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NABL NEWSLETTER

June 2020

Contents
Chief Executive Officer’s Message ................................................................................................................... 2
Extension in Validity of Accreditation .............................................................................................................. 4
Information from Quality Desk ......................................................................................................................... 5
Information from Government / Regulators .................................................................................................... 11
Opportunities for NABL Accredited Laboratories .......................................................................................... 12
Article: TEC Designation of NABL Accredited CABs ................................................................................... 20
Fresh Accredited Laboratories ......................................................................................................................... 22
Accreditation Granted to Calibration Laboratories ...................................................................................... 22
Accreditation Granted to Medical Testing Laboratories .............................................................................. 23
Accreditation Granted to Proficiency Testing Providers ............................................................................. 25
One-time revocation of adverse decisions ....................................................................................................... 26
NABL Response to COVID-19 ....................................................................................................................... 27
NABL 4th PTP/RMP Conclave ........................................................................................................................ 28
E-Learning July 2020 ....................................................................................................................................... 29
World Accreditation Day 2020 ........................................................................................................................ 31
Important Communications - Reprint .............................................................................................................. 34

NABL NEWSLETTER 1|Page


Chief Executive Officer’s Message

Dear NABL Patrons,


Hope all are keeping safe and are able to operate with the recommended practices of health safety.
I am happy to inform that NABL has granted accreditation to more than 300 private medical testing
laboratories for RTPCR RNA virus testing. We have also granted accreditation to about 15 labs for PPE and
all in short span of time. I take this opportunity to thank all NABL staff, NABL assessors, accreditation
committee members and labs for the support and cooperation given during this process.
We are trying to extend full support to all the CABs in every possible ways and means in view of
COVID-19 pandemic and business impact of CABs. We have granted extension to all accredited CABs for a
period of one year. We have allowed the laboratories for extending the use of their existing reference materials
and / or reference standards up to a maximum period of 6 months. We are also giving a one-time revocation
from the adverse decisions (suspension, withdrawn or debar) taken.
Further, to reduce the size of the assessment team in the assessment, we are planning to benefit labs who are
successfully participating in the PT programs conducted by NABL accredited PT providers. To that effect, we
have revised the policy for PT participation and aligned it with accreditation cycle (2 years). We are planning
to take the PT results directly from the PT providers to pass on the benefits. The document
NABL-163 is revised and placed for stakeholder comments. Needless to mention that strengthening the PT
participation of the laboratories will build the confidence in the entire system.
All testing and calibration laboratories are requested to complete their transition of ISO/IEC 17025 standard
from 2005 version to 2017 version positively before the deadline of March 2021.
As the nation realizes the importance of NABL accreditation and the role of accredited laboratories in ensuring
the safety of citizens, I urge all our laboratories to provide the best of their capability in service to the nation.

N. Venkateswaran

NABL NEWSLETTER 2|Page


NABL NEWSLETTER 3|Page
Extension in Validity of Accreditation
1) Extension in validity of accreditation is given to all accredited CABs. (Testing Laboratories,
Calibration Laboratories, Medical Laboratories, PTPs and RMPs).

2) No separate / Individual letter is being issued to any of the CABs in this regard.

3) Documents w.r.t. NABL 218, additional internal audit, document, control charts / trends, etc are to
be provided along with annual accreditation Fees, as per accreditation cycle.

Example:

Accreditation Cycle Extended Up to Action to be taken


15.01.2018 14.01.2020 14.01.2021 The documents as stated above are due to be provided by
14.01.2020 / 14.04.2020 / 14.02.2020.
15.04.2018 14.04.2020 14.04.2021 Since there is a time lapse, the documents can be provided
in July 2020.
15.02.2019 14.02.2021 14.02.2022 If assessment is completed then no action is warranted.
The documents as stated above are to be provided by
15.06.2020 14.06.2022 14.06.2023
14.06.2021 and accreditation cycle to be followed.
The documents as stated above are to be provided by
15.07.2018 14.07.2020 14.07.2021
14.07.2020 and accreditation cycle to be followed.

4) The CABs which have already submitted reassessment application or desktop surveillance
documents can opt to undergo renewal assessment or desktop surveillance

Transition assessment for Testing and Calibration laboratories

Example:

Accreditation Cycle Extended Up to Action to be taken


Transition assessment to be conducted on or
15.01.2018 14.01.2020 14.01.2021
before 14.01.2021
Transition assessment to be conducted on or
15.02.2019 14.02.2021 14.02.2022
before 14.02.2021
Transition assessment to be conducted on or
15.06.2020 14.06.2022 14.06.2023
before 31.03.2021
Transition assessment to be conducted on or
15.07.2018 14.07.2020 14.07.2021
before 31.03.2021
Transition assessment to be conducted on or
15.04.2018 14.04.2020 14.04.2021
before 31.03.2021

Note: Any CAB may take up transition assessment at any point of time before the accreditation cycle as an
additional visit.

NABL NEWSLETTER 4|Page


Information from Quality Desk

Extension in Transition of Laboratories from ISO/IEC 17025: 2005 to ISO/IEC 17025: 2017

NABL had adopted ILAC recommendation to give accredited testing and calibration laboratories a
3-year transition period for conversion from ISO/IEC 17025:2005 to ISO/IEC 17025:2017 i.e. till 29th
November 2020. However, the transition period has been extended from 30 November 2020 to 1 June
2021 by ILAC.

This extension has been granted to ensure all accreditation bodies and the accredited laboratories are
able to achieve the remaining transitions in a robust manner under the restrictions imposed as a result of
the global coronavirus disease 2019 (COVID-19) outbreak.

All laboratories accredited in accordance with ISO/IEC 17025: 2005 are required to undergo transition to
ISO/IEC 17025: 2017 by any one of the following options:

a) Taking an onsite assessment (one man-day) as per their existing cycle and before 31 March 2021.

b) Laboratory may opt to convert their desktop surveillance to on-site surveillance to undergo
transition to ISO/IEC 17025: 2017.

Note: Assessments will not be conducted as per ISO/IEC 17025: 2005.

NABL NEWSLETTER 5|Page


Information from Quality Desk

Process Improvement - Use of Reference materials / Reference Standards during accreditation


validity period

It is understood that labs are facing difficulties in procuring CRMs, calibrating their master (Reference
standards), etc. The point was deliberated and decided to allow the labs for extending the use of their
existing reference materials and / or reference standards up to a maximum period of 6 months.

This will be permitted subject to the following documentary evidence:


1) Other QC checks (such as retesting, replicate testing, etc.)
2) ILC report (PT / ILC report).
3) Validation data
4) Valid justification for extending the use of existing reference materials and / or reference standards
(Masters).

The results of the use of Master / reference standard / materials in the extended period to be reviewed for
validity, once these are procured / calibrated with higher order / NMI level.

Laboratories are required to submit their request to the respective fields email id as given below.
Testing laboratories to send to testing@nabl.qcin.org
Calibration laboratories to send to calibration@nabl.qcin.org
Medical laboratories to send to medical@nabl.qcin.org

NABL will review the request and allow / deny the laboratory to use Master / reference standard / materials
in the extended period.

This is applicable up to 31.12.2020 or till situation of lockdown improves.

NABL NEWSLETTER 6|Page


Information from Quality Desk

Use of NABL Accredited CAB combined ILC MRA Mark

Clarification regarding permission from NABL to use NABL Accredited CAB Combined ILAC MRA
Mark
If any NABL accredited CAB wishes to use the NABL Accredited CAB Combined ILAC MRA Mark, they
shall need to fill in the Appendix ‘A’- Agreement for use of NABL Accredited CAB Combined ILAC MRA
Mark and submit it to NABL.
The NABL accredited CAB shall use the NABL Accredited CAB Combined ILAC MRA Mark only after
getting written permission from NABL.
The permission granted from NABL to accredited CAB for use of NABL Accredited CAB Combined ILAC
MRA Mark is valid only up to the date of validity mentioned in the accreditation certificate and agreement.
In case of renewal of accreditation, CAB is required to seek fresh permission for use of NABL Accredited
CAB Combined ILAC MRA Mark in the renewed accreditation cycle even though there may be no break in
continuity of accreditation between two accreditation cycles.
(for eg. a CAB whose accreditation cycle was 03.06.2018-02.06.2020, got renewed without break in
continuity of accreditation from previous cycle to the next. For the new cycle i.e. 03.06.2020- 02.06.2022
CAB is required to seek fresh permission from NABL for use of NABL Accredited CAB Combined ILAC
MRA Mark.
NABL shall only grant permission to use ‘NABL Accredited CAB Combined ILAC MRA Mark’ to NABL
accredited CABs established in economies where the ILAC MRA Mark is registered, or where an
application for registration has been lodged and registration is pending.
NABL shall not permit the use of NABL Accredited CAB Combined ILAC MRA Mark to the CAB, if there
is any on-going complaint against that particular CAB.
The NABL Accredited CAB Combined ILAC MRA Mark shall be reproduced only as per the copy of the
image provided by NABL.
The NABL Accredited CAB Combined ILAC MRA Mark is for use only in reports / certificates issued by
the accredited CAB during the accredited period. It shall not be used in any other way by the accredited
CAB.
The accredited CAB can issue report / certificate with
NABL Accredited CAB Combined ILAC MRA mark only
for the accredited scope.
The ILAC MRA Mark shall be positioned at the left side
of the NABL symbol, but shall appear in close proximity
to each other.

NABL NEWSLETTER 7|Page


Information from Quality Desk

Permission for use of NABL Accredited CAB combined ILC MRA Mark

The agreement to use NABL accredited CAB combined ILAC MRA Mark is to be submitted afresh for each
accreditation cycle after renewal of accreditation to seek permission to use the mark.

Also, in case of discontinuity in between the accreditation cycle for any adverse action, the agreement is no
longer valid and CAB has to seek fresh permission to use the mark.

The permission to use NABL Accredited CAB combined ILAC MRA Mark is not applicable during the
period when validity of accreditation has been extended.

Existing Permission is valid till the date of accreditation validity mentioned in the accreditation certificate
only.

NABL NEWSLETTER 8|Page


Information from Quality Desk

Recent Changes in NABL Documents

NABL has revised/amended the following documents and these can be downloaded from the publication
section of the website and also by using the following link
http://13.127.105.244/nabl/index.php?c=publicaccredationdoc&m=index&docType=both&Itemid=199

S.No. Doc. No. Document Name


1 NABL 100 General Information Brochure

2 NABL 131 Terms & Conditions for Obtaining and Maintaining NABL accreditation

3 NABL 136 Specific Criteria for Accreditation of Quality Assurance Agencies for Diagnostic
Radiology X-Ray Equipment

4 NABL 151 Application Form for Testing Laboratories

5 NABL 152 Application Form for Calibration Laboratories

6 NABL 216 Procedures for Dealing with Adverse decisions

7 NABL 218 Desktop Surveillance

8 NABL 222 Assessment Forms and Checklist (Medical Imaging – Conformity Assessment
Bodies)

The following document is withdrawn and the policies are included in the above revised documents:

S.No. Doc. No. Document Name


1 NABL 165 NABL's Policies for Accreditation as per ISO/IEC 17025:2017

NABL NEWSLETTER 9|Page


Information from Quality Desk
Comments invited for document revision

NABL 163: ‘Policy for participation in Proficiency testing activities’ has been revised.

Comments from interested parties are invited in the following format:

TEMPLATE FOR COMMENTS

Document NABL 163: Policy for Participation in Proficiency Testing Activities (Draft)
Name and Reference Type of Existing Text Proposed Text Comments / Remarks by NABL
details Clause No. / comment* Justification for
(Person and Page No. (G,TE,ED) change
Organization)

*G: General, TE: Technical, ED: Editorial

Kindly address your comments (on or before 29.07.2020) to anita@nabl.qcin.org / mallika@nabl.qcin.org

NABL NEWSLETTER 10 | P a g e
Information from Government / Regulators
The BEE Standards & Labeling Program for Positive displacement air compressors is an upcoming
program.

Laboratories having accreditation for similar product and tests may explore this opportunity to serve the
industry by enhancing their current scope of accreditation.

The standard to be followed is:


IS/ISO 1217:2009 with all amendments, Displacement Compressors: Acceptance Tests
IS 5456 Testing of positive displacement type air compressor and exhausters – code of practice
IS 10431 Measurement of air flow of compressors and exhausters by nozzles.
Laboratories are encouraged to take up this testing activity in the interest of the industry and contribute in
enhancing the quality infrastructure of the nation.

Important testing parameters are:


• Full load operating pressure
• Rated volume flow rate at full load operating pressure
• Total package input power at rated capacity and full load operating pressure
• Specific power consumption at rated capacity and full load operating pressure
• Isentropic efficiency at rated capacity and full load operating pressure

NABL NEWSLETTER 11 | P a g e
Opportunities for NABL Accredited Laboratories
Business Opportunity for Laboratories which are capable of testing medical textiles as per Indian Standard

IS 17334 Medical Textiles: Surgical Gowns and Surgical Drapes - specifications

Laboratories having accreditation for similar product and tests may explore this opportunity to serve the
industry by enhancing their current scope of accreditation.

NABL NEWSLETTER 12 | P a g e
Opportunities for NABL Accredited Laboratories

Business Opportunity for Laboratories accredited for Safety testing facility under Electrical testing
discipline.
Laboratories with existing and minor addition of resources can be capable and competent for the additional
scope of testing of essential performance and safety parameters of critical care ventilators.

The standard to be followed is


IS/ISO 80601-2-12: Medical electrical equipment - Particular requirements for basic safety and essential
performance of critical care ventilators

Laboratories may like to take up this testing activity in the interest of the nation under the current situation
created by COVID-19 pandemic.

Freedigitalphoto.net

NABL NEWSLETTER 13 | P a g e
Opportunities for NABL Accredited Laboratories

Quality Control Order on Steel and Steel Products

Technical Regulations are being brought out in a phased manner by various ministries to improve the quality
of products being placed in the domestic market. Essential requirements in testing of Chemicals, textiles,
electronic products, medical devices etc. will be mandated.
Quality Control Order (QCO) on various Steel and Steel products.
Laboratories having accreditation for similar product and tests may explore this opportunity to serve the
industry by enhancing their current scope of accreditation.

NABL NEWSLETTER 14 | P a g e
Opportunities for NABL Accredited Laboratories

Quality Control Order on Domestic Pressure cooker – Amendment Order

Quality Control Order (QCO) on Domestic Pressure cooker in accordance with IS 2347: 2017
Laboratories having accreditation for similar product and tests may explore this opportunity to serve the
industry by enhancing their current scope of accreditation.

NABL NEWSLETTER 15 | P a g e
Opportunities for NABL Accredited Laboratories

Quality Control Order on Safety Glass – Amendment Order

Quality Control Order (QCO) on Safety Glass in accordance with IS 2553 (Part 1 and Part 2)
Laboratories having accreditation for similar product and tests may explore this opportunity to serve the
industry by enhancing their current scope of accreditation

NABL NEWSLETTER 16 | P a g e
Opportunities for NABL Accredited Laboratories

Quality Control Order on Flat Transparent Sheet Glass – Amendment Order

Quality Control Order (QCO) on Flat transparent sheet Glass in accordance with IS 2835
Laboratories having accreditation for similar product and tests may explore this opportunity to serve the
industry by enhancing their current scope of accreditation.

NABL NEWSLETTER 17 | P a g e
Opportunities for NABL Accredited Laboratories
Notification on addition of product categories (Phase IV)
MEITY has notified on addition of product categories to
the schedule of the ‘Electronics and Information
technology goods (Requirements for Compulsory registration) order, 2012
Laboratories having accreditation for similar product and tests may explore this opportunity to serve the
industry by enhancing their current scope of accreditation.

NABL NEWSLETTER 18 | P a g e
Opportunities for NABL Accredited Laboratories

Business Opportunity for laboratories which are capable of testing Rubber and rubber products

Standard
IS 9168: 2018 Automotive Vehicles – All rubber flaps for pneumatic tyres - specification

NABL NEWSLETTER 19 | P a g e
Article: TEC Designation of NABL Accredited CABs
Telecommunication Engineering Center (TEC) is a technical body functioning under Department of
Telecommunications (DoT), Ministry of Communications and IT, Government of India.
TEC has been appointed as the Designating Authority (DA) on behalf of DoT for telecom equipment.
As Designating authority (DA), TEC designates Conformity Assessment Bodies (CABs) / Certification
Bodies (CBs) to perform testing and certification of telecom products.
Laboratories located and legally identifiable in India can apply for TEC designation once they are accredited
by NABL.
One critical aspect for laboratories applying for TEC designation is the scope of accreditation.
It is important the laboratory update their scope of accreditation with the proper Technical specification
numbers such as TEC GR/IR/ER/Standards and International specifications with the correct clause number,
amendment number, amendment year in the application.
Also, laboratories need to maintain the proper range of testing during application.
Laboratories should inform NABL in regard to any changes in the scope of accreditation.

IEC: 60950 / IEC60950-1 05 IEC 60950-1: 2005+A1: 2009+A2: 2013


TEC/SD/DD/EM-10-16; TEC/GR/SAR-09 TEC/SD/DD/EM/C-221/05/OCT-16

The list of NABL accredited laboratories designated by TEC can be found on TEC website at
https://www.tec.gov.in/list-of-cabs-designated-by-india/

Laboratories capable of testing the following products can look forward to enhance their scope for TEC
designation:
• PABX Networks

• EMC/EMI testing on telecom equipment

• Specific absorption rate (SAR) testing on Mobiles

NABL NEWSLETTER 20 | P a g e
• Safety testing of equipment as per IEC 60950

• Environmental testing of telecom equipment

• Radio conformance testing in frequency bands

• Point of Sales (POS) testing

• Modem, Fax machine testing

• Information technology equipment safety testing

• Safety testing of Batteries

NABL NEWSLETTER 21 | P a g e
Fresh Accredited Laboratories

Accreditation Granted to Calibration Laboratories

II. CALIBRATION LABS ACCREDITED IN THE MONTH OF JUNE 2020


S.No. Name of the laboratory Discipline Certificate No.
1 Mechatronics Calibration Services FF, M, T CC-3133
2 Anandha Jothi Industries ET CC-3134

ET-Electro-Technical; M-Mechanical; FF – Fluid Flow; T-Thermal;

NABL NEWSLETTER 22 | P a g e
Accreditation Granted to Medical Testing Laboratories

III. MEDICAL LABS ACCREDITED IN THE MONTH OF JUNE 2020


S.No. Name of the Laboratory Discipline Certificate
No.
1 Jupiter Life Line Hospitals Limited Molecular Testing MC-3407
2 Clinicare Speciality Laboratory Pvt. Ltd. Molecular Testing MC-3408
3 Mvr Cancer Centre And Research Institute Molecular Testing MC-3409
Laboratory Services
4 Nm Medical - A Unit Of Rahu Health & Medical Molecular Testing MC-3410
Tourism Pvt Ltd.
5 Care N Cure Laboratories And Invitro Allergy Clinical MC-3411
Testing Biochemistry,Haematology
6 Hakeem Abdul Hameed Centenary Hospital Molecular Testing MC-3412
Laboratory & Himsr, Jamia Hamdard Campus
7 Balaji Medical Centre Molecular Testing MC-3413
8 Lepra Society-Blue Peter Public Health And Molecular Testing MC-3414
Research Center
9 Central Pathology Laboratory-Virology, People's Molecular Testing MC-3415
Hospital
10 Mediclu Diagnostics & Speciality Centre(A Unit Of Molecular Testing MC-3416
Vijayalakshmi Diagnostics Private Limited)
11 Department Of Microbiology - Molecular Lab, Molecular Testing MC-3417
Velammal Medical College Hospital And Research
Institute (Unit Of Velammal Educational Trust)
12 Department Of Lab Services, Balco Medical Centre Molecular Testing MC-3418
(Vedanta Medical Research Foundation)
13 Meenakshi Medical College Hospital And Research Molecular Testing MC-3419
Institute
14 Manipal School Of Life Sciences Cytogenetics,Flow MC-3420
Cytometry,Molecular
Testing
15 Aarthi Scans And Labs (A Unit Of Aarthi Scans Molecular Testing MC-3421
Private Limited)
16 Primegen Healthcare Laboratories Private Limited Molecular Testing MC-3422
17 Suriyaa Diagnostics Molecular Testing MC-3423
18 Laboratory Services, Sri Ramakrishna Hospital(A Molecular Testing MC-3424
Unit Of Snr Sons Charitable Trust)
19 Department Of Laboratory Medicine, Avitis Super Molecular Testing MC-3425
Specialty Hospitals Private Limited
20 Department Of Microbiology, Jubilee Mission Molecular Testing MC-3426
Medical College And Research Institute
21 Microbiology Lab, Csi Scudder Memorial Molecular Testing MC-3427
Hospital(A Unit Of The Church Of South India
Trust Association)
22 Aza Diagnostic Centre Molecular Testing MC-3428
23 Endocare Diagnostic Centre Molecular Testing MC-3429
24 Dr. Chopra's Path Clinic Molecular Testing MC-3430

NABL NEWSLETTER 23 | P a g e
III. MEDICAL LABS ACCREDITED IN THE MONTH OF JUNE 2020
S.No. Name of the Laboratory Discipline Certificate
No.
25 Meenakshi Hospital Laboratory Services Molecular Testing MC-3431
26 Jagannath Gupta Institute Of Medical Sciences And Molecular Testing MC-3432
Hospital (A Unit Of Urmila Devi Jagannath Gupta
Charitable Trust)
27 Laboratory Medicine, Narayana Hrudayalaya Molecular Testing MC-3433
Limited
28 Department Of Laboratory Medicine, North-East Molecular Testing MC-3434
Health City Pvt. Ltd.
29 Laboratory Medicine, Premium Medical and Health Molecular Testing MC-3435
care providers private limited
30 Genx Diagnostics Molecular Testing MC-3436
31 Srcc Children's Hospital (A Unit Of Narayana Molecular Testing MC-3437
Hrudayalaya Limited)

NABL NEWSLETTER 24 | P a g e
Accreditation Granted to Proficiency Testing Providers

III. PTP ACCREDITED IN THE MONTH OF JUNE 2020


S.No. Name of the Laboratory Discipline Certificate
No.
1 Neu-QAP(Neuberg Anand Academy of Laboratory
Medicine Pvt LTD Quality Assessment Program) Medical PC-1047

NABL NEWSLETTER 25 | P a g e
One-time revocation of adverse decisions
In view of COVID-19 Pandemic and business impact, NABL has decided to give a one-time revocation on
the adverse decisions already taken for the following labs.

Testing Laboratories Calibration Labs Medical Labs


S.No. Lab Id S.No. Lab Id S.No. Lab Id S.No. Lab Id
1. T-0185 21. T-3814 1. C-0006 1. M-0375
2. T-1308 22. T-3903 2. C-0188 2. M-0518
3. T-1315 23. T-3915 3. C-0293 3. M-0726
4. T-1553 24. T-3959 4. C-0397 4. M-0773
5. T-1964 25. T-3996 5. C-0468 5. M-0956
6. T-2126 26. T-4006 6. C-0502 6. M-0967
7. T-2212 27. T-4101 7. C-0520 7. M-0976
8. T-2223 28. T-4208 8. C-0597 8. M-1092
9. T-2328 29. T-4310 9. C-0771 9. M-1144
10. T-2812 30. T-4312 10. C-1036 10. M-1159
11. T-2828 31. T-4388 11. C-1081 11. M-1193
12. T-2869 32. T-4390 12. C-1121 12. M-1234
13. T-2914 33. T-4410 13. C-1158 13. M-1387
14. T-3012 34. T-4429 14. C-1184 14. M-1538
15. T-3101 35. T-4448 15. C-1212 15. M-1583
16. T-3158 36. T-4467 16. C-1347 16. M-1734
17. T-3263 37. T-4490 17. C-0657 17. M-1800
18. T-3305 38. T-4542 18. M-0821
19. T-3703 39. T-4601 19. M-1417
20. T-3789 40. T-2294 20. M-1063

The accreditation will be restored for the remaining period of accreditation cycle after receipt of the
following:
a) Undertaking on a non-judicial stamp paper for complying to NABL 131 terms and conditions for
obtaining and maintaining accreditation.
b) Action taken report

NABL NEWSLETTER 26 | P a g e
NABL Response to COVID-19
NABL has published the list of laboratories which help in combating COVID-19.
The below laboratory list is being updated regularly, kindly download the latest list on NABL website
(www.nabl-india.org)

1. List of Medical Laboratories for testing of RT PCR RNA

2. Click the below links for list of NABL accredited testing and calibration laboratories

performing activities related to addressing COVID-19

a. List of Labs for testing of Ventilators

b. List of Labs for testing of PPE (Coverall / Medical Protective clothing)

c. List of Labs for testing of Sanitizer - Efficacy

d. List of Labs for testing of Gloves

e. List of Labs for testing of Mask

f. List of Labs for testing of Textile - Water repellency / resistance

g. List of Labs for testing of Medical devices - as per ISO 10993 (various parts)

h. List of Labs for testing of Endotoxin in surgical / medical items

i. List of Labs for testing of pyrogen in medical devices

j. List of Labs for Calibration of Medical Equipment

(Patient Monitor, Ventilator, Infusion Pump, Syringe Pump, Defibrillator, Suction Pump, BP

Apparatus, ECG Machine, Nebulizer, Radiator Warmer & Infant Incubator, Pulse Oxymeter,

Boyles Apparatus, Blood Gas Analyzer, Semi Auto Analyzer, Hematology Analyzer, OT

Table, Flow Meter, BiPAP, Autoclave)

k. List of Labs for testing of ‘Thermographs for human febrile temperature screening’

3. Standards made available free of cost to combat COVID-19

NABL NEWSLETTER 27 | P a g e
NABL 4th PTP/RMP Conclave

Link for Registration


Register
Now!
https://nablwp.qci.org.in/4thptprmpconclave2020/Registration
NABL NEWSLETTER 28 | P a g e
E-Learning July 2020

NABL NEWSLETTER 29 | P a g e
E-Learning July 2020

NABL NEWSLETTER 30 | P a g e
World Accreditation Day 2020
NABL jointly with NABCB celebrated World Accreditation Day 2020 on 09th June 2020
This year theme being “Accreditation: Improving Food Safety”.
This WAD was conducted on an online platform and was attended by more than 500 participants.

Inaugural session
The inaugural session witnessed the address by eminent personalities such as Mr. Adil Zainulbhai,
Chairman, QCI; Dr. R P Singh, SG, QCI; Mr. N. Venkateswaran, CEO, NABL; Mr. Sudhanshu Pandey,
Secretary, Department of Food and Public distribution, Ms. Rita Teaotia, Chairperson, FSSAI and Mr.
Rajesh Maheshwari, CEO, NABCB.

NABL NEWSLETTER 31 | P a g e
The inaugural session witnessed insights on the importance of food industry and the necessity for
regulations and accredited testing laboratories in ensuring the safety of food and eliminating food borne
diseases. CEO, NABL delivered the ILAC IAF message and stressed upon the importance of
accreditation in food sector.
The various safeguards being observed currently in the nation and the need for additional regulations and
the importance accreditation plays in the testing of food, was discussed at length.
This was followed by two technical sessions. Technical session 1 emphasized on regulator’s perspective
and technical session 2 emphasized on Industry’s perspective.
Technical Session I
Technical session I was chaired by Dr. D. K. Aswal, Director, NPL and Chairman, NABL. The
distinguished personalities in this session were Dr. N Bhaskar, Advisor, FSSAI; Dr. J. S. Reddy,
Additional Director, EIC; Dr. Ravishankar C.N., Director, CIFT and Dr. C. Vasudevappa, Vice
Chancellor, NIFTEM.

The session observed interesting topics on Food safety, Export compliance and recognition schemes in
the food sector. The importance of leveraging accreditation in ensuring compliance to food regulations
was explained by Dr. N. Bhaskar. Dr. J S Reddy explained the significance of accredited conformity
assessment in global food trade. Dr. Ravishankar C.N., explained on raising the quality through
integrated assessments and accreditation.
Dr. C. Vasudevappa stressed upon developing the quality infrastructure of MSME food sector in the
country.

NABL NEWSLETTER 32 | P a g e
Technical Session II
Technical session II was chaired by Mr. Shyam Bang, Chairman, NABCB, the session had well known
speakers from industry like Ms. Madhumita Guha, TIC Council; Mr. Sudhir Sitapathi, Executive director
(Food and Refreshment), HUL; Dr. Indrani Ghose, Strategic Advisor (Food Safety & Quality), CII-
FACE; Dr. Manish Pande, Director & Head PADD, QCI.

The session observed interesting topics on Supply Chain, Food processing, food safety and certification
schemes in the food sector. Ms. Madhumita elaborated on inspection and certification in improving food
quality. Mr. Sudhir sitapati emphasized on the sustainable development of the supply chain to protect the
nation’s food safety.
Dr. Indrani explained the steps needed for enhancing productivity in food processing and improving the
competitiveness which further leads to improvement in food quality. Dr. Manish explained the various
certification schemes related to the food sector and how the Indian state of Goa benefitted from the
formalin testing of fish.
A few questions from various laboratories and inspection agencies were taken at the end of the sessions.
The online program was widely acclaimed by the participating laboratories and stake holders.

NABL NEWSLETTER 33 | P a g e
Important Communications - Reprint
NABL Policy for Use of NABL Symbol

• Extension in implementation of NABL 133 (Issue 09) till 30.06.2020

The transition period for Implementation of NABL 133 ‘Policy for use of NABL symbol and / or
claim of accreditation by accredited conformity assessment bodies (CAB) & NABL accredited CAB
combined ILAC MRA Mark’ Issue 09, Issue Date 13-Dec-2019 has been extended till 30.06.2020.

Compliance of the policy shall be verified from 01.07.2020 and CABs are required to submit self-
declaration before the deadline. The declaration can be sent to testing@nabl.qcin.org for testing
laboratories, calibration@nabl.qcin.org for calibration laboratories and medical@nabl.qcin.org for
medical laboratories or the email ID mentioned in CAB dashboard on NABL web portal.

• The agreement to use NABL accredited CAB combined ILAC MRA Mark is to be submitted afresh
for each accreditation cycle after renewal of accreditation to seek permission to use the mark. Also,
in case of discontinuity in between the accreditation cycle for any adverse action, the agreement is no
longer valid and CAB has to seek fresh permission to use the mark.

• NABL 133 Issue No: 9 Amendment No: 2 Amendment Date: 29.04.2020 has been amended with
respect to the following:

o Clarification for use of NABL symbol in test reports / calibration certificates


o Clarification on applicability of NABL accredited CAB Combined ILAC MRA Mark and
condition when permission will not be granted.
o Clarification included about symbol not permitted
o Modifications in line with ILAC R7 for NABL Accredited CAB combined ILAC MRA
Mark.
o Amendment in Terms and Conditions for use of NABL accredited CAB Combined ILAC
MRA Mark in Appendix A

Extract of NABL 133 (Policy): Example of


Policy NABL Symbol
For use of NABL symbol

Use of NABL symbol is mandatory for the parameters / tests covered under NABL accredited scope on all
the test report / certificate, medical test report / certificate, calibration certificate / report, PT report and RM
document issued by NABL Accredited CAB. Narrative reference to accredited status in place of NABL
symbol is not acceptable in test reports / calibration certificates / PT report / RM document.
NABL accreditation is location specific. The accreditation claim shall be related only to the specific CAB
location that is covered under the NABL scope of accreditation, and not with any other non-accredited
locations.

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Important Communications – Reprint
Separate report/certificate be issued for non-accredited parameters. Asterisk mark or any other symbol is not
allowed / not permitted to use in the report / certificate containing accredited parameters. (The intent of the
para is to avoid misuse of NABL symbol and not to mislead customers about accreditation status. So, NABL
symbol was not allowed/ not permitted in pages and/or part of a report/certificate where non accredited
parameters occur).

For Claim of Accreditation


Accredited CAB can claim accreditation in narrative reference also. Where the claim of accreditation is
made in a narrative reference to accredited status in publicity material, it shall be accompanied by the
‘Accreditation Certificate number’.
For example, in case of testing laboratory, it shall be as
- NABL accredited testing laboratory vide certificate number TC-XXXX
- Accredited by NABL vide Certificate number TC-XXXX
- ISO/IEC 17025 Accredited testing laboratory by NABL vide Certificate number TC-XXXX
The claim of accredited status is not to be done on any report / certificate / document which contains non-
accredited parameters.

For use of NABL Accredited CAB Combined ILAC MRA Mark


NABL Accredited CAB {Testing Laboratory / Medical testing Laboratory / Calibration Laboratory /
Proficiency Testing Provider (PTP)} wishing to use ‘NABL Accredited CAB Combined ILAC MRA Mark’
shall obtain approval in writing from NABL and agree to the rules for the use of the Accredited CAB
Combined ILAC MRA Mark.
The NABL accredited CAB shall use the NABL Accredited CAB Combined ILAC MRA Mark only after
getting written permission from NABL. If any NABL accredited CAB wishes to use the NABL Accredited
CAB Combined ILAC MRA Mark, they shall need to fill in the Appendix ‘A’- Agreement for use of NABL
Accredited CAB Combined ILAC MRA Mark and submit it to NABL.
NABL shall only grant permission to use ‘NABL Accredited CAB Combined ILAC MRA Mark’ to NABL
accredited CABs established in economies where the ILAC MRA Mark is registered, or where an
application for registration has been lodged and registration is pending.
NABL shall not permit the use of NABL Accredited CAB Combined ILAC MRA Mark to the CAB, if there
is any on-going complaint against the that particular CAB.

Example of
NABL Accredited CAB Combined ILAC MRA MARK

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Important Communications – Reprint
Changes in CAB operations (Personnel)

• Procedure for Change in CAB personnel for review, report and authorizing the results

During the accredited period, there can be


addition/deletion of CAB personnel for review, report
and authorizing the results
For this the CAB is required to inform NABL and
submit the following documents.

A. CAB to submit the request to NABL along with


detailed bio-data/CV of the person and
applicable existing fees.

B. CAB to provide recommendations of new persons from existing NABL accepted personnel who
review, report and authorize results. If there are no existing NABL accepted personnel for the
particular scope, then the CAB to submit a competence report (as per lab procedure) of the person's
competence.

C. CAB to submit a declaration by the Head of organization that the person proposed meets the
qualification and experience requirements for the scope as per the relevant International Standard
(ISO/IEC 17025 or ISO 15189 or ISO/IEC 17043 or ISO 17034) and NABL criteria.

D. NABL will process the case in any of the following ways:


1. Accept the documentary evidence and confirm to the lab. The person can be alternate to the
existing accepted personnel.
2. Accept the documents (confirm the lab for provisional acceptance). An Assessment
(verification for competence of personnel) will be conducted on-site in the next routine assessment.
If desktop is due, then it will be converted into onsite assessment.
3. NABL may conduct an assessment to confirm competence of the personnel, if the change is
CAB head or as deemed fit by NABL
In all cases, Approval from competent authority for acceptance of person is obtained.

Note:
i. In case, the provisional accepted person leaves the CAB, the procedure is repeated for deletion and
addition
ii. In case of any specific certification (like in NDT, etc) or knowledge of additional regulatory
requirement (like in EIC, etc) is needed, then the same will be emphasized for accepting the request
of CAB.

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Important Communications – Reprint
Changes in CAB Operation
(test / calibration method and / or equipment)
• Procedure for change in test / calibration method and / or equipment

During the accredited period, there can be changes (revision, amendment, modification, etc) /
updation in test method and/or equipment of laboratory

For this, the laboratory must inform NABL and submit the following documents.

A. Laboratory to inform regarding the changes to NABL along with details as per format attached
and applicable existing fees.

B. Laboratory to submit evidence in the form of records or competence report (as per laboratory
procedure) for the changes made. For example, it can be a validation record and/or calibration
certificate, as relevant to the changes.

C. Laboratory to submit a declaration (format attached) by the Head of Organization that the
laboratory complies with the changes for the scope as per the relevant International Standard
(ISO/IEC 17025 or ISO 15189) and corresponding NABL criteria.

D. NABL will process the case in one of the following ways:

1. Accept the documentary evidence and confirm to the laboratory for use of NABL symbol in test
reports/calibration certificates in case of no change in

i) Equipment (Purchase new or additional equipment and/ or replaced existing equipment etc).
ii) technique or technology
iii) test/calibration method (for example, if it is dual standard, equivalent standard, similar
standard, version change, etc.)

which doesn’t result in re-issue of scope of accreditation. Verification shall be done in next on-
site assessment and scope will be amended & re-issued.

Example 1: Laboratory is required to follow the latest version of the test/calibration method and is
allowed to use NABL symbol. But if its customer requires in older version, then laboratory to
document that it has informed the customer about latest version and is still required to be done as per
older version. The laboratory can then do it in older version and is allowed to use NABL symbol in
test reports.

Example 2: Only the version of the standard has changed e.g. APHA 22nd Edition has changed to
APHA 23rd Edition but in the new edition, the method used by laboratory for a parameter e.g. for
chloride APHA 4500 Cl Argentometric method remains unchanged. Lab is allowed to use NABL
symbol in test reports after acceptance and confirmation by NABL.

Example 3: Laboratory can procure a new equipment with exactly same technique, for tests in
accredited scope. The laboratory can conduct testing / calibration using the new equipment and is
allowed to use NABL symbol in test reports / calibration certificates after acceptance and
confirmation by NABL.

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Important Communications – Reprint
Example 4: The laboratory is using Noise meter of Type-2 but for better accuracy replaces it by a
Noise meter of Type-1. Lab is allowed to use NABL symbol in test reports after acceptance and
confirmation by NABL.

Example 5: In testing of metals in soil or hazardous waste, digestion is done by wet method but
changes to Microwave-digestion systems. Lab is allowed to use NABL symbol in test reports after
acceptance and confirmation by NABL

2. Accept the documentary evidence (or otherwise) with an expert comment (or conduct
supplementary visit) and confirm to the laboratory for use of NABL symbol in test
reports/calibration certificates in case of significant change in

a) Equipment (increase in capability, etc.)


b) technique or technology [addition of new molecule or change in Maximum Residue Level
(MRL), etc]
c) test and / or calibration method

which will result in re-issue of scope of accreditation. Assessment (verification for changes) will
be conducted on-site in the next routine assessment. If desktop assessment is due, then it will be
converted into onsite assessment.

Example 1: If there is addition of new molecule or changes in MRL, the lab can do the necessary
validation and inform NABL for inclusion in the scope of accreditation. Lab is allowed to use NABL
symbol in test reports after acceptance and confirmation by NABL.

Example 2: If a testing laboratory has accreditation for testing pesticide formulations, it may be
capable of testing other pesticides also. The lab can do the necessary validation and inform NABL
for inclusion in the scope of accreditation. Lab is allowed to use NABL symbol in test reports after
acceptance and confirmation by NABL.

Example 3: If a calibration laboratory has accreditation for calibrating weights up to 5 kg, it can be
capable of calibrating up to 50 kg. The Lab can inform NABL for inclusion of weights up to 50 kg in
the scope of accreditation. Lab is allowed to use NABL symbol in test reports after acceptance and
confirmation by NABL.

3. NABL may conduct an assessment to confirm competence for the changes in test/calibration
method and/ or equipment, if the change is within a month of onsite audit or frequent change or as
deemed fit by NABL.

In all cases, Approval of the competent authority for acceptance is to be obtained and laboratory can
use NABL symbol from the date of acceptance by NABL. Evidence of acceptance to be maintained
by laboratory to avoid action on misuse of NABL symbol, if any.

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Important Communications – Reprint
Information regarding changes

1. Test / Calibration Method

a) Testing Laboratories – Test Method


S. Materials or Component, Test Method Range of Measurement
No. Products tested parameter or Specification against Testing/ Uncertainty
characteristic which tests are Limits of
()
tested/ Specific performed and/or the detection
Test Performed/ techniques/ equipment at Observed
Tests or type of used Value
tests performed

b) Medical Laboratories – Test Method


S. Materials or Component, Test Method Range of % CV / MU
No. Products tested parameter or Specification against Testing/
()
characteristic tested/ which tests are Limits of
Specific Test performed and/or the detection
Performed/ Tests or techniques/ equipment
type of tests used
performed

c) Calibration Laboratories – Calibration Method


S. Measurand or Reference Calibration or Measurement range and Calibration and
No. Material/ Type of instrument Measurement additional parameters Measurement
or material to be calibrated or Method or where applicable Capability (CMC)
measured/ Quantity Measured Procedure (Range and Frequency) (±)
/ Instrument

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Equipment
a) Testing or Medical Laboratories

S. Name of Model/ type/ Receipt date & Range Date of Calibration Calibrated
No. equipment year of make date placed in and last due on by
service accuracy calibration

b) Calibration Laboratories

i.Standard Maintained

S. Field & Standard Model/ Receipt Range Measurement Dt. of last Calibrated
No Parameter maintained type/ dt. & dt. Uncertainty calibration/ by
year of placed calibration
make in due on
service

ii.Calibration Facilities

S. Field & Major Model/ Receipt Range Overall Date of last Remarks
No Parameter Equipment type/ dt. & Measurement calibration/
year of dt. Uncertainty calibration
make placed due on
in
service

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Declaration regarding changes in test /calibration method and/or equipment

CAB Name: ……….……………………………………………………………….………………….

CAB ID : …..……………………………………………………………………………………………

Certificate Number and Validity of the Accreditation Certificate:


…………….……………………………………………………………….……………………………

1. Changes in test/ calibration method


S. No. Existing method Changes Remarks

2. Changes in equipment
S. No. Existing Equipment changes Remarks

3. Attachment: Records / competence report (as per lab procedure) for the changes
made………………………………………………………………………………………..
(Example: Validation record and/or calibration certificate, as relevant to the changes)

I hereby declare that the above information provided is true and the laboratory complies with the changes for
the scope as per relevant requirements of the Standard (ISO/IEC 17025 / ISO 15189) and NABL policies &
criteria for the scope of accreditation.

I also understand and accept that in case, if the above information is found false or ambiguous, NABL has the
right to take any adverse (suspend or deny or debar or otherwise) actions against the above changes and/or
laboratory’s full scope (as per NABL 216) as deemed appropriate.

Signature of Laboratory Head

(Date, Name & Designation)

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Important Communications – Reprint
Official Communications from NABL

Due care should be taken by all NABL stakeholders to prevent misrepresentation of NABL officials and
inadvertently sharing any sensitive information.

Please note that official website of NABL is (www.nabl-india.org)

Official Emails are with the following domain “xx@nabl.qcin.org”


Other webpages under the ambit of NABL are:
✓ NABL Web portal (nablwp.qci.org.in)
✓ NABL Payment gateway
(https://smarthubgovernment.hdfcbank.com/SmartHubGovt/NABLMainPage.jsp)
Note: All the above web portals to be accessed through NABL website (www.nabl-india.org)
To share updates of NABL with improved visibility, NABL utilizes the following social media accounts.
Kindly note that these channels are used only for announcement of NABL information.
▪ NABL Twitter Handle @NABL_QCI (https://twitter.com/nabl_qci)
▪ NABL LinkedIn Webpage (https://www.linkedin.com/company/nabl-india)
Please take due care if you are receiving emails other than the above domains and from emails
impersonating NABL officials.

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NABL ACCREDITED LABORATORIES AS ON 30TH JUNE 2020

Fields Number of Laboratories


Testing 3270

Calibration 929

Medical 1237

PTP 43

RMP 14

Total 5493

We have introduced a new email id ‘care@nabl.qcin.org’ to take feedback and suggestions from all our stakeholders for
improvement in the system.

We invite the views of laboratories on aspects of accreditation, which can be published in our newsletter and will be
beneficial to the entire laboratory community.

You may send your suggestions to ‘newsletter@nabl.qcin.org’

National Accreditation Board for Testing and Calibration Laboratories


NABL House
Plot No. 45, Sector 44
Gurugram – 122003
Ph: 0124 – 4679700
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Email: info@nabl.qcin.org

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