02 - DA-Acr-13D See 03 Proficiency Testing Guideline (Final Revised)

CRITERIA GUIDELINE FOR PARTICIPATION Code: DA-acr-13D
IN PROFITNESS Version: 03
TESTS/INTERLABORATORY Page: 1 of 13
INACAL COMPARISONS
National Quality Institute
Accreditation
PARTICIPATION IN PROFITNESS TESTS/INTERLABORATORY COMPARISONS

Policy and Criteria for participation on Proficiency Testing
Version 03
Reviewed by:
Produced by: Approved by:
Patricia Aguilar
Technical Committee 2018-09-18 Mónica Núñez Date: 2018-09-18
Signature: in original Signature: in original
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CRITERIA GUIDELINE FOR PARTICIPATION
Code: DA-acr-13D
IN PROFITNESS
Version: 03
INACAL COMPARISONS
Accreditation
INDEX
No. Qualification P.
1 AIM 3
2 POLICY 3
3 GENERALITIES 3
4 SCOPE 3
5 REFERENCE DOCUMENTS 3
6 DEFINITIONS 4
7 GENERAL REQUIREMENTS 4
8 6
CRITERIA TO CONSIDER FOR PARTICIPATION
9 CRITERIA FOR EVALUATION 6
No. ANNEXES P.
1 ANNEX 1 -A 9
2 ANNEX 1-B 14
3 APPENDIX 2 15

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1. AIM
Establish the criteria for the participation of laboratories and inspection bodies in proficiency
testing as a tool to evaluate their technical competence, in order to apply it in the different
accreditation processes.1 administered by the INACAL Accreditation Directorate, hereinafter
INACAL-DA.
2. POLICY
• It is the policy of INACAL-DA to require laboratories and, if applicable, inspection bodies, to

demonstrate their technical competence in the execution of tests, calibrations, clinical
analyzes or inspections, through their satisfactory participation in testing programs. fitness
• INACAL-DA promotes and disseminates proficiency testing programs, at the national,

regional or international level to provide service to laboratories and inspection organizations
accredited or in the process of accreditation.
3. GENERALITIES
Participation in proficiency testing activities is one of the mechanisms used by the

Accreditation Directorate to:
a) Ensure compliance by the laboratories with the requirement of the current NTP-ISO/IEC
17025 and NTP-ISO 15189 standards, as part of the laboratories' responsibility to ensure
the validity of the results.
b) Comply with the policies that international organizations such as the IAAC, ILAC,
APLAC, have established as requirements, for obtaining and maintaining mutual
recognition agreements between laboratory accreditation systems and inspection
organizations.
c) Ensure that laboratories and, if applicable, inspection bodies demonstrate their technical
competence through their participation in these programs.
4. SCOPE
This guideline applies to testing, calibration, clinical laboratories and, if applicable, inspection
organizations that are accredited or in the process of accreditation before INACAL –DA.
5. REFERENCE DOCUMENTS
• NTP ISO/IEC 17025 General requirements for the competence of testing and calibration
laboratories.
• NTP-ISO 15189 Clinical Laboratories. Particular requirements for quality and competence.
• NTP ISO/IEC 17020 Conformity Assessment. Requirements for the operation of different
types of organizations that carry out inspection.
1Accreditation processes: accreditation, renewal, follow-ups, among others.

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• NTP ISO/IEC 17043 Conformity assessment. General requirements for proficiency testing
• ISO 17034. General requirements for the competence of reference material producers.
• ISO/IEC Guide 99 International vocabulary of metrology -- Basic and general
concepts and associated terms (VIM)
• APLAC PT 006 – 09/2010 Proficiency Testing Frequency Benchmarks
• ILAC P9:06/2014 ILAC Policy in participation in proficiency testing activities
• NTP ISO/IEC 17011 General requirements for Bodies that carry out the evaluation and
accreditation of Conformity Assessment Bodies.
6. DEFINITIONS
In addition to the following definitions, for the purposes of this document the definitions of
NTP Standard ISO/IEC 17043 are applicable
Aptitude Test : Evaluation of the performance of participants with respect to previously

established criteria through interlaboratory comparisons. ILAC- P9:06/2014
Proficiency Testing Provider : Organization that is responsible for all tasks related to the
development and operation of a proficiency testing program. NTP ISO/IEC 17043 standard,
item 3.9.
Interlaboratory Comparisons : Organization, performance and evaluation of measurements

or tests on the same item or similar items by two or more laboratories or inspection
organizations, according to predetermined conditions. ILAC-P9:06/2014
Test Item: Sample, product, artifact, reference material, part of equipment, measurement
standard, data set or other information used in a proficiency test. NTP ISO/IEC 17043
standard, item 3.8.
7. GENERAL REQUIREMENTS
7.1 Laboratories must demonstrate their technical competence in the execution of clinical
analyses, assays or calibrations, through satisfactory participation in proficiency testing
programs. Where relevant, this also applies to accredited inspection bodies.
Note: Satisfactory participation is understood as the conclusion reported by the proficiency

test provider, which indicates whether or not the result obtained by the participating
laboratory is close to the average obtained by the other participating laboratories. Generally
this conclusion is based on the Z-score parameter. The conclusion of participation is by
analyte and measurement range in which the laboratory participated. For cases in which
more than one parameter is reported, such as the Z-score, the normalized error or
others; just one

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of them is not satisfactory for participation in the proficiency test to be considered

unsatisfactory.
7.2 Minimum participation in Proficiency Tests for Testing or Calibration laboratories:
- Laboratories applying for accreditation for the first time will be required to submit records
of their successful participation in at least one proficiency test in each discipline. The date
of issuance of the report of this participation must not be more than two (02) years at the
time of requesting accreditation.
Note 1: If this participation is not available, the accreditation request will not be accepted.
- In the case of follow-up evaluations, at least one participation related to each sub-
discipline of the scope of the laboratory's accreditation is required in a period of two years.
INACAL-DA will evaluate that the laboratory has covered its entire accredited scope
in an accreditation cycle. The laboratory can demonstrate this by grouping similar
test methods within a subdiscipline, which must be supported and documented.
- For those laboratories that request extension of accreditation, they will be required to
present records of their satisfactory participation in at least one proficiency test
corresponding to the sub-discipline involved.
Note 2: For the classification of disciplines or subdisciplines of tests or calibrations, refer
to Annex 1-A. This also applies to the Matrix, Material or Product indicated in said
annex for testing laboratories.
Note 3: If this participation is not available, the extension request will not be accepted.
7.3 Minimum participation in Proficiency Tests for Clinical Laboratories:
- For laboratories requesting accreditation for the first time, for follow-up evaluations and
accreditation extension processes, INACAL-DA will require the participation of the
laboratory in at least 3 proficiency tests per year for each analyte and with results
satisfactory in 80% of them. The date of issuance of the last report of this participation
must not be more than 4 months at the time of requesting accreditation.
7.4 Minimum participation in Aptitude Tests for Inspection Bodies:
- For inspection bodies applying for accreditation for the first time, they will be required to
submit records of their successful participation in at least one proficiency test in each
sub-discipline included in the scope of the requested accreditation. The date of
issuance of the report of this participation must not be more than two (02) years at the
time of requesting accreditation.
- In the case of follow-up evaluations, at least one participation related to each sub-
discipline of the scope of the inspection body's accreditation is required, in a period of no
more than two (02) years.
- For those inspection bodies that request expanded accreditation, they will be required to
submit records of their satisfactory participation.

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in at least one aptitude test corresponding to the sub-discipline involved.
Note 4: For the classification of disciplines or subdisciplines of inspections, refer to Annex 1-
B.
8. CRITERIA TO CONSIDER FOR PARTICIPATION

8.1 INACAL-DA will judge the suitability of proficiency testing providers based on compliance
with any of the following criteria:
a. That they are accreditation bodies that are signatories of the MLA of IAAC or the MRA
of APLAC or ILAC.
b. That they are included as providers of aptitude tests in the European Proficiency
Testing System (EPTIS).
c. That have been accredited with the NTP ISO/IEC 17043 Standard or that demonstrate
that they comply with this technical standard.
d. Whether it is a National or International Metrology Institute.
Note 5: INACAL-DA may disseminate participation in proficiency tests organized by

national organizations, regional cooperation or other interested parties for
accredited laboratories.
8.2 If there is no supplier for a certain analysis, assay or calibration, at a national or

international level, for an analyte or a subdiscipline within the scope of a laboratory's
accreditation:
a) Laboratories will be allowed to promote programs or rounds of aptitude tests, in this
case they must comply with the guidelines established by INACAL-DA (See Annex 2),
or
b) Only in exceptional cases, duly supported and previously evaluated by INACAL-DA,
the laboratory will be able to demonstrate its technical competence through the
program to ensure the validity of its results, carried out internally in compliance with
section 7.7 of the NTP-ISO standard. /IEC 17025 or section 5.6 of NTP-ISO 15189, as
appropriate.
Note 6: The application of literal b) will only be accepted when it has been demonstrated that
literal a) is not possible.
9. CRITERIA FOR EVALUATION
To ensure the adequate performance of the laboratories and, if applicable, the inspection
bodies, INACAL-DA will review and evaluate the results obtained by the laboratories and
inspection bodies in their participation in proficiency tests, for which:

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- It will require laboratories and inspection bodies to submit their records of participation in
proficiency testing, in order to be evaluated, at the beginning of an accreditation, renewal,
extension or monitoring process.
- Accredited laboratories must have a proficiency testing participation program, which must be
reviewed in response to changes in personnel, equipment, methodology or others. If there
is more than one location, the laboratory will present the proficiency testing program
per location.
Note 7: Testing laboratories must use the DA-acr-05P-29F format, calibration laboratories
the DA-acr-05P-30F format and clinical laboratories DA-acr-05P-33F, for the calibration
testing programs. fitness.
- If the results of participation in the aptitude tests are unsatisfactory or questionable:
1. The laboratory and the inspection body must review their analysis, testing, calibration or
inspection processes and identify the causes that did not allow the expected result to be
achieved. The laboratory and the inspection body must propose their corrective actions
to prevent the problem from recurring and must define the deadlines required to
implement them and demonstrate their effectiveness (in no case should these deadlines
exceed two years for the testing or calibration laboratories and in the following
proficiency test for clinical laboratories and inspection bodies). The actions taken must
be reported by the laboratory and the inspection body to INACAL-DA for evaluation and
monitoring. When INACAL-DA considers necessary, it may carry out extraordinary “on-
site” evaluations to confirm that the actions proposed by the laboratory and the
inspection body have been effective.
2. The laboratory and inspection body must re-participate in a new proficiency testing
program with the same test method/calibration procedure with which they obtained
unsatisfactory results and in the same Matrix (this participation must consider all
analytes with those for which the laboratory is accredited), Material or
Product/Equipment, Measuring Instrument or Artifact in the case of testing and
calibration laboratories respectively.
Note 8 : INACAL-DA will not accept the results of participation in rapid tests such
as QUICK RESPONSE or similar.
Failure to take corrective actions in a timely manner will be considered a violation of this
Guideline, resulting in the suspension of the accreditation of the laboratory or inspection body
in the affected analysis/testing methods/calibration procedures or products/inspection activities.
In the event that the laboratory or inspection body obtains unsatisfactory or questionable results
in two consecutive proficiency testing programs and does not demonstrate that it has taken
appropriate corrective actions or that these have not been effective, INACAL-DA will suspend
the accreditation of the analysis method. /testing/calibration procedure or products/inspection
activities. Accreditation for this analysis/test/calibration procedure or products

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/inspection activities may only be reinstated after the laboratory or inspection body
demonstrates satisfactory results in a subsequent proficiency testing program.

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ANNEX 1-A
TEST LABORATORIES
Matrix, Material or Product Discipline Sub Discipline
Water biology Qualitative Microbiological
Microbiological Semi-quantitative
Quantitative Microbiological
Hydrobiological
Microscopy
Molecular
Physical Gravimetric
chemistry Volumetric
Qualitative
Opticians
Electrometric
Instrumental Liquid/Ionic Chromatography
Chemistry Gas Chromatography
Molecular Spectrophotometry (Uv-Vis)
Atomic Spectrophotometry (Emission)
Atomic Spectrometry (Absorption)
Mass spectrometry
X-ray spectrometry
IR spectrometry
Physics Mechanical
Air and Emissions biology Qualitative Microbiological
Molecular
Qualitative
Electrometric
Instrumental Liquid Chromatography
Mass spectrometry
X-ray spectrometry
Soils 2 , Sludge and Sediments biology Qualitative Microbiological
Molecular
Microscopy
Qualitative
Opticians
Electrometric
Chemistry Liquid/Ionic Chromatography
2
The soil matrix intended for the construction sector must be classified in the “Construction Materials” matrix

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TEST LABORATORIES
Instrumental
Gas Chromatography
Mass spectrometry
X-ray spectrometry
Animal and/or plant tissue (Biota), Instrumental Atomic Spectrophotometry (Emission)
biological fluids Chemistry Mass spectrometry
biology Molecular
Food and Beverages for human biology Qualitative Microbiological
and animal consumption (Includes Microbiological Semi-quantitative
food products from the livestock and Quantitative Microbiological
fishing industry)
Molecular
Microscopy
Bioassay
Qualitative
Opticians
Electrometric
Instrumental Liquid/Ionic Chromatography
Mass spectrometry
X-ray spectrometry
IR spectrometry
Combustion
Pesticides Instrumental Liquid Chromatography
Physicochemical Electrometric
Volumetric
Gravimetric
Fertilizers Instrumental Atomic absorption spectroscopy
Chemistry
Physicochemical Electrometric
Volumetric
Gravimetric
Construction materials Chemicals Gravimetric
Volumetric
Physicists Mechanics
Geotechnical
Instrumental Molecular Spectrophotometry (Uv-Vis)
Chemistry Atomic Absorption Spectrophotometry
X-ray spectrometry
Textile products Physicists Physical-Organoleptic Inspection (e.g. color,
defects)
Mechanics
Physicochemical Volumetric
Gravimetric

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TEST LABORATORIES
Electrometric
Color fastness
Instrumental Atomic absorption spectroscopy
Chemistry Molecular Spectrophotometry (Uv-Vis)
Metals Physical Volumetric
chemistry Gravimetric
Chemistry Atomic Spectrophotometry (Emission)
Mass spectrometry
X-ray spectrometry
plastic industry Instrumental Liquid Chromatography
Mass spectrometry
IR spectrometry
Physical-Organoleptic Inspection (e.g. color,
defects)
Physicochemical Gravimetric
Paper and graphics industry Physical Gravimetric
Volumetric
Hydrocarbons in general Physical Gravimetric
Volumetric
Instrumental Gas Chromatography
Chemistry Liquid Chromatography
Mass spectrometry
Others Others
Minerals Physical Gravimetric
Electrometric
Chemistry Atomic Spectrophotometry (Emission)
Mass spectrometry
X-ray Spectrometry
Wood Physicists Mechanics
Physicochemical Gravimetric
Volumetric
Footwear industry Instrumental Atomic absorption spectroscopy
Chemistry Molecular Spectrophotometry (Uv-Vis)
Chemistry Volumetric
Gravimetric
Electrometric

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TEST LABORATORIES
Physics Physical-Organoleptic Inspection (e.g. color,
defects)
Mechanics
Chemistry Atomic Spectrophotometry (Absorption)
Toys and stationery
Instrumental ICP-Mass
Note: If the laboratory is accredited or in the process of being accredited in a discipline or

subdiscipline that is not listed in this table, this does not exempt it from participating in a proficiency
testing program.
CALIBRATION LABORATORIES
AREA Discipline Subdiscipline
(MAGNITUDE)
Temperature
Dew point temperature
Temperature by simulation
TEMPERATURE TEMPERATURE
electric
Characterization of media
isotherms
RH
HUMIDITY HUMIDITY Characterization of media
isotherms
Strength: Stress ratio
Strength: deformation
FORCE and TORQUE FORCE and TORQUE
Strength: Strength
Torque
MASS Mass
MASS
Weighing instruments
Hydraulic absolute pressure
Pneumatic absolute pressure
Hydraulic differential pressure
Pneumatic differential pressure
PRESSURE AND
PRESSURE AND VACUUM Hydraulic relative pressure
VACUUM
Pneumatic relative pressure
Simulation of sign for
transmitters and transducers
Empty
Gas flow
FLOW FLOW
Liquid flow
Liquid volume
VOLUME VOLUME Solids volume
Gas volume
AC and DC voltage
AC and DC intensity
ELECTRICITY ELECTRICITY AC and DC resistance
Ability
Energy Meters
TIME AND FREQUENCY TIME AND FREQUENCY Time interval
Frequency: Period
Frequency: Frequency
ACOUSTICS ACOUSTICS Acoustics

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Length: Length
Rugosity
Angles
Shapes: Cylindricity;
Sphericity; Parallelism;
DIMENSIONAL DIMENSIONAL Thread parameters;
Perpendicularity; Flatness;
Rectitude; Roundness; Other
forms
particle size
HARDNESS HARDNESS Hardness
GOO Dynamic viscosity
GOO Kinematic viscosity
DENSITY DENSITY Density
POTENTIOMETRY Potentiometry
ELECTROCHEMICALS Conductometry
CONDUCTOMETRY
Radioactive source activity
Dosimetric quantities: Exposure;

Kerma in the air; Exposure rate; Air
kerma rate; Radiometric quantities.
Radioprotection magnitudes: Dose
equivalent
IONIZING RADIATION IONIZING RADIATION environmental;
Personal equivalent dose;
Equivalent doses; Rate of
dose
equivalent; Rate of dose
environmental equivalent; Personal
equivalent dose rate; Weaving rate
under a certain thickness; Absorbed
Colorimetry
Optical fibers
Photometric quantities
OPTICS OPTICS Radiometric quantities
System properties
optical
CONCENTRATION GAS gas mixture
OF GASES CONCENTRATION Gas analyzers
Magnetic flux density
Magnetic induction
MAGNETISM MAGNETISM Properties of materials
magnetic: Permeability;
Magnetic losses
AIR SPEED air speed
AIR SPEED

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ANNEX 1-B
INSPECTION AGENCIES
Discipline Subdiscipline
ELECTRICITY energy meters
LIQUID FLOW water meters

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APPENDIX 2
GUIDELINES THAT MUST BE FOLLOWED BY LABORATORIES THAT PROMOTE

PROGRAMS OR ROUNDS OF APPROPRIATE TEST TO ENSURE EFFECTIVENESS
OF THESE TESTS.
1. Number of participating laboratories:
Given the influence that the number of participants has on the calculation of the value assigned by
consensus, it should be taken into account that a low number of participants may have limited
statistical validity (DIN 38402 Part 41 and 42, IUPAC Technical Report, AQA 2007).
In the event that an adequate number of participants cannot be ensured, the assigned value can be
obtained through standards, reference materials, prepared items, calibration reference laboratories,
etc.
Participating laboratories must be accredited or in the process of accreditation with ISO/IEC 17025,
ISO/IEC 17020 or ISO 15189, as applicable.
2. The aptitude test must be developed under the guidelines of NTP ISO/IEC 17043, which must
be evidenced in the documentation.
3. Report:
The report must be detailed and must include all the necessary information to evaluate the
effectiveness and validity of the exercise.

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CRITERIA GUIDELINE FOR PARTICIPATION Code: DA-acr-13D

PARTICIPATION IN PROFITNESS TESTS/INTERLABORATORY COMPARISONS

EVERY PAPER COPY IS AN UNCONTROLLED DOCUMENT

EVERY PAPER COPY IS AN UNCONTROLLED DOCUMENT

• It is the policy of INACAL-DA to require laboratories and, if applicable, inspection bodies, to

• INACAL-DA promotes and disseminates proficiency testing programs, at the national,

Participation in proficiency testing activities is one of the mechanisms used by the

1Accreditation processes: accreditation, renewal, follow-ups, among others.

Aptitude Test : Evaluation of the performance of participants with respect to previously

Interlaboratory Comparisons : Organization, performance and evaluation of measurements

Note: Satisfactory participation is understood as the conclusion reported by the proficiency

EVERY PAPER COPY IS AN UNCONTROLLED DOCUMENT

of them is not satisfactory for participation in the proficiency test to be considered

CRITERIA GUIDELINE FOR PARTICIPATION

EVERY PAPER COPY IS AN UNCONTROLLED DOCUMENT

8. CRITERIA TO CONSIDER FOR PARTICIPATION

Note 5: INACAL-DA may disseminate participation in proficiency tests organized by

8.2 If there is no supplier for a certain analysis, assay or calibration, at a national or

9. CRITERIA FOR EVALUATION

CRITERIA GUIDELINE FOR PARTICIPATION

- If the results of participation in the aptitude tests are unsatisfactory or questionable:

EVERY PAPER COPY IS AN UNCONTROLLED DOCUMENT

EVERY PAPER COPY IS AN UNCONTROLLED DOCUMENT

EVERY PAPER COPY IS AN UNCONTROLLED DOCUMENT

EVERY PAPER COPY IS AN UNCONTROLLED DOCUMENT

EVERY PAPER COPY IS AN UNCONTROLLED DOCUMENT

Note: If the laboratory is accredited or in the process of being accredited in a discipline or

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Dosimetric quantities: Exposure;

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LIQUID FLOW water meters

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GUIDELINES THAT MUST BE FOLLOWED BY LABORATORIES THAT PROMOTE

1. Number of participating laboratories:

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