NABL NEWS

Memorandum of Understanding between

NABL and ESMA
NABL has signed a Memorandum of Understanding
(MoU) with Emirates Authority for Standardization
& Metrology (ESMA), Abu Dhabi, UAE for
technical co-operation in accreditation activities.
This MoU was signed on 26th March 2007 in New
Delhi by Director NABL and Director General of
ESMA. This MoU has been signed with an objective
to serve the interests of both NABL and ESMA, and
to facilitate trade.
The cooperation shall include the common fields of
work between NABL & ESMA, particularly with
respect to:
1. Developing mutual recognition of laboratory
accreditations granted by both NABL & ESMA in
accordance with the standards, guides and
documents of the specialized international
organizations
2. Use of assessors approved by NABL & ESMA in
carrying out assessments to grant accreditation in
UAE and in India as required.
3. To set up a special program for the inter-laboratory
comparisons for the laboratories between the two
countries in order to build mutual confidence in test
results.
4. Exchange visits of experts and trainees.
5. Exchange of information including bulletins, training
courses, studies and statistics and information related
to the interpretation of accreditation & conformity
assessment requirements.
6. Common organizing of the training courses,
conferences and meetings that are related to
accreditation fields.
7. Exchange of experience between assessors,
accreditation and technical committees of both
parties.
8. Study visits for staff to NABL and ESMA.
Any activity to be undertaken under this MoU is to be agreed
by NABL and ESMA in advance before commencement of the
activity.

NABL Secretariat shifts to new premises

NABL Secretariat has shifted to a new premises and address for any communication is:
NABL
3rd Floor, NISCAIR
14, Satsang Vihar Marg
New Mehrauli Road
New Delhi - 110067
The telephone / fax numbers remains unchanged.
Tel: +91 - 11 - 26529718 - 20 / 26526864
Fax: +91 - 11 - 26529716
E-mail: info@nabl-india.org

NABL NEWS, ISSUE NO. 46, APRIL 2007 1

 Validation of Calibration Result and Generation of Stability Data of
Reference Standard using Control Chart Method
An approach for implementation
Introduction
Reference standards are the most critical instruments
for a calibration agency. Most of the activities of
every calibration lab are centered upon reference
standards. Calibration of the reference standard
through an external calibration agency requires the
selection of calibration agency that can provide
reliable calibration results and decision on re-
calibration interval. However, in most of the cases
the decision to select a Calibration Lab for calibration
of standard is guided by the financial factors i.e.
calibration charges and overhead charges for
calibration.
There is a possibility that the calibration results
reported by calibration agency are unreliable and do
not match with true value of standard. Hence, criteria
to validate the calibration results are needed so that
unreliable results, if any, may be identified &
removed. Otherwise, it will continue to harm even
after the expiry of validity period of the certificate by
creating doubts on the integrity standard.
Manufacturer provides initial information on
calibration interval. However, this information is not
exactly based on stability of the particular standard
but on the past stability data of same model of other
standards. As each standard is different from other
standard, after few years of use, each standard should
be characterized by its own stability data.
Lot of literature is available for providing guidelines
for recommendation on calibration interval. But it is
very difficult to implement the guidelines available
in these literatures. Hence, most of the labs are
prompted to follow the recommendation of the
manufacturer or they are requesting the calibration
agencies to give their opinion for the same. But, in
2 NABL NEWS, ISSUE NO. 46, APRIL 2007
view of recently published 'NABL Policies and
Guidelines for Electro-Technical Calibration
Laboratories', the stability data shall be generated by
preparation of control / trend chart based on successive
calibration of standard(s)/ master(s). The same is to be
established by laboratories within two years from the
date of application. Hence, all the laboratories have to
use some or other method for generating stability data.
Present Criteria for selection of a Calibration
Lab and need of Validation of Results
Scope of accreditation
Every calibration lab is audited by the NABL assessors
for implementation of Quality system based on
ISO/IEC17025:2005 and outcome of NABL assessment
is the scope of accreditation awarded by NABL. Scope of
accreditation of a calibration lab is the best measurement
capability of that lab for the respective range/parameters.
Although scope of accreditation is one of the very
important criteria for the selection of calibration lab, but
it is extremely difficult to make an assessment of
competence of a lab just by looking at the scope of
accreditation and knowing about best measurement
capability of the lab.
Performance of lab in Proficiency Testing/Inter-
laboratory comparison
As per the guidelines of NABL, a NABL accredited lab
has to demonstrates its proficiency by participation in
Proficiency Testing (PT) program to cover its entire
scope in a period of four years. Due to lack of sufficient
number of PT programs, NABL has now introduced
Inter-laboratory Comparison Programs for this. Most of
the laboratories are lacking in implementation of these
programs. But, at present customer does not have access
to results of PT or Inter-laboratory comparison program.
Data of Internal Quality Checks
The data generated by labs as a part of internal quality
checks to demonstrate the implementation of quality
system is also not shared with the customers.
Even though a customer might select a calibration lab
for calibration of its standards using any criteria,
including above-mentioned criteria, to assess the
proficiency of the lab. But, there exist a possibility of
unreliable results being given in the calibration
certificate. If results of calibration are not validated
to remove erroneous results, traceability chain may
be broken. Hence, it is ultimately up to the customer
to validate the received calibration result or be
prepared to bear the consequences related with poor
results. In fact, even a single unidentified erroneous
result, can continue to create doubts in the integrity of
the standard.
Role of Stability Data of reference
standard
NABL has also made it mandatory for the labs to
generate the stability data of all their reference
standards and to use it as one of the type 'B'
contribution in place of accuracy of standard.
Calibration data of the standard can be used to draw a
control chart/ trend line to generate stability data of
the standard.
Stability data as important Type 'B' contributions
towards overall measurement uncertainty of
calibration
When a calibration agency uses the reference
standard for the calibration of working standards or
any other instrument, it has to decide upon the
significant contributors for overall measurement
uncertainty. Stability data is one of the influencing
factors for Type 'B' calculation. Till now, most of the
calibration labs take accuracy provided by
manufacturer for this. However, after recent NABL
guidelines, all the calibration labs need to use
stability data in place of accuracy in type 'B'
uncertainty calculations.
NABL NEWS, ISSUE NO. 46, APRIL 2007
Determination of calibration interval of reference
standard
Also as per the norms of ISO/IEC 17025:2005, a NABL
accredited calibration lab can't give recommendation on
calibration interval on its own. It is the responsibility of
the user lab to decide the calibration-interval with the
help of some supporting data. Calibration interval of a
standard is a time period where the value of the standard
remains within specified accuracy limits. Calibration
interval recommended by a calibrating agency can be
validated or a user can on its own decide optimum
calibration interval using stability data of standard.
Generation of stability data using control
charts
Description of approach
In this paper Linear regression (Curve fitting) has been
used to draw a control chart with the help of history of
calibration data of the instrument.
The basic requirement for this approach is the 5 to 6 data
of previous calibration results from a good recognized
lab, preferably the results shall be from National Physical
Laboratory.
Linear regression establishes a relationship between
two parameters, one considered the independent and
the other the dependent parameter. The independent
parameter is the time and dependent parameter is the
value of a given parameter. From this we are able to
compute the value at times past and to predict its
value in the future.
An uncertainty can be assigned to those values,
provided the assumptions are met: points normally
distributed around the regression line, white noise,
and the underlying function really is linear. A
regression line, which describes a standard's
behavior over time, provides a better value for the
standard than any individual measurements or
calibrations that have been made.
Following assumptions are being made for the presented
approach.
3
* It has been assumed that the standards follow a
relatively linear drift.
* It has been assumed that calibration results of
standards over the years follow normal
distribution.
* As the data are finite, this approach takes in to
consideration the Student's t function. This
function is widely used in type 'A' calculation of
measurement uncertainty with limited data.
This approach has been explained in the following
paragraphs.
For a fixed standard, record 'n' number of data for
calibration results (y) and calibration dates (x). Draw
a regression line on the basis of least square method.
This line can be expressed with following equation.
Y = bX + a
In above formula 'b' is the slope of line; The slope of
the regression line (also called "Regression
Coefficient") can be given by (Microsoft Excel
Worksheet has a built in function called 'Slope' which
directly returns value of slope for a set of paired data)
nS xy - S x S y
b=
2 2
nS x - (S x)
'a' being termed as intercept at 0, is the value of Y at
X = 0, is given by (Microsoft Excel Worksheet has a
built in function called 'Intercept' which directly
returns value of Intercept for a set of paired data)
Sy-b Sx
a=
n with reference to 'value of intercept' & 'its associated
The variance of points about the line is given by
n-1
Sy|x2 = (sy2-b2sx2 )
n-2
Where 'sy' and 'sx' are the standard deviations of the
'y' (calibration value) and 'x' (date of calibration)
values, respectively.
4 NABL NEWS, ISSUE NO. 46, APRIL 2007
The standard error of the regression coefficient (slope) is
Sy|x
Sb =
Sx Ö( n-1)
and at a given confidence level, confidence interval for
the true slope 'b' is
b= ± ts b
Where 't' is 'student's t function' for desired confidence
level and n-2 degree of freedom.
Confidence interval for intercept is
tSy|x
±
Ön
Use of statistical data generated through control chart
For calculation of Calibration Interval
Calibration interval of a standard can be calculated
using stability data:
Accuracy - Uncertainty of calibration as per Cal. Cer.
Slope + |Uncertainty of slope |
In above-mentioned formula 'slope' and 'uncertainty of
slope' are the stability data generated from control chart.
For use of Type 'B' contribution
As per the recent guidelines NABL, stability data ('slope'
and 'uncertainty of slope') can be used as Type 'B'
contribution in place of accuracy of standard.
For validation of calibration data
For this purpose, the results reported in recent calibration
certificate and its associated uncertainty is validated
uncertainty' on the date of calibration by assessment of
'En value' derived using following formula..
Value reported in calibration certificate -
value of intercept on the date of calibration.
En =
Ö{(Uncertainty reported in calibration
certificate)2 + (uncertainty of intercept)2}
 This approach has already been successfully applied
in Cal Lab, ITI Limited, Naini for following types of
standards.
1. Fixed Capacitors.
2. Fixed Inductors.
3. Fixed Resistors.
4. Current Shunt.
5. Time Mark Generators.
6. Attenuators.
7. DC Voltage Sources.
8. Multi-function Calibrators.
9. Leveled Sine Wave Generator.
10. Calibration Generator.
In most of the cases the results have been found to be
encouraging. The use of this method has already
resulted in the following benefits for the lab.
1. Stability data of the most of the standard sources
have been generated.
2. Stability data of the standards has been used to
decide Calibration Periodicity of the most of the
standards.
3. For most of the standards Long-term drift has
been brought down. Long-term drift of Time
mark generator has been brought down from
20 ppm to 6 ppm.
4. Estimated value of intercept & its associated
uncertainty is being used as an effective basis for
validation of calibration results. Results are
satisfactory in all cases. In case of doubtful
results, we were able to convince the calibration
agency that results obtained by them during the
calibration of our standards are not satisfactory.
5. Use of control charts also gave us lot of
confidence due to which many reference
standards which were earlier sent to external
agency for routine calibration are now being kept
as working standards and are being calibrated in-
house.
All above factors have resulted into significant
savings towards periodic calibration charges of the
standards of our lab. It has also improved our best
measurement capability in almost all the parameters.
NABL NEWS, ISSUE NO. 46, APRIL 2007
It also gave us confidence that we can provide good
services to the external customer. We can now help
customers by providing a value added service of giving
statistically appropriate calibration interval of their
instruments.
Case Studies
1. Identification of an erroneous calibration value of
1mH Inductor used as reference standard
We have participated in a PT program for 1mH inductor.
Our reference standard and a stable LCR meter were used
to calibrate the artifact for PT by comparison method.
Calibration values were calculated using apparent values
of DUC & STD and actual value of reference standard as
reported by the calibration agency. Uncertainty
calculations were done considering Type 'A' and
following type 'B' contributions.
(a) Stability of standard as given by manufacturer.
(b) Uncertainty as reported in calibration certificate.
(c) Short term stability of LCR meter.
Results of calibration of artifact of PT were sent to nodal
lab. When interim findings of PT were reported to us, it
was informed that our results were not satisfactory and
we were asked to identify the cause of non-conformance
and report back the corrected results.
At the time of participation in above-mentioned PT, the
validation of calibration results and generation of
stability data was not done as per presently used
technique in Calibration Lab of ITI Ltd. Naini. Our 1 mH
reference inductor was procured in July 1982 and has
been regularly calibrated through National Physical
Laboratory, except in the last calibration when it was sent
to one of the NABL accredited calibration lab.
After thorough analysis of previous calibration results of
the reference standards using statistical techniques, it
was concluded that cause of non-conformance might be
due to erroneous results of last calibration, which was
performed by a NABL accredited Lab. Calculation were
again carried out using revised Stability Data and
estimated value of reference inductor on the date of PT.
Estimated value of the inductance standard was
5
projected using calibration data of all available data Control chart was prepared and which is shown in Fig I.
except data of last calibration. Corrected result,
1000.06 -
which was within the limits, was again sent to nodal
lab and identified cause of non-conformance was V
1000.04 -

also informed. Afterwards the same reference al 1000.02 -

ue
standard was again sent to NPL and our doubts were 1000.00 -

proved correct. Thus we were able to remove an In 998-98 -

erroneous calibration result by using presented p 999.96 -
statistical technique. F
999.94 -

2. Deciding calibration interval of 1000 pF 999.92 -

standard capacitor 999.90 -

We are having GR's 1404 series Reference capacitor.

82 84 86 88 90 92 94 96 98 00 02 04 06 08
These are mostly calibrated from NPL. NPL used to
report a calibration interval of two years that was still
more than calibration interval of one year normally Accuracy - Uncertainty of
calibration as per Cal. Cer.
reported by other NABL accredited labs. Estimated calibration - interval =
Slope + |Uncertainty of slope |
Approach used in this paper as applied to this
capacitor is being presented herewith. The previous
calibration data as on July 2002 are as follows: 20 - 10
= ----------- = 6.5 years
Date of Cal (x) Jul-82 Apr-85 Sep-90 Jul-97 Apr-00 Jul-02
1.53
VALUE_obs (y) 999.998 999.995 999.995 999.997 999.99 1000.006
It was felt that estimated value of 6.5 years is too long and
After step by step calculation as explained above,
lot of risk is associated if standard changes its
stability data obtained is summarized below:
characteristics during this period. So a reduced period of
b(slope) 1.3170E-04 3.5 years was decided as calibration interval.
a(intercept at 0) 999.99807 Conclusion
sy/x 0.0058 It may be concluded that projected value of standard &
t factor for n-2,99% 4.60 stability data is quite useful for validation of calibration
conf_int_slope(tsb) 1.4431E-03 results, for deciding calibration interval and as important
type 'B' contribution for drift' to implement recent
ci for intercept 1.0828E-02
guidelines of NABL regarding stability data. Thus it
A close observation of above data will reflect that helps to improve the reliability of results of a calibration
resultant value of drift per year (i.e.0.13 ppm ± 1.4 lab, improves best measurement capability of lab and
ppm) is much lower than the value provided by results in saving on expenditure towards calibration.
manufacturer (20 ppm).
Disclaimer
For a target accuracy of approximately 20 ppm,
revised calibration interval was calculated for Mr. S. K. Gupta from ITI Limited, Naini, Allahabad has
uncertainty of calibration as 10 ppm reported during written this article and is being published for the benefit
last calibration as below: of calibration laboratories. This article reflects the
views of the author and is not a NABL Guideline.

6 NABL NEWS, ISSUE NO. 46, APRIL 2007

 NABL PROFICIENCY TESTING PROVIDER
ACCREDITATION PROGRAM
Proficiency Testing (PT) is the use of inter-laboratory
comparison to provide quality assurance for
determination of performance by individual
laboratories for specific tests and measurements. All
accredited laboratories have to participate in
proficiency testing activity once in four years for all
major disciplines to satisfy International Laboratory
Accreditation Co-operation (ILAC) requirement.
ILAC is considering revision in this requirement by
enhancing the frequency of Proficiency Testing
Participation. Presently NABL offers PT Schemes
for testing and calibration laboratories in cooperation
with accredited testing laboratories or the national
meteorological institute (NPL, India). There is a
progressive increase in the number of accredited
laboratories with increased diversity in fields of
accreditation. There is thus increase in the demand to
fulfill the number of PT Schemes needed to cover PT
participation requirements of laboratories. Keeping
this in view, NABL proposes to start the program for
accreditation of Proficiency Testing Scheme
Providers (PT Providers) as per ILAC G: 13 and
ISO/IEC Guide 43: Part 1,1997.
To find out interest of different organizations in
accreditation as Proficiency Testing Providers,
th
NABL conducted a workshop on 9 Oct 2006 at NPL,
7 NABL NEWS, ISSUE NO. 46, APRIL 2007
New Delhi, which was attended by 70 participants from
various sectors. This workshop was also used to sensitize
potential Proficiency Testing Providers on requirements
for accreditation of Proficiency Testing Schemes.
To train assessors to evaluate the competence of the
organization for this scheme, NABL invited faculty
members from United Kingdom Accreditation Scheme
(UKAS) as this is a new activity for NABL in view of
UKAS long experience in this area. The training program
for assessors as per ILAC G:13 and ISO/IEC Guide 43:
nd rd
Part 1, 1997 was organized by NABL on 2 - 3 April
2007. Twenty assessors from various discipline of
Testing, Calibration and Medical fields were trained to
assess applicant organization as per ILAC G:13 and
ISO/IEC Guide 43: Part 1,1997.
NABL has also prepared necessary documents for this
scheme, which will be uploaded on NABL website by 1st
June 2007. Interested Organizations are requested to
download these documents and submit application form
and Quality Manual (as per ILAC G: 13 and ISO/IEC
Guide 43: Part 1,1997) to NABL.
In case of any clarifications / queries / comments or
feedback related to the documents, organizations may
contact Dr. Aparna Dhawan, Accreditation Officer
(aparna@nabl-india.org).
NEWBORN SCREENING QUALITY ASSURANCE
PROGRAM (NSQAP) in India
A major public health responsibility, newborn
screening for detection of treatable, inherited
metabolic diseases is a system consisting of six parts:
education, screening, follow-up, diagnosis,
management, and evaluation. Effective screening of
newborns using dried-blood-spot (DBS) specimens
collected at birth, combined with follow-up
diagnostic studies and treatment, helps prevent
mental retardation and premature death. If these
diseases are not accurately diagnosed and treated,
they cause mental retardation, severe illness, and
premature deaths in newborns.
Within 48 hours of a child's birth, a sample of blood is
obtained from a "heel stick," and the blood is
analyzed for treatable diseases, including
phenylketonuria, sickle cell disease, and
hypothyroidism. The sample, called a "blood spot,"
is tested at a laboratory. Accurate screening ensures
that-
 Affected babies are identified quickly.
 Cases of disease are not missed.
 The number of false-positive results is
minimized.
 Early treatment can begin that will prevent
negative and irreversible health outcomes for
affected newborns.
NABL NEWS, ISSUE NO. 46, APRIL 2007
Quality Assurance and Proficiency Testing for
Newborn Screening
For more than 26 years, Centers for Disease Control and
Prevention (CDC), Atlanta, Georgia, USA has been the
only comprehensive source in the world for quality
assurance and proficiency testing involving the testing of
newborns for preventable diseases, the Newborn
Screening Quality Assurance Program (NSQAP). The
program started in November 1979 with DBS specimens
for T4 and TSH. CDC's Newborn Screening Laboratory
Branch evaluates the performance of all participating
laboratories (73 domestic and one or more laboratories in
53 other nations), ensuring that they analyze the blood
spots correctly and providing technical assistance to
resolve any diagnostic problems.
Thousands of children are living healthy and productive
lives as a result of newborn screening and the Newborn
Screening Laboratory's quality assurance and
proficiency testing program. The QA program consists of
materials for quarterly (4 times each year) proficiency
testing (PT). Six DBS proficiency testing programs are
offered for metabolic disorders, tandem mass
spectrometry (MS/MS) measured analytes, sickle cell
disease & other hemoglobinopathies, cystic fibrosis,
Type I diabetes mellitus and anti-HIV-1.
The PT program provides laboratories with quarterly
panels of blind-coded DBS specimens and gives the
laboratory an independent external assessment of its
performance. Each year several laboratories misclassify
at least one PT specimen and are provided immediate
consultation to resolve the analytical problem.
8
The NSQAP is designed to help screening
laboratories achieve excellent technical proficiency
and maintain confidence in their performance.
Through the interactive efforts with the program's
participants, the program strives to grow and evolve
with the changing needs.
Program Operations
NSQAP's purpose is to improve interlaboratory
comparability and to work toward interlaboratory
harmonization of newborn screening tests that use
DBSs. Participants may include newborn screening
laboratories, confirmatory testing laboratories, diet
monitoring laboratories, and manufacturers.
NSQAP prepares PT quarterly reports that show the
distributions of analytical values and qualitative
assessments reported by participants. NSQAP offers
PT programs for the following parameters:
 T4
 TSH
 17-OHP
 Total Galactose
 Biotinidase
 Galactose-1-phosphate uridyltransferase
 Amino acids (Phe, Leu, Met, Tyr, Val, Cit)
 Acylcarnitines (C3, C4, C5, C5DC, C6, C8,
C10, C14, C16)
 Sickle cell disease (SCD) and other
hemoglobinopathies
 Immunoreactive trypsinogen (IRT) and
mutations
 Antibodies( IgG and IgM) to toxoplasmosis
9 NABL NEWS, ISSUE NO. 46, APRIL 2007
These parameters cover following diseases:
 Congenital hypothyroidism
 Phenylketonuria
 Galactosemia
 Congenital adrenal hyperplasia, Maple syrup urine
disease
 Homocystinuria
 Biotinidase deficiency
 Galactose-1-phosphate uridyltransferase (GALT)
deficiency
 Cystic fibrosis (CF)
 Hemoglobinopathies
 Toxoplasmosis
(Currently, the PT panels for SCDs and other
hemoglobinopathies are limited to specimens containing
hemoglobins related to SCDs, alpha-thalassemia,
hemoglobin E-related disorders, and hemoglobins
representative of beta-thalassemia in
combination with a structural variant). This program has
limited enrollment because of the availability of
quantities of pre-screened cord blood.
At the end of each year, a summary of all PT and QC data
reported for that year will be prepared and distributed to
all participants. Distributions of PT panels occur in
January, April, July, and October. There is no cost to the
participant for products or shipping.
Filter Paper
The paper disk punched to aliquot DBS specimens is a
volumetric measurement and requires degree of
uniformity among and within production lots. As a part
of the QA program, an isotopic method developed at
CDC's Newborn Screening Laboratory is used to
evaluate and compare different lots of filter paper.
Mean counts per minute of added isotopic- labeled
thyroxine (T4) within a 1/8- inch disk are equated
with the serum volume of the disks from the dried
whole blood specimens. In comparing production
lots, statistical analyses of the counting data used to
determine values for homogeneity and serum
absorption of the disks.
For historical reference and for maintaining
uniformity of testing on all the paper production lots,
lysed- cell procedure is used. Performance is also
measured with intact cell preparations. The
published & standardized acceptable volumes per
1/8-inch disc are 1.30 ± 0.19 l (mean value & 95%
confidence interval) for lysed-cell blood and 1.54 ±
0.17l for intact-cell blood.
Specimen Preparation and Data Handling
The total concentration of each specimen or lot is
equal to the sum of the enriched concentration and
the endogenous concentration (nonenriched). Some
specimens were enriched above the endogenous T4
concentration and some were enriched with T4 after
T4 depletion of the base serum. Except for
biotinidase and GALT, all DBS specimens in the PT
surveys were prepared from whole blood of 55%
hematocrit. Purified analytes or natural donor blood,
except for TSH, which uses the Second International
Reference Preparation (80/558), are used for all
enrichments. For galactosemia, enrichments are
made with galactose, galactose-1- phosphate, or both
so that both free galactose and total galactose (free
galactose plus galactose present as galactose-1-
phosphate) could be measured. For biotinidase and
GALT, individual case donor blood was used. All
reported analytic values outside the 99% confidence
limits are excluded from the summaries of
quantitative results.
NABL NEWS, ISSUE NO. 46, APRIL 2007
Proficiency Testing
All PT panels contain 5 blind coded 75µl or 100µl DBS
specimens. Specimens in the PT panels contained either
endogenous levels or are enriched with predetermined
levels of T4, TSH, Phe, Gal, 17-OHP, Leu, Met, and
acylcarnitines. Specimens for the CF panel are prepared
with IRT enriched blood. Special separate panels for
biotinidase deficiency and for GALT deficiency are
prepared with purchased blood from donors with enzyme
deficiencies. Specimens for the hemoglobinopathies
panel are prepared from umbilical cord blood. Specimen
sets are packaged in a zip-closed metallized plastic bag
with desiccant, instructions for analysis, and data report
forms for those labs that did not report data by internet.
Reports are prepared and distributed quarterly of all
results that are received by the cutoff dates. The PT
quantitative results are grouped by kit or method to
illustrate any method-related differences.
NSQAP in India
Association of Clinical Biochemists of India (ACBI) in
collaboration with Newborn Screening Branch at the
Centers for Disease Control (CDC), Atlanta, Georgia,
USA has launched the Newborn Screening Quality
Assurance Program (NSQAP) in India from January
2007 as detailed above.
The laboratories preforming newborn sceening can
enroll in this international program. The laboratory
must use neonatal screening kits for performing the
above mentioned tests and sampling should be done
on dried blood spots (DBS).
The program comes at NO COST TO THE LAB.
For details contact:
Dr. Puneet K. Nigam
Head, NSQAP ACBI
Email: nsqap2007@gmail.com
10
 TRAINING ACTIVITIES
NABL has discontinued conducting training program on Laboratory Quality Management System and Internal Audit
for ISO/IEC 7025:2005. However for the benefit of the laboratories, NABL publishes information on training
programs offered by other established training Institutes. It may please be noted that NABL is not involved in design
or conduct of these courses. NABL will however conduct training programs based on ISO 15189 for the benefit of
medical laboratories and schedule of these courses will be available on NABL website.

Training Schedules

S. Date
No. Program Name Venue Contact Person
From To
1. Measurement Centre for Electronics Test Ms. Veena S. Kamath 09/04/07 11/04/07
Uncertainty (Chemical Engineering, ETDC [cetebg@etdcbg.org]
Parameters) for Campus, 100 Feet Road,
Laboratories Peenya Industrial Estate,
Bangalore
2. Measurement Indian Institute of Quality Mr. B. Singh 16/04/07 18/04/07
Uncertainty (Electro- Management, Malviya [iiqmetdc@sancharnet.in]
technical & Mechanical Industrial Area, Jaipur.
Parameters) for
Laboratories
3. Laboratory Quality Indian Institute of Quality Mr. B. Singh 07/05/07 10/05/07
Management System & Management, Malviya [iiqmetdc@sancharnet.in]
Internal Audit as per Industrial Area, Jaipur.
ISO/IEC 17025:2005
4. General Requirements Institute for Design of Mr. S. G. Khaladkar 08/05/07 11/05/07
for the Competence of Electrical Measuring [info@idemi.org]
Testing & Calibration Instruments (IDEMI),
Laboratories and Eastern Express Highway,
Internal Audit as per Opposite Everard Nagar,
ISO/IEC 17025:2005 Sion, Chunabhatti,
Mumbai - 400 022.
5. RF Measurements Centre for Electronics Test Ms. Veena S. Kamath 09/05/07 11/05/07
Engineering, ETDC Campus, [cetebg@etdcbg.org]
100 Feet Road, Peenya
Industrial Estate, Bangalore

11 NABL NEWS, ISSUE NO. 46, APRIL 2007

6. Measurement Centre for Electronics Test Ms. Veena S. Kamath 09/05/07 11/05/07
Uncertainty (Electro- Engineering, ETDC Campus, [cetebg@etdcbg.org]
technical & Mechanical 100 Feet Road, Peenya
Parameters) for Industrial Estate, Bangalore
Laboratories
7. Laboratory Quality Centre for Electronics Test Ms. Veena S. Kamath 22/05/07 25/05/07
System, Management Engineering, ETDC Campus, [cetebg@etdcbg.org]
and Internal Audit as 100 Feet Road, Peenya
per ISO/IEC 17025:2005 Industrial Estate, Bangalore
8. Workshop on Institute for Design of Electrical Mr. S. G. Khaladkar 24/05/07 25/05/07
Estimation & Evaluation Measuring Instruments (IDEMI), [info@idemi.org]
of Total Uncertainty in Eastern Express Highway,
Measurement as per Opposite Everard Nagar,
NABL 141. Sion, Chunabhatti,
Mumbai - 400 022.
9. Certified Calibration Centre for Electronics Test Ms. Veena S. Kamath 11/06/07 16/06/07
Professional Engineering, ETDC Campus, [cetebg@etdcbg.org]
100 Feet Road, Peenya
Industrial Estate, Bangalore.
10. Measurement Indian Institute of Quality Mr. B. Singh 18/06/07 20/06/07
Uncertainty (Chemical Management, Malviya [iiqmetdc@sancharnet.in]
Parameters) for Industrial Area, Jaipur.
Laboratories
11. Laboratory Quality Indian Institute of Quality Mr. B. Singh 16/07/07 19/07/07
Management System & Management, Malviya [iiqmetdc@sancharnet.in]
Internal Audit as per Industrial Area, Jaipur.
ISO/IEC 17025:2005
12. Laboratory Quality Centre for Electronics Test Ms. Veena S. Kamath 24/07/07 27/07/07
System, Management Engineering, ETDC Campus, [cetebg@etdcbg.org]
and Internal Audit as per 100 Feet Road, Peenya
ISO/IEC 17025:2005 Industrial Estate, Bangalore
13. Measurement Uncertainty Indian Institute of Quality Mr. B. Singh 06/08/07 08/08/07
(Electro-technical & Management, Malviya [iiqmetdc@sancharnet.in]
Mechanical Parameters) Industrial Area, Jaipur.
for Laboratories
14. General Requirements Institute for Design of Electrical Mr. S. G. Khaladkar 07/08/07 10/08/07
for the Competence of Measuring Instruments (IDEMI), [info@idemi.org]
Testing & Calibration Eastern Express Highway,
Laboratories and Opposite Everard Nagar,
Internal Audit as per Sion, Chunabhatti,
ISO/IEC 17025:2005 Mumbai - 400 022.
15. Measurement Centre for Electronics Test Ms. Veena S. Kamath 20/08/07 22/08/07
Uncertainty (Electro- Engineering, ETDC [cetebg@etdcbg.org]
technical & Mechanical Campus, 100 Ft Road,
Parameters) for Peenya Industrial Estate,
Laboratories Bangalore

NABL NEWS, ISSUE NO. 46, APRIL 2007 12

 NABL Laboratory Assessors Training Course
NABL is currently looking for experts in the following areas to train as NABL Assessors:

Calibration Laboratories: Dimension, Mass, Density, 1. Educational qualification:

Volume, Force, Torque, Hardness, Pressure, Vacuum,
Electro-technical, Thermal, Optical, Fluid Flow
Testing Laboratories: Plastics, Petroleum &
Petrochemicals, Pigments, inks & dyes, Pesticides
Microbiology, Drugs & Pharmaceuticals, Pollution &
environment, Food, Explosives, Ores & minerals, Metals,
Fertilizers, Gold assaying, Forensic science and NDT
Medical Laboratories: Clinical Biochemistry, Clinical
Pathology, Haematology and Immunohaematology,
Microbiology and Seerology, Histopathology,
Cytopathology, Genetics.
l For Testing and Calibration laboratories: Post
graduation in Science or Graduate in Engineering
with 5 years post qualifacation experience in Testing
/ Calibration laboratory
l For Medical Laboratories: M.D. (Pathology), M.D.
(Microbiology) / Ph.D. (Microbiology) with M.Sc.
(Medical Microbiology), M.D. (Biochemistry) /
Ph.D. (Biochemistry) with M. Sc. (Biochemistry),
M.S. (Anatomy) / Ph.D. with M. Sc. (Human
Anatomy) / Ph.D. (Genetics) / Ph.D. (Applied
Biology) with experience in genetics, M.D. in Lab
Medicine with 5 years post qualification experience
in Medical Laboratory

Experts must have experience in both the management
and operation of testing & calibration laboratories and be
technically knowledgeable in one or more areas of testing
and calibration. The criteria for the selection of experts to
be trained as assessors are as follows :
l DCP with 7 years post qualification experience in
medical laboratory
2. Should be currently working in the laboratory.
3. Should have good communication skills.

Interested candidates may send their bio-data in the format given in document no. NABL - 221
(document can be downloaded from NABL website) to :
Mr. M.V.N. Mohan, In-charge (Training)
National Accreditation Board for Testing and Calibration Laboratories,
3rd Floor, NISCAIR, 14, Satsang Vihar Marg
New Mehrauli Road, New Delhi - 110067
Phone: 011- 26529718- 20, 26526864
Fax: 011- 26529716
E-mail: training@nabl-india.org
Assessor training course is a five-day residential training programme and the course fees is Rs 7,500/- per participant.
This fee shall be paid on receipt of invitation for participation

(For updated information on schedules of NABL training courses,

you are requested to visit NABL web-site: www.nabl-india.org)

14 NABL NEWS, ISSUE NO. 46, APRIL 2007

 NEW ACCREDITATION GRANTED
( JANUARY – MARCH 2007 )
Testing Laboratories
S. No. Laboratory Name Field (s)
1. Coal Testing Lab, Panipat Thermal Power Station, Panipat C
2. Consumer Testing Services-Laboratory, SGS India Private Limited, Bangalore B
3. Electronics and Quality Development Centre, Gandhinagar FF
4. Electronics and Quality Development Centre, Vadodara E
5. Export Inspection Agency - Kochi Laboratory, Kochi C, B
6. Fertiliser Testing Laboratory, Aurangabad C
7. Fertilizer Testing Laboratory, Pune C
8. Haryana Test House & Consultancy Services, Panipat M
9. Indian Institute of Packaging, Mumbai P
10. Indian Oil Corporation Limited - Kandla Laboratory, Kutch, Gujarat C
11. Quality Control Testing Laboratory, Sanghi Industries Ltd., Sanghipuram, Kutch, Gujarat C, M
12. Radiotech - NDT Laboratory, Ahmedabad NDT
13. Regional Laboratory, Textiles Committee, Guntur M
14. S.N. Metallurgical Services, Aurangabad C, M
15. SGS India Private Limited, Karur C, M
16. SQAE (ME) Testing Laboratory, Itarsi C, M
17. Sunflag Laboratory, Bhandara C, M
18. Superintendence Company of India (P) Ltd., Kolkata C
19. Susira Industries Limited Calibration and Testing Laboratory, Chennai M
20. Testtex India Analytical Laboratory, Mumbai C, M
21. Wool Research Association - Textile Lab, Thane C, M

NABL NEWS, ISSUE NO. 46, APRIL 2007 14

 Calibration Laboratories
S. No. Laboratory Name Field (s)
1. A. A. Calibration Pvt. Ltd., Ghaziabad T
2. Aar Gee Engineering, Chennai M
3. Acumen Measurements & Consultancy Pvt. Ltd., New Delhi T
4. Belz Calibration Laboratory, Faridabad T
5. Calibration Laboratory, Jain Scientific Glass Works, Ambala Cantt. M
6. Cal-Tech Calibration Services Pvt. Ltd., Pune M
7. Cross Calibration Center, Faridabad M
8. Electrometer Corporation, Kolkata FF
9. Electronics Regional Test Laboratory (E), Kolkata FF
10. Madhya Pradesh State Electronics Development Corporation Ltd., Bhopal ET
11. Material Testing Department-Calibration Lab, Vehicle Factory, Jabalpur M
12. Metrological Testing & Calibration Centre, Bangalore ET
13. Sadbhav Calibration Services, Vadodara M
14. Vashisth Calibration Centre, Ballabgarh ET, T

Medical Laboratories
S. No. Laboratory Name Field(s)
1. APL Diagnostic Expert - Clinical Biochemistry,
Ashish Pathology Laboratory, Ahmedabad Haematology & Immunohaematology
2. Apollo Hospitals, Chennai Clinical Biochemistry,
Clinical Pathology,
Haematology & Immunohaematology,
Microbiology & Serology,
Histopathology,
Cytopathology,
Genetics
3. Divine Diagnosis Centre Private Limited, Clinical Biochemistry,
Kolkata Clinical Pathology,
Haematology & Immunohaematology

15 NABL NEWS, ISSUE NO. 46, APRIL 2007

S. No. Laboratory Name Fields
4. Eastern Diagnostics & Clinical Biochemistry,
Medical Centre Ltd., Kolkata Clinical Pathology,
Haematology & Immunohaematology
5. Final Diagnosis Pvt. Ltd., Noida Clinical Biochemistry,
Haematology & Immunohaematology
6. Green Cross Pathology & Clinical Biochemistry,
R.I.A. Laboratory, Ahmedabad Clinical Pathology,
Haematology & Immunohaematology,
Microbiology & Serology
7. St. John's Laboratory Services, Bangalore Clinical Biochemistry,
Clinical Pathology,
Microbiology & Serology,
Genetics
8. Star Imaging & Path Lab, New Delhi Clinical Biochemistry,
Clinical Pathology,
Haematology & Immunohaematology,
Microbiology & Serology,
Cytopathology

Abbreviations used : C-Chemical, M-Mechanical, E-Electrical, T-Thermal, B-Biological, FF-Fluid Flow,

P-Photometry, L-Electronics, F-Forensic Testing, NDT-Non Destructive Testing,
R-Radiological, ET-Electrotechnical, O-Optical, T&O-Thermal & Optical

Scope of Accreditation and other details of all Accredited Laboratories are available on
NABL web site “www.nabl-india.org” under ‘Laboratory Search’

Accreditation Withdrawn & Accreditation Voluntary

Laboratory Debarred Withdrawn

NABL has withdrawn accreditation of Standard KBM Engineering Research Laboratory,

Analytical Laboratory, Delhi in the fields of Ahmedabad has voluntarily withdrawn from
Biological testing (Certificate No. T-0781) and NABL accreditation in the field of Mechanical
Chemical testing (Certificate No. T-0780) w.e.f. testing (Certificate No. T-0476 valid till 25-08-
2nd March 2007 for misuse of NABL 2008) w.e.f. 4th April 2007.
accreditation. NABL has also debarred the
laboratory from applying for accreditation for a
period of two years.

NABL NEWS, ISSUE NO. 46, APRIL 2007 16

 MASTER LIST OF NABL DOCUMENTS
S.No. Document Title Issue Issue Amend. Amend.
No. No. Date No. Date

1. NABL 100 General Information - 01.05.2006 00 -

Brochure

2. NABL 102 Specific Criteria for Biological 02 06.02.2007 00 -

Testing laboratories

3. NABL 103 Specific Guidelines for 02 28.02.2003 01 05.07.2005

Chemical Testing laboratories

4. NABL 104 Specific Criteria for Electrical 02 02.04.2003 01 05.07.2005

Testing laboratories

5. NABL 105 Specific Criteria for Electronics 01 1995 02 05.07.2005

Testing laboratories

6. NABL 106 Specific Criteria for Fluid Flow 01 1994 02 05.07.2005

Testing laboratories

7. NABL 107 Guidelines and Specific 02 01.11.1999 02 05.07.2005

Criteria for Accreditation of
Mechanical Testing laboratories

8. NABL 108 Specific Criteria for Non- 01 01.01.1994 02 05.07.2005

Destructive Testing laboratories

9. NABL 109 Specific Criteria for Photometry 01 01.04.1998 02 05.07.2005

Testing laboratories

10. NABL 110 Specific Criteria for Radiological 01 01.01.1994 02 05.07.2005

Testing laboratories

11. NABL 112 Specific Criteria for Accreditation 02 11.05.2005 04 16.01.2007

of Medical laboratories

12. NABL 113 Specific Guidelines for Accreditation 01 18.06.1998 02 05.07.2005

of Forensic Science Laboratories
& Checklist for Assessors

13. NABL 113 A Specific Guidelines for Accreditation 01 29.12.1999 02 21.10.2003

of DNA Fingerprinting Laboratories
& Checklist for Assessor

17 NABL NEWS, ISSUE NO. 46, APRIL 2007

S.No. Document Title Issue Issue Amend. Amend.
No. No. Date No. Date

14. NABL 114 NABL Guidelines for 02 05.07.2005 00 -

Food Testing Laboratories

15. NABL 121 Specific Criteria for Calibration 03 08.10.2002 01 05.07.2005

Laboratories in Electro-Technical
Discipline

16. NABL 122 Specific Criteria for Calibration 03 08.10.2002 01 05.07.2005

Laboratories in Mechanical
Discipline

17. NABL 123 Specific Criteria for Calibration 03 08.10.2002 01 05.07.2005

Laboratories in Radiological
Discipline

18. NABL 124 Specific Criteria for Calibration 03 08.10. 2002 02 05.07.2005
Laboratories in Thermal &
Optical Discipline

19. NABL 125 Specific Criteria for Calibration 03 08.10. 2002 01 05.07.2005
Laboratories in Fluid Flow Discipline

20. NABL 130 Specific Criteria for Site Testing 02 13.08. 2002 01 05.07.2005
and Site Calibration Laboratories

21. NABL 131 Terms and Conditions for 05 02.11.2005 02 08.02.2007

Maintaining NABL Accreditation

22. NABL 132 Procedure for Dealing with 02 20.02.2006 00 -

Complaints

23. NABL 133 NABL Guidelines to Accredited 03 20.01.2006 00 -

Laboratories for use of NABL Symbol

24. NABL 134 Procedure for Dealing with Appeals 01 20.02.2006 00 -

Against Adverse Decisions Taken
by NABL

25. NABL 141 Guidelines for Estimation & 02 02.04.2000 03 18.08.2000

Expression of Uncertainty in
Measurement

26. NABL 142 Policy on Calibration and 03 18.10.2004 02 05.07.2005

Traceability of Measurements

NABL NEWS, ISSUE NO. 46, APRIL 2007 18

S.No. Document Title Issue Issue Amend. Amend.
No. No. Date No. Date

27. NABL 151 Application Form for Testing 10 14.02.2006 00 -

Laboratories

28. NABL 152 Application Form for 10 14.02.2006 00 -

Calibration Laboratories

29. NABL 153 Application Form for Medical 01 14.02.2006 00 -

Testing Laboratories

30. NABL 160 Guide for preparing a Quality Manual 03 05.07.2005 00 -

31. NABL 161 Guide for Internal Audit and 02 02.04.2002 02 05.07.2005
Management Review for Laboratories

32. NABL 162 Guidelines for Proficiency Testing 03 04.04.2001 01 05.07.2005

Programme for Testing &
Calibration Laboratories

33. NABL 163 Policies & Procedures for Inter- 04 13.08.2002 04 18.10.2004
laboratory comparisons and/or
Proficiency Testing

34. NABL 164 Guidelines for Inter-Laboratory 01 28.04.2005 00 -

Comparison for Calibration
Laboratories where formal PT
programmes are not available

35. NABL 174 Sample Calculations for 02 04.10.2004 01 05.07.2005

Uncertainty of Measurement
in Electrical Testing

36. NABL 209 Pre-Assessment Guidelines and Forms 01 02.12.2002 01 05.07.05

37. NABL 210 NABL Assessor Guide 03 01.05.2002 03 05.07.05

40. NABL 215 Assessment Forms & Checklists 03 05.07.2005 04 13.02.07

(Based on ISO/IEC 17025)

19 NABL NEWS, ISSUE NO. 46, APRIL 2007

S.No. Document Title Issue Issue Amend. Amend.
No. No. Date No. Date

41. NABL 216 Procedures for Dealing with Adverse 03 21.02.2006 00 –

Decisions

42. NABL 217 Assessment Forms and Checklist 01 16.01.2007 00 –

(Based on ISO 15189: 2003)

43. NABL 221 Bio-data of Assessors 01 02.08.2004 00 --

44. NABL 400 Directory of Accredited Testing - 01.02.2007 00 –

Laboratories

45. NABL 500 Directory of Accredited Calibration - 01.02.2007 00 –

Laboratories

46. NABL 600 Directory of Accredited Medical - 01.02.2007 00 –

Testing Laboratories

WITHDRAWN DOCUMENTS
S. Document Name Doc. Last Last Withdrawn Reasons
No. No. Issue No. Amend No. w.e.f.
1. Policy and Procedures for Assessment, NABL Included in
Surveillance & Re-Assessment of Laboratories 214 03 05 14.02.07 NABL 100

Note : 1. All NABL documents can be downloaded free of cost from NABL website :www.nabl-india.org
2. The Master list is updated on a regular basis and is also available on NABL website.

Editorial Board
Rajesh Maheshwari - Member
R. Srikanth - Member
NABL NEWS is quarterly published by
National Accreditation Board for Testing and Calibration Laboratories (NABL)
3rd Floor, NISCAIR, 14, Satsang Vihar Marg
New Mehrauli Road, New Delhi - 110067
Tel.: 011-26529718-20, 26526864, Fax: 011-26529716
E-mail: info@nabl-india.org, Website: www.nabl-india.org
Registered Office : Department of Science & Technology
Technology Bhavan, New Mehrauli Road, New Delhi-110016

NABL NEWS, ISSUE NO. 46, APRIL 2007 20