CUESTIONARIO DE EVALUACIÓN DE LABORATORIOS

1. GENERAL INFORMATION
LABORATORY
ADDRESS
CITY
REPRESENTATIVE
AUDITOR
E-MAIL
PHONE
EVALUATION DATE
EVALUATION DUE DATE

Note: The validity period of the evaluation is according to the scenario in which the evaluation to be carried out is identified. Section 2.1 = Validity of 12 months,
this validity may be reduced to 6 months if the grade is less than 79% (section 5) Section 2.2 = Validity of 12 months, this validity may be reduced to 6 months if
the rating is less than 79% (section 5) Section 2.3 = Validity of 18 months, this validity may be reduced to 12 months if the rating is less than 79% (section 5)
Section 2.4 = Validity of 18 months, this validity may be reduced to 12 months if the rating is less than 79% (section 5)

2. EVALUATION QUESTIONNAIRE
Four different scenarios are presented with different questionnaires for the laboratory evaluation, so you must select the one that best suits the laboratory evaluation
needs. If by mistake the unsuitable scenario is selected and you want to change the scenario, you can select the GO button of scenario 2.1 WITHOUT ACCREDITATION this
will show all the items to be evaluated
2.1 WITHOUT ACCREDITATION

When the CPR requires to contract and use the testing service with laboratories that are not accredited, the CPR is only required to evaluate the
IR
laboratory, the technical requirements of the ISO/IEC 17025:2017 standard, without it being necessary to evaluate the requirements. management

2.2 ACCREDITATION WITHOUT SCOPE

When the laboratory that is used by the CPR has accreditation in ISO/IEC 17025 from ONAC or from an Accreditation Body, a member of the
ILAC MLA, with scope in tests other than the required one, the CPR does not require evaluation in the laboratory the entire ISO/IEC 17025 IR
standard

2.3 ACCREDITATION OF DIFFERENT STANDARD

When the laboratory that is used by the CPR has accreditation in ISO/IEC 17025 from ONAC or from an Accreditation Body, a member of the
ILAC MLA for the required test method and measurement range, but with a different standard than that established in the technical IR
specification of the product.

2.4 ACCREDITATION WITHOUT MEASUREMENT RANGE

When the laboratory that is used by the CPR has accreditation in ISO/IEC 17025 from ONAC or from an Accreditation Body, a member of the IR
ILAC MLA, in the required test method, but the measurement range of the test is not covered for accreditation, technically evaluate the
measurement range not included in the ONAC scope.

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RESULT
No. REQUIREMENT Does not
Compliant Fails
apply

4.1 IMPARTIALITY
Laboratory activities must be carried out in an impartial and structured manner, and must be
4.1.1 managed to safeguard impartiality.

The laboratory must be responsible for the impartiality of its laboratory activities and must
4.1.3
not allow commercial, financial or other pressures to compromise impartiality.

OBSERVATION

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6.4 EQUIPMENT
The laboratory must have access to the equipment (including, but not limited to, measuring
instruments, software, measurement standards, reference materials, reference data,
6.4.1 reagents, consumables or auxiliary apparatus) that is required for the correct performance
of the activities. laboratory and that can influence the results.

When the laboratory uses equipment that is outside its ongoing control, it must ensure that
6.4.2 the requirements of this document for the equipment are met.

The laboratory must have a procedure for the handling, transportation, storage, use and
planned maintenance of the equipment to ensure proper functioning and in order to prevent
6.4.3
contamination or deterioration.

The laboratory must verify that the equipment meets the specified requirements before
6.4.4 being installed or reinstalled for service.

The equipment used for measurement must be capable of achieving the measurement
6.4.5 accuracy and/or measurement uncertainty required to provide a valid result.

6.4.6 Measuring equipment must be calibrated when:

- measurement accuracy or uncertainty affects the validity of the reported results, and/or
6.4.6.1

- calibration of the equipment is required to establish metrological traceability of the reported

6.4.6.2 results.

The laboratory should establish a calibration program, which should be reviewed and
6.4.7 adjusted as necessary, to maintain confidence in the calibration status.

All equipment requiring calibration or having a defined validity period must be labeled,
coded or otherwise identified to allow the user of the equipment to easily identify the
6.4.8
calibration status or validity period.

Equipment that has been subjected to overload or improper use, gives questionable results,
or has been shown to be defective or outside of specified requirements must be taken out of
service. This must be isolated to prevent use or clearly labeled or marked out of service until
6.4.9 it has been verified that it is functioning correctly (see 7.10).

Where intermediate checks are necessary to maintain confidence in the performance of the
equipment, these checks should be carried out in accordance with a procedure.
6.4.10

When calibration and reference material data include reference values or correction factors,
the laboratory must ensure that the reference values and correction factors are updated and
6.4.11 implemented, as appropriate, to meet the specified requirements.

The laboratory must take feasible actions to avoid unforeseen adjustments to the equipment
6.4.12 that would invalidate the results.

Records must be maintained of equipment that may influence laboratory activities. The
6.4.13 records must include, at least, the following:

6.4.13.a equipment identification, including software and firmware version;

the manufacturer's name, type identification, and serial number or other unique identification
6.4.13.b

6.4.13.c evidence of verification that the equipment meets the specified requirements
6.4.13.d the current location
calibration dates, calibration results, adjustments, acceptance criteria, and next calibration
6.4.13.e date or calibration interval

documentation of reference materials, results, acceptance criteria, relevant dates and

6.4.13.f validity period;

the maintenance plan and maintenance carried out to date, where relevant to the
6.4.13.g performance of the equipment;

the details of any damage, malfunction, modification or repair made to the equipment
6.4.13.h

OBSERVATION

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7.2 SELECTION, VERIFICATION AND VALIDATION OF METHODS

7.2.1 Method selection and verification
7.2.1.1 The laboratory shall use appropriate methods and procedures for all laboratory activities
and, where appropriate, for the evaluation of measurement uncertainty, as well as statistical
techniques for data analysis.

7.2.1.2 All methods, procedures and supporting documentation, such as instructions, standards,
manuals and reference data relevant to laboratory activities, must be kept up to date and
readily available to personnel.

7.2.1.3 The laboratory must ensure that it uses the latest version of a method, unless this is not
appropriate or possible. Where necessary, the application of the method should be
supplemented with additional details to ensure its consistent application.

7.2.1.4 When the client does not specify the method to be used, the laboratory must select an
appropriate method and inform the client about the chosen method. Methods published in
international, regional or national standards or by recognized technical organizations, or in
relevant scientific texts or journals, or as specified by the equipment manufacturer, are
recommended. Laboratory-developed or modified methods may also be used.

7.2.1.5 The laboratory must verify that it can properly carry out the methods before using them,
ensuring that the required performance can be achieved. Records of the verification must
be maintained. If the method is modified by the body that published it, the verification must
be repeated, to the necessary extent

7.2.1.6 When a method is required to be developed, it must be a planned activity and must be
assigned to competent personnel provided with adequate resources. As the method is
developed, periodic reviews should be carried out to confirm that the client's needs continue
to be met. Any modification to the development plan must be approved and authorized

7.2.1.7 Deviations from methods for all laboratory activities should only occur if the deviation has
been documented, technically justified, authorized and accepted by the client.

7.2.2 Validation of the methods

7.2.2.1 The laboratory must validate non-standardized methods, laboratory-developed methods,
and standardized methods used outside their intended scope or otherwise modified.
Validation should be as broad as necessary to meet the needs of the given application or
field of application.

7.2.2.2 When changes are made to a validated method, the influence of these changes must be
determined, and when it is found that they affect the initial validation, a new validation of the
method must be performed.

7.2.2.3 The performance characteristics of validated methods as evaluated for their intended use
must be relevant to the customer's needs and must be consistent with the specified
requirements.

7.2.2.4 The laboratory must maintain the following validation records:

7.2.2.4.a the validation procedure used
7.2.2.4.b the specification of the requirements;
7.2.2.4.c determining the performance characteristics of the method;
7.2.2.4.d the results obtained;
7.2.2.4.e a statement of the validity of the method, detailing its fitness for its intended use
OBSERVATION

7.7 ASSURANCE OF THE VALIDITY OF THE RESULTS

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7.7.1 The laboratory must have a procedure to track the validity of the results. The resulting data
should be recorded so that trends are detectable and, where possible, statistical techniques
should be applied to review the results. This monitoring should be planned and reviewed
and should include, where appropriate, but not limited to:

7.7.1.a use of reference materials or quality control materials;

7.7.1.b use of alternative instruments that have been calibrated to obtain traceable results;

7.7.1.c Functional checks of test and measurement equipment; functional checks of test and
measurement equipment;

7.7.1.d Use of verification patterns or work patterns with control charts, when applicable;

7.7.1.e intermediate checks on measuring equipment

7.7.1.f repetition of the test or calibration using the same or different methods
7.7.1.g retesting or recalibration of retained items
7.7.1.h correlation of results for different characteristics of an item
7.7.1.i review of reported results
7.7.1.j intralaboratory comparisons
7.7.1.k blind sample tests
7.7.2 The laboratory should monitor its performance by comparison with the results of other
laboratories, when available and appropriate. This monitoring should be planned and
reviewed and should include, but not be limited to, one or both of the following:

7.7.2.a participation in aptitude tests;

7.7.2.b participation in interlaboratory comparisons other than proficiency tests
7.7.3 Data from monitoring activities should be analyzed, used to monitor and, where applicable,
improve laboratory activities. If data analysis results from monitoring activities are detected
to be outside the predefined criteria, appropriate actions should be taken to prevent
incorrect results from being reported.

OBSERVATION

7.8 RESULTS REPORT

7.8.1.1 Results must be reviewed and authorized before release.
7.8.1.2 The results must be provided accurately, clearly, unambiguously and objectively, usually in a
report (for example, a test report or a calibration certificate or sampling report), and must
include all information agreed with the client and the necessary for the interpretation of the
results and all the information required in the method used. All issued reports must be kept
as technical records.

7.8.1.3 In the case of a customer agreement, the results can be reported in a simplified manner.
Any information listed in sections 7.8.2 to 7.8.7 that is not reported to the client must be
readily available.

7.8.2 Common requirements for Reports (testing, calibration or sampling)

7.8.2.1 Each report must include at least the following information, unless the laboratory has valid reasons not to do so, thereby minimizing
any possibility of misinterpretation or incorrect use:

7.8.2.1.a a title (for example, "Test Report", "Calibration Certificate" or "Sampling Report";

7.8.2.1.b the name and address of the laboratory;

7.8.2.1.c the location where laboratory activities are performed, including when performed at the
customer's premises or at sites remote from the laboratory's permanent facilities, or at
associated temporary or mobile facilities;

7.8.2.1.d a unique identification that all its components are recognized as a part of a complete report
and a clear identification of the end;

7.8.2.1.e the customer's name and contact information;

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7.8.2.1.f identification of the method used
7.8.2.1.g a description, unambiguous identification and, where necessary, the condition of the item
7.8.2.1.h the date of receipt of the calibration or test items, and the date of sampling, when this is
critical for the validity and application of the results;

7.8.2.1.i the dates of execution of the laboratory activity;

7.8.2.1.j the date of issuance of the report;
7.8.2.1.k reference to the sampling plan and method used by the laboratory or other bodies, when
relevant to the validity or application of the results
7.8.2.1.l a statement that the results relate only to the items tested, calibrated or sampled;

7.8.2.1.m results with units of measurement, where appropriate;

7.8.2.1.n additions, deviations or exclusions from the method;
7.8.2.1.o the identification of the people who authorize the report;
7.8.2.1.p clear identification when results come from external providers
7.8.2.2 The laboratory must be responsible for all information provided in the report, except when
the information is provided by the client. The data provided by the client must be clearly
identified. Additionally, a disclaimer must be included in the report when the information is
provided by the client and may affect the validity of the results. Where the laboratory has not
been responsible for the sampling stage (for example, the sample has been supplied by the
client), the report should indicate that the results apply to the sample as received.

7.8.3 Specific requirements for test reports

7.8.3.1 In addition to the requirements of section 7.8.2, test reports must include the following, where necessary for the interpretation of the
test results:

7.8.3.1.a information on specific test conditions, such as environmental conditions;

7.8.3.1.b where relevant, a declaration of conformity with the requirements or specifications (see
7.8.6);

7.8.3.1.c where applicable, the measurement uncertainty presented in the same unit as the
measurand or in a term relative to the measurand (e.g., percentage) when:

7.8.3.1.c - is relevant to the validity or application of the test results;

7.8.3.1.c - an instruction from the client that requires it; either
7.8.3.1.c - measurement uncertainty affects conformity with a specification limit; (7.8.3.1.c)
7.8.3.1.d where appropriate, opinions and interpretations (see 7.8.7);
7.8.3.1.e additional information that may be required by specific methods, authorities, clients or client
groups.

7.8.3.2 Where the laboratory is responsible for the sampling activity, test reports shall comply with
the requirements listed in section 7.8.5, where necessary for the interpretation of test
results.

7.8.6 Information on declarations of conformity

7.8.6.1 When providing a statement of conformity with a specification or standard, the laboratory
must document the decision rule applied, taking into account the level of risk (such as
incorrect acceptance or rejection and statistical assumptions) associated with the decision
rule used. and apply said rule

7.8.6.2 The laboratory must report on the declaration of conformity, in a way that clearly identifies:

7.8.6.2.a to which results the declaration of conformity applies;

7.8.6.2.b what specifications, standards or parts thereof are or are not met;
7.8.6.2.c the decision rule applied (unless inherent to the requested specification or standard).

7.8.8 Modifications to reports

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7.8.8.1 When an already issued report needs to be changed, corrected or reissued, any change in
information should be clearly identified, and where appropriate, the reason for the change
should be included in the report.

7.8.8.2 Modifications to a report after its issuance must be made only in the form of another
document, or a data transfer, that includes the statement: "Modification to report, serial
number... [or otherwise identified ]" or an equivalent form of writing. These modifications
must meet all requirements of this document.

7.8.8.3 Where a new full report needs to be issued, it must be uniquely identified and contain a
reference to the original it replaces.

OBSERVATION

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3. LIST OF EVALUATED TESTS

TEST STANDARD EQUIPMENT USED TRACEABILITY

Metrological Equipment
Testing Name of equipment or Test conditions Calibration Calibration
Requirement Version (year) Version (year) Characteristic identification
method equipment used (1) (3) Code (5) expiration (6)
(2) (4)
dd/mmm/yyyy
dd/mmm/yyyy
dd/mmm/yyyy
dd/mmm/yyyy
dd/mmm/yyyy
dd/mmm/yyyy
dd/mmm/yyyy
OBSERVATION

Note
(1) Name of the equipment or equipment that are used for the evaluated tests
(2) Class, tolerance, precision or dimensions of equipment to carry out the test.
(3) Temperature and humidity required for the test (when applicable).
(4) Code as the organization identifies the equipment used for trial testing

(5) Code assigned by the calibration laboratory to the equipment after the calibration activity.
(6) If at the time of verifying and/or using the laboratory evaluation, the calibration of any equipment is expired, the information must be updated, otherwise this laboratory
evaluation cannot be used (The date must be filled out according to the last calibration performed of the equipment, and schedule established by the organization)

(7) Laboratory where the calibration of the equipment used in the evaluated test methods was carried out
(8) The calibration of the equipment(s) used corresponds to a calibration laboratory accredited by ONAC or a laboratory that belongs to the ILAC group (If the calibration carried
out is not from an Accredited laboratory, the metrological confirmation must be reported)

4. NON-CONFORMITIES DETECTED
NC status
NC NC type Requirement number Observation
(closed/open)
Non-conformities from the Greater
previous evaluation Minors
Number of nonconformities Greater
detected in this evaluation Minors

Note 1: When there are no non-conformities, "Not Applicable" must be indicated. Note 2: Critical requirements are those whose numerals are
in bold and underlined. The laboratory cannot be used until this aspect is resolved.

4.1 COMPLEMENTARY EVALUATION RESULTS

Was complementary evaluation carried out at the testing laboratory?

If your answer is affirmative, please indicate:

Describe here the major nonconformities identified in this evaluation or the minor nonconformities pending from the previous evaluation that
were not resolved and that were verified during the complementary evaluation, the evidence that supports their closure and whether they were
effective.

If your answer is negative, justify it

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Proposed Action plan
Proposed
Requirement numeral Non-conformity Analysis of corrective review and
No. Description of the breach correction
causes action and acceptance
and date
(Applicable questionnaire) date date
Elderly Minor

Note: When there are no non-conformities, "Not Applicable" must be indicated.

5. EVALUATION RESULTS

To determine the Final Grade of the Laboratory Evaluation, the following formula must be applied: Result (% Final Grade): = # Compliant / (#
Total Requirements – # Requirements that Do Not Apply) x 100%, where all requirements are in agreement to each scenario

5.1 QUALIFICATION
PARTIAL BALANCE OF EVALUATED REQUIREMENTS
CRITERION #C # NC # NA OBSERVATIONS
Management requirements
Technical requirements
Final balance

Note: The number of requirements to be evaluated from the ISO/IEC 17025:2017 standard per scenario are as follows: Section 2.1 =
131 requirements Section 2.2 = 94 requirements Section 2.3 = 71 requirements Section 2.4 = 92 requirements

FINAL SCORE %

1 to 65% = Not Passed The laboratory is not competent to carry out certification tests.
The laboratory may be used to execute certification tests, but it is conditional on the implementation of
66 to 79% = Conditional corrective actions for non-compliances detected, before the next follow-up audit.
Approval.

80 to 100% = Passed. The laboratory is competent to carry out certification tests.

Conclusion:

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