NABL 103 DRAFT

NABL

NATIONAL ACCREDITATION
BOARD FOR TESTING AND
CALIBRATION LABORATORIES

SPECIFIC CRITERIA
for

CHEMICAL TESTING
LABORATORIES

ISSUE NO : xx
ISSUE DATE: -

AMENDMENT NO : 00
AMENDMENT DATE: --

AMENDMENT SHEET
Sl

Page
No.

Clause
Date of
No. Amendment

Amendment made

Reasons

Signature
QM

Signature
Director

10

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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

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CONTENTS
Sl

Title

Page

Amendment Sheet

Abbreviations

ii

Contents

iii

Introduction

Terms and Definitions

Scope

Management Requirements

Technical Requirements

GroupWise Codification for Chemicals Tests

30

References

41

Annexure A

38

Annexure B

41

Appendix A

42

Appendix B

45

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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).

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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).

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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 laboratorys accreditation certificate. A laboratorys 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 laboratorys 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.

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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 GCMS/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.

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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 like instrument breakdown, unavailability of trained staff for a short period.
The subcontracting of any test(s), 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 identify the subcontracted tests in the test reports.
If an accreditation body allows an accredited laboratory 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
subcontractors report or certificate;

the subcontractor is itself accredited for the specific tests or calibrations

concerned and the results have been included in the subcontractor laboratorys
endorsed report or certificate.

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.
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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 the 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.

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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.

Lower formal qualifications (minimum higher secondary in science or equivalent) may be
acceptable when staff have extensive relevant experience and/or the scope of activities
covering simple tests. Chemical analysis should be carried out under adequate
supervision.
Note: The technical personnel who perform chemical testing should be free from colour
blindness, evidence for which is necessary.
5.2.2

Authorized signatory is one whose signatures must be there on all the reports issued by
laboratory. (Note: There may be other persons signing on the test reports as per inhouse requirements of a laboratory)
The minimum requirement for an authorized signatory shall be graduate in Science
(relevant field) with 4 years experience or graduate in Engineering/ Post graduate in
Science /Engineering (relevant field) with 2 years experience. Personnel having
Doctorate degree may be exempted from experience requirement if the research work
commensurate with the relevant field.
The person should also have knowledge of laws or protocols in the group of products,
material or items tested so as to enable him to give opinions and interpretations in test
reports.

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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 group 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,

NABL

accredited

laboratories

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

The Quality Manager of a Chemical testing laboratory should be a person having a

recognized graduate degree in science or Bachelor degree / diploma in engineering or
specialized course and at least two years experience.

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

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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
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

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

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 manufacturers 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.
5.4 Test Methods and Method Validation:
5.4.1

Laboratory should generally use standard methods/internationally published methods/inhouse 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:

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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 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
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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.
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 Quantitation : Limit of quantitation 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:

Quantitation: 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

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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
comparison with results obtained by a definitive method or other alternative
procedures and via intercomparison 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.

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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.
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. Inhouse 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
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Limit of Quantitation

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.
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.

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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.

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 softwares. 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 programme 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);

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iii)

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

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

iv)
5.5.2

physical standards (weights, reference thermometers);

General Service Equipment

General service equipment are 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).

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.

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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 equipments 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.
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.
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5.6 Calibration & Measurement Traceability

5.6.1

The overall programme 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
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.

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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.
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 customers premises) e.g. collecting a sample of water
from customers tube well or taking a sample of cement from a lot at customers
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

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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.

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.

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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.
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

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 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
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 during the next accreditation cycle.

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

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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. Air, Gases & Atmosphere

Industrial gases

Gases for medical use & diving

Reference gases & mixtures

Compressed gases

Miscellaneous

6.2. Building and Construction Materials

Cement & other mortars

Cement concrete

Refractories

Refractory cement

Sand

Clays & soils

Pozzolonic materials

Fly-ash

Waterproofing compounds

Thermal insulation materials

Masonry bricks/blocks, etc.

Ceramics (glass, porcelain, refractories)

Aggregates

Rocks

Admixtures inorganic & organic

6.3. Coal, Coke & other Solid Fuel

Coal/coke
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Coal carbonization products

Charcoal

Briquetted solid fuels

Bitumen
6.4. Cosmetics & Essential Oils

Perfumes

Essential oils

Cosmetics

Intermediates and miscellaneous chemicals for cosmetics

Herbal-based cosmetics

6.5. Dye , Pigments and Inks

Synthetic dyes

Dye intermediates

Natural dyes & colouring materials

Pigments

Inks (Printing, writing, duplicating inks)

6.6. Disinfectants

Disinfectants and their formulation

Sanitizer

6.7. Drugs & Pharmaceuticals

Synthetic drugs

Natural drugs (medicinal plant preparations)

Pharmaceutical formulation

Drug intermediates and raw materials

Veterinary preparations (herbal & synthetic)

Vitamins

Vaccines & sera

Antibiotics

Enzymes

Hormones

Chemicals used in compounding pharmaceuticals

Ayurvadic

Homeopathic
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natural drugs and supplements

6.8. Explosives & Pyrotechnics

Ammunitions

Industrial explosives & associated material

Pyrotechnics

Explosives chemicals and allied materials

6.9. Fertilizers

Nitrogeneous fertilizers

Phosphatic fertilizers

Fertilizer mixtures

Potash fertilizers

Micronutrients

Organic manure and Compost

Liquid Fertilizers

6.10.Agricultural Products

Alcoholic drinks & beverages

Products of Cereals pulses and others (atta, maida, semolina, etc)

Coffee, cocoa and by-products

Tea and tea products

Starch and starchy products

Honey and honey products

Fruits and vegetable products

Spices condiments and Herbs

Nuts & nut products

Organic foods

GM Foods

Seed

Tobacco and tobacco products

Cereals, grains, pulses, oil seeds

6.11. Non Agricultural Products
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Animal feeds
Milk and dairy products
Fish and fishery products
Meat and meat products
Egg & egg products

6.4.12 Processed food and Food additives

Bakery and confectionery products
Food additives
Colour, flavour & preservatives
Infant foods
Sugar and by-products
Fruit juices & concentrates
Vitamins in foods
Oil, fats and related products
Enzymes

6.4.1.1.1.1.13 Food Packaging Material

Paper packaging

Plastics and polymer

Aluminium foils

Metal cans

Others
6.14.

Industrial and Fine Chemicals

Inorganic chemicals

Organic chemicals

Electroplating chemicals

Solvents

Laboratory chemicals

Analytical reagents

Speciality chemicals for:

Leather industry

Rubber industry

Textiles industry

Electronics industry

Photographic industry
Agricultural chemicals

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Firefighting chemicals

Carbon black

Wood and timber treatment chemicals

Industrial alcohols

Alcohols based chemicals

6.15.Lac & Lac Products

Lac

Lac products
6.16.Leather and Leather products

Leather products

Natural and Synthetic Leather

6.17.Lubricants

Oils & greases

Solid lubricants

Aviation lubricants

Lubricant additives

Microcrystalline wax

6.18.Ores & Minerals

Iron ores

Copper ores

Zinc ores

Nickel ores

Manganese ores

Tin ores

Lead ores

Titanium ores

Molybdenum and tungsten ores

Chromium ores

Precious metals ores

Rare metals ores

Radio active metals ores

Bauxite
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Limestone & dolomite

Rock phosphate

Gypsum

Silica sands

Mineral sands

Mineral for refractories

Mineral for insulation materials (like asbestos, glass wool, rock wool, mineral wool)

Other minerals

Minor elements

Geochemical samples for trace elements

6.19.Metals and Alloys

Iron, steel and ferro-alloys

Special steel
Copper & its alloys
Aluminium & its alloys
Tin and tin alloys
Zinc & inc alloys
Lead & lead alloys
Magnesium & magnesium alloys
Nickel, chromium, cobalt & their alloys
Titanium & titanium alloys
Tungsten & its alloys
Other metal alloys

6.20.Paints and Surface Coating

Paints and enamels

Vehicles, solvents, thinners

Pigments and extenders

Polishes

Painters materials (gums, driers, paint removers)

Drying oils

Powder coating

Resin coatings

Anti corrosive coatings

6.21.Paper and Pulp

Pulp

Paper, paper board and speciality papers

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Newsprint and board packing materials

Composite packing materials

6.22.Petroleum and products

Crude petroleum

Fuels-gaseous, liquid & solid

Aviation fuels

Waxes and jellies

Miscellaneous products, white oil, anti-freeze, solvents insulation oils, feed-stock

Pour point depressants (flow improvers)

Petrochemical feedstocks

De-icing fluids

Hydraulic fluids

Fuel additives including corrosion preventives

6.23.Plastics and Polymers

Plastics & polymers

Raw materials

Plastic films

6.24.Rubber, Resins and Adhesives

Natural rubber

Synthetic rubber

Resin

Starch based adhesives

Natural gums

Glues

Polymer based adhesives (Synthetic)

6.25.Agrochemicals

Synthetic pesticides (insecticides, weedicides, herbicides, fungicides, etc) & their

formulations
Natural pesticides (Biopesticides) & their formulations

Pheromones, chitin inhibitors

Growth Regulators

6.26.Pollution & Environment

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Ambient Air Quality

Indoor air quality (to review the test method and equipment)

Fugitive/Process Emissions

Stack Emissions

Wastewater (Effluents/Sewage)

Solid wastes

Hazardous wastes

Soil/sediments

Surface/Ground water

Ambient Noise Levels (Excluding vibration)

Source Noise Levels (Excluding vibration)

Meteorological

Vehicular Emission

Effluents toxicity (Bioassay)

Used/Waste oil

6.27.Rubber Resins and Adhesives

Natural rubber

Synthetic rubber

Resin

Starch based adhesives

Natural gums

Glues

Polymer based adhesives (Synthetic)

6.28.Soap Detergents and Toiletries

Soaps

Synthetic detergents

Wetting and emulsifying agents

6.29.Textile & Textile Auxiliaries

Fibre & filaments

Yarns & chords

Fabrics, garments, coated and laminated fabrics and made-ups

Technical textiles (geo-textiles, medical textile, automotive textiles)

Non-woven textile

Woven textile

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Textiles accessories like zippers, buttons.

Jute and Jute products

6.30.Water

Drinking water- Potable and domestic

Packaged drinking water

Packaged Natural Mineral Water

Reagent Grade Water

Water for Swimming Pools

Water for ICE Manufacture

Water for Processed Food Industry

Feed Water, Boiler Water, and Condensate for High Pressure Boilers

Water for Storage Batteries

Water for Construction purpose

Water for Injection/Medicinal purpose

Water for use for irrigation purpose

Others

6.31.Metallic Coatings and Treatment Solutions

Metallic coatings
Conversion coatings
Plating solutions
Anodizing solutions
Metal finishing materials

6.32.Group Residues and Trace Elements

Food products

Agricultural products

Water

Environment

Textile products

Toys

Drugs and Pharmaceuticals

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Cosmetics

Nutritional supplements

Industrial and Fine chemicals

Others

Note: Residues include pesticides, antibiotics, toxins, and contaminants as PAH, PCB,
VOC etc.

6.33.Gem & semi-precious stones

Gem & semi-precious stones

Precious metals

Gold

Silver

Platinum

Miscellaneous

6.34.Bituminous products

6.35

6.36

Bitumen

Asphalt

Coal tars

Toys

Plastic toys

Soft toys

Wooden toys

Metal toys

Ceramics

Glass

Porcelain

Tiles

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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.

Guide to the Expression of Uncertainty

ISO/BIPM/IEC/IFCC/IUPAC/IUPAP/OIML

in

Measurement,

1 st

Ed.,(1995),

ILAC-G9:2005 "Guidelines for the Selection and Use of Reference Materials"

VIM 1993 - Ref B6

ISO 78-2:1982, 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
n
o

Group
of
products,
materials or
items tested

Specific
tests
or
types of
tests
performed

Specification
,
standard
(method) or
technique
used

Range of
testing/
Limit
of
detection
/
quantificat
ion

MU
( )

This
column
is
explanation only
and not part of format

for

1. Pollution and Environment

This is group 6.25 in section-6
Effluents

This is sub group in 6.25

Alkalinity
as HCO3

Residual
Chlorine

APHA-21st
Ed.
20052320 B
IS 3025
(P-23) 1986
R1998
Amnd.1
APHA-21st
Ed.
20054500-Cl:B
Iodometric
method

5600mg/L

6 + 0.2
mg/l
553.7+
8.8 mg/l

>1 mg/l

1.2+ 0.1
mg/l

0.1-2 mg/l
0.2+
0.02
mg/l

APHA-21st
Ed.
20054500-Cl:G
DPD
Colorimetric
method

This is correct way of writing.

For each specific test if
laboratory
uses
different
methods than it should write
each method for which it
wants
accreditation
and
describe range of testing/
LOQ and MU for each method
if its different. The complete
details of test methods
including year/edition and
amendments needs to be
written

Ambient
Air /
Work Zone /
Fugitive
Monitoring

Sulphur
dioxide

IS: 5182 (Pt2) 2001

5-1050
g/m3

Clubbing of sub group here is

wrong as the test method IS:
5182 are for ambient air and
not for work zone and fugitive
monitoring.

Ambient Air

PM 2.5

1-300
g/m3

This is correct

Sludge

Ni
in
Leachate

Manufacture
rs
manual
and
Draft
CPCB
Guidelines(Lab/SOP/
AIR /06)
IS 3025 :
Part 54 :
2003
or
APHA
21st

0.1
-3
mg/kg

1.1
0.08

This is correct

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Ed.2005
(Leachate
preparation
by
LATS/9/2008
-09)
Wastewater

PAH

APHA,
21stEd.6440
B

0.1 mg/l

Poly
Chlorinate
d
Biphenyls
(PCB)
Volatile
Organic
Compoun
ds (VOC)

Annex. M of
IS:13428
(GC-ECD)

0.01 mg/l

21st

0.01mg/l

APHA,
Ed.

PAH, PCB or VOC represent

a group of compounds.
Methods as referred here are
for detection of multiple
compounds. The laboratory
should
specify
which
individual compounds it can
detect, if it cannot detect all
compounds as given in
method referred and does not
have CRM for that particular
compound

2. Textile and Textile Auxiliaries

This is group 6.28 in section-6
- Fibre &
Filaments
- Yarns &
Chords,
Fabrics,
Garments
and madeups
- Auxiliaries
- Technical
textile
(GeoTextiles,
Medical
Textiles,
Automotiv
e
Textiles)

Solvent
Extractabl
e Matter

IS:43902001,
(RA-07)

0.1-10%

GC-MS

0.0001
mg/l

These are sub groups in 6.28.

If the same test method is
applicable to different test
items, these items can be
clubbed together.

3. Agricultural Products
Pesticide
residues
4-Bromo2chlorophe
nol,
Aldrin,
Chlordan

It is not correct to just write

instrument name used for
analysis

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Fruits and
vegetables

8.
.

e,

Pesticide
residues
Aldrin,
Chlordan
e,
Cyfluthrin,
Cypermet
hrin

Laboratory
Validated
Methods
(Number and
date) Based
on
AOAC
and
International
Standards &
QuEchers
using
GCMS
(Lab/SOP/R
esidue/Fruit
&
Vegetables/0
6)

0.0001
mg/kg (for
solid
matrix)
and mg/L
for liquid
matrix)

This is correct .Lab to specify

the product

Synthetic
Drugs like
Alkylating
Agents

Clarity
and
Colour of
solution

IP.2007/BP.2
010/USP32.2009

Qualitativ
e

This is correct

Pharmaceut
ical
Raw
materials

(i)
Identificati
on
(ii)
Impurities

IP.2007/BP.2
010/USP32.2009

Qualitativ
e

Items (like paracetamol) to be

specified with specific tests
such
as
identification,
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.
S.No
.
1.

3.

4.

Type
of
Equipment/Instrument
/ Calibration Item
BALANCES

Recommended
Frequency
of
Calibration
Every years or
on repair ;

WEIGHTS

Temperature
Controlled
Enclosures/
Thermostatically
Controlled
Equipment as Ovens,
Incubators,
Aging,
Vacuum;
;
Environmental
Conditioning
chambers;
Temperature
Controlled
enclosure
Autoclave,
Temp
controlled
waterbath,
furnances
Thermometers
(Liquid in glass)

Weights have to
be
calibrated
externally by an
accredited
laboratory,
at
least once in two
years.
Preferably from
an
accredited
calibration
laboratory.

Intermediate Checks
(a) Each weighing do Zero
check
(b) One Month- One point
check using a
calibrated
weight close to working
capacity
(c) Six months- Repeatability
checks at the upper and
lower ends of the scale using
a calibrated weight
-

Remarks

Reference
weights to be
used should be
standard class F2
or
better
with
established
permissible errors.
-

Six monthly temperature

check around working range

Maintain
parameters to an
accuracy of within
a
range
as
stipulated
in
methods.

Once a year Check at ice

point or at points of use.

Ice
point.
If
outside five times
the
uncertainty of the
calibration,

To be carried out
based on usage

Calibration from
accredited
laboratory.

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complete
recalibration
required.
5

rRTD,
Thermocouple
indicator

PRT,
with

6.
7.

TIMING DEVICES
Stop watches, clock,
Hygrometer

8.

Pressure Gauge

10.

Volumetric labware
(Burette, Pipette and
Volumetric flask)*

12.

Flow
Rota meters

is

Every
year,
across working
range
or
at
points of use
from
an
accredited
calibration
laboratory.
Every Year
Calibration by an
accredited
calibration
laboratory
Calibration by an
accredited
calibration
laboratory
Internal
calibration
on
receipt.

Initial
and
recalibration
after two years
from
an
accredited
calibration
laboratory

It
should
be
verified that the
tolerance is in
desired
acceptable
limit
(Class A & Class
B glasswares)
Once a year against standard
soap bubble meter

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
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calibration
laboratory
Initial,
recalibration
after two years

13.

Gas sensors

14.

UV-Visible / IR / FT-IR
Spectrophotometer
/ Colorimeter

Using
gases.

standard

Using CRM
QuarterlyPhotometric
Absorbance and
wavelength
accuracy for the
working range

15

Atomic Absorption
Spectrophotometer

Performance
check by f Cu
CRM as per
manufacturers
instruction.

When
used,
solution of
specific element

Standard

16

Conductivity Meter

Once a year, Full

range calibration
with CRM

17

Gas
Chromatograph, GCMS/HPLC / LC-MS

18

pH Meter

19

Micropipettes

Quarterly,
System
performance
including:
Resolution,
sensitivity,
repeatability,
retention time
and noise level
Once a year, Full
range calibration
with CRM
Once a year
internal
calibration

Monthly, Reference standard,

One point calibration. Adjust
cell constant if necessary.
When
used,
Standard
solution
When
used,
Standard
solution / mixture

Generally
the
performance
check is done
against the initial
value checked at
the
time
of
installation.

To be checked with working

standard before use.

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 Programme
d. Manufacturers 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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National Accreditation Board for Testing and Calibration Laboratories

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CALIBRATION

APPENDIX

--:

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 manufacturers instructions and maintenance schedules
must be available and details of critical checks must be recorded.
Note*: For use of appropriate reference material, guidance provided in ILAC-G9:2005
"Guidelines for the Selection and Use of Reference Materials" may be referred.
.
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

Secretariat: Plot No. 45, Sector-44,
Near HUDA City Centre,
Gurgaon-122002, Haryana
Tele: 0124-4679700 (30 lines)
Fax: 0124-4679799
Website: www.nabl-india.org

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