Nabl 123 PDF
Nabl 123 PDF
Nabl 123 PDF
NABL
NATIONAL ACCREDITATION
BOARD FOR TESTING AND
CALIBRATION LABORATORIES
SPECIFIC CRITERIA
for
CALIBRATION
LABORATORIES IN
RADIOLOGICAL
DISCIPLINE
ISSUE NO : 04
ISSUE DATE: 28.03.2008
AMENDMENT NO : 01
AMENDMENT DATE: 27.06.2012
AMENDMENT SHEET
Sl
Page
No.
Clause No.
5,13,
17
1,2,
Gen.
remarks
Date of
Amendment
27.06.2012
Amendment made
BMC changed to
CMC
Reasons
Signature
QO
Signature
Director
Adoption of
ILAC Policy
10
Page No: 1 / 18
PREFACE
This document clarifies NABLs stand on the accuracy and measurement capability levels.
NABL intends to uphold its policy of granting accreditation to laboratories as per their
requirements of accuracy and measurement capability.
These criteria are applicable to laboratories, which perform repetitive calibrations in various
parameters and desire accreditation from NABL.
These criteria provide guidelines for use by laboratories and those who are associated with the
programme of accreditation of calibration laboratories e.g. experts, assessors, officials engaged
with day-to-day activities of accreditation. These criteria cover all areas/ fields of calibration.
This document provides the laboratories with necessary information on the requirements for
assessment/ surveillance and to assist them in carrying out internal audit of their system.
The information in this document has been compiled in three parts.
PART I
General Guidelines for Accreditation of Calibration Laboratories
This part contains relevant information on general requirements of a laboratory engaged in
Calibration in the field of Radiological Measurements. The laboratory seeking accreditation
must comply with the requirements of ISO/ IEC 17025: 2005 and this document.
PART II
Specific Criteria for Accreditation of Calibration Laboratories
This part provides information on special requirements of the laboratories, which are specific to
the parameters covered in the respective fields
PART III
Guidelines Regarding Accuracy of Standards & Measurement Uncertainty in Calibration
This part contains guidelines of the Specified accuracies of measurement standard and
uncertainties of measurement generally achieved in laboratories using equipment and
instruments of different classes of accuracies/ uncertainties for different parameters under
Radiological measurements.
Page No: 2 / 18
CONTENTS
Sl.
Title
Page No.
Amendment Sheet
Preface
Contents
PART I
1
Scope
Organisation
Management System
Personnel
Equipment
10
PART - II
1
Scope
Environmental Conditions
10
10
11
12
Safety Precautions
12
Page No: 3 / 18
Sl.
Table
Page No.
PART - III
13
Radiological Measurement
14
Page No: 4 / 18
PART I
1.0
SCOPE
1.1
1.2
Calibration and Measurement Capability (CMC) is one the parameters that is used by
NABL to define the scope of an accredited calibration laboratory, the others being
parameter/quantity measured, standard/master used, calibration method used and
measurement range. The CMC is expressed as the smallest uncertainty that a
laboratory can achieve when calibrating the best existing device. It is an expanded
uncertainty estimated at a confidence level of approximately 95% corresponding to a
coverage factor k=2.
Note: Refer NABL 143 on NABL policy on Calibration and Measurement Capability (CMC) and
uncertainty in calibration
The laboratorys ability to achieve their claimed CMC shall be evaluated based on its
performance during the on-site assessment and by review of proficiency testing results,
wherein the laboratory has participated.
1.3
The definition of CMC implies that within its accreditation a laboratory is not permitted
to report a smaller uncertainty of measurement than the CMC endorsed on its scope of
accreditation. This means that the laboratory shall be required to state a uncertainty not
better than that corresponding to the CMC whenever it is established that the actual
calibration process adds significantly to the uncertainty of measurement. The CMC is
applicable only to the results for which the laboratory claims its status as accredited
laboratory. It is therefore a realistic means for customers to select and compare
accredited laboratories capabilities.
1.4
All the parameters for which accreditation is sought must be expressed in S.I. Units,
wherever applicable.
Page No: 5 / 18
2.0
staff,
equipment
and
traceability
of
its
calibration,
laboratory
3.0
ORGANISATION
3.1
The Calibration Laboratory shall be organized in such a way that all staff members are
aware of both the extent and the limitations of their area of responsibility.
This
organization shall specify and document the responsibility and authority of the Head of
the Calibration Laboratory/ Technical Manager/ Quality Manager with direct access to
the top management. All personnel will perform or verify work affecting the quality of
calibrations as per general guidelines and specific criteria laid down for the accredited
parameters. The calibration laboratory shall be organized in such a way so as to
ensure the integrity and training of its staff and operations for ensuring unbiased
Calibration.
3.2
A Deputy Head/ Technical Manager may also be nominated to take over the
responsibility in the absence of the Laboratory Head. In case there is no Deputy-incharge, the authorities concerned may appoint a suitable person to look after the
laboratory, under intimation to NABL. The laboratory shall also clearly define authorized
signatory for the calibration certificates/ reports issued by the laboratory.
Page No: 6 / 18
4.0
MANAGEMENT SYSTEM
4.1
The calibration laboratory shall have a Quality Manual which shall be maintained up-todate and available for scrutiny, in compliance with ISO/ IEC 17025: 2005 and NABL
requirements, with emphasis on following information:
a)
b)
c)
d)
e)
f)
g)
The reference list of all national/ international standards being referred to or used
in the performance of calibration work (copies of such standard specifications
should be available in the laboratory for the use of calibration staff.)
h)
All amendments made in any of the documents must be dated and listed in the
Quality Manual and brought to the notice of NABL.
4.2
The calibration facilities established in accordance with the general guidelines and
specific criteria shall be audited periodically and reviewed by or on behalf of the
management to ensure the continued effectiveness of the system.
4.3
The calibration laboratory shall clearly specify, document and make known to the
customers, the administrative and other procedures to be followed for getting
calibration done from the laboratory.
Page No: 7 / 18
4.4
The laboratory shall have authorized signatories for approving and issuing calibration
certificates for each calibration parameter as mentioned in the scope of accreditation.
Any officer competent to evaluate calibration results critically and occupying a position
involving responsibility for the adequacy of calibration results is eligible for approval by
NABL as an authorized signatory of endorsed calibration documents. Consequently
approved
authorized
signatories
must
demonstrate
understanding
of
these
requirements.
5.0
PERSONNEL
5.1
The calibration laboratory shall have adequate number of qualified competent and
trained personnel as follows:
Laboratory personnel performing calibration: Diploma in Engineering (relevant branch)
or Science graduate (with Physics) with 1 year of experience in the field of Radiological
Measurements and calibration practices in the relevant parameters.
Authorized Signatory: Bachelor of Engineering/Post Graduate in Science (relevant
branch) with 1 year of relevant experience or Diploma in Engineering (relevant branch)
with minimum 3 years of experience in the field of Radiological Measurements and
calibration practices.
5.2
5.3
The Head of the calibration laboratory shall be at least a Post Graduate in Physical
Science or Graduate in Electrical/ Electronics/ Instrumentation Engineering or
equivalent with specialised knowledge and adequate experience in precision
Radiological and other relevant parameter measurements. In exceptional cases, a
graduate in physics or diploma holder in Electrical or Electronics Engineering with long
experience could be accepted.
Page No: 8 / 18
6.0
6.1
Vibrations
The calibration area shall be adequately free from vibrations generated by central airconditioning plants, vehicular traffic and other sources to ensure consistent and uniform
operational conditions. The laboratory shall take all special/ protective precautions like
mounting of sensitive apparatus on vibration free tables and pillars etc., isolated from
the floor, if necessary.
6.2
Acoustic Noise
Acoustic noise level in the laboratory shall be maintained to facilitate proper
performance of calibration work. A threshold noise level of 60 dBA is recommended
unless otherwise stated.
6.3
Illumination
The calibration area shall have adequate level of illumination. Where permissible,
fluorescent lighting is preferred to avoid localized heating and temperature drift. The
recommended level of illumination is 450-700 lux on the working table with glare index
of 19 for the laboratory.
6.4
6.5
Page No: 9 / 18
7.0
EQUIPMENT
Each calibration laboratory should have measurement standards or equipment of
required accuracy in respect of each parameter covered by it in order to be able to
realize and to substantiate the corresponding measurement capability claimed.
Stability of the standards, accuracy of the values realized through them and
repeatability, should be regularly monitored.
Any bias resulting from ageing of standards should be precisely determined.
Instructions for operating each standard and equipment/ instrument should be readily
available for use by the laboratory staff members.
7.2
7.3
7.4
Proper record shall be maintained for each standard and equipment with the following
information:
a)
b)
c)
d)
e)
Details of Calibration
f)
g)
h)
Details of periodic calibration schedule of new and old standards and measuring
equipment should be worked out in consultation with higher accuracy laboratory and
this schedule should be observed.
Page No: 10 / 18
7.5
7.6
Any alterations in the observations/ data shall be signed by the calibration staff and
duly authenticated. Instructions to this effect should be printed on data sheet used for
writing observations/ data in the laboratory.
8.0
8.1
8.2
All the Standard Equipment of the Laboratory shall be calibrated periodically against
Calibration Standards of a laboratory accredited by NABL/ equivalent MRA partners
having superior measurement capability or NPL/ other international NMIs.
8.3
9.0
9.1
The result of calibration carried out by the calibration laboratory, shall be presented in a
comprehensive manner, using a standard format which shall unambiguously and
objectively present the measurement results and all relevant information in order to
facilitate easy comprehension and usage.
Page No: 11 / 18
9.2
The calibration report/ certificate shall include the following additional information:
a)
Date of receipt of the item and date of completion of the calibration work
b)
c)
d)
e)
f)
g)
9.3
The calibration report/ certificate shall not contain any recommendation on the
calibration interval except where this has been agreed with the client. This requirement
may be superseded by legal regulations.
10.0
10.1
Page No: 12 / 18
PART II
1.0
SCOPE
1.1
1.2
Sl.
Parameter
Activity radionuclides
Exposure
(Co-60 ref)
X-rays & Gamma rays
Dose equivalent
2.0
2.1
Page No: 13 / 18
3.0
ENVIRONMENTAL CONDITIONS
3.1
The lab shall specify limits on the environmental conditions to be achieved in the
laboratory. The condition shall appropriate to the level of accuracy required for the
calibration undertaken by the laboratory.
3.2
4.0
4.1
The calibration laboratory shall make arrangement for regulated and uninterrupted
power supply. The recommended regulation level is 1 % or better on the calibration
bench.
4.2
Relevant IS specifications (IS : 1248 , IS : 4722 ) regarding total harmonic content and
variation in supply frequency should be followed. Voltage stabilizers of low harmonic
content should be used to comply with this requirement.
4.3
4.4
The laboratory shall use if necessary, isolation transformers and filters etc. to ensure
minimization of ground current and effects of mains hum interference.
4.5
The power supply to the calibration laboratory shall be directly obtained from the sub
station as far as possible and shall not be on the same feeder line which is supplying
power to workshops and other production areas which require operation of heavy duty
machines.
4.6
Page No: 14 / 18
4.7
Special care shall be taken about the location of magnetic field sources like,
transformers, looped wires, ferrous materials etc., in order to minimize magnetic
interference in the measurements.
4.8
4.9
4.10
The laboratory shall be sealed against dust and external air pressure. Wherever
required positive air pressure shall be maintained inside the laboratory.
4.11
Adequate protective measures, like use of transient suppressors etc. shall be taken by
the laboratory to ward off high current spikes and transients emanating from witching
off and on the heavy machines, surges in power lines and other such reasons from
reaching the electronics equipment in general and computer based systems involving
data storage facilities in particular.
5.0
5.1
A separate repair and maintenance facility adequately equipped with repair facilities
and qualified & experienced manpower shall be available in house or by any other
means effectively accessible to the calibration laboratory. This facility shall also assist
in identifying the preventive maintenance procedures, which should be brought to the
attention of the personnel engaged in calibration work for taking necessary precautions.
The repair facility should cover digital and programmable instruments also.
Page No: 15 / 18
5.2
6.0
6.1
6.2
7.0
SAFETY PRECAUTIONS
7.1
Relevant fire extinguishing equipment for possible fire hazards shall be available in the
corridors or convenient places in the laboratory. Adequate safety measures against
electrical/ chemical fire hazards must be available at the work place. Laboratory rooms/
areas where highly inflammable materials are used/ stored should be identified.
Access to relevant fire equipment should be assured near these rooms/ areas.
7.2
Specifications SP.3.1 1986, a special publication in the form of a wall chart, giving the
method of treatment in case of electric shock, should be followed. The chart should be
placed near the power supply switchgear and at other prominent places as prescribed
under Indian Electricity Rules 1956.
7.3
Means shall be provided for Safety against radiation hazards in the laboratory. Special
warning and protection devices shall be available for the safety of workers.
Page No: 16 / 18
PART III
GENERAL REMARKS
The following pages may be referred as guidelines and not mandatory recommendations for the
laboratories. The accredited calibration laboratories are no longer required to be categorized
into Echelon/ level I, II, III. Part III of this document is aimed to provide guidance to the
laboratories regarding the precautions they should take with respect to Environmental
conditions as appropriate to respective Calibration and Measurement Capability of the
laboratories. The laboratories, on their own, should decide/ determine to have environmental
conditions in their premises, for the Calibration and measurement capability claimed
corresponding to their scope of accreditation applied for. Further to note that:
1)
2)
3)
ENVIRONMENTAL CONDITIONS
Standards atmospheric condition for calibration in a Radiological Measurement Laboratory shall
be as follows:
Level
II
Temperature
25 C 0.5 C
Relative humidity
35 C to 65%
III
25 C 2.5 C
0
25 C 4.0 C
35 C to 65%
Page No: 17 / 18
TABLE-I
RADIOLOGICAL MEASUREMENTS
Parameter
Range
Level-I
-2
-2
1.
Activity
radionuclides
10 to 10 Bq
2.
Yield of neutron
Sources
10 to 10 ns
3.
Thermal
neutron flux
density
10 to 10 n cm S
4.
Fast neutron
flux density
(14MeV)
10 to 10 n cm S
5.
Exposure
(Co-60 ref)
10 to 10 kg
X-rays &
Gamma rays
5x10 to
-5
-1
5x10 C kg
Absorbed dose
(fast electrons
X-rays and
gamma rays
6.
7.
Level-II
Level-III
Field Requirements
Medical
Industrial
0.3 to 1% 3%
10%
5% (10 to
20%)**
10 to 20%
0.7 to
1.2%
5%
10%
20 to 30%
-1
2%
5%
10%
20 to 30%
-1
4%
7%
15%
5%
20 to 30%
0.8%*
2%
3%
5%
10 to 15%
3%*
7%
10%
15%
15%
10 to 15 Gy
2%*
3%
5%
5 to 10%
(Co-60)
0.1 to 5 Gy
1%*
2%
3%
5%
Dose
equivalent
10 to 10 Sv
15%
25%
30 to50%
30 to50%
-3
-1
-1
-7
-4
-2
-1
-4
1Ci = 3.7x10 Bq
-1
IR = 2.5x 10 C.Kg.
* 2 level
Others are at 1 level
Page No: 18 / 18