FDAS100 Information Brochure 30 Oct 2023
FDAS100 Information Brochure 30 Oct 2023
FDAS100 Information Brochure 30 Oct 2023
Information Brochure
FDAS 100
31 Oct 2023
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FDAS POLICY
CABs operating as Test Laboratories, Calibration Laboratories and Medical Laboratories, in a timely
manner, irrespective of the size and ownership and to operate its documented management system
Director, FDAS
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1.0 Introduction
The management system of FDAS is as per ISO/IEC 17011:2017, and is committed to grant Accreditation to
Test, Calibration, and Medical laboratories, as per respective international standards like ISO/IEC
17025:2017 / ISO 15189:2022 and ILAC/APAC norms. The commitment of FDAS to abide by the norms from
international institutions like ISO, IEC, ILAC, APAC etc., has enabled it to attain Asia Pacific Accreditation
Cooperation (APAC) MRA Signatory status which in turn provides global equivalence to its accredited
CABs/Laboratories. After its evaluation by APAC, FDAS became APAC MRA (Mutual Recognition
Arrangement) signatory/Full Member of APAC on 16th June 2023 and became ILAC MRA signatory/Full
Member of ILAC on 28th Aug 2023 for the scope of testing and calibration.
The need for creating additional accreditation body for India must be seen in conjunction with the need
of country which has about six lakh laboratories, consisting of about three lakh testing laboratories and
more than three lakhs medical laboratories. Though the laboratory accreditation program was
approved by the Govt. of India in 1981, it started granting accreditation in 1989, from
Department of Science and Technology, by National Coordination of Testing and Calibration Facilities
(NCTCF), the name of accreditation program, which was transformed to NABL in 1992, and to meet
international (ISO/IEC) norms.
As on date the number of accredited laboratories is less than nine thousand laboratories, although the
best is being done. The country is aspiring to become a five trillion economy and must have matching
means to achieve desired goal and therefore needs additional accreditation body.
Keeping this in mind an NGO was formed as a society for laboratory accreditation, which is now
APAC/ILAC MRA Signatory and serves the Indian economy to meet its needs.
FDAS, the NGO registered under the “Registration and Regulation of Societies Act, 2012 of Haryana
Government”, aims to serve the community as a charitable organization and as a non-profit making body
and by maintaining financial sustainability.
FDAS is committed to being professional in its approach with laboratories in general and specifically
with its accredited CABs/laboratories, by keeping them informed with justification before making a
change in its management system that may affect CABs/laboratories functioning, and to incorporate
their views to the extent possible. FDAS has the complaints & Appeals redressal system, also when
resolved complaints are not to the satisfaction of CABs/laboratories, they are free to make an appeal
against the decision of FDAS, which are considered by the Jury, which is not involved in the decision
making & is independent to consider such appeals and to pronounce its judgment, which is a binding
to the parties concerned. The jury would have more than one expert.
FDAS is open to grant accreditation to all willing laboratories (CABs), irrespective of ownership, size, or
affiliations, and from all sectors of the economy and committed to maintaining impartiality in its
functioning from the test, calibration, and medical laboratories. As a policy, its management, staff,
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committee members, assessors, and experts involved in the process of accreditation are required to
pledge to maintain impartiality and confidentiality. FDAS has a website (www.fdasindia.org) and it gives
the details of scope of accreditation of laboratories along with the certificate. FDAS accreditation is an
acknowledgement for the competence of the applicant for the scope of testing/calibration parameters
identified by FDAS and is not to certify a product.
FDAS grants accreditation to the applicant CABs (test, calibration, and medical laboratories) for the
defined scope subject to the demonstration of competence and compliance to the following applicable
norms.
5.1 General requirement for the competence of testing and calibration laboratories ISO/IEC
17025: 2017.
5.2 Medical laboratories – Requirements for quality and competence, ISO 15189:2022
FDAS has adopted ILAC documents from the P & G series, where available, and can be downloaded from:
www.ilac.org
6.1 Biological
6.2 Chemical
6.3 Electrical
6.4 Electronic
6.5 Fluid Flow
6.6 Mechanical
6.7 Non-Destructive (NDT)
6.8 Optical and Photometry
6.9 Radiological
6.10 Thermal
7.0 Fields have been divided groups & subgroups.
7.1 Biological Testing
Group Sub-group
Bio-chemical Blood bank serology
Testing Hematology
Clinical Immunology
Anatomical pathology
Clinical biochemistry
Bioavailability studies drugs
Bio-efficiency Pesticide
Plant hormones
Weedicides
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Biological assay Industrial culture
Antibiotics and other drugs
Disinfectants
Vaccines and sera
Miscellaneous micro-biological products
Vitamins and enzymes
Hormones
Environmental Toxicity to fish
biology Toxicity to birds
Toxicity to domestic animals
Identification of benthic and macro-organisms
Toxicity to Wildlife etc.
Biotoxins and microbial toxins
Food and Alcoholic drink & soft drink beverages
agricultural Animal feeds
products Bakery & Confectionary
Cereals, pulses & cereal products
Coffee & cocoa products
Milk & dairy products
Tea
Starch & starchy products
Fish & fishery products
Ready to eat products/ Proprietary products
Calorific value/energy
Food additives/preservatives& antioxidants
Honey & honey products
Fruit & vegetable products
Infant foods
Meat & meat products
Whole & ground spices & condiments
Spice oil & oleoresins
Sugar and sugar products
Tobacco & tobacco products
Nut and nut products
Sensory evaluation filth & extraneous matter in food
Oil, fats & related products
Forensic analysis Analysis of biological fluids & typing
Testing of hair, bones, tissues, etc.
Botanical examination & testing
Genetic activity Bacterial & cell cultures
Seed purity & germination and freedom from disease
Other products
Industrial culture Yeasts
Rhizobial Cultures
Dairy starter culture
Inhalation Acute toxicity
toxicology Sub-acute toxicity
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Microbiological Cosmetics
tests (Bacteria, Vitamin & enzymes
fungus) Raw & processed foods
Water & Wastewater
Sewage, effluents & industrial
Milk and other dairy products
Surgical items
Pharmaceuticals
Mycotoxins Mycotoxins in foods & feeds
Pharmacology Bioassay
tests Biological test for identity
Pyrogen tests
Histamine tests
Antigenicity tests
Group Sub-group
Air gases & Ambient air monitoring.
Atmosphere Stack emission monitoring.
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Fugitive emission monitoring.
Solid particulate matter:
-Size distribution
-Chemical analysis
Liquid mists, aerosols:
-Chemical analysis
Gaseous pollutants:
-Chemical analysis
Industrial gases
Gases for medical use & diving
Reference gases & mixtures
Liquified/compressed gases
Fuel gases
Alcohol & allied Industrial alcohols.
chemical Allied chemicals.
Adhesives Starch based adhesives.
Natural gums.
Glues.
Building materials Cement:
Cement & other mortars
Cement concrete
Refractories
Refractory cement
Sand
Clays & soils
Pozzolanic materials
Fly ash
Limestone, lime gypsum
Waterproofing/bituminous materials
Thermal insulation materials
Masonry bricks/blocks etc.
Wood testing & identification
Coal, coke & other Coal/coke
solid fuel Coal carbonization products
Coal tar/bitumen:
Charcoal
Other solid fuels
Dye & Synthetic dyes
intermediates Dye intermediates
Natural dyes & colouring materials
Disinfectants Disinfectants & their formulation
Drugs & Synthetic drugs
pharmaceuticals Natural drugs(medical plant)
cosmetics Preparations
Pharmaceutical preparations
Drugs intermediates & raw materials
Cosmetics
Intermediates and misc.
Chemicals for cosmetics
Perfumes
Essential oils
Explosives and Service explosives
pyrotechnics Industrial explosives
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Pyrotechnics
Explosive chemicals & allied materials
Fertilizers Nitrogen fertilizers
Phosphorous fertilisers
Fertiliser mixtures
Potassium fertilisers
Micronutrients
Bio-Fertilizers
Food & Alcoholic drinks & beverages
agricultural Animal feeds
products Bakery and confectionary products
(Chemical/Physical Cereals, pulses & by-products
Test) Coffee, cocoa & by-products
Milk and dairy products.
Tea and tea products
Starch and starchy products
Fish and fishery products
Food additives:
Colour,Flavour and Preservatives
Honey and honey products
Fruits & vegetable products
Infant foods
Meat and meat products
Spices & condiments
Sugar and by -products
Tobacco and by-products
Sensory evaluation-flavour
Oil, fats and related products
Soft drinks
Pan Masala and similar products
Chewing Gum and similar products
Forensic analysis Chemical analysis of trace materials as clues
Analysis of poisons/drugs
Specialised testing by Physicochemical techniques
Inks Printing inks
Liquid inks and allied products
Raw materials-carbon black dyes,etc.
Industrial and fine Inorganic chemicals misc.
chemicals Organic chemicals misc.
Electroplating chemicals
Solvents misc.
Laboratory chemicals
Analytical reagents.
Lac & lac products Lac
Lac products
Leather Leather
Chemicals for leather
Synthetic leather
Ores & Minerals Iron ores
Copper ores,
Zinc ores
Other common metal ores
Precious metal ores
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Rare metals ores
Radio active metals ores
Bauxite
Limestone & Dolomite
Rock phosphate
Gypsum
Silica sands
Mineral sand
Mineral for refractories
Mineral for insulation materials
Other minerals
Trace element analysis
Metals & alloys Iron steel & ferro alloys
Copper and its alloys
Aluminium and its alloys
Tin and tin alloys
Zinc and its alloys
Lead & its alloys
Magnesium & its alloys
Nickel,chromiums,cobalt and its alloys
Titanium & its alloys
Tungsten and its alloys
Other metal alloys
Precious metals
Metallic coating and treatment solutions
Corrosion testing
Trace element analysis
Paints & surface Paints and enamels
coating Vehicles,solvents,thinners
Pigments and extenders
Polishes
Painter’s materials (gums,driers,paint removers)
Drying oils
Paint removers
Outdoor weathering tests
Artificial weathering tests
Fresh water immersion tests
Marine under water tests
Humidity tests
Salt spray tests
Underground tests
Paper and pulp Pulp, paper and products
Paper and board packing materials
Additive& coating materials
Group Sub-group
Distribution Battery Testing
System Distribution Equipment Testing
Domestic Equipment testing
Environmental testing
Explosion proof testing
Illuminated testing
IP cubicle testing
Relay testing
High Current Switching duty test (HV)
Switching duty test (LV)
Short-time current test
Short circuit withstand test
Rated make/break test
Electrical endurance test
Temperature rise test
Locked rotor tests on Motors
Load loss & No load loss test
High voltage Corona inception/extinction
Front of wave impulse flashover
High voltage dc
Impulse flashover
Impulse withstand
Pollution performance
Porosity test
Power frequency flashover voltage
Power frequency sparkover
Power frequency voltage withstand
Puncture withstand voltage
Radio interference voltage
Switching impulse voltage
Temperature cycle
Visible discharge
Voltage distribution
Insulation Ageing tests on insulation
Arc resistance
Cable testing
Capacitor testing
Chemical tests on electrical insulation metals
Comparative tracking index
Dielectric constant
Dielectric strength
Electrical conductivity
Fire resistance testing
Heat cycle
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IDE measurement
Inductance measurement
Insulation resistance
Leakage current
Load cycle
Mechanical tests on electrical insulating materials
Overload run test on capacitors.
Physical tests on electrical
Insulating materials
Partial discharge tests
Resistance measurement
Self-healing test on capacitors
Stability test on capacitors
Surface resistivity
Thermal resistivity
Transient over voltage on capacitors
Verification of Insulating properties
Volume resistance
Volume resistivity
Wrapping tests on cables
Material Testing Combustion testing
Insulation oil testing
Metallurgical testing
Refractory material testing
Thermal testing of materials
Power system Analogue simulation
Grounding system testing
Meter testing
Transmission line Line material testing
testing Tower testing
Vibration testing
Group Sub-group
Air Delivery Air displacement by fans (ceiling,table,petestral)
System Air delivery by exhaust fans
Air delivery by blowers (centrifugal & positive displacement) rate
of flow & static pressure measurement
Air delivery by blowers:
Integrated quantitative flow measurement
Air quantity measurement in compressed air systems
Air flow measurement in ducts.
Atmospheric Wind velocity
air/Environment Wind direction
Compressed gases Flow rate measurement in pipelines
and steam Integrated quantity measurement (Volumetric)
Mass flow measurement
Corrosive liquids Volumetric (mass flow metering rates)
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Integrated volume/mass flow
Flue Flow rate and quantitative
gases/emission Measurement of gases in chimneys (circular and rectangular
ducts)
Gas-liquid Flow rate measurement (aerosols)
systems Integrated flow measurement
Concentration
Gas-solid systems Flow rate measurement (slurries)
Bed movement (fluidized system)
Concentration
Liquid gases Flow rate
Mass flow (integrated)
Liquid-solid Flow rate measurements (Slurries)
systems Integrated flow measurement
Concentration
Multicomponent Flow measurement
system Integrated flow measurement
Individual component measurement
Multiphase Flow measurement
system Integrated flow measurement
Individual component measurement
Non-Newtonian Flow rate
fluids Integrated mass flow metering
Petroleum and Flow rate measurement in pipes
related products Mass flow rate in pipes
Integrated volumetric flow metering
Integrated mass flow metering
Ultra low flow Leak rate of gases
Leak rate of liquids
Volatile liquids Flow rate measurement in pipes
Mass flow rate in pipes
Integrated volumetric flow metering
Integrated mass flow metering
Water, other Flow rate measurement in open channels, streams
liquids (Milk, oil Flow rate measurement in closed channels, sewers
etc.) and effluents Flow rate measurement in pipeline
Integrated volumetric flow metering in pipelines
Mass flow measurement
Flow measurement at different heads from pumps and other
similar devices.
Group Sub-group
Mechanical Properties of Tensile Test
Material Hardness test by Vickers
Hardness test by Brinell
Hardness test by Rockwell
Micro hardness test
Izod impact test
Charpy impact test
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Bend test
Fatigue test
Lapping/wrapping/colling test
Measurement of surface finish
Shear test
Torsion test
Transverse test
Bulging test for tube
Crushing strength for tube
Cupping Test
Compression Test
Dimension
Rebend Test
Drifted expansion Test
Breaking Load Test
Weldability tests:
-Implant cold cracking test
-Y-Groove cracking test
-Verestraint hot-cracking test
-Circular patch test
-Diffusible Hydrogen measurement by Hg Method
-Gas Chromatography for diffusible Hydrogen
-Thermal cycle reheat cracking test
-Thermal hot ductility tests
-Delta ferrite measurement by magnetic method
Lime testing:
-Residue on slaking
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-Workability test
-Volume yield test
-Popping and filling test
Tiles testing:
-wet transverse test
-Impact test
-Crushing strength
Concrete testing:
-Compressive strength
-Determination of proportion of mortar concrete in a set
mix
-Bond strength
-Deflection and ultimate load
-Flakiness index for aggregates for concrete and road
Stone/Aggregate testing:
Elongation index for aggregate
Adhesion of aggregate to tar
-Moh’s hardness number
-Point load strength index
-Durability test
-Permeability test
-Surface softening test
-Toughness test
-Weathering test
Soundness
Seave analysis in aggregates
Soil Testing:
-Liquid limit
-Plastic limit
-Shrinkage limit
-Proctor test
-Triaxial shear strength
-California bearing capacity
-Bearing capacity
-North Dakota cone test
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-Direct Shear Strength
-Consolidation Test
-Unconfined Compression
- Permeability Test
-Determination of Specific Gravity
-Determination of Moisture content
-Vane Shear Test
-Sieve Analysis
-Hydrometer Analysis
-Free Swell Test
-Field Density Test
Timber testing:
-Moisture content using moisture meter
-Moisture content using hot air oven method
-Specific gravity
-static bonding test
-Impact bending test
-Compression test
-Shear test
-Tension test
-Nail holding test
-Screw holding test
-Impact test
-Torsion test
-Determination of specification
Plyboard testing:
-Resistance to dry heat
-Fire resistance
-Glue shear strength
-Adhesion of plies
-Water resistance
-Nycological test
-Fibre diameter
-Friability
- Revovery after compression
-Incombustibility
-Moisture absorption
-Linear strinkage
-Water vapour permanence
-Dimension
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Textile/Fabrics/wool/yarn Any type of physical/mechanical test
1. Yarn
2. Fabrics, Garments & Other textile material
Test on bicycle:
-Frame
-Pedal
-Crank and chain
-Wheels
-Handle bar
-Hub
-Spoke
Test on Burners
Test on Bib tap and stop tap
Test on Ball valves
Test on Centrifugal pumps
Test on Commercial cooking range
Test on domestic pressure cooker
Test on Gas cylinders
Proof load tests on chains
Compression test for bridge bearings
Load test on Draw bar hooks
Load test on Laminated springs
Kg
0-100 Kg
Above 100 Kg
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Load test on Hydraulic jacks:
Proof load upto 100 tons
Proof load 100 to 150 tons
Proof load above 150 tons
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7.7 NDT Testing
Group Sub-group
Eddy current Conductivity variation measurement
testing Detection of surface and sub surface defects
Dimensional variations
Irregularities in micro structures
Variation in chemical composition
Emerging Areas Acoustic emissions
testing (Acoustic Holography
& others) Infra-red applications
Leakage flux techniques
Microwave applications
Neutron radiography
Relative radiography
Leak test Argon leak test
Detection of leak pressure rise of pressure drop
Halogen leak test
Helium leak test
Radio-isotope cracer leak test
Ultrasonic leak test
Magnetic Detection of sub surface flaws
Particle Testing Detection of surface flaws
Penetrant Detection of surface flaws of materials with visible dye
Testing Detection of surface flaws of materials with fluorescent dye
Radiographical Fluoroscopy
Testing Detection of flaws with radio isotopes
Detection of flaws with X-ray
Ultrasonic Corrosion survey
Testing Detection of internal flaws
Detection of surface and sub surface flaws
Thickness measurements
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General tests of Dimensional measurements
Optical Optical aberrations
instruments Numerical aperture
Shutter speed
Wavelength calibration
Veiling glare
Resolution
M.T.F.
Lasers Laser power
Laser energy
Angular divergence and beam spot size
Output wavelength
Coherence (Spatial,temporal and mutual)
Polarisation
Mode spectrum (including stability and reproducibility)
Noise amplitude
Noise Phase
Modulation
Micrometrology Dimensional measurements
Optical aberrations
Numerical aperture
Shutter speed
Wavelength
Veiling glare
Ophthalmic Power spherical
lenses Power cylindrical
Power prismatic
Axis and centering
Spectral transmission
Photochromic glass colour building time
Photochromic glass fading time
Optical Flatness and parallelism
components & Sphericity
systems Prismatic angle
Surface quality
Aperture
Field of view
Focal length
Optical aberration
Resolving power
Magnifying power
MTF
Optical Refractive index
materials Material dispersion
Material strain
Scattering & Homogeneity
Transmittance
Reflectance
Bubbles & seeds
Birefringence
Photometry Luminous intensity
Intensity distribution from luminaires
Illuminance and its distribution
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Luminance and its distribution
Luminous output
Life tests and performance of lamps
Photosensitive Sensitivity/speed
films, places Emulsion thickness
&detectors Granularity
Resolution
H & D curve (gamma)
Spectral response
Quantum efficiency
Modulation transfer function
Noise effective power
Polarimetry Optical rotation
Rotatory dispersion
Absorption coefficient
Phase change on reflection
Stokes parameters
Radiometry Radiant intensity
Irradiance (total/spectral)
Emillance (Spectral/total)
Spectral reflectance
Spectral transmittance
Spectral absorptance
Thin film optics Reflectance
Transmittance
Polarisation changes
Bandwidth
Hardness
Scattering
Group Sub-group
Radiation Area survey instruments
Monitors Fixed monitors
Personnel monitoring dosemeters
Control monitors
Environmental radiation monitors
Others
Radiation Diagnostic X-ray machines
Sources Medical X-ray scanners like CAT scanners
Therapy X-ray machine
Industrial X-ray machines
Isotopic sources used in industrial gauges
Isotopic sources used in medical brachytherapy
Cobalt machines
Caesium machines
Medical accelerators
Industrial accelerators
Accelerators used in research
Diffraction X-ray machines
Dental X-ray machines
X-ray machines used in consumer product testing
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X-ray machines for baggage checking
Neutron generators
Beam welding equipment
Radiological Medical gamma camera
Equipment & Industrial gama radiography equipment
nucleonic Radiography camera
equipment Thickness gauges
Gamma Switches
Nucleonic weighing machines
Smoke detectors containing sources
Nucleonic level gauges
Nucleonic moisture and density gauges
Group Sub-group
Ablative Decomposition (pyrolysis temperature)
properties Ablation temperature
Heat of pyrolysis
Heat of ablation
Insulation index
Arrehenious kinetic constant
Calorific values Calorific value of solid fuels
Calorific value of liquid fuels
Calorific value of gaseous fuels
Combustion Heat of combustion
properties Thermal stability -Time/temp rating
Incombustibility
Fuel burning properties
Heat flux Heat flux
Latent heat Latent heat of melting
Latent heat of vapourisation
Radiation Emissivity (Total hemispherical emittance and total normal
properties emittance)
Reflectivity.
Absorptivity.
Solar Absorbitivity.
Black Body Temperature.
Rate constant Peserve
Specific heat Specific heat of metals and alloys.
Specific heat of non-metallic solids.
Specific heat of liquids.
Specific heat of gases and gaseous mixtures.
Thermal Thermal Conductivity of metals and alloys.
Conductivity Thermal Conductivity of composite,
ceramics, refractories, plastics, etc.
Thermal conductivity of honeycomb materials, foam, garnulor and
fibrous insulations.
Thermal conductivity of liquids.
Thermal conductivity of gases and gaseous mixtures.
Thermal conductivity of colloidal solutions & slurries.
Thermal Thermal diffusivity of metals and alloys.
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diffusivity Thermal diffusivity of composite ceramics, refractories, plastics, etc.
Thermal diffusivity of honeycomb,
foam, granular and fibrous insulations.
Thermal diffusivity of liquids.
Thermal diffusivity of gases and gaseous mixtures.
Thermal diffusivity of colloidal solutions and slurries.
Thermo- Bulk modulus for liquids
Mechanical Bulk modulus for gases
Properties Coefficient of linear expansions/contractions
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9.3 Groups in Fluid Flow Calibration
9.3.1 Flow rate by mass
9.3.2 Flow rate by volume
9.3.3 Quantity by mass
9.3.4 Quantity by volume
9.3.5 Velocity at a point for gases only
9.3.6 Mean velocity in the closed conduit as well as open channel for water and gases
9.3.7 Viscosity of gases and liquids
9.4.3 Density
Hydrometers
Density measuring instruments
Specific gravity
9.4.4 Moisture
Moisture meters
Moisture balance
9.4.5 Force
9.4.5.1 Force
Proving devices
Force measuring devices.
Force Machines
9.4.5.2 Hardness
Hardness testing machines, Brinell
Hardness testing machines, Vickers
Hardness testing machines, Rockwell
Hardness Standards Diamond and Ball Indenters
Microhardness, Knoop Hardness, Durometers
Leeb hardness and Rubber hardness shore A and D
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9.4.5.3 Impact
Izod impact testing machines
Charpy impact testing machines
9.4.5.4 Torque
Torque tester, torque wrench, torque measuring devices, Torque machines, torque generating
devices.
9.4.8 Acoustics
Pressure and power
Vibration amplitude acceleration
Attenuation
Frequency
Noise
Velocity
Others
9.5.2 Radiometry
Radiance
Irradiance
Emittance
9.5.4 Colorimetry/Chromometry
Color
Color distribution
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Color corelated temperature
9.5.5 Polarimetry
Polarization
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OT Table
Radiant warmer
Irrandiance meter
Phototherapy unit
Others
9.8.3 Monitoring unit
Patient monitors
Apnea monitors
Fetal monitor
Therapeutic stimulator
Weighing scale
Hematology analyser
Others
9.8.4 Imaging/Plotters
Trans illuminator light source
EEG
Fetal Doppler
ECG
X-Ray Diagnostic equipment
Others
11.2 Testing Laboratories operating in more than one field of testing are required to submit
a single application by separating the details of the scope field-wise with respective
details of Scope, Personnel and Equipment sequentially, for each field.
- Textile & Leather laboratories to apply for Chemical and Physical (Mechanical) testing.
- Metallurgical laboratories to apply for Chemical, Mechanical & NDT testing.
- Plastic laboratories to apply for Chemical, Mechanical, Optical, NDT testing etc.
- Building/Construction material laboratories to apply for Chemical, Mechanical, NDT testing etc.
- Environment, Pollution, Forensic, Environmental testing laboratories to apply for each field
in which they operate.
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11.4 Applicant laboratories are advised to seek accreditation for only those parameters for which
resources and competence are available.
11.5 Calibration laboratories, when operating in more than one field of calibration, are to apply
field wise, by defining scope of calibration.
11.6 Medical laboratories to apply for the field(s) they operate and defining scope of test.
11.7 Applicants are advised to read the relevant documents available at the website of FDAS,
including its policy documents.
11.8 Applicant must ensure that accreditation requirements have been addressed prior to
the commencement of assessment activities for accreditation of applied scope.
Note: Applicant laboratory not providing the required information till three months from the
date of FDAS letter, would be treated as closed. However, it can be revived on request by paying
half of the application fee, till one year from the date of FDAS letter.
Reassessed CABs/laboratories are subjected to desktop surveillance around the middle of the
accreditation period of two years.
As per FDAS norms accreditation status would remain valid, till 2 months after the expiry of validity
period of accreditation.
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14.0 FDAS Policy on Legal Entity*
Note 1: Opening of bank account or paying taxes has nothing to do with legal entity.
Note-2: Legal entity of a laboratory makes it legally responsible for its laboratory activities and its
accreditation status ensures the same to its users globally. This clause of the standard safeguards the interest
of the users of the accredited laboratories.
Note-3: Laboratories registered by MSME is the recognition for its category as per MSME rules. MSME
recognition does not provide legal status.
Accredited laboratories/CABs are entitled to use FDAS symbol subject to compliance of the “Terms and
conditions for use of FDAS symbol by laboratories” and FDAS symbol can be obtained from FDAS by the
accredited CABs/Laboratories.
15.1 Initial Assessment
15.2 Reassessment
15.4.1 When the Application for expansion of the scope of accreditation is from same
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field/group, FDAS seeks the evidence on resources and competence, to determine, if the site
visit is required. If the documentary evidence found to be enough, the accreditation is possible
without organizing lab visit.
Example: A mass, pressure, temperature calibration lab can expand its range, by
procuring required resources.
15.4.2 Expansion of scope of accreditation from new field/ group would require on site assessment.
15.4.3 All midterm accreditations would be co-terminus, with main accreditation.
15.6 FDAS Norms for the reproduction of FDAS symbol & FDAS symbol combined ILAC MRA mark
It is not mandatory for accredited laboratories to use the FDAS symbol & FDAS symbol combined ILAC
MRA mark, but laboratories using must comply to FDAS 132 Terms and conditions for use of FDAS symbol
L& FDAS symbol combined ILAC MRA mark by laboratories.
16.0 Conditions to be met by CABs when shifting of the location of CAB is involved.
16.1 The laboratory should inform FDAS well in advance, before shifting the location of CAB with
the following information.
• Date(s) of shifting.
• Address of new location with documentary evidence for the right to use the premises.
• With applicable fee.
Note: Documentary evidence should suffice (including Documentary evidence to display right to use the
new premises), but in certain cases a visit by FDAS may be required. In view of this, interested CAB
should remain in touch with FDAS, so that FDAS can act in time.
16.3 After completion of shifting, FDAS is to be informed about the date from which it intends to
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commence its commercial services for its customers for the approval of FDAS.
FDAS approval involves issue of revised accreditation certificate, scope to indicate change of address.
clauses 6.2.2:
“The laboratory shall document the competence requirements for each function influencing the results of
laboratory activities, including requirements for education, qualification, training, technical knowledge,
skills and experience”.
Explanation: Since FDAS is not defining competence norms for laboratory’s personnel, laboratory to define
the competence for each level of function in terms of education, qualification, training, technical
knowledge, skills, and experience.
17.2 Training
FDAS gives due recognition to in-house trainings given by competent laboratory personnel.
17.3 Equipment
clauses 6.4.2:
When the laboratory uses equipment outside its permanent control, it shall ensure that the requirements.
for equipment of this document are met.
Applicability of the above clause:
In those situations, where Lab’s own equipment has gone out of order, in the middle of testing and
customer’s need must be met, laboratory can use equipment outside its permanent center, subject to
compliance of ISO/IEC 17025: 2017, Example: weighing balance.
18.0 Complaints
Laboratories & its stakeholders are free to lodge a complaint to FDAS on any of their concerns, FDAS would
process the complaint as per its procedure. Procedure for Complaints is available on the websiteof FDAS.
Complainants are advised to address their complaint to the Quality Manager, FDAS.
19.0 Appeals
Laboratories have the right to Appeal against the adverse accreditation decision of FDAS and also its
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decision on complaints made to it, and such appeals are handled as per FDAS procedure for handling
appeals, which can be seen at FDAS website. Appellants are advised to send their appeals to Quality
Manager, FDAS.
• Determines the gaps in the existing documented management system against the
requirement of ISO/IEC 17025 or ISO 15189, using applicable checklist - 1, (available at
www.fdasindia.org) & bridge the gaps if any.
• It is mandatory to have documented management system as per the requirement of
ISO/IEC 17025/ISO 15189, which can be documented by the laboratory in its manual
(Quality manual or Laboratory manual), procedures, Instructions, log-sheets etc.
When documented management system complies to the requirement (ISO/IEC 17025 or ISO
15189), submit application for accreditation along with
• Applicable fee
• Checklist – 1(ISO/IEC 17025)- FDAS 111/Checklist-1 (ISO-15189) – FDAS 112
• Management System Manual
• FDAS – 131 (Terms & conditions of FDAS to maintain accreditation)
• FDAS – 132 (Terms and conditions for use of FDAS symbol L& FDAS symbol combined ILAC MRA
mark by laboratories)
• FDAS – 138 (Legally enforceable agreement between FDAS and its accredited laboratories)
First time applicants are subjected to initial assessment, however if applicant request for preliminary
visit, FDAS is open to it, to determine the preparedness of the laboratory, through LA, & as non-
consultant activity.
ii. Assessment team lead by LA, conducts the assessment which involves examination of
documents, work records, witnessing the test/calibration, interviewing of personnel etc. Lab is
informed about the corrective action required (CAR) to be taken by the laboratory in agreed
time.
iii. LA sends team’s recommendation to the concerned dealing officer, as per the assessment format of
FDAS, pending the completion of corrective action required, if any.
iv. On receipt of the details of the corrective action taken by the laboratory along with
documentary evidence, the concerned assessor/LA, would forward to the dealing officer
stating that required corrective action (CAR) has been taken and NC(s) is/are being
removed/withdrawn.
v. After examination of the assessment report, and action taken by the lab for corrective
action required, dealing officer submits his recommendation for grant of accreditation to
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Director.
vi. Director asks QM to examine the compliance to the procedures involved and based on the
report from QM, Director takes appropriate action for grant of accreditation to the applicant
laboratory, which in turn is communicated to the laboratory through accreditation certificate
with the recommended scope of accreditation.
Note - 1: Assessors are not empowered to change the applied scope of accreditation while on-site
except on technical matters.
Note-2 Assessors are empowered to give a time of one month for required corrective action,
beyond which the dealing officer is to be contacted.
Note-3: Laboratories are free to appeal against the findings of the assessment.
Application Fee
1 Biological Lab for up to 2 groups (Refer 7.1 in FDAS 100) 20000.00 for up to two groups
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(in already accredited field) 5000.00 per group
Assessment Charges a. Actual expenditure incurred
by assessment team on
account of their travel,
boarding and lodging.
b. The honorarium @
Rs.5000.00 per day for Lead
Assessor (LA) & Rs.4000.00
per day to each Assessor/
Technical assessor (TA) T.
Any Change in the name and /Premises/Legal identity 5,000.00
In addition to the above-mentioned fee, GST @18% or as applicable from time to time to be paid.
Application Fee
1 Biological Lab for up to 4 groups (Refer 7.1 in FDAS 100) 500.00 for up to four groups
Application Fee
1 Biological Lab for up to 4 groups (Refer 7.1 in FDAS 100) 700.00 for up to four groups
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21.4 Fee Structure: Calibration Laboratories in India
S.No Calibration Laboratory Fees (Rs.)
Application Fee
1 Chemical (all parameters) 40000/-
2 Electro-Technical (all parameters) 25000/-
3 Fluid Flow (all parameters) 20000/-
4 Mechanical – for up to 2 groups 20000/-
(Refer 9.4 in FDAS 100)
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21.6 Fee Structure: Calibration Laboratories in Other countries.
S.No Calibration Laboratory Fee (USD)
Application Fee
1 Chemical (all parameters) 800.00
2 Electro-Technical (all parameters) 800.00
3 Fluid Flow (all parameters) 800.00
4 Mechanical – for upto 4 groups 800.00
(Refer 9.4 in FDAS 100)
Additional Group 200.00 per group
5 Optical & Photometry (all parameters) 800.00
6 Radiological (all parameters) 800.00
7 Thermal (all parameters) 800.00
8 Medical Devices – for up to 2 groups 800.00
Additional groups 400.00 per group
Annual Accreditation Fee 500.00/Field
Surveillance/Desktop Fee 300.00
Expansion of Scope fee
Addition of new groups (in already accredited field) 400.00/up to 2 groups
Enhancement of range in existing accredited groups/field 200.00/per group
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NEFT/RTGS to the following A/C
Name of the A/C Federation for Development of Accreditation Services
Name of the Bank & Union Bank of India,
Address G/ 6 A, Bestech Square, Sector 56
Gurgaon (Haryana) 122002
A/C No. 579201010050690
Type of A/C Current
IFSC Code UBIN0557927
MICR Code 110026093
.
Website: www.fdasindia.org
*******************************************************************************
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FAMILIARIZATION WITH ACCREDITATION PROCESS
Applicant Laboratory
APPLICANT LABORATORY
Initial Assessment by assessment team (LA and Technical assessors/Technical experts) and
Recommendation for accreditation after required corrective action by lab (if NCs reported)
Examination by Quality Manager for the compliance to the procedure(s) used by Dealing
officer & Assessment team
Recommendation by Director
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