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 laboratory, IR
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 specification of IR
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 not
4.1.3
allow commercial, financial or other pressures to compromise impartiality.

OBSERVATION

6.2 STAFF
All laboratory personnel, whether internal or external, who can influence laboratory activities
must act impartially, be competent and work in accordance with the laboratory management
6.2.1 system.

The laboratory must document competency requirements for each function that influences the
results of laboratory activities, including requirements for education, qualification, training,
6.2.2 technical knowledge, skills, and experience.

The laboratory must ensure that personnel have the competence to carry out the laboratory
activities for which they are responsible and to evaluate the significance of deviations.
6.2.3

Laboratory management must communicate to staff their tasks, responsibilities and authority
6.2.4

6.2.5 The laboratory must have procedures and maintain records to:
6.2.5,a. determine competency requirements
6.2.5,b. select personnel;
6.2.5,c. train staff;
6.2.5,d. supervise staff;
6.2.5,e. authorize staff;
6.2.5,f. Monitor staff competency.
The laboratory must authorize personnel to carry out specific laboratory activities, including, but
6.2.6 not limited to, the following

6.2.6.a. develop, modify, verify and validate methods

analyze the results, including statements of conformity or opinions and interpretations;
6.2.6.b.

6.2.6.c. .report, review and authorize results.

OBSERVATION

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6.3. FACILITIES AND ENVIRONMENTAL CONDITIONS

Facilities and environmental conditions must be suitable for laboratory activities and must not
6.3.1 adversely affect the validity of the results.
Requirements for the facilities and environmental conditions necessary to perform laboratory
6.3.2 activities must be documented.

The laboratory must monitor, control and record environmental conditions in accordance with
relevant specifications, methods or procedures, or when they influence the validity of the result
6.3.3

Measures to control the facilities must be implemented, monitored and periodically reviewed
6.3.4 and must include, but not be limited to, the following

6.3.4.a access and use of areas that affect laboratory activities

prevention of contamination, interference or adverse influences in laboratory activities
6.3.4.b

6.3.4.c effective separation between areas in which there are incompatible laboratory activities
When the laboratory carries out laboratory activities at sites or facilities that are beyond its
permanent control, it must ensure that the requirements related to the facilities and
6.3.5 environmental conditions of this document are met.

OBSERVATION

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, reagents,
6.4.1 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 the
6.4.2 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 being
6.4.4 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 adjusted
6.4.7 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 calibration status or
6.4.8
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 it
6.4.9 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 records
6.4.13 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 date
6.4.13.e or calibration interval

documentation of reference materials, results, acceptance criteria, relevant dates and validity
6.4.13.f period;

the maintenance plan and maintenance carried out to date, where relevant to the performance
6.4.13.g 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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6.5 METROLOGICAL TRACEABILITY

6.5.1 The laboratory must establish and maintain metrological traceability of its measurement results
through an uninterrupted and documented chain of calibrations, each of which contributes to
measurement uncertainty, linking them to the appropriate reference.

6.5.2 The laboratory must ensure that measurement results are traceable to the International System of Units (SI) by:

6.5.2.a calibration provided by a competent laboratory;

6.5.2.b the certified values ​of certified reference materials provided by competent producers with
established metrological traceability to the SI; either
6.5.2.c the direct realization of SI units secured by comparison, direct or indirect, with national or
international standards.

6.5.3 When metrological traceability to SI units is not technically possible, the laboratory must
demonstrate metrological traceability to an appropriate reference, such as:

6.5.3.a certified values ​of certified reference materials supplied by a competent producer;

6.5.3.b results of reference measurement procedures, specified methods, or consensus standards that
are clearly described and accepted in the sense that they provide measurement results suitable
for their intended use and assured by appropriate comparison.

OBSERVATION

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

7.4 HANDLING OF TEST OR CALIBRATION ITEMS

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7.4.1 The laboratory must have a procedure for the transport, receipt, handling, protection, storage,
preservation and disposal or return of test or calibration items, including all provisions
necessary to protect the integrity of the test or calibration item, and to protect the interests of
the laboratory and the client. Precautions should be taken to prevent deterioration,
contamination, loss or damage to the item during handling, transportation, storage/holding, and
preparation for testing or calibration. The handling instructions supplied with the item must be
followed.

7.4.2 The laboratory must have a system to unambiguously identify test or calibration items.
Identification must be kept while the item is under the responsibility of the laboratory. The
system must ensure that items are not confused physically or when referenced in records or
other documents. The system must, if appropriate, allow the subdivision of an item or groups of
items and the transfer of items

7.4.3 Upon receipt of the calibration or test item, deviations from the specified conditions must be
recorded. When there is doubt about the suitability of an item for testing or calibration, or when
an item does not conform to the description provided, the laboratory must consult the customer
for additional instructions before proceeding, and must record the results of this consultation.
When the client requires that the item be tested or calibrated allowing for a deviation from the
specified conditions, the laboratory must include in the report a disclaimer indicating what
results may be affected by the deviation.

7.4.4 When items need to be stored or conditioned under specified environmental conditions, these
diti tb i t i d t k d d d d
OBSERVATION

7.5 TECHNICAL RECORDS

7.5.1 The laboratory must ensure that the technical records for each laboratory activity contain the
results, the report and sufficient information to facilitate, if possible, the identification of the
factors affecting the measurement result and its associated measurement uncertainty and
enable the repetition of the laboratory activity in conditions as close as possible to the original
ones. Technical records must include the date and identity of the personnel responsible for
each laboratory activity and for verifying data and results. Original observations, data, and
calculations should be recorded at the time they are made and identified with the specific task.

7.5.2 The laboratory must ensure that modifications to technical records can be traceable to previous
versions or original observations. Both original and modified data and files must be retained,
including the date of correction, an indication of what was corrected, and the personnel
responsible for the corrections.

OBSERVATION

7.6 EVALUATION OF MEASUREMENT UNCERTAINTY

7.6.1 Laboratories must identify contributions to measurement uncertainty. When assessing
measurement uncertainty, all contributions that are significant, including those arising from
sampling, should be taken into account using appropriate methods of analysis.

7.6.2 A laboratory that performs calibrations, including those of its own equipment, must evaluate the
measurement uncertainty for all calibrations

7.6.3 A laboratory that performs testing must evaluate measurement uncertainty. When the test
method does not allow a rigorous evaluation of measurement uncertainty, an estimate must be
made based on an understanding of the theoretical principles or practical experience of
performing the method.

OBSERVATION

7.7 ASSURANCE OF THE VALIDITY OF THE RESULTS

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

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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;

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

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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

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 Calibration
Requirement Version (year) Version (year) Characteristic identification Accredited (8)
method equipment used (1)
(2)
(3)
(4)
Code (5) expiration (6) Laboratory (7)

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 NC type Requirement number NC status (closed/open) Observation

Non-conformities from the previous Greater

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
date date
(Applicable questionnaire) 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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