NABL NEWSLETTER
May 2020
Contents Chief Executive Officer’s Message ...... 2 Obituary ...... 4 Information from Quality Desk ...... 7 Information from Government / Regulators ...... 10 Opportunities for NABL Accredited Laboratories ...... 11 Fresh Accredited Laboratories ...... 16 Accreditation Granted to Testing Laboratories ...... 16 Accreditation Granted to Calibration Laboratories ...... 17 Accreditation Granted to Medical Testing Laboratories ...... 18 NABL Response to COVID-19 ...... 20 Important Communications - Reprint ...... 21 World Accreditation Day 2020 ...... 30 E-Learning June 2020 ...... 32
NABL NEWSLETTER 1 | P a g e
Chief Executive Officer’s Message
Dear NABL Patrons, I thank all laboratories for providing their cooperation during the lockdown and re-starting their operations back taking due care to prevent any mishaps due to COVID-19. It is with profound grief we inform that Prof. S K Joshi, Chairman, NABL left for heavenly abode on 15th May 2020. Prof. Joshi, was a kind and considerate person and guided NABL as chairman, through many wonderful years and under his leadership NABL has evolved into a better organization, upholding the principles of quality service. Prof. Joshi will be missed by all of us at NABL. We will cherish all his memories and strive to uphold the values for which he stood. NABL has extended all possible support to laboratories during these difficult times, by providing extension in validity of accreditation, flexibility in submission of desktop surveillance, modifying NABL policies to ease changes in CAB operations in accreditation activities such as changes in equipment, mandatory training requirement, etc. The importance of accreditation and the contribution from accredited laboratories has been well recognized during these tough times. As we move forward, I request laboratories to avail the upcoming business opportunities and enhance their scope thereby contributing in rebuilding the economy. As we start resuming our operations, I would like to reiterate the importance of hygiene and care in safeguarding health of our stakeholders and advise them to adhere to the various restrictions in place. Annually, we celebrate World Accreditation Day (WAD) on the 09th June 2020, this year theme being “Accreditation: Improving Food Safety”. I would like to invite all our stakeholders to participate in WAD 2020.
N. Venkateswaran
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OBITUARY
Prof. S K Joshi, 84, left for his heavenly abode on the evening of 15th May 2020.
Prof. Joshi a Padma Bhushan and Padma Shri and a veteran scientist was fondly revered in his remarkable career as a professor of physics at the IIT, Roorkee, Director, National Physical Laboratory (NPL), Director General, CSIR and Chairman, National Accreditation Board for Testing and Calibration Laboratories (NABL).
Prof. Joshi was considerate and guided NABL as chairman for many wonderful years. Under his able guidance, NABL has evolved into a better organization. NABL will feel the void of his inspiring and visionary leadership
He said, "NABL's mission should be the upliftment of the National Quality as a backbone in accreditation". We will feel the void of his inspiring and visionary leadership and guidance on strengthening NABL’s role in the quality infrastructure of the country.
Prof. Joshi will be missed by all of us at NABL. We will cherish all his memories and deeds.
PROF. You are not working in a job at NABL; you are on mission for the upliftment of National Quality as a backbone in S K JOSHI accreditation Prof. S K Joshi CHAIRMAN NABL
6.6.1935 – 15.5.2020
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Obituary
Shri Krishna Joshi
1935-2020
Shri Krishna Joshi, popularly known as Professor S K Joshi, one of the best science leader and condensed matter physicist of this country left to his heavenly abode on 15 May 2020 at the age of 86 at his residence in Gurugram, Haryana. It was only a few days ago before the corona lock-down started in the country in the month of March, I visited him and had a long chat with him about his health. At that time, he was suffering from cancer in his thigh and was confined to bed. He had his usual charismatic smile beneath which the deep pain of the illness was evident. In several hours’ long discussion, he narrated his journey from a small village of Uttarakhand to raising the position of Director General of Council for Scientific and Industrial Research, (DG, CSIR), New Delhi. Today 16 May, 2020 the present DG Dr. Sekhar Mande and my-self joined his last journey and remembered his immense contributions to the Indian science and technology. His demise is truly an end of era.
Professor S K Joshi was born on 6 June 1935 in a small village of Anarpa in Kumaun, Uttarakhand, India. During his schooling days, he used to walk everyday several kilometers of tough terrains of Himalaya to reach his school. For his higher education, he moved to Allahabad University and obtained BSc and MSc (Physics)degrees, both with first class. In 1957, being the Gold medalist in MSc, he was offered the position of Lecturer in Physics at Allahabad University. In parallel, he started his research work in measurement of diffuse X-ray scattering from organic crystals for his doctoral degree with K Banerjee and received his PhD degree in 1962. In 1965 he was offered a position of Visiting Lecturer by University of California, Riverside, USA.
After working two years in USA, he returned India and joined as a Professor of Physics, at a pristine age of 32 years, at the University of Roorkee (now IIT Roorkee). His experimental work during his PhD and his experience in US, got him seriously interested in theoretical studies of lattice vibrations i.e. phonons in metals and insulators. In metals, the frequencies of phonons depend on the response of conduction electrons to ion motion, and he proposed a successful phenomenological model incorporating electron response. He was one of the pioneers to understand the lattice dynamics of d-electron metals (e.g. copper and nickel)using a non- interacting s and d bands model. He investigated the electronic band structure using Korringa-Kohn-Rostoker method. The virtual crystal and the coherent potential approximation were used to calculate the electron states in a number of disordered binary alloys. He was one of the rarest Indian scientists who contributed a Chapter in Solid State Physics, published by Academic Press in 1968 on Lattice Dynamic of Metals, and other NABL NEWSLETTER 4 | P a g e
contributors in this book include Charles Kittle. For his outstanding work, he was awarded with prestigious Shanti Swarup Bhatnagar Award (Physical sciences) in 1972and by Meghnad Saha Award for Research in Theoretical Sciences in 1974. His group investigated physical properties like electrical conductivity, Hall effect and surface segregation in disordered binary alloys. His contributions to electron correlations in narrow band ferromagnets using the Hubbard model and its generalizations are highly appreciated. He was elected as a Fellow of Indian Academy of Sciences, Bangalore, Fellow of Indian National Science Academy (INSA), Indian Academy of Sciences (IAS), National Academy of Sciences India (NASI), Third World Academy of Sciences (TWAS), and Russian Academy of Sciences (Foreign Member).
In 1986, he moved from IIT Roorkee to New Delhi to take over the position of the Director of National Physical Laboratory (NPL). It was a coincidence that the discovery of high temperature superconductors also took place in 1986. His expertise in the lattice vibrations made it easy for him to take the research activities of high temperature superconductors at NPL. He proposed a new variational method for the periodic Anderson model to study the ground state behavior of heavy fermions and estimated the c-axis resistivity of high temperature superconductors. NPL also started the work on nanotechnology. He investigated transport of electrons in mesoscopic systems, particularly, the conductance of a single quantum dot and a double quantum dot system. Apart from being an outstanding scientist, he was a visionary leader as well. For visitors coming to NPL, he got a guest house built at NPL campus so that they can work comfortably even beyond the office hours. To attract research scholars to NPL, he got a hostel built for them. For his distinguished contributions in science, Government of India honored him with Padma Shri in 1991.
In1991, Prof. S.K. Joshi was elevated to the position of Director General of CSIR and Secretary, DSIR, Government of India. It was the time that coincided with beginning of the economic liberalization in India and he successfully steered CSIR for the national scientific and technological needs.
After his superannuation in 1995, his official address became “252, National Physical Laboratory, Dr KS Krishnan Marg, New Delhi” and remained till his demise. The NPL Research Council, chaired by Prof. Arun K. Grover suggested that he should continue as “Scientist of Eminence” at NPL and his vast knowledge should be utilized by the scientists of NPL. He served the nation in various ways. He played a crucial role in establishing new institutes of higher learning viz IISER, NISER, New IITs etc. He guided leading institutions of the country through the Chairmanship of their apex Boards, including IIT Roorkee, Institute of Mathematical Sciences, Chennai, Institute of Physics, Bhubaneswar, Indian Association for Cultivation of Science, Kolkata, Recruitment Assessment Center (RACDRDO), Recruitment Assessment Board(RAB CSIR), Visvesvaraya National Institute of Technology (VNIT Nagpur), Inter-University Accelerator Centre (IUAC), UGC-DAE, Indore etc.He also served as a member of the Scientific Advisory Committee to Government of India. He also served as Chairman of selection committees to select Directors and Vice Chancellors of many prestigious Institutes and Universities. For his contributions, in 2003 he was honored by Padma Bhushan, the third-highest civilian award in the Republic of India.
In 2015, when I took over the position of Director, NPL, I made a courtesy visit to him. It was a coincidence that he was also just took over as the Chairman of the National Accreditation Board for Testing and Calibration Laboratories (NABL). We had a great discussion on how NPL (the apex body of measurement in the country) and NABL (the apex accreditation body of laboratories in the country) can ensure the quality of Made- in-India products at par with international standards. It was agreed upon that NPL will NABL NEWSLETTER 5 | P a g e
increase the Calibration and Measurement Capabilities (CMCs) and the International Bureau of Weights and Measures, France and NABL will try to increase the number of accredited laboratories across the country, which are metrological traceable to SI units of measurements though NPL. In addition, NPL launched several Certified Reference Materials, under the trademark of Bhartiya Nirdeshak Dravyas (BNDs)that provides direct measurement traceability to the laboratories. Many of the BNDs were launched by Prof. Joshi himself. He used to say that NPL should develop all the BNDs so that India becomes self-reliant.
At the end of December 2019, when he started feeling weak the responsibility of the Chairman, NABL was entrusted to me. During my last meeting with him, I ensured him that I will carry forward the good work done by him. I was waiting to end the lockdown to tell him that during the period of COVID pandemic, NABL has done a wonderful job by providing the on-line accreditation to 142 medical testing laboratories across the country for RT-PCR RNA Virus/ COVID-19, which has greatly benefited the country in terms of conducting these very important tests. Unfortunately, he left us before I could inform him.
Prof. Joshi immensely contributed to Indian science and academies by serving at various positions including Secretary, Indian National Science Academy (INSA), Foreign Secretary of the Indian National Science Academy (INSA), President of the of the Indian National Science Academy (INSA), Vice President of the Indian Academy of Sciences, President of the National Academy of Sciences President of Indian Physics Association, President of the Materials Research Society of India, President of the Indian Science Congress Association. Prof. Joshi was the brainchild behind enhancing the industry-academia interactions, and bringing the national labs to the ambit of deemed universities e.g. TIFR, HBNI etc. He was also the Chairman of the elite committee who established 5 DST-Centers Higher Education Institutes, including the Punjab University, Chandigarh. He was awarded a D.Sc. honoris causa from Kumaun University, Kanpur University, Benaras Hindu University and the University of Burdwan.
His passing is a great loss to the nation. Those of us who have been fortunate enough to know and work with him have lost a great teacher and mentor.
Prof. S.K. Joshi was married to Hema, a gracious and charming lady, who during their 55 years of togetherness supported him in his personal (a strict follower of early to bed and early to rise) as well as professional (follower of simple living and high thinking) life. He leaves behind his wife and a son Sanjay, who is well settled at a high position in USA with his family.
Dinesh K Aswal Director, NPL Chairperson, NABL
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Information from Quality Desk 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 127 Procedure for Integrated Assessment & Additional Requirements of Regulatory Body(ies) for Testing Laboratories 2 NABL 130 Specific Criteria for Site Testing and Site Calibration Laboratories 3 NABL 132 Procedure for Dealing with Complaints 4 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 5 NABL 134 Procedure for Dealing with Appeals against Adverse Decisions taken by NABL 6 NABL 136 Specific Criteria for Accreditation of Quality Assurance Agencies for Diagnostic Radiology Xray Equipment 7 NABL 137 Specific Criteria for Accreditation of Software & IT System Testing Laboratories 8 NABL 141 Guidelines for Estimation and Expression of Uncertainty in Measurement 9 NABL 142 Policy on Traceability of Measurement Results 10 NABL 143 Policy on Calibration and Measurement Capability (CMC) and Uncertainty in Calibration 11 NABL 151 Application Form for Testing Laboratories 12 NABL 152 Application Form for Calibration Laboratories 13 NABL 153 Application Form for Medical Testing Laboratories 14 NABL 154 Application Form for Integrated Assessment of Testing Laboratories 15 NABL 156 Application Form for Medical Imaging – Conformity Assessment Bodies (MI- CAB) 16 NABL 160 Guide for Preparing Management System Document / Quality Manual 17 NABL 161 Guide for Internal Audit and Management Review for Conformity Assessment Bodies (Laboratories / PTP / RMP) 18 NABL 164 Guidelines for Inter-Laboratory Comparison for Calibration Laboratories where formal PT programs are not available 19 NABL 174 Sample Calculations for Uncertainty of Measurement in Electrical Testing 20 NABL 210 Assessor Guide 21 NABL 221 Biodata of Assessors 22 NABL 230 Contract Between NABL & Assessors
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Use of NABL Accredited CAB Combined ILAC 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 ILAC MRA mark in 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.
TC-XXXX / CC-XXXX MC-XXXX / PC-XXXX / RC-XXXX NABL NEWSLETTER 8 | P a g e
Updates from NABL
NABL is committed towards the safety and well-being of its customers and stakeholders and is undertaking business continuity measures for laboratories from NABL accreditation point of view and constraints due to COVID-19:
• As you are aware, lockdown has been partially lifted, NABL office has opened from 26.05.2020. We are also available to assist you through email and NABL web portal in case you are not able to reach us through telephone.
• As laboratories have also started operations, conduct of assessments with local assessors has been started in some areas. However, assessments related to emergency in respect to COVID-19 are being conducted remotely in respective areas, whilst not compromising on the integrity of the accreditation process.
• Extension of accreditation is given to the laboratories which had applied six months in advance (before expiry) as per procedure for maintaining continuity of accreditation. Extension will be provided for maximum of 6 months. Assessments will be conducted as per lab’s convenience and based on self- declaration to comply with requirements.
• Special Case-1: In view of the lockdown situation for laboratories (accreditation status expiry in March, April and May 2020), extension was granted till 30.06.2020 to such laboratories which could submit the renewal application at least two months before expiry.
• Further special cases: In view of lockdown and still in containment zones and not able to take up assessment, etc., NABL is planning to extend the accreditation validity to those labs which are submitting a self-declaration of compliance to the International standard and NABL specific criteria & policies. For all cases, the renewal application should have been submitted at least 2 months before expiry and ready to undertake assessment
• Assessors and CABs are advised to follow all elements of standard precautions that is consistent with recommendations of Center for Disease Control and Prevention (CDC).
• The list of NABL accredited Testing, Medical and Calibration Laboratories related to addressing COVID- 19 have been listed separately as well under the news and announcement section in NABL website in order to enable interested parties to directly find the reference of such laboratories.
• Applicant laboratories can continue to apply online through our website using the option "Apply Now for NABL Accreditation".
NABL will continue to closely monitor the situation and will continue to keep you updated as the situation evolves. The labs are requested to update NABL about any changes in the lab operations and contact details. We thank you for your patience and understanding.
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Information from Government / Regulators The Standards & Labeling Program for Advanced Chemistry Cell (ACC) & Batteries is an upcoming program.
If your laboratory is already accredited for Cells & batteries group under Electrical testing the testing requirements for ACC & Batteries are of similar nature. Above laboratories can become capable with existing and minor addition of resources and gain competence for the additional scope of Advanced Chemistry Cell (ACC) & Batteries.
The standard to be followed is ISO 12405-4:2018, Electrically propelled road vehicles —Test specification for lithium-ion traction battery packs and systems — Part 4: Performance testing 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.
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Opportunities for NABL Accredited Laboratories
Business Opportunity for Laboratories which are capable of testing Respiratory masks as per Indian Standard
IS 9473 “Respiratory protective devices – Filtering Half masks to protect against particles” ISO 18184: 2019 “Textiles – Determination of antiviral activity of textile products”
Laboratories having accreditation for similar product and tests may explore this opportunity to serve the industry by enhancing their current scope of accreditation.
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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
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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.
Steel and steel To view complete order – products (Quality Control) Order, 2020.pdf
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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.
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Opportunities for NABL Accredited Laboratories Business Opportunity for laboratories which are capable of testing the following chemicals. Department of Chemicals & Petro-chemicals has made the following BIS standards mandatory https://chemicals.nic.in/bis-standards-mandatory Laboratory having accreditation for similar products and tests may explore this opportunity to serve the industry by enhancing their current scope of accreditation.
S.No. Title of Chemical Indian Standard 1 Pyridine IS 8058: 2012
2 Gama Picoline IS 16113: 2013 RA 2018
3 Beta Picoline IS 16112: 2013
4 Morpholine IS 12084: 2018
5 Sod Sulphide IS 297: 2001 RA 2017
6 Phenol IS 538: 2000 RA 2015
7 Pot Carb Anhydrous IS 7129: 1992 RA 2015
8 Acetone IS 170: 2004 RA 2015
9 Phos Trichloride IS 4581: 1978 RA 2015
10 Phos Pentachloride IS 11744: 1986 RA 2015
11 Phos Oxychloride IS 11657: 1986 RA 2015
12 Hydrogen Peroxide IS 2080: 1980 RA 2016
13 Barrium Carbonate IS 3205: 1984 RA 2015 IS 12928: 1990 RA 2017
14 Sod For Sulphoxylate IS 4505: 2015
15 Sod Tripolyphosphate IS 6100: 1984 RA 2015
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Fresh Accredited Laboratories
Accreditation Granted to Testing Laboratories I. TESTING LABS ACCREDITED IN THE MONTH OF MAY 2020 S.No. Name of the Laboratory Discipline Certificate No. 1 Testing Lab, M.P. Laghu Udyog Nigam Ltd. M TC-8923 2 Brachi Testing Services (BD) Ltd, Narayanganj Bangladesh C, M TC-4001
C-Chemical; M-Mechanical;
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Accreditation Granted to Calibration Laboratories
II. CALIBRATION LABS ACCREDITED IN THE MONTH OF MAY 2020 S.No. Name of the laboratory Discipline Certificate No. 1 Regional Calibration Facility R CC-3127 2 AKGEC Skills Foundation Calibration & Testing Centre M CC-3128 3 Regal Technical Services ET, M, T CC-3129 4 Rudraja Engineers & Consultants M, T CC-3130 5 Hi Tech Measurements and Calibration M CC-3131 6 ADNA Technology Services ET, M, T CC-3132
ET-Electro-Technical; M-Mechanical; R-Radiological; T-Thermal;
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Accreditation Granted to Medical Testing Laboratories
III. MEDICAL LABS ACCREDITED IN THE MONTH OF MAY 2020 S.No. Name of the Laboratory Discipline Certificate No. 1 Department Of Microbiology, Christian Medical College MC-3368 MT 2 Sterling Accuris Diagnostics, A Division Of Sterling Accuris MC-3369 MT Wellness Pvt. Ltd. 3 Molecular Testing, Institute Of Laboratory Medicine, Kovai MC-3370 MT Medical Center and Hospital 4 Apollomedics Super Speciality Hospitals - A Unit Of Medics MC-3371 MT International Life Sciences Limited 5 Hybrinomics Life Science and Diagnostics LLP MC-3372 MT 6 Molecular Lab, Microbiology Dept., Rural Medical College, MC-3373 MT Pravara Institute Of Medical Sciences 7 KRSNAA Diagnostics Pvt. Ltd. MC-3374 CB 8 Shri Ramkrishna Institute Of Medical Sciences and Sanaka MC-3375 MT Hospitals 9 Laboratory Medicine, Bansal Hospital, A Unit Of Ayushman MC-3376 MT Medical Diagnostics Private Limited 10 Molecular Laboratory, Department Of Microbiology, S.S. MC-3377 MT Institute Of Medical Sciences and Research Centre 11 Molecular Laboratory, Parul Institute Of Medical Sciences And MC-3378 MT Research, Parul Arogya Seva Mandal 12 Green Cross Genetics Lab Private Limited MC-3379 MT 13 Asian Institute Of Gastroenterology Department Of Laboratory MC-3380 MT Medicine 14 Premier Health Center MC-3381 MT 15 Dr. D. Y. Patil Medical College, Hospital & Research Institute MC-3382 MT ( D. Y. Patil Education Society) 16 Department Of Laboratory Medicine, MC-3383 MT Royalcare Super Speciality Hospital Limited 17 Central Research Laboratory, Dr. D.Y. Patil Medical College MC-3384 MT Hospital & Research Center Under D.Y. Patil Vidyapeeth 18 Metropolis Healthcare Limited MC-3385 MT 19 Sen Diagnostics Private Limited MC-3386 MT 20 Microcare Laboratory & TRC MC-3387 MT 21 NIMS Medicity Department Of Laboratory Medicine MC-3388 MT 22 Dr P. Bhasin Pathlabs (P) Ltd. MC-3389 MT 23 J. J. M. Medical College - Molecular Lab MC-3390 MT 24 Center For Molecular Unitary Diagnostics, Research And MC-3391 MT Advancements (C-Mudra), Sri Balaji Vidyapeeth 25 Molecular Lab, Dhiraj Hospital MC-3392 MT
MT – Molecular Testing; MIDS – Microbiology & Infectious Disease Serology;
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III. MEDICAL LABS ACCREDITED IN THE MONTH OF MAY 2020 S.No. Name of the Laboratory Discipline Certificate No. 26 Orbito Asia Diagnostics MC-3393 MT 27 Justice K.S Hegde Charitable Hospital Laboratory Services MC-3394 MT 28 Molecular Laboratory, Jaipur National University Institute for MC-3395 MT Medical Sciences and Research Centre 29 Department Of Virology, Narayan Medical College & Hospital MC-3396 MT 30 KRSNAA Diagnostics Pvt. Ltd. MC-3397 MT 31 Narayana Nethralaya, Dept Of Molecular Diagnostics MC-3398 MT 32 HIV Testing Laboratory Government Medical College MC-3399 MIDS 33 Suvishwas Diagnostic Lab MC-3400 MT 34 Amaltas Institute Of Medical Sciences MC-3401 MT 35 Kingsway Hospitals, MC-3402 MT (A Unit Of Spanv Medisearch Lifesciences Pvt. Ltd.) 36 Molecular Laboratory, Jaslok Hospital and Research Centre MC-3403 MT 37 Maharajah's Institute Of Medical Sciences Central Laboratory (A MC-3404 MT Unit Of Sri Rama Educational Trust) 38 Diagnostic Laboratory, United Hospital (A Unit Of United MC-3405 MT Brotherss Healthcare Services Pvt Ltd) 39 VHS Laboratory Services MC-3406 MT
MT – Molecular Testing; MIDS – Microbiology & Infectious Disease Serology;
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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. Precautionary measures from NABL in response to COVID-19 Pandemic
4. Standards made available free of cost to combat COVID-19
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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 [email protected] for testing laboratories, [email protected] for calibration laboratories and [email protected] 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 TC-XXXX / CC-XXXX For use of NABL symbol MC-XXXX / PC-XXXX / RC-XXXX 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
TC-XXXX / CC-XXXX MC-XXXX / PC-XXXX / RC-XXXX
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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. This addition of authorized signatory will be completed withing 24 working hours.
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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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Important Communications – Reprint 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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Important Communications – Reprint 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 “[email protected]” 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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World Accreditation Day 2020
NABL jointly with constituent boards of QCI is planning to celebrate World Accreditation Day 2020 on 09th June 2020
Annually, World Accreditation Day (WAD) is celebrated on 09th June 2020, this year theme being “Accreditation: Improving Food Safety”. Accreditation supporting the achievement of Sustainable development goals related to food safety and how accreditation is contributing in reducing the illnesses caused by foodborne diseases and improving the global trade of safe food. Webinar Details & Registration: https://equest.co.in/events/world-accreditation-day-2020/
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World Accreditation Day 2020 Accreditation: Improving Food Safety
WEBINAR 09th June 2020
10.00 - 11.00 hrs Inaugural Session
10.00 - 10.10 hrs Welcome Address Dr. R P Singh Secretary General, QCI 10.10 - 10.20 hrs WAD 2020 Joint Message (ILAC-IAF Mr. N. Venkateswaran Chair) and WAD Video CEO, NABL 10.20 - 10.30 hrs Keynote Address Mr. Adil Zainulbhai Chairman, QCI 10.30 - 10.40 hrs Special Address Mr. Sudhanshu Pandey Secretary, D/o Food & Public Distribution 10.40 - 10.55 hrs Inaugural Address Ms. Rita Teaotia Chairperson, FSSAI 10.55 - 11.00 hrs Vote of Thanks Mr. Rajesh Maheshwari CEO, NABCB 11.00 - 12.00 hrs Technical Session I: Food Safety - Regulator’s Perspective 11:00 - 11:10 hrs Introductory Remarks by Session Chair: Dr. D.K. Aswal, Director NPL and Chairman, NABL 11.10 - 11.25 hrs Food Safety: Leveraging Accreditation in Dr. N. Bhaskar, Ensuring Compliance to Food Advisor, FSSAI Regulations 11.25 - 11.40 hrs Export Compliance: Significance of Dr. J. S. Reddy, Accredited Conformity Assessment in Additional Director, EIC Global Food Trade 11.40 - 11.55 hrs Recognition Schemes: Raising Quality Mr. V.K. Vidyarathi, through Integrated Assessments & General Manager, APEDA Accreditation 11.55 - 12.00 hrs Concluding Remarks by Session Chair 12.00 - 13.30hrs Technical Session II: Food Safety - Industry’s Perspective 12:00 - 12:10 hrs Introductory Remarks by Session Chair: Mr. Shyam Bang, Chairman, NABCB 12.10 - 12.25 hrs Food Safety: Inspection & Certification in Rep. of TIC Council Improving Food Quality 12.25 - 12.40 hrs Supply Chain: Sustainable Development Rep. of ITC / Nestle / Danone and Food Safety 12.40 - 12.55 hrs Food Processing: Enhancing Productivity Ms. Meetu Kapur & Improving Competitiveness ED, CII-FACE 12.55 - 13.10 hrs QCI Certification Schemes: Food Sector Dr. Manish Pande, Director & Head PADD 13.10 - 13.30 hrs: Q&A and Closing Session
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E-Learning June 2020
PLEASE VISIT NABL
WEBSITE
WWW.NABL-INDIA.ORG FOR BROCHURE AND REGISTRATION DETAILS
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NABL ACCREDITED LABORATORIES AS ON 31ST MAY 2020
Fields Number of Laboratories Testing 3367
Calibration 955
Medical 1252
PTP 45
RMP 14
Total 5633
We have introduced a new email id ‘[email protected]’ 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 ‘[email protected]’
National Accreditation Board for Testing and Calibration Laboratories NABL House Plot No. 45, Sector 44 Gurugram – 122003 Ph: 0124 – 4679700
Email: [email protected] NABL NEWSLETTER 33 | P a g e