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.

Source: https://committee.iso.org/home/tc176/iso-9001-auditing-practices-group.html

Industry Update – Addendum to NABL 112

ISO 15189:2022 is an international standard that specifies the requirements for quality and competence in medical lab environments. It is a standard that requires labs to develop a robust, reliable quality management system (QMS) to establish their competence.

This standard promotes the welfare of patients and satisfaction of laboratory users.

NABL 112 is a Specific Criteria for Accreditation of Medical Laboratories, prepared by a Technical Committee, which is aligned as per ISO 15189: Medical laboratories- Requirements for Quality & Competence

NABl has released the addendum document to NABL 112. Table specifying the applicability of this document to different clauses of ISO 15189:2022 are given below

ISO 15189: 2022 RequirementRefer NABL 112 Issue No. 4 Requirements
5.1 Legal entity
5.2 Laboratory Director
Page No. 10 – Organization and management responsibility
6.7 Service agreements   Agreement with laboratory users Agreement with POCT operatorsPage No. 11 – Service Agreements  
6.8.2 Referral laboratories and consultants
6.8.3 Review and approval of externally provided products and services      
Page No. 11 – 4 Examination by referral laboratories  
5.3.3 Advisory activitiesPage No. 12 – Advisory services
8.4 Control of records   Creation of records Amendment of records Retention of recordsPage No. 13 – Control of records  
8.8 EvaluationsPage No. 14 – Evaluation and audits
6.2 Personnel5.1 Personnel
6.3 Facilities and environmental conditions5.2 Accommodation and environmental conditions
6.4 Equipment
Equipment requirements
Equipment acceptance procedure
Equipment instructions for use
Equipment adverse incident reporting
Equipment records

6.5 Equipment calibration and Metrological traceability

6.5.2 Equipment Calibration  

6.6 Reagents and consumables
Receipt and storage
Acceptance testing
Inventory Management
Instructions for use
Adverse Incident Reporting
5.3 Laboratory equipment, reagents and consumables  
7.2 Pre-examination processes  
Primary Sample collection and handling
Sample transportation
Sample receipt
Pre-examination handling, preparation and storage
5.4 Pre-examination processes  
7.2 Examination processes  
Verification of examination methods
Validation of examination methods
Evaluation of Measurement Uncertainty
Biological reference interval and clinical decision limits Documentation of examination procedures
5.5 Examination processes  
7.3.7 Ensuring the validity of examination results Internal quality Control External quality assessment Comparability of examination results5.6 Ensuring quality of examination results  
7.3 Post examination processes   Reporting of results Post-examination handling of samples5.7 Post examination processes  
7.4.1 Reporting of results
Critical result reports
Special considerations for results
Automated selection, review, release and reporting of results Requirements of reports
Amendments to reported results
5.8 Reporting of results  
7.4.1.2 Result review and release5.9 Release of results
7.6 Control of data and information management  
Authorities and responsibilities for Information management Information Systems management
Downtime plans
Off site management
5.10 Laboratory information management  

Source: https://nabl-india.org/

NABL Document Review Checklist

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’.

Source:https://nabl-india.org/

Conference on Telehealth

SMART Hospitals India Conference 2023 at Medical Fair India, Pragati Maidan, New Delhi

SMART Hospitals India Conference 2023 at Medical Fair India, New Delhi

Conference Theme 2023

Telehealth : Where SMART Technologies connect with healthcare settings for better patient outcomes

Healthcare Service Providers are increasingly adopting multiple digital health initiatives for better patient connect and seamless delivery of patient care. FUTURE SMART Healthcare Establishments focus on providing solutions to meet the rising needs of SMART PATIENTS across the globe.

Smart Hospitals Business Sessions this year are designed to create focused discussions around TELEHEALTH Technologies as listed below

Session 1 – Telehealth Technologies , Solutions for Better Patient Care in Healthcare Settings in India

Session 2 – Delivering Quality Care through Telehealth Quality System Program in Clinical Settings

Session 3 – Health Technology Assessments and Regulatory Requirements of Telehealth Solutions in India

Program Date :

Date: 29th April 2023 – Saturday
Time: 10:00 a.m. – 5:00 p.m.
Venue: Hall 5, Pragati Maidan, New Delhi

For more information on program, registration links, do visit – https://www.medicalfair-india.com/en/Special_Shows/Smart_Hospitals

Prior registration is a must to attend the conference.

For enquiries related to Conference Partnerships, Stall bookings in the Expo, enquiries, 𝗽𝗹𝘀 𝘄𝗿𝗶𝘁𝗲 𝘁𝗼 :

VermaA@md-india.com / +91-124-4544507


For enquiries related to Delegate Registration to the Conference, please write to :

Ms Rama Venugopal
Vice Chairperson – SMART Hospitals Conference
Email – info@smarthospitals.events
WhatsApp – +91 7338992778 / +91 9840870532