Nabl 103
Nabl 103
Nabl 103
ISSUE NO. : 04
ISSUE DATE : 25-Apr-2016
AMENDMENT NO. : 00
AMENDMENT DATE : --
AMENDMENT SHEET
Sl
no
Page
No.
Clause
No.
Date of
Amendment
Amendment
Reasons
Signature
QM
Signature
Director
10
Amend Date: --
ABBREVIATIONS
AOAC
APHA
APLAC
AS
American Standard
ASTM
BIS
BIPM
BS
British Standard
CRM
ISO
EA
FTIR
GFAAS
e.g.
For Example
GUM
ICP-AES
ICP-MS
IEC
ILAC
IUPAC
NABL
NATA
NIST
NMR
QC
Quality Control
w.r.t.
With Respect To
NBC
Amend Date: --
CONTENTS
Sl
Title
Page
Amendment Sheet
Abbreviations
Contents
1.
Introduction
2.
3.
Scope
4.
Management Requirements
5.
Technical Requirements
10
6.
29
7.
References
45
46
49
50
53
Amend Date: --
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
1.3
Laboratories conducting tests on food/water should also consult NABL Specific Criteria
on Biological testing (NABL 102).
Amend Date: --
2.
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
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).
Amend Date: --
3.
SCOPE
3.1
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.
Amend Date: --
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 equipments
List of CRMs
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.
Amend Date: --
4.
MANAGEMENT REQUIREMENTS
4.1
4.2
Laboratory shall clearly identify the subcontracted tests in the test reports as described
in NABL 133.
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;
Amend Date: --
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
4.5
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.
Amend Date: --
TECHNICAL REQUIREMENTS
5.2
Personnel
5.2.1
5.2.2
Minimum Years of
Experience
Minimum
Qualifications
Degree (Engg.) /
Post Graduate in Science
Diploma (Engg.) /
Graduate in Science
ITI / Equivalent
Two
Same field of
testing
---
Five
Similar field of
testing
Same field of
testing
--
Ten
-Similar field of
testing
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
disciplines;
Amend Date: --
(c)
5.2.3
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.
Amend Date: --
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.
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.
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.
Amend Date: --
5.3.2
5.3.3
waste disposal
Fire Safety: Laboratory shall follow latest norms as per NBC of India.
Amend Date: --
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.
Amend Date: --
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/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
5.4.4
5.4.5
Amend Date: --
Amend Date: --
Amend Date: --
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.
Amend Date: --
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
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.
Amend Date: --
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:
Amend Date: --
Equipment
5.5.1
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)
iii)
iv)
5.5.2
Amend Date: --
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.
Amend Date: --
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
Amend Date: --
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)
(iv) Laboratories may use chemicals of known purity in case on non-availability of CRM.
5.6.3
Amend Date: --
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
5.7.1
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.
Amend Date: --
5.7.4
Sample registration
Laboratory shall uniquely identify and register the sample received in the laboratory to
establish audit trail.
5.7.5
Records of environmental
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.
Amend Date: --
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
Amend Date: --
5.9.1
5.9.2
5.10
Amend Date: --
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
Amend Date: --
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 Qualitly
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
Amend Date: --
Pozzolanic materials
Refractory materials
Sand
Water-proofing compounds
Other
6.6
6.7
Corrosion tests
Salt Spray Tests
Dezincification Tests
Other
6.8
Amend Date: --
Oral Liquids
Oral Powders
Parenteral Preparations
Tablets
Vitamins
Harmones
Other
6.9
6.10
Fertilizers
Nitrogenous Fertilizers
Phosphatic Fertlizers
Potassic Fertlizers
Fertiliser Mixtures
Micronutrients
Macrnutrients
Fortified Fertilizers
Bio-Fertilizer
Other
6.11
Amend Date: --
6.12
Amend Date: --
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
Amend Date: --
6.16
6.17
6.18
Amend Date: --
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
6.22
Amend Date: --
6.23
6.24
Amend Date: --
6.25
Amend Date: --
6.26
6.27
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)
Amend Date: --
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
Amend Date: --
6.31
6.32
Amend Date: --
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
Amend Date: --
6.35
6.36
6.37
Solid Fuels
Coal
Coke
Charcoal
Briquettes
Oil Shale
Coal tar/Bitumen
Others
6.38
Amend Date: --
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
Amend Date: --
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 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)
Amend Date: --
Annexure A
Scope of accreditation
Sl
no
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 /
quantificati
on
MU
( )
Effluents
Residual
Chlorine
st
APHA-21 Ed.
2005- 2320 B
IS 3025
(P-23)
1986
R1998 Amnd.1
st
APHA-21 Ed.
20054500Cl:B
Iodometric
method
5-600mg/L
6 +
mg/l
0.2
553.7+
8.8 mg/l
1.2+ 0.1
mg/l
>1 mg/l
0.1-2 mg/l
0.2+ 0.02
mg/l
st
APHA-21 Ed.
20054500Cl:G
DPD
Colorimetric
method
Ambient Air /
Work Zone /
Fugitive
Monitoring
Sulphur
dioxide
5-1050
3
g/m
Ambient Air
PM 2.5
1-300
3
g/m
Sludge
Ni
in
Leachate
Manufacturers
manual
and
Draft
CPCB
Guidelines(Lab/SOP/ AIR
/06)
IS 3025 : Part
54 : 2003 or
st
APHA
21
Ed.2005
(Leachate
preparation by
LATS/9/200809)
0.1
mg/kg
-3
1.1 0.08
This is correct
Amend Date: --
Wastewater
PAH
APHA,
21stEd.6440B
0.1 mg/l
Poly
Chlorinated
Biphenyls
(PCB)
Volatile
Organic
Compound
s (VOC)
Annex. M of
IS:13428
(GC-ECD)
0.01 mg/l
st
APHA, 21 Ed.
0.01mg/l
Solvent
Extractable
Matter
IS:4390-2001,
(RA-07)
0.1-10%
3. Agricultural Products
Pesticide
residues
4-Bromo-2chlorophen
ol,
Aldrin,
Chlordane,
Fruits
and
vegetables
GC-MS
0.0001 mg/l
Laboratory
0.0001
This is correct .Lab to specify the
Validated
mg/kg (for
product
Methods
solid
(Number and matrix) and
date)
Based mg/L
for
on AOAC and liquid
International
matrix)
Standards
&
QuEchers
using GC-MS
(Lab/SOP/Resi
National Accreditation Board for Testing and Calibration Laboratories
Doc. No: NABL 103
Issue No: 04
Pesticide
residues
Aldrin,
Chlordane,
Cyfluthrin,
Cypermethr
in
Amend Date: --
due/Fruit
&
Vegetables/06
)
8..
Synthetic
Drugs like
Alkylating
Agents
Pharmaceutic
al
Raw
materials
Clarity and
Colour
of
solution
IP.2007/BP.20
10/USP32.2009
Qualitative
This is correct
(i)
Identificatio
n
(ii)
Impurities
IP.2007/BP.20
10/USP32.2009
Qualitative
Amend Date: --
Annexure - B
EQUIPMENT CALIBRATION INTERVALS
b)
c)
Intermediate checks
d)
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.
Amend Date: --
1.
Type of Equipment /
Instrument / Calibration
Item
BALANCES
WEIGHTS
3.
Temperature
Controlled Enclosures/
Thermostatically
Controlled Equipment as
Ovens, Incubators,
Aging, Vacuum;
Environmental
Conditioning chambers;
Temperature
Controlled enclosure
4.
Autoclave, Temp
controlled waterbath,
furnances
Thermometers (Liquid
in glass)
rRTD, PRT,
Thermocouple with
indicator
6.
TIMING DEVICES
Stop watches, clock,
Recommended
Frequency of
Calibration
Every years or
on repair ;
Weights have to
be calibrated
externally by an
accredited
laboratory, at
least once in two
years.
Preferably from
an accredited
calibration
laboratory.
Intermediate Checks
Remarks
Reference weights to
be used should be
standard class F2 or
better with established
permissible errors.
Maintain parameters
to an accuracy of
within a range as
stipulated in methods.
To be carried out
based on usage
Calibration from
accredited
laboratory.
Every year,
across working
range or at points
of use from an
accredited
calibration
laboratory.
Every Year
Amend Date: --
7.
Hygrometer
8.
Pressure Gauge
10.
Volumetric labware
(Burette, Pipette and
Volumetric flask)*
12.
Flow
Rota meters
Pitot tube
Orifice Plate
13.
Gas sensors
14.
UV-Visible / IR / FT-IR
Spectrophotometer
/ Colorimeter
15
Atomic Absorption
Spectrophotometer
Calibration by an
accredited
calibration
laboratory
Calibration by an
accredited
calibration
laboratory
Internal
calibration on
receipt.
It should be verified
that the tolerance is in
desired acceptable
limit (Class A & Class
B glasswares)
Initial and
recalibration
after two years
from an
accredited
calibration
laboratory
Initial and
recalibration
after three years
from an
accredited
calibration
laboratory
Initial and
recalibration
after three years
from an
accredited
calibration
laboratory
Initial calibration
from an
accredited
calibration
laboratory
Initial,
recalibration after
two years
QuarterlyPhotometric
Absorbance and
wavelength
accuracy for the
working range
Performance
check by f Cu
CRM as per
manufacturers
instruction.
Using CRM
Generally the
performance check is
done against the initial
value checked at the
time of installation.
Amend Date: --
16
Conductivity Meter
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
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. 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.
Amend Date: --
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)
c)
d)
e)
Note: This annexure may be treated as a guideline and not as NABL requirement.
Amend Date: --