Training Program on ISO 15189:2022 Standard

Medical Education and Learning Point (MELAP) is conducting the following Training programs in Chennai

4 days Onsite Training program on IA&QMS as per ISO 15189:2022 standard

Medical Education and Learning Point (MELAP) in collaboration with Dept of Biochemistry – Madras Medical College ( MMC ) is conducting 4 Day IA & QMS / QC training program as per the New version of standard ISO 15189 : 2022. This course is Accredited by NBQP, Division of QCI

Program Details are given below:

Date & Time    : 27th – 30th March  2023  9.30 am to 4.00 pm

Venue              : Madras Medical college – Chennai

Regn Fee         : For Doctors / Senior Resident – Rs.11000 (incl of tax)

                          For Technical staff / PG Students – Rs.9000 (incl of tax)

For Registration/Query : kindly contact

Mr .Anil Saini #7042949292 &9899869683

Ksaini.anil@gmail.com

Ms.Tripti Madan – 9958697309

Onsite 2 day Refresher course as per ISO 15189:2022  Standard for those who have already done 2012 version (Accredited by NBQP, Division of QCI)

Medical Education and Learning Point (MELAP) in collaboration with Department of Regenerative Medicine & Research, Govt Stanley Hospital Chennai is conducting a 2 day refresher course as per ISO 15189:2022  Standard

Program details are given below

Date                :           24th & 25th March2023

Venue             :           Department of Regenerative Medicine & Research, Govt Stanley

Hospital Chennai

Regn fee          :           Rs.6500 (incl of tax)

For Registration/Query : kindly contact

Mr .Anil Saini #7042949292 &9899869683

Ksaini.anil@gmail.com

Ms.Tripti Madan – 9958697309

Seats are limited & available on first come basis only

ISO 15189:2022 FOR MEDICAL LABS PUBLISHED

ISO 15189:2022 – Medical laboratories — Requirements for quality and competence

This document specifies requirements for quality and competence in medical laboratories.

This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.

This document is also applicable to point-of-care testing (POCT).

NOTE : International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This fourth edition cancels and replaces the third edition (ISO 15189:2012), which has been technically revised. It also replaces ISO 22870:2016.

The main changes are as follows:

  • Alignment with ISO/IEC 17025:2017 resulted in the management requirements now appearing at the end of the document;
  • Requirements for point-of-care testing (POCT), previously in ISO 22870, have been incorporated;
  • Increased emphasis on risk management.

Introduction

The objective of this document is to promote the welfare of patients and satisfaction of laboratory users through confidence in the quality and competence of medical laboratories.

This document contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities for improvement. Benefits of this approach include: increasing the effectiveness of the management system, decreasing probability of invalid results, and reducing potential harm to patients, laboratory personnel, the public and the environment.

The requirements for risk management are aligned with the principles of ISO 22367.

The requirements for laboratory safety are aligned with the principles of ISO 15190.

The requirements for sample collection and transport are aligned with ISO 20658.1

This document contains the requirements for point-of-care testing (POCT) and supersedes ISO 22870, which will be withdrawn upon publication of this document.

The format of this document is based on ISO/IEC 17025:2017.

The medical laboratory is essential to patient care; activities are provided within an ethical and governance framework, that recognizes the obligations of healthcare providers to the patient. These activities are undertaken in a timely manner to meet the needs of all patients and the personnel responsible for the care of those patients. Activities include arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, processing of patient samples, selection of examinations that are fit for intended use, examination of samples, sample storage, as well as subsequent interpretation, result reporting and advice to laboratory users. This may also include the provision of results to the patient, arrangements for urgent testing and the notification of critical results.

While this document is intended for use throughout the currently recognized medical laboratory disciplines, it can effectively be applied to other healthcare services, such as diagnostic imaging, respiratory therapy, physiological sciences, blood banks and transfusion services.

The use of this document facilitates cooperation between medical laboratories and other healthcare services, assists in the exchange of information, and in the harmonization of methods and procedures.

The comparability of patient examination results between medical laboratories, regardless of city or country, is facilitated when medical laboratories conform to this document.

When a laboratory seeks accreditation, it should select an accreditation body which operates in accordance with ISO/IEC 17011, and which takes into account the particular requirements of medical laboratories.

Comparisons between this document, ISO 9001:2015 and ISO/IEC 17025:2017 are in Annex B. The comparison of ISO 15189:2012 to ISO 15189:2022 (this document) is in Annex C.

Source : https://www.iso.org/standard/76677.html

Transition Timeline Announcement

ILAC Announcement – 8th

ISO 15189:2022 Medical Laboratories – Requirements for quality and competence has now been published.

Further a resolution was endorsed at the ILAC General Assembly to allow a 3-year implementation period from the date of publication of this revised standard (ie now December 2025) as shown below:

ILAC Resolution GA 26.08

As the revised version of ISO 15189 is scheduled for publication in 2022 or early 2023, the General Assembly endorses the recommendation of the AIC that a transition period of 3 years from the date of publication be adopted. 

Noting that the requirements for Point of Care Testing (POCT) contained in ISO 22870:2016 have been incorporated into the revised ISO 15189, ISO 22870:2016 in conjunction with ISO15189:2012 will still be recognised as a Level 4 standard for POCT for the duration of the transition period

At the end of the transition period, accreditation of a medical laboratory to ISO 15189:2012 and accreditation of POCT to ISO 22870:2016 in conjunction with ISO15189:2012 will not be recognised under the ILAC Arrangement.

The implementation of this transition period for ISO 15189:2022 by the signatories to the ILAC MRA for the accreditation of medical laboratories will be monitored by the ILAC AMC to ensure the deadline is achieved. The process used by the AMC to monitor this implementation of the revised standard will be similar to that used during the implementation of ISO/IEC 17025:2017

Posted on 08th December 2022

Source :https://ilac.org/latest_ilac_news/iso-151892022-for-medical-labs-published/

Transition Timeline Announcement of NABL

NABL has released transition announcement for Accredited Medical Testing Labs in the country

Pathcon & Lab Expo 2022

6th Annual Conference of the Association of Practising Pathologists, India
(PATHCON & Lab Expo 2022)

Pleasure to invite you all to “6th Annual Conference of the Association of Practising Pathologists, India (PATHCON & Lab Expo 2022), which is going to be held virtually on 17th (Saturday) December 2022 &  in Hybrid mode at The Hotel Vivanta by Taj, Dwarka, New Delhi on 18th (Sunday) December 2022. This conference will bring together all of us who have put in a lifetime of effort to bring this association to this landmark event.

Date: 17th (Saturday) December 2022Virtual Mode
Date: 18th (Sunday) December 2022Hybrid Mode

Participants will learn of the rapid development and spread of technical advancement in recent years, the people who made this possible and the necessary equipment, regulations and other requirements for setting up new centres. The scientific program will cover the latest developments in all disciplines of Lab medicine. The emphasis will be on interactive sessions and panel discussions with clinical colleagues to encourage active participation of all delegates. We hope the students and residents will benefit from the experience of their colleagues and teachers and gather encouragement from the pioneers in research. Several well renowned speakers have confirmed their active participation, and this will add to the academic benefits of this conference. Save the dates in your diary today. We look forward to greeting you in what promises to be an exciting and fruitful meeting with a high scientific standard.

Keeping in mind the interest of our young participants, we shall be inviting posters and abstracts for oral presentation from all across the country and details are available on the website.

This year the venue which we have finalised is situated in Dwarka, New Delhi which is well connected all across Delhi & NCR through Delhi metro and other modes of transportation. It is just 3.5 Kms away from the IGI Airport. Delhi has a wide choice of hotel accommodation for different budgets. Kindly make your arrangements for travel and stay well in advance. The weather in Delhi in December is cool and pleasant, though light jackets may be required in the evenings. The organising committee welcomes all delegates to avail the discounted early registration rates and actively participate in this landmark event in the history of our Association.

Delhi is a historical city & always been a centre of power with many monument, multiple cuisine restaurants & it is a shoppers’ paradise and very well connected by road, rail and air to all major cities of India.

Conference Registration Fee mentioned below in Brochure Please check

ABSTRACT SUBMISSION GUIDELINES

> Abstracts for Oral Presentation/Poster Presentation are to be submitted online through the conference website only.
> You need to register yourself on the online portal for submission of the abstract. You can make the registration payment later, but submission of relevant information is must.
> The presenting author MUST be registered for the conference.
> The number of papers to be accommodated are limited. You can indicate your preference during submission (oral/poster). Some abstract requests for Oral presentations will be shifted to the poster section. Case reports, unless carrying a very novel message, will not be considered for oral presentations.
> It is mandatory that the Presenting author is registered for the conference to be eligible for presentation and for awards.
> The cut-off date will be 31 Oct 2022 by 1700 hrs. No abstracts will be considered after this Deadline.
> Abstracts will be listed on the conference website by 10 Nov 2022. The abstract is restricted to a maximum of 300 words. It should include: Objectives, Methods, Results, Conclusions, and Keywords.
> One participant may submit upto 3 abstracts, and only one abstract would be considered for Oral Presentation.

Conference Manager

Mr. Saurabh Sharma
Phone: +91 9871799136
Email: secretariat.pathcon@gmail.com

Conference Secretariat
Tripti : +91 – 9958697309
Dr Neeraj Jain : +91 – 9810492621
Dr Rajan Verma : +91 – 9999138158

IPC National Conference

National conference on Strengthening Medical Product Safety Surveillance

IPC in association with Ruby Hall Clinic, Pune is organizing a national conference on “Strengthening Medical Product Safety Surveillance” on November 12, 2022 at Sheraton Grand Hotel, Bund Garden Road, Pune- 411001

For more Information Please Check Here: https://bit.ly/3fvDobv

Source:https://www.ipc.gov.in/news-highlights/1048-ipc-in-association-with-ruby-hall-clinic,-pune-is-organizing-a-national-conference-on-%E2%80%9Cstrengthening-medical-product-safety-surveillance%E2%80%9D-on-november-12,-2022-at-sheraton-grand-hotel,-bund-garden-road,-pune-411001.html

HTCT Certification Program

HIV Testing and Counselling Training (HTCT) Certification program

The forthcoming session of a 2-day online HIV Testing and Counselling Training (HTCT) Certification program will be on 15th & 16th (Tuesday and Wednesday) November 2022, this virtual program is conducted between 1.00 PM to 5.00 PM on these 2 days.

This HIV test counselling training certification program (HTCT) is meant for the professionals/staff in the Hospitals, Diagnostic Laboratories and Blood Banks which are NABL (ISO 15189: 2012) / NABH accredited or under preparation for accreditation. This certification program provides training as per the NABL-112 document and NACO guidelines, occupational exposure & post-exposure prophylaxis (PEP), legal and ethical issues related to HIV testing.

Please refer to the attached brochure below for more details about the program and please register via online form using the following link:
https://forms.gle/cVan7oYwvgneje8v7 (this online form needs to be filled in after making the payment)

For queries,
please contact via email: HTCTSAVEETHA@gmail.com / mobile: 7448444221.

WAD 2022 Celebrations from CCC

2 Days Conference on Sustainability – World Accreditation Day 2022 Celebrations at Chennai on June 9-10 2022 (Hybrid Session)

About #WAD2022

June 9th 2022 marks World Accreditation Day (#WAD2022), a global initiative established by ILAC and IAF to promote the value of accreditation.

Download the following announcements :

This year’s theme :

Accreditation: Sustainability in Economic Growth and the Environment, focuses on how accreditation supports the United Nations Sustainable Development Goals – (SDGs) 6, 7, 8, 9, 11, 12, 13, 14, 15.

#WAD Celebrations – an annual initiative from Consultants Consortium of Chennai (CCC)

CCC has been organising series of Knowledge Sessions for the benefit of the industry during WAD Month since its inception. WAD 2020 and WAD 2021 were well received by the industry. We had conducted virtual learning sessions during this period.

#WAD2022 Celebrations

WAD 2022, however would be a Hybrid Session. We are planning to organise a physical session in University Auditorium in Chennai with a target audience of around 100 -150 members (offline) and plus online viewers.

The Conference is jointly organized by International Accreditation Service (IAS), USA and Bureau of Indian Standards

International Accreditation Service

IAS is a nonprofit, public-benefit corporation that help organizations demonstrate compliance and competence to their customers, regulators and the public. IAS has been providing accreditation services since 1975. IAS accredits a wide range of companies and organizations including governmental entities, commercial businesses, and professional associations. IAS accreditation programs are based on recognized national and international standards that ensure domestic and/or global acceptance of its accreditations.

IAS also maintains signatory status in a number of global multilateral recognition arrangements under Asia Pacific Accreditation Cooperation (APAC), International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC). IAS is a member of the ICC Family of Solutions.

As one of the leading accreditation bodies in the United States, IAS is a signatory to the three primary international organizations that form a unified system for evaluating and recognizing competent accreditation bodies worldwide.

Bureau of Indian Standards

BIS is the National Standard Body of India established under the BIS Act 2016 for the 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 – providing safe reliable quality goods; minimizing health hazards to consumers; promoting exports and imports substitute; control over proliferation of varieties etc. through standardization, certification and testing

Keeping in view, the interest of consumers as well as the industry, BIS is involved in various activities as given below:

Standards Formulation
Product Certification Scheme
Compulsory Registration Scheme
Foreign Manufacturers Certification Scheme
Hall Marking Scheme
Laboratory Services
Laboratory Recognition Scheme
Sale of Indian Standards
Consumer Affairs Activities
Promotional Activities
Training Services, – National & International level
Information Services

Conference Theme :

Sustainability in Economic Growth and the Environment
-How accreditation supports the United Nations Sustainable Development Goals (SDGs) 6, 7, 8, 9, 11, 12, 13, 14, 15.

Conference Sessions are built for multiple sectors touching upon the Sustainability Initiatives in various sectors and applicability of various Standards, Certifications, Accreditations , Regulations to ensure that Sustainable Products and Services are offered to Consumers.

Sustainability is a Trade Issue and World Markets are linking World Trade to Sustainability initiatives adopted by various countries.

ESG is based on standards set by lawmakers, investors, and ESG reporting organizations (e.g., GRI, TCFD, MSCI), whereas Sustainability Standards — while also set by standards groups like GHG Protocol — are more science-based and standardized.

Dates :
June 9th and 10th 2022 – Thu & Fri
Time – 10 00 am – 5 45 pm IST
Session Mode – Hybrid (Online and Physical)
Venue – Auditorium inside Anna University Campus

Who should attend ?

Sessions would be open to Accreditation Bodies, Certification Agencies, Conformity Assessment Bodies, Inspection bodies, Govt organisations, Members of Trade & Industry Associations, Chambers of Commerce, Entrepreneurial Hubs, MS Consultants, Technical Experts, Startups, Innovators

Sessions at a glance :

Program Agenda
Day 1 – Inaugural Session

Registration Details

Open to all stakeholders in Conformity Assessment.

Industry, ABs, CBs, CABs, Inspection bodies, Consultants, Technical Experts, Industry Associations, Innovators, Start-ups, Entrepreneurial Platforms, Government organisations.

There is NO REGISTRATION FEE

However prior registration is a must for participation.


Contact Co-ordinators

Ms Rama Venugopal, President
Whatsapp +91 9840870532
Email – contact@ccc-consultants.org

Mr D Srikanthan, Secretary
Whatsapp +91 9003056539
Email – secretariat@ccc-consultants.org

Secretariat Office
Phone+044 24462337 / 24462338
Email – communication@cccassociation.org

Announcement

Announcement from NABL on CABs

Sharing the recent announcement from NABL on CABs.

There is a fast track focus at the market place to seek Certifications fast. This trend is more visible at the market place now. Fast tracking , resorting to various acts as listed in the announcement is not a healthy sign for the industry.

Certificates , Certifications are of no use, of no relevance when the users, payers, for the services don’t experience “the showcased Quality of Service”. There is a structure , methodology that needs to be followed while seeking Quality Systems Certifications.

The sudden rush for Certificates must be driving businesses to resort to unhealthy practices is what is understood from the notification !

Sharing this here to as information update for industry to take cognizance of the notification.

NABL Announcement

NABL Announcement for Calibration Laboratories

Guidelines for Interlaboratory Comparison for Calibration Laboratories where Formal PT Programs are not available
Posted on 25.10.2021

NABL has released guidelines for ILC for Calibration Labs where PT Programs are not available.

The guideline is for the Calibration laboratories which are accredited and applicant to NABL. Calibration laboratories shall participate in Proficiency Testing Program of accredited Proficiency Testing Providers. This procedure is be used only as an alternative in the absence of formal Proficiency Testing programs to meet the requirements of NABL 163.

For more information, download the document here :

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

For Clarifications and guidance , reach out to :

A A Srinivasan, Principal Consultant – srinivasanaa@valueaddedin
Mobile – +91 98404 90368

NABL Training Programs

Training Programs from NABLAnnouncement

Training Programs from NABL

Download the Brochure here :

Registration Link :

Laboratory Excellence Award

Prof. S.K. Joshi Laboratory Excellence Award from QCI NBQP

Prof. S.K. Joshi – Laboratory Excellence Award has been instituted to promote Laboratory Quality and performance improvement in the country. The award has been incepted to ensure the laboratory’s commitment to achieve excellence in providing high precision testing and calibration services in line with the prevalent national/international quality systems legislations including Health, Safety, Environment (HSE).

The Award is to recognize Laboratories (Testing, Medical and Calibration) those have established outstanding achievements in the field of Quality in services and benchmarked in their domain for their best practices

Eligibility:

1.This award is open to all currently operational Laboratories pertaining to Testing, Calibration & Medical including their Proficiency Testing Providers & Reference Material Producers located in India.
2.Participating labs are required to operate the applicable Quality System according to the requirements as stipulated in ISO 17025/ISO 15189/ISO 17043/ISO 17034, regarding its implementation and monitoring.
3. The award require labs to operate with proper HSE measures.
4.The Laboratory should not have been convicted by any Court.
5.A Laboratory once awarded can be considered only after a period of 3 Years

The 5 stages of assessment by Technical Expert Committee (TEC) are as follows:-

Stage 1: Application Document Evaluation
Stage 2: Physical/Virtual Presentation
Stage 3: Site Assessment / verification
Stage 4: Evaluation through Reference check of customer in special case
Stage 5: Inputs to Jury for final evaluation

Assessment Criteria

The assessment of the application submitted by the laboratory is made on the basis of various parameters which have been identified by a team of experts from NBQP/QCI.

Primary Parameters:

  1. Management Commitment – Qualification, Experience, Training & Innovation, Quality Improvement and skill upgradation.
  2. Strategy – Accreditation for entire Laboratory activities (to ensure Sustainability).
  3. Processes – Standard Method (National/International), Validation/Verification, Equipment/Techniques used and Measurement Traceability to SI units.
  4. Infrastructure & Quality Control Resources – Facilities and Environmental Conditions (Innovation for enhancing Good Laboratories Practices) owned by Lab. Use of Certified Reference material, Proficiency Testing Program participation and Inter-Laboratory Comparison and other QC checks.
  5. Customer Complaints, Feedback and Improvement – Diagnosis of the problem (Root Cause Analysis & Quality tools deployed)
  6. Key Results/Satisfaction – Reports, Customer Results, Society Results and Employee Satisfaction. Tangible benefits, intangible benefits or socio economic and environmental benefits

Terms & Conditions Of The Award:

1. Non – disclosure and confidentiality
I. The names of the applicants, evaluation and scoring system developed for the assessment process will be regarded as proprietary and kept confidential. Such information shall be made available only to those individuals who will be directly involved in the assessment and administrative process and shall not be disclosed.
II. QCI will not disclose the details about the shortlisted/non-shortlisted laboratories at any stage of the assessment. The qualified laboratories will be notified via e-mail/call by the QCI office directly.
2. Any misinterpretation of facts will disqualify the laboratories from Awards.
3. Applications received with incomplete data will not qualify.
4. Any Award applicant and Awardee cannot use the NBQP and QCI logo in anyway that suggests that QCI is affiliated with, sponsors, approves or endorses you, your organization, your websites, your products or your services etc.

Application Fees

There is no Application Fees

Award Presenatation

The awards will be presented during a special Award Ceremony

Where to Apply ?

Award Details

check here to know more about various awards and details

When is the Last date for applying ?

Last date for submitting the application form is 16th November 2021

For any queries, contact :

Source – https://labexcellenceaward.qcin.org/Home.aspx