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NABL 103

National Accreditation Board for Testing


and Calibration Laboratories (NABL)

Specific Criteria for Chemical


Testing Laboratories

ISSUE NO. : 04 AMENDMENT NO. : 02


ISSUE DATE : 25-Apr-2016 AMENDMENT DATE : 19-Feb-2018
AMENDMENT SHEET

Sl Page Clause Date of Amendment Reasons Signature Signature


no No. No. Amendment QM CEO
1 11/53 5.2.5 09.03.2017 Quality Manager Uniformity with Sd/- Sd/-
qualification other discipline

2 33-45 ---- 19.02.2018 Alignment of Product Internal review Sd/- Sd/-


group classification as & Internal
highlighted & addition of feedbacks
new group-Wood &
wood product. Deletion
of repeated groups

10

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 103 Specific Guidelines for Chemical Testing Laboratories
Issue No: 04 Issue Date: 25-Apr-2016 Amend No: 02 Amend Date: 19-Feb-2018 Page No: 1/53
ABBREVIATIONS

AOAC : Association of Official Analytical Chemists


APHA : American Public Health Association
APLAC : Asia Pacific Laboratory Accreditation Cooperation
AS : American Standard
ASTM : American Society for Testing and Materials
BIS : Bureau of Indian Standards
BIPM : Bureau International des Poids et Measure (International Bureau of
Weights and Measures)
BS : British Standard
CRM : Certified Reference Material
ISO : International Organization for Standardization
EA : European Cooperation for Accreditation
FTIR : Fourier Transform Infrared
GFAAS : Graphite Furnace Atomic Absorption Spectrometer
e.g. : For Example
GUM : Guide to the Expression of Uncertainty in Measurement
ICP-AES : Inductively Coupled Plasma - Atomic Emission Spectrometer
ICP-MS : Inductively Coupled Plasma – Mass Spectrometer
IEC : International Electrotechnical Committee
ILAC : International Laboratory Accreditation Cooperation
IUPAC : International Union of Pure and Applied Chemists
NABL : National Accreditation Board for Testing and Calibration Laboratories
NATA : National Association of Testing Authorities
NIST : National Institute of Standards and Technology
NMR : Nuclear Magnetic Resonance
QC : Quality Control
w.r.t. : With Respect To
NBC : National Building Code

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 103 Specific Guidelines for Chemical Testing Laboratories
Issue No: 04 Issue Date: 25-Apr-2016 Amend No: 02 Amend Date: 19-Feb-2018 Page No: 2/53
CONTENTS

Sl Title Page
Amendment Sheet 1

Abbreviations 2

Contents 3

1. Introduction 4

2. Terms and Definitions 5

3. Scope 6

4. Management Requirements 8

5. Technical Requirements 10

6. GroupWise Codification for Chemicals Tests 29

7. References 45

Annexure – A : Scope of Accreditation 46

Annexure – B : Equipment Calibration Intervals 49

Appendix – A : Calibration of Common Test Equipment 50

Appendix – B : Calibration of Instrumentation (Comparative Techniques) 53

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 103 Specific Guidelines for Chemical Testing Laboratories
Issue No: 04 Issue Date: 25-Apr-2016 Amend No: 02 Amend Date: 19-Feb-2018 Page No: 3/53
1. INTRODUCTION

1.1 The requirements for accreditation are laid down in the International Standard ISO/IEC
17025: 2005 (General requirements for the competence of calibration and testing
laboratories). These requirements apply to all types of objective testing but in certain
instances additional guidance is necessary to take account of the type of testing and the
technologies involved.

1.2 This document has been prepared by a Technical Committee constituted by NABL as a
supplement for ISO/ IEC 17025: 2005 standard and sets out additional technical
requirements specific to chemical testing discipline.

1.3 Laboratories conducting tests on food/water should also consult NABL Specific Criteria
on Biological testing (NABL – 102).

National Accreditation Board for Testing and Calibration Laboratories


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2. TERMS AND DEFINITIONS:
For the purpose of reference few definitions have been described, however the final
version of VAM definitions would prevail.
2.1 Reference Material
A reference material (RM) is a material or substance one or more properties of which are
sufficiently established to be used for the calibration of an apparatus, the assessment of
a measurement method, or for assigning values to materials.

2.2 Certified Reference Material


A certified reference material (CRM) is a reference material one or more of whose
property values are certified by a technically valid procedure, accompanied by, or
traceable to a certificate or other documentation which is issued by a certifying body.
2.3 Sample
A portion of material selected to represent a larger body of material.

2.4 Sample handling


This refers to the manipulation to which samples are exposed during the sampling
process, from the selection of the original material through to the disposal of all samples
and test portions.

2.5 Sub-sample
This refers to a portion of the sample obtained by selection or division; an individual unit
of the lot taken as part of the sample or; the final unit of multistage sampling

2.6 Sample preparation


This describes the procedures followed to select the test portion from the sample (or
subsample) and includes: in-laboratory processing; mixing; reducing; coning and
quartering; riffling; and milling and grinding.

2.7 Test portion


This refers to the actual material weighed or measured for the analysis.

2.8 Traceability
‘Property of the result of a measurement or the value of a standard whereby it can be
related to stated references, usually national or international standards, through an
unbroken chain of comparisons all having stated uncertainties’ (VIM 1993 - Ref B6).

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 103 Specific Guidelines for Chemical Testing Laboratories
Issue No: 04 Issue Date: 25-Apr-2016 Amend No: 02 Amend Date: 19-Feb-2018 Page No: 5/53
3. SCOPE

3.1 The Scope of accreditation of a laboratory is the formal statement of the range of
activities for which the laboratory has been accredited; the scope is recorded in detail on
a laboratory’s accreditation certificate. A laboratory’s scope should be defined as
precisely as possible so that all parties concerned know accurately and unambiguously
the range of tests / Limit of Quantification (LOQ)/Limit of Detection (LOD) and/or
analyses covered by that particular laboratory’s accreditation.
The guideline for the applicant laboratories to describe group of products, material or
items tested for scope of accreditation is given in section-6. The format to write scope of
accreditation is given in NABL-151 and is presented with few examples for
understanding (Annexure A).

3.2 There are many tests where measurement stage may be covered by a single method.
However, the methods used to prepare the samples for subsequent analysis may vary
considerably according to the nature of the analyte and sample matrix.
In such cases the statement in the column, ‘Specification, standard (method) or
technique used’, of format to write scope of accreditation will normally take the form of
“Documented In-House Methods”, which should elaborate on methods used to prepare
samples or both standard method for preparation for sample and for measurement stage
may be written.

3.3 Where a laboratory uses analytical tools such as mass spectrometry, NMR or FTIR, it
may be appropriate to use the terms qualitative and/or quantitative chemical analysis
under the type of test heading. However, the onus will be on the laboratory to
demonstrate to the assessors that in using these techniques, it is meeting all of the
criteria for accreditation. In particular, the experience, expertise and training of the staff
carrying out the tests and those interpreting the data involved will be a major factor in
determining whether or not such analyses can be accredited.

It is accepted that sometimes it is not practicable for laboratories to use a standard


method in the conventional sense with an instrument specifying each sample type and
determinant.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 103 Specific Guidelines for Chemical Testing Laboratories
Issue No: 04 Issue Date: 25-Apr-2016 Amend No: 02 Amend Date: 19-Feb-2018 Page No: 6/53
In this case, the laboratory must have its own method or procedure for the use of the
instrument in question, which includes a protocol defining the approach to be adopted
when different sample types are analysed. Full details of the procedures, including
instrument parameters, used must be recorded at the time of each analysis such as to
enable the procedure to be repeated in precisely the same manner at a later date.
Where a particular analysis subsequently becomes routine, a full method as required by
NABL must be written and followed. The statement in the column of the methods
schedule will normally take the form of “Documented In-House Methods” using GC-
MS/NMR/FTIR, ICP-MS, XRF and XRD etc. (Refer ISO/IEC 17025: 2005 para 5.4.2,
5.4.3, 5.4.4 and 5.4.5). Whenever there are deviations from standard method or
inadequate clarification in Standard Method, the laboratory needs to develop effective
procedure for ensuring the quality of results.

Note: Wherever Sampling is a part of Test method, it shall not be included as test in the
recommended scope.

3.4 Laboratory can apply for addition or amendment in the scope at any time by writing to
NABL of the tests, which it wishes to add to its scope, by providing the following
information to NABL in the formats given in NABL 151:
 Scope to be added
 List of authorized manpower
 List of equipments
 List of CRMs
 Quality assurance including PT/ILC participation

In addition to the above the laboratory should also provide a layout plan showing the
area where it plans to conduct additional tests as relevant.

National Accreditation Board for Testing and Calibration Laboratories


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Issue No: 04 Issue Date: 25-Apr-2016 Amend No: 02 Amend Date: 19-Feb-2018 Page No: 7/53
4. MANAGEMENT REQUIREMENTS

4.1 The internal management system documents shall be comprehensively reviewed for
suitability at appropriate frequency to be documented by the lab. The procedure for
document control shall include the control of external documents including standard test
methods. Evidence of ensuring the revision status of the standard test methods shall be
available.

4.2 Laboratory can subcontract testing to another accredited laboratory under unavoidable
circumstances only like instrument breakdown, unavailability of trained staff for a short
period. The subcontracting of any test, for which the laboratory is not accredited, is
done, then the laboratory cannot claim accreditation status while incorporating the
results of these test(s) in their test report, even if the test(s) is/are performed in an
accredited laboratory.

Laboratory shall clearly identify the subcontracted tests in the test reports as described
in NABL 133.

If an accreditation body allows CAB to include results of subcontracted tests or


calibrations in its endorsed reports or certificates, the accreditation body shall define
such circumstances. These shall include:

 the accredited laboratory takes full responsibility for the subcontracted tests or
calibrations and, unless it is an accredited branch of the same laboratory, has
informed the customer of the proposed subcontracting and has obtained his/her
prior approval;
 approval has been obtained from the subcontractor to report excerpts from the
subcontractor’s report or certificate;
 the subcontractor is itself accredited for the specific tests or calibrations
concerned and the results have been included in the subcontractor laboratory’s
endorsed report or certificate.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 103 Specific Guidelines for Chemical Testing Laboratories
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4.3 Storage requirements and shelf life (where applicable) of the various chemicals and
other critical consumables which can deteriorate over a period of time shall be
documented. In case of various solutions prepared, the container should be labeled
incorporating the name of the solution, date of preparation and date of expiry. The
quality of water used shall be checked to ensure its compliance with the requirements of
the intended use.

4.4 Verbal complaints shall also be registered by the laboratory.

4.5 Deficiencies encountered such as poor performance in ILC/PT, non repeatability of test
results while performing quality checks shall be registered as non conforming testing
work and suitable corrective actions taken after conducting root cause analysis.

4.6 Records of personnel including training records shall be kept permanent - i.e. so long as
the person is working in the laboratory. Similarly, history of individual equipments shall
be kept permanent – so long as the equipment is used in the laboratory.

4.7 Internal audit of the laboratory shall be conducted at least once in 12 months and shall
cover all the sections including the testing section(s) and covering all the applicable
requirements of ISO/IEC 17025:2005 and NABL 103. The technical audit should be
conducted by a trained auditor who is qualified and conversant with the technical
activities performed. Specific observations about the key requirements of the standard
ISO/IEC 17025:2005, both positive and negative shall be recorded by the auditor to give
evidence of having covered all the elements of the standard. Apart from conducting
horizontal audit covering all applicable elements of ISO/IEC 17025:2005, Vertical audit
should also be conducted. For this purpose different samples or test reports covering the
entire period and commensurate with the number of samples between internal audits
shall be selected and compliance with management and technical requirements shall be
verified.

For meeting requirement of Internal Audit in the Laboratory having different Section must
have sufficient no's of Technical Personnel (apart from Technical Manager & Quality
Manager) having formal training on Internal Audit for avoiding the conflict of Interest.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 103 Specific Guidelines for Chemical Testing Laboratories
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5 TECHNICAL REQUIREMENTS

5.2 Personnel

5.2.1 The Technical Manager of a Chemical testing laboratory shall be a person preferably
having a recognized post graduate degree in science or Bachelor degree in engineering
or specialized course and at least two years experience in analysis/R&D/quality control.

The minimum qualification for the technical staff in a Chemical testing laboratory shall be
Graduate in Science with chemistry as one of the subjects or Diploma in chemical
engineering / technology or equivalent or specialization in relevant fields like Textile,
Polymer, Food etc. The staff shall have sufficient training and exposure in analytical
chemistry and in analysis and testing of appropriate products. All technical staff must
have minimum training in requirements of ISO/IEC 17025. Training record and
evaluation for effectiveness of training for the System must be documented.

Note: The technical personnel who perform chemical testing should be free from colour
blindness, evidence for which is necessary.

5.2.2 Authorized signatory should fulfill either of the following requirements:


Minimum Years of Two Five Ten
Experience
Minimum
Qualifications
Degree (Engg.) / Same field of Similar field of --
Post Graduate in Science testing testing
Diploma (Engg.) / -- Same field of Similar field of
Graduate in Science testing testing
ITI / Equivalent -- -- Same field of
testing

Note -
(a) Similar field may be considered when that particular subject / field of testing is
covered in at least one year of the course;
(b) Qualification with specialized field like food, civil, textile, pharma, metallurgy,
plastic, rubber etc. shall be considered eligible for groups falling under multi-
disciplines;

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 103 Specific Guidelines for Chemical Testing Laboratories
Issue No: 04 Issue Date: 25-Apr-2016 Amend No: 02 Amend Date: 19-Feb-2018 Page No: 10/53
(c) In each case, merely requisite qualifications and experience is not sufficient to
become the Authorized signatory; the technical competence will be verified by
NABL assessment team before recommending as authorized signatory.

5.2.3 Chemical testing laboratory involved in testing different group of products, material or
items must have a minimum one number of technical staff involved in testing of that
group of products, material or items in addition to authorized signatory. The laboratory
should justify total staff with reference to volume of work handled. The in-charge shall
have adequate relevant experience in addition to the minimum qualification as specified
in 5.2.1.

5.2.4 There shall be a system for imparting periodic, internal and external training to the
laboratory technical staff at different levels wherever required before assigning any
analytical and testing work. Internal trainings must be documented in detail providing
identity of trainer, training contents, duration, methodology, identity of participants.

Internal Training alone may not be considered adequate to make the staff
knowledgeable on the latest status of science and technology. It must be supplemented
if required with external training. The duration of the external training should
commensurate with contents and conducted / organized by Universities, Research
Institutes, Professional Bodies, Industry, Associations / NGOs or other recognized
organizations. The certificate of successful completion of training should be available.

In addition relevant laboratory staff particularly Technical Manager / Authorized


Signatory should also participate in awareness programs / workshops / conferences to
update them on knowledge of laws or protocols in the group of products, material or
items tested so as to remain updated on latest in their field.

Feedback by participants on training and evaluation of participants by laboratory are two


important elements of the training activity and must be documented.

5.2.5 Quality Manager shall have undertaken at least 4-day training course on requirements of
ISO/IEC 17025:2005.

5.2.6 Any testing conducted away from the base laboratory (such as in field laboratories, in a
mobile testing laboratory or in the field) must also be under adequate technical control.
National Accreditation Board for Testing and Calibration Laboratories
Doc. No: NABL 103 Specific Guidelines for Chemical Testing Laboratories
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This would normally require either the location of Authorized Signatory at each facility or
having an Authorized Signatory visit each facility at appropriate intervals commensurate
with the volume, complexity and range of such tests and the maintenance of a diary
recording the dates and relevant activities of each visit.

5.3 Environment and Accommodation Condition

5.3.1 Laboratory accommodation and layout should consider provision of areas for -
(a) Sample receipt and customer dealing (b) Sample pre-treatment (c) Sample storage
(d) Storage for chemicals/ consumables (e) Test areas as for wet analysis; heating,
digestion & extraction; instrumentation (f) In-house calibration (g) Maintenance (h)
Stores say for records (i) Waste management (j) Reporting (k) miscellaneous as per the
requirements of the lab. This does not necessarily mean separation by walls and may
vary widely depending upon group of products, material or items tested for which the
laboratory seeks or maintains accreditation.

Samples, reagents, measurement standards and reference materials must be stored so


as to ensure their integrity. In particular, samples must be stored in such a way that
cross contamination is not possible. The laboratory should guard against their
deterioration, contamination and loss of identity.

Floor wise laboratory layout giving dimensions and highlighting the above provisions
should be provided in Quality Manual. Drawings shall show key equipment. Future space
requirements can be shown in shaded.

Laboratory shall maintain, monitor and record environmental conditions (air quality,
ventilation, temperature, humidity, luminance, noise and vibration levels, radiation, and
electromagnetic disturbances) for proper working as per the requirements of the test
specifications. The laboratory environment should be sufficiently uncrowned, clean and
tidy to ensure the quality of the work carried out is not compromised. See 5.3.2 for more
details.

5.3.2 There shall be effective separation between neighbouring areas in which incompatible
activities are being performed in laboratories that cover different products and tests.
Typical Examples are separate areas for handling of test items and sample preparation.
Even though analysis of trace metals/residues may be done on same AAS/GC-MS, but
sample handling, storage and preparation areas for food samples and sewage shall be

National Accreditation Board for Testing and Calibration Laboratories


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different. Separate area shall be available for proper storage and maintenance of field
monitoring equipments.

5.3.3 It may be necessary to restrict access to particular areas of laboratory because of the
nature of the work carried out there. Restrictions might be made because of security,
safety, or sensitivity to contamination. Typical examples might be work involving
explosives, radioactive materials, carcinogens, toxic materials and trace analysis. Where
such restrictions are in force, staff should be aware of:
i. the intended use of a particular area;
ii. the restrictions imposed on working within such areas;
iii. the reasons for imposing such restrictions

5.3.4 Health and Safety


One key responsibility of the laboratory management is to provide safe working
environment which include the following:
 head and eye shower
 cleaning and decontamination procedures for radioactive spills,
 waste disposal
 evacuation procedures including a plan of the facility showing the location of
safety equipments and fire extinguishers/sand bucket,
 protective clothing eg. gowns, coats, gloves, goggles etc
 Appropriate fume evacuation system
 routine cleaning and disinfection for work benches, floors, centrifuges,
Refrigerators, etc
 handling hazardous substances

Fire Safety: Laboratory shall follow latest norms as per NBC of India.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 103 Specific Guidelines for Chemical Testing Laboratories
Issue No: 04 Issue Date: 25-Apr-2016 Amend No: 02 Amend Date: 19-Feb-2018 Page No: 13/53
Fume hoods: Laboratory operations often involve use of toxic, hazardous or odoriferous
chemicals. The handling of these chemicals particularly digestion activities should be
safely performed in a fume hood. The size and type of fume hood (Bench or Walk-in)
shall depend upon lab requirements and volume of work. The non AC labs may use
conventional type or automatic by-pass fume hoods. The AC labs shall use auxiliary or
variable flow volume fume hoods.

A dedicated fume hood is required for extensive usage of perchloric acid greater than
50% of total chemical usage.

Note: A dedicated hood is required because; organic chemicals should not be used
with perchloric acid. Explosion may occur when perchloric acid reacts with
organic materials. Fume hood manufacturer shall be contacted for specific
materials requirements if any for explosion proof electrical fixtures or for
radiological purposes.

Personal Protection Equipments: Suitable protective clothing/equipment must be


available at all the times in the laboratory. The nature of these items will be dependent
on the work being undertaken and might include: laboratory coats/gowns; disposable
gloves; rubber gloves; heat/cold resistant gloves; protective eye wear; face masks;
plastic/rubber aprons; foot wear. The laboratory should list out its requirements
depending upon material or items tested in its health and safety manual.

Dedicated emergency Safety Shower/Safety-cum Eye shower shall be available in


clear approachable area away from electrical service within easy accessibility from
relevant work areas). Individual eye wash units may also be provided. Unit design shall
provide twin stream nozzles to flush both eyes at once, and in a hands-free mode. Unit
shall be securely positioned in place, universally reachable, preferably installed at a sink,
away from any obstructions. Safety shower signage/ Eyewash signage shall be
provided. These shall be installed as per manufacturer’s instruction and shall be
standard equipments.

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Gas Cylinder Storage: Cylinders shall not be stored in test areas. Cylinders storage
areas shall be prominently identified as to the type gas contained. All gas cylinders shall
be secured with appropriate restraints (like chain). Where permanent connection hoses
and lines are provided for cylinder gases, they shall be marked to identify the gas they
contain and the direction of gas flow.
Laboratory should ensure that it has taken necessary steps to meet the
Regulatory requirement of respective pollution control board for waste disposal.

5.4 Test Methods and Method Validation:

5.4.1 Laboratory should generally use standard methods/internationally published methods/in-


house validated methods.

5.4.2 The validation of a standard or collaboratively tested methods should not be taken for
granted, no matter how impeccable the method's pedigree - the laboratory should satisfy
itself that the degree of validation of a particular method is adequate for the required
purpose, and that the laboratory is itself able to verify any stated performance criteria.

5.4.3 Methods developed in-house must be adequately validated, documented and authorised
before use. Where they are available, matrix matched reference materials should be
used to determine any bias, or where this is not possible, results should be compared
with other technique(s), preferably based on different principles of measurement.
Measurement of the recovery of gravimetrically added spike analyte, measurement of
blanks and the study of interferences and matrix effects can also be used to check for
bias or imperfect recovery. Estimation of uncertainty must form part of this validation
process and in addition to covering the above factors, should address issues such as
sample homogeneity and sample stability.

5.4.4 Laboratory, whenever using non-standard methods or a standard method beyond the
stated limits of operation is required to validate such test methods. The guidance
document on Validation of Test Methods; Eurachem Guide for Method Validation and
Related Topics (1998) may be referred.

5.4.5 The important performance characteristics for method validation include:

a) Selectivity: Selectivity of a method refers to the extent to which it can determine


particular analyte(s) in a complex mixture without interference from the other
components in the mixture. A method which is perfectly selective for an analyte
National Accreditation Board for Testing and Calibration Laboratories
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or group of analytes is said to be specific. The applicability of the method should
be studied using various samples, ranging from pure standards to mixtures with
complex matrices. In each case the recovery of the analyte(s) of interest should
be determined and the influences of suspected interferences duly stated. Any
restrictions in the applicability of the technique should be documented in the
method.

b) Range: For quantitative analysis the working range for a method is determined
by examining samples with different analyte concentrations and determining the
concentration range for which acceptable uncertainty can be achieved. The
working range is generally more extensive than the linear range, which is
determined by the analysis of a number of samples of varying analyte
concentrations and calculating the regression from the results, usually using the
method of least squares. The relationship of analyte response to concentration
does not have to be perfectly linear for a method to be effective. For methods
showing good linearity it is usually sufficient to plot a calibration curve using
measurement standards at 5 different concentration levels (+ blank). More
measurement standards will be required where linearity is poor. In qualitative
analysis, it is common place to examine replicate samples and measurement
standards over a range of concentrations to establish at what concentration a
reliable cut-off point can be drawn between detection and non-detection

c) Linearity: Linearity is determined by the analysis of samples with analyte


concentrations spanning the claimed range of the method. The results are used
to calculate a regression line against analyte calculation using the least squares
method. It is convenient if a method is linear over a particular range but it is not
an absolute requirement. Where linearity is unattainable for a particular
procedure, a suitable algorithm for calculations should be determined
Note: Linearity to be conducted for standard as well as matrix match standard.

d) Sensitivity: Sensitivity is the difference in analyte concentration corresponding to


the smallest difference in the response of the method that can be detected. It is
represented by the slope of the calibration curve and can be determined by a
least squares procedure, or experimentally, using samples containing various
concentrations of the analyte.

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e) Limit of Detection: Limit of Detection of an analyte is determined by repeat
analysis of a blank test portion and is the analyte concentration whose response
is equivalent to the mean blank response plus 3 standard deviations. Its value is
likely to be different for different types of sample.

f) Limit of Quantification: Limit of Quantification is the lowest concentration of


analyte that can be determined with an acceptable level of accuracy and
precision. It should be established using an appropriate standard or sample, i.e. it
is usually the lowest point on the calibration curve (excluding the blank). It should
not be determined by extrapolation.

Note:
 Quantification: The batch of unknown samples for estimation of an analyte
must be analysed in parallel with spiked sample for quantitative estimation
of an analyte. The calculation of an analyte should not be on standard
solutions.
 Confirmatory Analysis: The positive detection of an analyte in any matrix
has to be confirmed by using the confirmatory technique of analysis
including the mass spectrometry.

g) Ruggedness: Sometimes also called robustness. Where different laboratories


use the same method they inevitably introduce small variations in the procedure,
which may or may not have a significant influence on the performance of the
method. The ruggedness of a method is tested by deliberately introducing small
changes to the method and examining the consequences. A large number of
factors may need to be considered, but because most of these will have a
negligible effect, it will normally be possible to vary several at once. The
technique is covered in detail by the AOAC (8). Ruggedness is normally
evaluated by the originating laboratory, before other laboratories collaborate

h) Accuracy: The accuracy of a method is the closeness of the obtained analyte


value to the true value. It can be established by analysing a suitable reference
material. Where a suitable reference material is not available, an estimation of
accuracy can be obtained by spiking test portions with chemical standards. The
value of spiking is limited; it can only be used to determine the accuracy of those
stages of the method following the spiking. Accuracy can also be established by
National Accreditation Board for Testing and Calibration Laboratories
Doc. No: NABL 103 Specific Guidelines for Chemical Testing Laboratories
Issue No: 04 Issue Date: 25-Apr-2016 Amend No: 02 Amend Date: 19-Feb-2018 Page No: 17/53
comparison with results obtained by a definitive method or other alternative
procedures and via inter-comparison studies.

Note: Accuracy to be estimated at LOQ level and further at 5, 10 or 50 times of


LOQ.
i) Precision: Precision of a method is a statement of the closeness of agreement
between mutually independent test results and is usually stated in terms of
standard deviation. It is generally dependent on analyte concentration, and this
dependence should be determined and documented. It may be stated in different
ways depending on the conditions in which it is calculated. Repeatability is a type
of precision relating to measurements made under repeatable conditions, i.e.
same method; same material; same operator; same laboratory; narrow time
period. Reproducibility is a concept of precision relating to measurements made
under reproducibility conditions, i.e. same method; different operator, different
laboratories; different equipment; long time period.

Note : Laboratories are estimating the linearity during validation of method where
the performance of different linear concentration of standards are studied,
however for Pesticide residue analysis along with linearity standard the laboratory
must estimate matrix match standard linearity. For this laboratory must have the
pesticide free matrix at initially least one matrix from the group of products.

Pesticide Residue Testing Laboratories should include in the validation that the
accuracy studies by spiking the matrix or sample at LOQ level, five times of LOQ
and ten or fifty times of LOQ.

Accreditation is normally granted only for nationally or internationally accepted standard


test procedures or non-standard procedures (in-house methods) that have been
appropriately validated and which are performed regularly.

5.4.6 When standard methods are used, laboratories should verify their own satisfactory
performance against the documented performance characteristics of the method, before
any samples are analyzed. Records of the verification must be retained. For published
test methods that do not include precision data, the laboratory must determine its own
precision data based on test data. All methods should include criteria for rejecting
suspect results.

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Where a test can be performed by more than one method there must be documented
criteria for method selection. Where relevant the degree of correlation between the
methods should be established and documented.

Laboratory Procedures can be written to document the above aspects. It is preferable


that a common format be adopted for writing up methods and suitable guidance is given
in ISO 78-2:1982, Layout for Standards – part 2: Standards for chemical Analysis

5.4.7 When In-house methods (Non Standard methods) validation shall be undertaken. In-
house methods could include but not be restricted to:
(a) Methods developed in the laboratory
(b) Methods developed by a client
(c) Methods developed for an industry group
(d) Modified standard test methods
(e) Methods from scientific publications but which have not been validated

5.4.8 Validation of a method establishes, by systematic laboratory studies, that the


performance characteristics of the method meet the specifications related to the
intended use of the analytical results. The performance characteristics determined
include:
- Selectivity & specificity
- Range
- Linearity
- Sensitivity
- Limit of Detection
- Limit of Quantification
- Ruggedness
- Accuracy
- Precision

These parameters should be clearly stated in the documented method so that the user
can assess the suitability of the method for their particular needs.

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In theory the development should include consideration of all of the necessary aspects
of validation. However, the responsibility remains firmly with the user to ensure that the
validation documented in the method is sufficiently complete to fully meet his or her
needs. Even if the validation is complete, the user will still need to verify that the
documented performance can be met

5.4.9 Kits : Commercial test systems (kits) will require further validation if the laboratory is
unable to source the validation data from manufacturers with a recognized quality
assurance system, reputable validation based on collaborative testing e.g. AOAC Official
Methods and/or associated JAOAC publications, or independently reviewed methods
e.g. AOAC Performance Tested Methods.

5.4.10 Test and calibration methods and method validation/verification published by BIS,
ASTM, AOAC, etc may be followed.

5.4.11 Developments in methodology and techniques will require methods to be changed from
time to time. Obsolete methods should be withdrawn but must be retained for archive
purposes and clearly labeled as obsolete. The revised method must be fully
documented, and indicate under whose authority the new method was issued (signed
and dated).

5.4.12 Lab should provide UOM in different individual range in absolute unit terms instead of
percentage. It is important for testing laboratories to understand the concept of
uncertainty of measurement. Laboratory management should be aware of the effect that
their own uncertainty of measurement will have effect on test results produced in their
laboratory.

While the concept and application of measurement uncertainty estimations have been
well established in metrology and calibration laboratories, the same cannot be said for
testing laboratories. The publication of ISO/IEC 17025 has prompted rigorous discussion
Internationally on uncertainty of measurement in chemical testing and a consensus
agreement on the definitive methodology to be used for estimating uncertainty is still to
be finalised.

The following details the current requirements for laboratories accredited by NABL:
 Laboratories need to make a formal estimate of measurement uncertainty for all
tests in the scope of accreditation that provide numerical results.

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 Where an estimate of measurement uncertainty is required, laboratories need to
document their procedures and processes on how this is to be done. This should
be on the basis of EURACHEM and GUM where standard methods include
uncertainty factors; laboratories may use them for the estimates.

5.4.14 Use of Computer

When laboratories use equipment/instruments that make use of computers or have built
in computers or laboratories use Laboratory Information Management Systems (LIMS)
for the acquisition, processing, recording, reporting, storage or retrieval of test data, the
laboratory shall ensure that it uses licensed software’s. The laboratory should be able to
demonstrate if required control of access to computer systems and various functions
including that procedures are established and implemented for protecting the data.

5.5 Equipment

5.5.1 As part of quality system, a laboratory is required to operate a program for the
maintenance and calibration of equipment used in the laboratory. Equipment normally
found in the chemical laboratory can be categorised as:

i) general service equipment not used for making measurements or with minimal
influence on measurements (eg hotplates, stirrers, non-volumetric glassware and
glassware used for rough volume measurements such as measuring cylinders)
and laboratory heating or ventilation systems;

ii) volumetric equipment (e.g. flasks, pipettes, pyknometers, burettes etc);

iii) measuring instruments (e.g. hydrometers, U-tube viscometers, thermometers,


timers, spectrometers, chromatographs, electrochemical meters, balances etc);

iv) physical standards (weights, reference thermometers);

5.5.2 General Service Equipment


General Service equipment is maintained by appropriate cleaning and checks for safety
as necessary. Calibrations or performance checks will be necessary where the setting
can significantly affect the test or analytical result (eg the temperature of a muffle
furnace or constant temperature bath).

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5.5.3 Volumetric equipment

5.5.3.1 The correct use of volumetric equipment is critical to analytical measurements and it
shall be suitably maintained and calibrated as per Appendix B. The correct functioning of
some specialist volumetric (and related) glassware is dependent on particular factors, eg
the performance of pyknometers and U-tube viscometers is dependent on ‘wetting’ and
surface tension characteristics, which may be affected by cleaning methods etc. Such
apparatus may therefore require more regular calibration, depending on use. For the
highest accuracy, measurements can often be made by mass depending on properly
calibrated weighing mechanism with traceability to accredited calibration laboratories (in
INDIA or abroad APLAC/EA Member Countries) rather than by volume.

5.5.3.2 Attention should be paid to the possibility of contamination arising from the equipment or
cross-contamination from previous use. The type used (glass, PTFE, etc), cleaning,
storage, and segregation of volumetric equipment is critical, particularly for trace
analyses when leaching and adsorption can be significant.

5.5.4 Measuring instruments/equipments

5.5.4.1 General Guidelines on calibration requirements and intermediate checks for specific
items of equipment are detailed in Appendix B.

It must be stressed that these frequencies of calibration are considered to be the


minimum appropriate, provided that the Laboratory uses standard equipments, perform
regular intermediate checks and or regular performance checks.

Performance checks e.g to check the response, stability and linearity of sources,
sensors and detectors, the separating efficiency of chromatographic systems, the
resolution, alignment and wavelength accuracy are needed for many types of equipment
as spectrometers. The frequency of such performance checks will be determined by
experience and based on need, type and previous performance of the equipment.
Intervals between checks should be shorter than the time the equipment has been found
to take to drift outside acceptable limits.

Where the above criteria cannot be met or the relevant standard methods have specified
more stringent requirements, the same may be adopted.

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Chemical testing laboratories are recommended to have these items calibrated by an
accredited external agency. If chemical testing laboratories wish to calibrate these items
themselves, a full measurement uncertainty budget is expected to be estimated along
with the necessary infrastructure. Records of calibrations carried out in-house must
confirm traceability of measurement. This is normally achieved by the record specifically
identifying the reference item used, the date and the person performing the work using
the documented procedure.

Uncertainty of measurement estimations for periodic checks conducted on in-house on


calibrated equipment (i.e. conducted between full calibrations) are not required.

5.5.4.2 It is often possible to build performance checks – system suitability checks – into test
methods (eg based on the levels of expected detector or sensor response to calibrants,
the resolution of calibrants in separating systems, the spectral characteristics of
calibrants etc). These checks should be satisfactorily completed before the equipment is
used.

5.5.5 Physical standards

5.5.5.1 Wherever physical parameters are critical to the correct performance of a particular test,
the laboratory shall have access to the relevant reference standard, as a means of
calibration.

5.5.5.2 Reference standards and accompanying certificates should be stored and used in a
manner consistent with preserving the calibration status. Particular consideration should
be given to any storage advice given in the documentation supplied with the standard.

5.6 Calibration & Measurement Traceability

5.6.1 The overall program for the calibration of measuring equipment in the chemical
laboratory shall be designed to ensure that, where the concept is applicable, all
measurements are traceable through certificates held by the laboratory, either to a
national or international standard or to a certified reference material. Where no such
reference standard or certified reference material is available, a material with suitable
properties and stability should be selected or prepared by the laboratory and used as a
laboratory reference. The required properties of this material should be characterized by

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repeat testing, preferably by more than one laboratory and using a variety of methods,
see ISO Guide 35, Certification of reference materials – General and statistical
principles.

5.6.2 Analytical tests may be sub-divided into three general classes depending on the type of
calibration required:

(i) In general, standards exist for ensuring traceability to international or national


standards for equipment used for the direct measurement of fundamental properties
(e.g., mass, length, temperature and time) or the simpler derived properties (e.g.,
area, volume and pressure). Where these properties have a significant effect on the
results of an analysis, the requirements of ISO/IEC 17025: 2005 shall be met.

(ii) Where a test is used to measure an empirical property of a sample, such as


flashpoint, equipment is often defined in a national or international standard method
and traceable reference materials should be used for calibration purposes where
available. New or newly acquired equipment should be checked by the laboratory
before use to ensure conformity with specified design, performance and dimension
requirements.
(iii) Instruments such as chromatographs and spectrometers, which require calibration
as part of their normal operation, should be calibrated using traceable and certified
chemicals.
(iv) Laboratories may use chemicals of known purity in case on non-availability of CRM.

5.6.3 Reference materials and Chemical standards

5.6.3.1 Laboratories shall use CRM wherever applicable.

5.6.3.2 In case of matrix interferences, a standard should be validated using a matched matrix
reference material certified in a reliable manner. If such a material is not available it may
be acceptable to use a sample spiked with a chemical standard.

5.6.3.3 Reference materials and chemical standards should be clearly labeled so that they are
unambiguously identified and referenced against accompanying certificates or other
documentation. Information should be available indicating shelf-life, storage conditions,
applicability, restrictions of use, etc and records should be maintained.

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5.6.3.4 Reference materials and standards should be handled in order to safeguard against
contamination or loss of determinant. Training procedures should reflect these
requirements.

5.7 Sampling and Handling of Test Items

5.7.1 Sampling may refer to following set of procedures and or activities

1. Where a sample is to be collected for analysis from outside the laboratory by


laboratory personal (may be customer’s premises) e.g. collecting a sample of water
from customer’s tube well or taking a sample of cement from a lot at customer’s
godown or collecting a sample of ambient air in a city. The sampling shall be
undertaken as per standard sampling procedures. Laboratory should have proper
sampling formats to be used by its staff to record all information that is required as
per clause 5.10 of ISO-17025:2005 including any deviations from standard test
methods.
2. Where customer provides a sample for analysis (sampling is not done by laboratory)
even in this case laboratory should have procedures to verify from customer atleast
those aspects (sample conditions as fitness for testing) that may have a bearing on
the results and maintain records of same.
5.7.2 The test reports should clearly identify whether sampling is done by laboratory (in which
case sampling procedure followed should be mentioned) or sample is provided by
customer. Once a sample is received in laboratory (test item) further sub-samples may
be need to be taken/prepared as per standard test methods.
The observations in many cases taken on site as recording environmental conditions as
pressure, temperature, measuring onsite DO-levels, checking pH at the time of sampling
on site also does not constitute field laboratory, such measurements shall be recorded
as Field Observations in the test reports.

5.7.3 Sample identification

The samples should be collected in containers or otherwise, preserved and transported


to laboratory as per Standard methods and any deviations should be recorded. The
laboratory should have written procedures on sample collection, preservation and
transportation including providing identification labels in field and in laboratory.

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5.7.4 Sample registration

Laboratory shall uniquely identify and register the sample received in the laboratory to
establish audit trail.

5.7.5 Sample retention and storage

Laboratory shall define Sample retention criteria based on the sample stability and
conditions. Laboratory may appropriately retain the sample to enable retesting wherever
possible. The retention and storage should also be based on applicable regulatory
requirements.
Samples should be stored so that there is no hazard to laboratory staff and the integrity
of the samples is preserved. Storage areas should be kept clean and organized so that
there is no risk of contamination or cross-contamination, nor of packaging and any
related seals being damaged. Adequate environmental conditions should be maintained,
to avoid damage or degradation of the test material. Records of environmental
monitoring to be maintained. An appropriate level of security should be exercised to
restrict unauthorized access to the samples.

All staff concerned with administration of the sample handling system should be properly
trained. The laboratory should have a documented policy for the retention and disposal
of samples. The disposal procedure should take into account the guidelines set out
above.

5.7.6 Reagents

The laboratory should purchase reagents only from reliable and reputed manufacturers.

The laboratory should also ensure that the quality of the reagents used is appropriate for
the tests concerned. The grade of reagent used (including water) should be as stated in
the method together with guidance on any specific precautions which should be
observed in its preparation or use. These precautions include toxicity; flammability;
stability to heat, air and light; reactivity to other chemicals; reactivity to particular
containers; and other hazards.

Labeling of reagents should identify substance, strength, solvent (where not water), any
special precautions or hazards, restrictions of use, and date of preparation and/or expiry.

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The person responsible for the preparation of the reagent shall be identifiable either from
the label or from records.

Reagents used as primary standards for volumetric and gravimetric methods should
have traceability to National and International standards. In cases where primary
standards are not available the reagents should be analytical grade (e.g. AR or GR) and
it should have certificate of analysis from the manufacturer along with it.

Acids and alkalies prepared for volumetric analysis should be periodically checked for
their strength and documented properly.

5.9 Assuring the quality of Test Results

Analytical performance must be monitored by using quality control procedures


appropriate to the type and frequency of the testing undertaken. The range of quality
control activities available to laboratories include the use of:
certified reference materials / reference materials
internally generated quality control materials
independent checks by other analysts/examiners
statistical quality control charts
positive and negative controls
replicate testing
alternative methods
spiked samples, standard additions and internal standards
correlation of results for different characteristics of an item
retesting of retained items

Depending on the particular test/examination, one or more of these examples may be


appropriate. Quality control procedures must be documented. A record must be retained
to show that appropriate quality control measures have been taken, that quality control
results are acceptable or, if not, that remedial action has been taken. Where appropriate,
quality control data must be recorded in such a way that trends in analysis can be readily
evaluated. It is desirable to participate in proficiency testing for better quality assurance
of test results

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5.9.1 Proficiency Testing / Inter Laboratory Comparisons (PT/ILC)
Laboratories have to successfully participate in one PT/ILC program prior to applying for
accreditation as per ILAC P: 9. The PT/ILC participation shall be done not more than one
year prior to application date of accreditation. NABL strongly encourages the
laboratories to participate in the PT services accredited to ISO/IEC 17043. In case
laboratory conducts ILC program they should be conducted with 8-11 accredited
laboratories to evaluate the results statistically. In exceptional cases few reputed non
accredited laboratories can also be considered as participant.

Laboratory shall have a plan for PT/ILC participation as per NABL 162 / 163. The
requirements of initial accreditation shall be applicable when the laboratory adds
additional scope particularly new group or sub-group.

Laboratory shall submit the PT participation records as per the plan submitted to NABL
during the next accreditation cycle. Refer NABL 163.

5.9.2 Internal Quality Control

NABL strongly encourages the laboratory to use statistical QC chart as Internal QC


measures. The level and frequency adopted for internal quality control checks should be
demonstrably sufficient to ensure the validity of the results. As a guide, for routine
analysis the level of internal QC typically should be not less than 5% of the sample
throughout, i.e. 1 in every 20 samples analyzed should be a QC sample. For more
complex procedures, even 20% is not unusual. For analyses performed infrequently, a
full system validation should be performed This may typically involve the use of a
reference material containing a certified or known concentration of analyte, followed by
replicate analyses of the sample and spiked sample (a sample to which a known amount
of the analyte has been deliberately added). Those analyses undertaken more frequently
should be subject to systematic QC procedures incorporating the use of control charts
and check samples.

5.10 Reporting the Results


In addition to the compliance to the requirements of clause 5.10 of ISO/IEC 17025:2005,
laboratory shall define its policy on use of NABL symbol and follow the same. NABL
symbol shall be used strictly as per NABL-133.

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6 GROUPWISE CLASSIFICATION FOR CHEMICAL TESTS

The Chemical discipline is described in terms of groups and subgroups of test. Application for
accreditation may be made for one or more groups of tests or for subgroups or specific test
within a single group or subgroup. Where the existing group does not appear to cover the needs
of a laboratory, NABL secretariat welcomes proposals for additional groups or tests to be
included in this discipline. The scope of accreditation may be reviewed and extended on
request, provided that the laboratory complies with conditions for accreditation for the groups of
test or specific tests involved.

6.1 Adhesives
Starch based adhesives
Natural gums
Glues
Polymer based adhesives (Synthetic)
Physical Properties
Other

6.2 Animal Food & Feeds


Pet Foods
Rapeseed Meal
Cotton seed cake
Guar Meal
Poultry feed additives
Animal Nutrition Supplements
Oil Cake
Groundnut meal
Miscellaneous

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6.3 AYUSH Products
Ayurvedic drugs
Unani Drugs
Siddha Drugs
Homeopathic Drugs
Herbal formulations
Other

6.4 Atmospheric Pollution


Ambient air
Work Environment and Indoor Air Quality
Stack emission
Process/Vent Emissions
Vehicle emission
Fugitive emission
Ambient Noise Levels (Excluding vibration)
Source Noise Levels (Excluding vibration) Particular Source to be specified
Meteorological Parameters

6.5 Building Material


Aggregates
Bitumens & asphalts
Bricks & pre-casted blocks
Cement
Ceramics
Concrete
Construction chemicals
Fly ash
Gypsum & its products
Lime
Mortars

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Pozzolanic materials
Refractory materials
Sand
Water-proofing compounds
Other

6.6 Cosmetics & Essential Oils


Essential oils and other natural fragrant raw materials
Aromatic chemicals
Fragrances and Indian attars
Synthetic essential oils
Cosmetics and toiletries
Intermediates and miscellaneous chemicals for cosmetics
Herbal based cosmetics
Other

6.7 Corrosion tests


Salt Spray Tests
Dezincification Tests
Other

6.8 Drugs & Pharmaceuticals


Physical and Physiological Methods
Chemical Methods
Pharmaceutical Aid (Raw material except API)
Drug Substance (API)
Capsules
Creams
Ear Drops
Eye Ointment
Gels
Ointment

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Oral Liquids
Oral Powders
Parenteral Preparations
Tablets
Vitamins
Harmones
Other

6.9 Explosives & Pyrotechnics


Ammunitions
Industrial explosives & associated materials
Pyrotechnics
Explosive chemicals & allied materials
Physical Properties
Other

6.10 Fertilizers
Nitrogenous Fertilizers
Phosphatic Fertlizers
Potassic Fertlizers
Fertiliser Mixtures
Micronutrients
Macrnutrients
Fortified Fertilizers
Bio-Fertilizer
Other

6.11 Fire Fighting Equipments & Accessories


Aqueous film forming foam concentates
Dry Chemical Powder
Foam Concentrates
Other

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6.12 Food & Agricultural products (except Human Milk)
Bakery & confectionery products
Beverages (Alcoholic / Non-alcoholic)
Canned & processed foods
Cereals, pulses & cereal products
Coconut and coconut products/Narural Plant Derivatives/Products
Coffee & cocoa products
Edible colours & flavours
Edible oils & fats
Food additives & preservatives
Fruit & fruit products
Herbs, spices & condiments
Honey & honey products
Infant foods
Jams, juices, sauces & concentrates
Meat & meat products
Milk & dairy products
Natural waxes
Nuts & nut products
Oil seeds & by-products
Poultry & poultry products
Starch & starch products
Sugar & sugar products
Tea
Tobacco & tobacco products
Vegetables & vegetable products
Other

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6.13 Gases
Industrial Gases
Liquefied Gases
Compressed Natural Gas (CNG)/ Piped Natural Gas (PNG)
Gases for medical use and diving
Reference Gases & Mixtures
Other

6.14 Glass
Clear glass
Tinted glass
Reflective Glass
Stain Glass
Textured or pattern glass
Laminated Glass
Wired Glass
Other

6.15 Hazardous & Restricted Chemicals


Textile & Textile products
Toys and sports equipment
Computing & communications equipment
Consumer electronics
Lighting: lamps, lighting fixtures, light bulbs
Power tools
Automatic dispensers
Small household appliances
Large household appliances
Plastics & other polymeric products
Leather products
Prints
Zippers
Paints
Other

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6.16 Industrial & Fine Chemicals
Organic Chemicals
Inorganic Chemicals
Electroplating Chemicals
Chemicals used in Leather Industry
Chemical used in Rubber Industry
Chemical used in Textile Industry
Chemicals used in Electronic industry
Chemicals used in Photographic Industry
Chemicals used in Refrigeration industry
Chemicals used in Agriculture
Alcohols & Alcohols based Chemical
Disinfectants
Other

6.17 Inks, dyes & pigments


Duplicating inks
Dye intermediates
Inorganic pigment powder & pastes
Natural dyes & colouring materials
Organic pigment powder & pastes
Printing inks
Synthetic dyes
Writing inks
Other

6.18 Lac & lac products


Lac
Lac products
Other

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6.19 Leather
Finished leather
Leather accessories
Leather products
Semi-finished leather
Synthetic leather
Other

6.20 Lubricants
Oils & greases
Solid lubricants
Aviation lubricants
Lubricant additives
Microcrystalline wax
Insulation oils
Other

6.21 Marine /Aqua culture Food Products


Prawn & Prawn Products
Fish& Fish Products
Shrimps
Artemia & Artemia Products
Oyster
Crab & Crab Products
Other

6.22 Metallic coatings & treatment solutions


Anodising solutions
Conversion coatings
Metal finishing materials
Metallic coatings
Plating solutions
Others

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6.23 Metals & Alloys
Ferro-alloys
Carbon Steel (low carbon, medium carbon & high carbon steel)
Alloy steel
Stainless steel
Tool steel
Special Steel
Copper & its alloys
Aluminium & its alloys
Tin and tin alloys
Zinc & inc alloys
Lead & lead alloys
Magnesium & its alloys
Nickel & its alloys
Chromium & its alloys
Cobalt & its alloys
Titanium & titanium alloys
Tungsten & its alloys
Other metal alloys
Precious metals
Rare earth alloys
Amalgam
Others

6.24 Nutraceuticals & Functional Foods


Probiotics
Dietary Fibres
Carotenoids
Flavonoids
Prebiotics
Soy Proteins
Fortified Food
Phytoestrogens
Others

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6.25 Ores & Minerals
Iron ores
Copper ores
Zinc ores
Nickel ores
Manganese ores
Tin ores
Lead ores
Titanium ores
Molybdenum Ores
Tungsten ores
Chromium ores
Precious metals ores
Rare metals ores
Radioactive metals ores
Aluminium Ores
Barium ore
Cobalt ore
Mercury ore
Alkali Metal Ores
Limestone & dolomite
Rock phosphate
Gypsum
Silica sands
Mineral sands
Mineral for refractories
Mineral for insulation materials
Other minerals
Minor elements
Gem & semi-precious stones
Geochemical samples for trace elements
Mercury

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6.26 Paints & Surface Coating
Drying oils
Gums, driers & paint removers
Paints & enamels
Pigments & extenders
Polishes
Powder coatings
Resin coatings
Solvents & thinners
Varnishes
Physical Properties
Others

6.27 Paper and Pulp


Paper
Paper board
Pulp
Pulpwood
Newsprint and board packing material
Composite packing material
Others

6.28 Pesticide Formulations


Technical Concentrates (TK)
Dustable Powders (DP)
Powders for Dry Seed Treatment(DS)
Granules (GR)
Tablets for Direct Application (DT)
Wettable Powders (WP)
Water Dispersible Powders for Slurry Seed Treatment (WS)
Water Dispersible Granules (WG)
Water Dispersible Tablets (WT)

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Emulsifiable Granules(EG)
Emulsifiable Powders (EP)
Water Soluble Poweders (SP)
Water Soluble Poweders for Seed Treatment (SS)
Water Soluble Granules (SG)
Water Soluble tablets( ST)
Soluble Concentrates(SL)
Solutions for Seed treatment(LS)
Oil Miscible Liquids(OL)
Ultra Low Volume Liquids(UL)
Emulsifiable Concentrates(EC)
Dispersible Concentrates(DC)
Emulsions,Oil in Water(EW)
Emulsions for Seed Treatment(ES)
Micro- Emulsions (ME)
Aqueous Suspension Concentrates(SC)
Suspension Concentrates for Seed Treatment(FS)
Aqueous Capsule Suspensions (CS)
Oil based Suspension Concentrates(OD)(Oil Dispersion)
Aqueous Suspo-Emulsions(SE)
Mixed Formulations of CS and SC(ZC)
Mixed Formulations of CS and EW(ZW)
Mixed Formulations of CS and EW(ZW)
Mosquito Coils (MC)
Vaporizing Mats(MV)
Liquid Vaporizers(LV)
Long lasting insecticidal NETS or NETTING(LN)
Others

6.29 Petroleum and Products


Crude petroleum
Petroleum products
Petrochemicals, Petroleum solvents

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Liquefied / compressed gases
Aviation fuels
Waxes and jellies
Petroleum additives
Petroleum feed stocks
Others

6.30 Plastic & Resins


Resin
Plastics & polymers
Raw materials
Plastic films

6.31 Pollution & Environment


Waste Water (Effluents/Sewage)
Municipal Solid wastes
Wastes (Liquid/Slurry/Sludge/Solid/Semi-Solid)
Soil/Sediments
Used/Waste oil
Effluents toxicity (Bioassay only qualitative- 90% survival of fish after 96 hours in 100
percent effluent)
Others

6.32 Residues in Food Products


Antibiotics
Pesticides
Mycotoxins
Trace metal elements
Chlorinated dioxins & dibenzofurans
Halogenated hydrocarbons
Phenols
Polycyclic aromatic hydrocarbons

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Polyhalogenated biphenyls
Others
Poly Chlorinated Biphenyl
Others

6.33 Residues in Water


Antibiotics
Pesticides
Mycotoxins
Trace metal elements
Chlorinated dioxins & dibenzofurans
Halogenated hydrocarbons
Phenols
Polycyclic aromatic hydrocarbons
Polyhalogenated biphenyls
Others
Poly Chlorinated Biphenyl
Others

6.34 Rubber & Rubber Products


Natural rubber
Synthetic rubber
Rubber compound
Rubber vulcanizates
Rubber Products
Thermoplastic elastomers
Hard rubber / ebonite Rubber
Natural / synthetic Latex
Latex goods
Textile rubber composite
Others

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6.35 Soap detergent & Toiletries
Soaps
Detergent
Wetting & Emulsifying agent
Others

6.36 Soil and Rock


Clays & Soils
Stones
Others

6.37 Solid Fuels


Coal
Coke
Charcoal
Briquettes
Oil Shale
Coal tar/Bitumen
Others

6.38 Textile
Fibre & filaments
Yarns & chords
Grey Fabrics
Finished fabric
Apparels/Garments
Made-ups
Carpet & rugs
Terry Fabrics & its products
Technical textiles
Geo-textiles

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Medical textile
Automotive textiles
Protective Textiles
Sports textiles
Packaging textiles
Industrial Textiles
Domestic Textiles
Agro-textiles
Others

6.39 Warfare Chemicals


Choking Agents
Blister Agents
Blood Agents
Nerve Agents
Riot Control Agents
Potential CW Agents
Mustard Agents
Psychotomimetic Agents
Toxins
Others

6.40 Water
Surface Water
Ground Water
Drinking Water
Packaged Drinking water
Construction Water
Swimming Pool Water
Industrial Water
Industrial water
Irrigation water
Water from purifiers
Others

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6.41 Wood & Wood Products
Structural Plywood
Marine Plywood
Block Boards
Particle Boards
Lignocellulosic Materials
Rubber Wood
Others

7 REFERENCES

 ISO/ IEC 17025: 2005 General Requirements for the Competence of Testing and
Calibration Laboratories

 ISO Guide 30 Terms and Definitions used in connection with reference materials.

 ISO/IEC Guide 98-3:2008 Uncertainty of measurement -- Part 3: Guide to the expression


of uncertainty in measurement (GUM:1995)

 ISO/IEC Guide 99:2007

 ISO 78-2:1999, Layout for Standards – part 2: Standards for chemical Analysis

 Eurachem Guide: The Fitness for Purpose of Analytical Methods – A Laboratory Guide
to Method Validation and Related Topics (1998)

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Annexure – A
Scope of accreditation

Sl Group of Specific Specification, Range of MU This column is for explanation


no products, tests or standard testing/ ( ) only
materials or types of (method) or Limit of and not part of format
items tested tests technique detection /
performed used quantificati
on
1. Pollution and Environment

This is group 6.25 in section-6

Effluents This is sub group in 6.25

st
Alkalinity as APHA-21 Ed. 5-600mg/L 6 + 0.2 This is correct way of writing. For
HCO3 2005- 2320 B mg/l each specific test if laboratory
IS 3025 uses different methods than it
(P-23) 1986 553.7+ should write each method for
R1998 Amnd.1 8.8 mg/l which it wants accreditation and
st
Residual APHA-21 Ed. >1 mg/l 1.2+ 0.1 describe range of testing/ LOQ
Chlorine 2005- 4500- mg/l and MU for each method if it’s
Cl:B different. The complete details of
Iodometric 0.1-2 mg/l test methods including
method 0.2+ 0.02 year/edition and amendments
mg/l needs to be written
st
APHA-21 Ed.
2005- 4500-
Cl:G
DPD
Colorimetric
method

Ambient Air / Sulphur IS: 5182 (Pt-2) 5-1050 Clubbing of sub group here is
3
Work Zone / dioxide 2001 µg/m wrong as the test method IS:
Fugitive 5182 are for ambient air and not
Monitoring for work zone and fugitive
monitoring.
Ambient Air PM 2.5 Manufacturer’s 1-300 This is correct
3
manual and µg/m
Draft CPCB
Guidelines-
(Lab/SOP/ AIR
/06)
Sludge Ni in IS 3025 : Part 0.1 -3 1.1  0.08 This is correct
Leachate 54 : 2003 or mg/kg
st
APHA 21
Ed.2005
(Leachate
preparation by
LATS/9/2008-
09)

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Wastewater PAH APHA, 0.1 mg/l PAH, PCB or VOC represent a
21stEd.6440B group of compounds. Methods as
referred here are for detection of
Poly Annex. M of 0.01 mg/l multiple compounds. The
Chlorinated IS:13428 laboratory should specify which
Biphenyls (GC-ECD) individual compounds it can
(PCB) detect, if it cannot detect all
st
Volatile APHA, 21 Ed. 0.01mg/l compounds as given in method
Organic referred and does not have CRM
Compound for that particular compound
s (VOC)

2. Textile and Textile Auxiliaries

This is group 6.28 in section-6

- Fibre & Solvent IS:4390-2001, 0.1-10% These are sub groups in 6.28.
Filaments Extractable (RA-07)
- Yarns & Matter If the same test method is
Chords, applicable to different test items,
- Fabrics, these items can be clubbed
Garments together.
and made-
ups
- Auxiliaries
- Technical
textile
(Geo-
Textiles,
Medical
Textiles,
Automotive
Textiles)

3. Agricultural Products

Pesticide GC-MS 0.0001 mg/l It is not correct to just write


residues instrument name used for
4-Bromo-2- analysis
chlorophen
ol,
Aldrin,
Chlordane,

Fruits and Pesticide


Laboratory 0.0001 This is correct .Lab to specify the
vegetables residues
Validated mg/kg (for product
Aldrin,
Methods solid
Chlordane,
(Number and matrix) and
Cyfluthrin,
date) Based mg/L for
Cypermethr
on AOAC and liquid
in International matrix)
Standards &
QuEchers
using GC-MS
(Lab/SOP/Resi
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due/Fruit &
Vegetables/06
)

8.. Synthetic Clarity and IP.2007/BP.20 Qualitative This is correct


Drugs like Colour of 10/USP-
Alkylating solution 32.2009
Agents
Pharmaceutic (i) IP.2007/BP.20 Qualitative Items (like paracetamol) to be
al Raw Identificatio 10/USP- specified with specific tests such
materials n 32.2009 as identification, impurities
(ii)
Impurities

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Annexure - B

EQUIPMENT CALIBRATION INTERVALS

Laboratory equipment calibration and check programs should cover:


a) Commissioning of new equipment (including initial calibration and checks after
installation);

b) Operational checking (checking during use with reference standards or reference


materials);

c) Intermediate checks

d) Scheduled maintenance by in-house or specialist contractors;

e) Complete recalibration.

Some items of equipment, such as balances, require rechecking if they are moved and
recalibration if they are repaired.

For in house calibrations, by laboratory staff, the laboratory shall be suitably equipped with
appropriate calibration procedures (along with the applicable measurement of uncertainty) and
the staff shall demonstrate its competence to perform in house calibrations.

Where calibrations are performed by laboratory staff, full records of these measurements must
be maintained, including details of the numerical results, date of calibration and other relevant
observations.

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CALIBRATION APPENDIX A: CALIBRATION OF COMMON TEST EQUIPMENT

The guidelines detailed below are provided as a reference to benefit laboratories and their users
and the laboratory can demonstrate the reasons for not following the same.

Sl. Type of Equipment / Recommended Intermediate Checks Remarks


Instrument / Calibration Frequency of
Item Calibration
1. BALANCES Every years or (a) Each weighing do Zero
on repair ; check Reference weights to
(b) One Month- One point be used should be
check using a calibrated standard class F2 or
weight close to working better with established
capacity permissible errors.
(c) Six months- Repeatability
checks at the upper and lower
ends of the scale using a
calibrated weight
2 WEIGHTS Weights have to - -
be calibrated
externally by an
accredited
laboratory, at
least once in two
years.
3. Temperature Preferably from Six monthly temperature Maintain parameters
Controlled Enclosures/ an accredited check around working range to an accuracy of
Thermostatically calibration within a range as
Controlled Equipment as laboratory. stipulated in methods.
Ovens, Incubators,
Aging, Vacuum;
Environmental
Conditioning chambers;
Temperature To be carried out
Controlled enclosure based on usage

Autoclave, Temp
controlled waterbath,
furnances
4. Thermometers (Liquid Calibration from Once a year Check at ice Ice point. If outside
in glass) accredited point or at points of use. five times the
laboratory. uncertainty of the
calibration, complete
recalibration is
required.
5 rRTD, PRT, Every year,
Thermocouple with across working
indicator range or at points
of use from an
accredited
calibration
laboratory.
6. TIMING DEVICES
Stop watches, clock, Every Year

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7. Hygrometer Calibration by an
accredited
calibration
laboratory
8. Pressure Gauge Calibration by an
accredited
calibration
laboratory
10. Volumetric labware Internal It should be verified
(Burette, Pipette and calibration on that the tolerance is in
Volumetric flask)* receipt. desired acceptable
limit (Class A & Class
B glasswares)
12. Flow
Rota meters Initial and Once a year against standard
recalibration soap bubble meter
after two years
from an
accredited
calibration
laboratory
Dry Gas Meter Initial and
recalibration
after three years
from an
accredited
calibration
laboratory
Pitot tube Initial and
recalibration
after three years
from an
accredited
calibration
laboratory
Orifice Plate Initial calibration
from an
accredited
calibration
laboratory
13. Gas sensors Initial, Using standard gases.
recalibration after
two years
14. UV-Visible / IR / FT-IR Quarterly- Using CRM
Spectrophotometer Photometric
/ Colorimeter Absorbance and
wavelength
accuracy for the
working range

15 Atomic Absorption Performance When used, Standard solution Generally the


Spectrophotometer check by f Cu of performance check is
CRM as per specific element done against the initial
manufacturer’s value checked at the
instruction. time of installation.

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16 Conductivity Meter Once a year, Full Monthly, Reference standard,
range calibration One point calibration. Adjust
with CRM cell constant if necessary.
When used, Standard solution
17 Gas Quarterly, When used, Standard solution
Chromatograph, GC- System / mixture
MS/HPLC / LC-MS performance
including:
Resolution,
sensitivity,
repeatability,
retention time
and noise level
18 pH Meter Once a year, Full To be checked with working
range calibration standard before use.
with CRM
19 Micropipettes Once a year
internal
calibration

 Note 1: the staff should be trained to handle the lab ware appropriately, to avoid abuse (avoid
overheating and use of corrosive solutions and ensure appropriate cleaning) of the volumetric
labwares, so as to ensure the validity of calibration through its life.
 Note 2; For instruments/ equipments not covered above, the following guidance documents
may be followed;
a. ISO/IEC 17025 Field Application Document Chemical Testing, NATA
b. Specific criteria chemical testing-International Accreditation, New Zealand;
c. Technical Notes C&B 002 Quality Assurance of Equipment Commonly Used in
Chemical and Biological Testing Laboratories SAC Accreditation Program
d. Manufacturer’s instruction manual.
 Note 3 ; The calibration history for each instrument must be recorded.
 Note 4 ; Calibrations using 2 or 3 points (and zero) must adequately cover the range. One
point must be between 75% and 90% of full scale.

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CALIBRATION APPENDIX B -- CALIBRATION OF INSTRUMENTATION (COMPARATIVE
TECHNIQUES)

The following general principles apply to the major analytical instruments used in the laboratory
that are calibrated primarily in-house by use of reference materials of known composition.

a) Sufficient and appropriate reference materials* must be used to calibrate instruments over
the full analytical range required to establish the measurement characteristics of the
instrument (linearity, sensitivity, etc).

b) Stability of measurement must be assessed with reference materials to establish the


required frequency of calibration.

c) Effects of interfering substances and differing matrices must be assessed.

d) Limits of detection must be established if the instrument is to be used at concentrations


approaching the limit of detection.

e) Operating parameters as set in manufacturer’s instructions and maintenance schedules


must be available and details of critical checks must be recorded.

Note: This annexure may be treated as a guideline and not as NABL requirement.

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National Accreditation Board for Testing and Calibration Laboratories (NABL)
NABL House
Plot No. 45, Sector 44,
Gurgaon - 122002, Haryana
Tel. no.: 91-124-4679700 (30 lines)
Fax: 91-124-4679799
Website: www.nabl-india.org