMS Specification, becoming a HR Issue in the Laboratory

Chithambaranathan Sivasubramonian, Associate Consultant

nathan@valueadded.in

Medical Laboratories & the need to create a dedicated Laboratory Director Post / Designation to satisfy QMS requirement

Isn’t this becoming a HR issue

A Laboratory Professional from a client organization reached out to us seeking clarification on Lab Director’s role in Accreditation process. She was asked by the Management to redesignate Lab Director as Lab head in Accreditation documents and she wanted to know if its ok to do so as Accreditation norm is asking for Lab Director designation.

This has triggered an internal discussion at office and we were debating about the need to create / insist on Lab Director’s designation / role in labs seeking accreditation.

Medical Labs were obtaining National / International Certifications, Accreditations all these years and each program has its own spec. However, the global trend in the last few years has shifted towards introducing Minimum Standards for Medical Labs and many countries have rolled out the program. India too has rolled out the Minimum Stds for Labs as Regulatory spec under Clinical Establishments (Registration and Regulation) Act, 2010.

Let’s take the case of a Lab appointing a Lab Director as an accreditation norm and see what is listed out by various National , International Stds for this requirement.

We have the following popular programs for Medical Labs running in our country :

  • Minimum Standards mandated under CEA. Both NABL, QAI offer Certification programs under this scheme in the country.
  • ISO 9001:2015 – Quality Management Systems Certification Program
  • Med Labs Certification Programs offered by NABH
  • Med Labs Accreditation Programs offered by NABL, CAP and QAI

Minimum Standards has mandated the Minimum qualification of Technical Head of Laboratory or Specialist or Authorized Signatories. Clearly defined spec on who should act as Technical head is mentioned. So any Certification program offered by NABL, QAI or any other body has to have the same spec in their Certification, Accreditation criteria as compliance to Minimum Standards is a Regulatory requirement.

ISO 9001:2015 Standard Clause 7 Support talks in general about Personnel competency, training needs etc. No other specification is listed as it’s a generic QMS Standard applicable for all businesses.

NABH Essential Standards for Medical Laboratories program talks about Personnel and its clearly mentioned about the Responsibility of Quality Manager & Technical Manager. But with respect to overall responsibility of the Laboratory Head, NABH Essential Standard for Medical Laboratories hasn’t mentioned anything much. So overall responsibility of Lab Head s not clear enough under this program.   

QAI’s Recognition for Medical Laboratory Program, in Human Resources section – MBBS Doctor or MSc Pathology/Medical Microbiology/Medical Biochemistry are recognized qualification for Authorized Signatory. But there is no evidence of defining the overall responsibility of the laboratory head and the same isn’t clear in the QAI Recognition of Medical Laboratory Program either.      

NABL’s Med Lab Accreditation Program mentions that Laboratory Director/ Head of Laboratory/ Technical Head (howsoever named), shall have the overall responsibility of Operations of the laboratory. Hence Lab Director’s Designation / Role is not mandatory. This is thee specific criteria document on NABL which is NABL 112. But the Standard for this program is ISO 15189:2012 which talks about the need to designate Laboratory Director.

CAP’s Laboratory Accreditation Program has a mandatory specification for Lab Director’s Designation and Role.

When 80-90% of the Labs in the country belong to Small labs category, can all qualify for Certifications, Accreditations. An ideal case is for Small labs to opt for Minimum Standards as 1st step towards the Quality journey before migrating to Certifications, Accreditations Programs. Compliance to Min Stds is also mandatory as it’s a Regulatory requirement.

My Thoughts as a Lab QMS Consultant :

I’m going back to the question asked by the Lab Professional whether its mandatory to have Lab Director Role and Designation in the Accredited Lab.

As a Consultant in healthcare industry, I would say it’s a debatable topic. The requirement depends on the National, International Standards followed by the Med Labs.

I have listed out the personnel spec given by each Standard for Med Labs. Lab Director’s Designation is a hierarchy in the organogram and can’t be maintained by all Labs. Labs can specify their own designations as listed in the NABL 112 Criteria OR criteria.