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ASSESSOR CHECKLIST: ISO/IEC GUIDE 25 GENERAL CRITERIA

(includes ISO/IEC 17025 gaps and the Advertising Policy and Traceability Policy requirements)

The following pages present the criteria from ISO/IEC Guide 25-1990, "General Requirements for the Competence
of Calibration and Testing Laboratories", the A2LA Advertising Policy, and the A2LA Policy on Measurement
Traceability in a checklist format. The laboratory's policies and procedures must meet these requirements. Quality
system documentation and supporting records must be available for the assessor's review.

This checklist also includes the ISO/IEC 17025 requirements that are new or significantly modified from the
ISO/IEC Guide 25 requirements. These are identified in bold italic print. If the assessment includes a gap analysis
for ISO/IEC 17025, these sections must be completed by the laboratory and assessor(s). If the assessment is only to
ISO/IEC Guide 25, these sections can be disregarded.

Laboratory Instructions: If the requirements include the need for a written policy, procedure or arrangement, that
requirement statement in this checklist is shaded. The laboratory must complete the document reference identifiers
in the checklist's second column (labeled Reference") for each shaded requirement. The appropriate "reference" can
include quality manual, laboratory manual, SOPs, records, etc. references. The references provided must specify
procedure number, page number and section number, if possible. Every checklist item should be accompanied by a
tick mark in the yes (Y), no (N), or not applicable (NA) space. Submit this checklist as part of the application for
accreditation. This serves to help both the laboratory and the assessors prepare for the assessment and may save a
significant amount of assessment time and cost. If the shaded references are not provided as described above,
the application will be considered incomplete and will be returned to the laboratory for the necessary
references.

Assessor Instructions: Review the laboratory's documented quality system to verify compliance with the applicable
Guide 25 documentation requirements. Assess to verify that the documented quality system is indeed implemented
as described. Record comments related to any requirement in the space provided and sign on the appropriate line on
page 2. Assess the laboratory's technical competence to perform specific tests or specific types of tests. Record
comments related to tests on the Test Method Matrix. Additional comments can be noted on the draft scope(s). All
deficiencies must be identified and explained in the assessor deficiency report.

Laboratory Name: _______________________________________________________________________

_______________________________________________________________________

City: _______________________________________________________________ State: ____________

Personnel Information (Names, Titles, and Responsibilities):

Technical Management: ________________________________________________________________________

________________________________________________________________________

Quality Manager: ________________________________________________________________________

Deputy QM: ________________________________________________________________________

Key Technical Staff and Their Unique Capability *:


_____________________________________________________________________________________________

_____________________________________________________________________________________________

* A "key technical staff person" is anyone whose absence or departure would remove the laboratory's competence to carry out one or more
specific tests and result in a reduction in the Scope(s) of Accreditation.
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ISO/IEC Guide 25 - 1990
Checklist

To the best of my knowledge, all laboratory document references below as well as actual laboratory practice have been assessed for compliance with the relevant
clauses of ISO/IEC Guide 25 - 1990. Any areas of noncompliance have been fully described in the Assessor Deficiency Report.

Assessor Signature: _____________________________________________________________________ Date: _____________________

Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]
4. ORGANIZATION AND MANAGEMENT
4.1 The laboratory shall be legally identifiable.
It shall be organized and shall operate in such a way that its permanent,
temporary and mobile facilities meet the requirements.
4.1.4 If the laboratory is part of an organization performing activities
other than testing and/or calibration, the responsibilities of key personnel
in the organization that have an involvement or influence on the testing
and/or calibration activities of the laboratory shall be defined in order to
identify potential conflicts of interest.
4.2 The laboratory shall:
a) have managerial staff with the authority and resources needed to
discharge their duties;
b) have arrangements to ensure that its personnel are free from any
commercial, financial and other pressures which might adversely affect the
quality of their work;
c) be organized in such a way that confidence in its independence of
judgement and integrity is maintained at all times;
4.1.5 d) have policies and procedures to avoid involvement in any
activities that would diminish confidence in its competence, impartiality,
judgement or operational integrity;
d) specify and document the responsibility, authority, and interrelation of all
personnel who manage, perform or verify work affecting the quality of tests;
e) provide supervision by persons familiar with the test methods and
procedures, the objective of the test and the assessment of the results. The
ratio of supervisory to non-supervisory personnel shall be such as to ensure
adequate supervision;
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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

f) have a technical manager (however named) who has overall responsibility


for the technical operations;
g) have a quality manager (however named) who has responsibility for the
quality system and its implementation. The quality manager shall have
direct access to the highest level of management at which decisions are
taken on laboratory policy or resources, and to the technical manager. In
some laboratories, the quality manager may also be the technical manager or
deputy technical manager;
h) nominate deputies in case of absence of the technical or quality manager;
i) where relevant, have documented policy and procedures to ensure the
protection of clients' confidential information and proprietary rights;
j) where appropriate, participate in interlaboratory comparisons and
proficiency testing programs. [Attach the last two copies of proficiency test
results for every program in which the laboratory should be enrolled. If the
proficiency testing programs' reports are sent directly to A2LA, only the
lab's code number is needed.]
5. QUALITY SYSTEM, AUDIT AND REVIEW
5.1 The laboratory shall establish and maintain a quality system appropriate
to the type, range and volume of testing activities it undertakes.
The elements of this system shall be documented.
The quality documentation shall be available for use by the laboratory
personnel.
The laboratory shall define and document its policies and objectives for, and
its commitment to good laboratory practice and quality of testing services.
The laboratory management shall ensure that these policies and objectives
are documented in a quality manual and communicated to, understood, and
implemented by all laboratory personnel concerned.
The quality manual shall be maintained current under the responsibility of
the quality manager.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

5.2 The quality manual, and related quality documentation, shall state the
laboratory's policies and operational procedures established in order to meet
the requirements. The quality manual and related quality documentation
shall also contain:
a) a quality policy statement, including objectives and commitments, by top
management;
4.2.2 The quality policy statement shall be issued under the authority of
the chief executive. It shall include at least the following:
4.2.2 a) the laboratory management's commitment to good professional
practice and to the quality of its testing and calibration in servicing its
clients;
4.2.2 b) the management's statement of the laboratory's standard of
service;
4.2.2 c) the objectives of the quality system;
4.2.2 d) a requirement that all personnel concerned with testing and
calibration activities within the laboratory familiarize themselves with the
quality documentation and implement the policies and procedures in their
work; and
4.2.2 e) the laboratory management's commitment to compliance with this
International Standard.
b) the organization and management structure of the laboratory, its place in
any parent organization and relevant organizational charts;
c) the relations between management, technical operations, support services
and the quality system;
d) procedures for control and maintenance of documentation;
4.3.2 Document approval and issue
4.3.2.1 All documents issued to personnel in the laboratory as part of the
quality system shall be reviewed and approved for use by authorized
personnel prior to issue. A master list or an equivalent document control
procedure identifying the current revision status and distribution of
documents in the quality system shall be established and be readily
available to preclude the use of invalid and/or obsolete documents.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

4.3.2.2 The procedure(s) adopted shall ensure that:


a) authorized editions of appropriate documents are available at all
locations where operations essential to the effective functioning of the
laboratory are performed;
b) documents are periodically reviewed and, where necessary, revised to
ensure continuing suitability and compliance with applicable
requirements;
c) invalid or obsolete documents are promptly removed from all points of
issue or use, or otherwise assured against unintended use;
d) obsolete documents retained for either legal or knowledge
preservation purposes are suitably marked.
4.3.2.3 Quality system documents generated by the laboratory shall be
uniquely identified. Such identification shall include the date of issue
and/or revision identification, page numbering, the total number of pages
or a mark to signify the end of the document, and the issuing
authority(ies).
4.3.3 Document changes
4.3.3.1 Changes to documents shall be reviewed and approved by the
same function that performed the original review unless specifically
designated otherwise. The designated personnel shall have access to
pertinent background information upon which to base their review and
approval.
4.3.3.2 Where practicable, the altered or new text shall be identified in
the document or the appropriate attachments.
4.3.3.3 If the laboratory's documentation control system allows for the
amendment of documents by hand pending the re-issue of the documents,
the procedures and authorities for such amendments shall be defined.
Amendments shall be clearly marked, initialed and dated. A revised
document shall be formally re-issued as soon as practicable.
4.3.3.4 Procedures shall be established to describe how changes in
documents maintained in computerized systems are made and controlled.
e) job descriptions of key staff and reference to the job descriptions of other
staff;
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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

f) identification of the laboratory's approved signatories (where this concept


is appropriate)
g) the laboratory's procedures for achieving traceability of measurements;
h) the laboratory's scope of tests;
i) arrangements for ensuring that the laboratory reviews all new work to
ensure that it has the appropriate facilities and resources before commencing
such work;
4.4 Review of requests, tenders and contracts
4.4.1 The laboratory shall establish and maintain procedures for the
review of requests, tenders and contracts. The policies and procedures for
these reviews leading to a contract for testing and/or calibration shall
ensure that:
a) the requirements, including the methods to be used, are adequately
defined, documented and understood (see 5.4.2);
b) the laboratory has the capability and resources to meet the
requirements;
c) the appropriate test and/or calibration method is selected and capable
of meeting the clients' requirements (see 5.4.2).
Any differences between the request or tender and the contract shall be
resolved before any work commences. Each contract shall be acceptable
both to the laboratory and the client.
4.4.2 Records of reviews, including any significant changes, shall be
maintained. Records shall also be maintained of pertinent discussions
with a client relating to the client's requirements or the results of the work
during the period of execution of the contract.
4.4.3 The review shall also cover any work that is subcontracted by the
laboratory.
4.4.4 The client shall be informed of any deviation from the contract.
4.4.5 If a contract needs to be amended after work has commenced, the
same contract review process shall be repeated and any amendments shall
be communicated to all affected personnel.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

j) reference to the test procedures used;


k) procedures for handling test items;
l) reference to the major equipment and reference measurement standards
used;
m) reference to procedures for calibration, verification and maintenance of
equipment;
n) reference to verification practices including interlaboratory comparisons,
proficiency testing programs, use of reference materials and internal quality
control schemes;
o) procedures to be followed for feedback and corrective action whenever
testing discrepancies are detected, or departures from documented policies
and procedures occur;
4.9.1 The laboratory shall have a policy and procedures that shall be
implemented when any aspect of its testing and/or calibration work, or the
results of this work, do not conform to its own procedures or the agreed
requirements of the client. The policy and procedures shall ensure that:
4.9.1 a) the responsibilities and authorities for the management of
nonconforming work are designated and actions (including halting of
work and withholding of test reports and calibration certificates, as
necessary) are defined and taken when nonconforming work is identified;
4.9.1 b) an evaluation of the significance of the nonconforming work is
made;
4.9.1 c) corrective actions are taken immediately, together with any
decision about the acceptability of the nonconforming work;
4.9.1 d) where necessary, the client is notified and work is recalled;
4.9.1 e) the responsibility for authorizing the resumption of work is
defined.
4.10.2 Cause analysis
The procedure for corrective action shall start with an investigation to
determine the root cause(s) of the problem.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

4.10.3 Selection and implementation of corrective actions


Where corrective action is needed, the laboratory shall identify potential
corrective actions. It shall select and implement the action(s) most likely
to eliminate the problem and to prevent recurrence.
Corrective actions shall be to a degree appropriate to the magnitude and
the risk of the problem.
The laboratory shall document and implement any required changes
resulting from corrective action investigations.
4.10.4 Monitoring of corrective actions
The laboratory shall monitor the results to ensure that the corrective
actions taken have been effective.
p) the laboratory management arrangements for exceptionally permitting
departures from documented policies and procedures or from standard
specifications;
q) procedures for dealing with complaints;
r) procedures for protecting confidentiality and proprietary rights;
s) procedures for audit and review.
4.2.3 The quality manual shall outline the structure of the documentation
used in the quality system.
5.3 The laboratory shall arrange for audits of its activities at appropriate
intervals to verify that its operations continue to comply with the
requirements of the quality system. Such audits shall be carried out by
trained and qualified staff who are, wherever possible, independent of the
activity to be audited. Where the audit findings cast doubt on the
correctness or validity of the laboratory's test results, the laboratory shall
take immediate corrective action and shall immediately notify, in writing,
any client whose work may have been affected.
4.13.2 The internal audit program shall address all elements of the quality
system, including the testing and/or calibration activities. It is the
responsibility of the quality manager to plan and organize audits as
required by the schedule and requested by management.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

4.13.3 The area of activity audited, the audit findings and corrective
actions that arise from them shall be recorded.
4.13.4 Follow-up audit activities shall verify and record the
implementation and effectiveness of the corrective action taken.
5.4 The quality system shall be reviewed at least once a year by the
management to ensure its continuing suitability and effectiveness and to
introduce any necessary changes or improvements.
4.14.1 The review shall take account of:
the suitability of policies and procedures;
reports from managerial and supervisory personnel;
the outcome of recent internal audits;
corrective and preventive actions;
assessments by external bodies;
the results of interlaboratory comparisons or proficiency tests;
changes in the volume and type of the work;
client feedback;
complaints;
other relevant factors, such as quality control activities, resources and
staff training.
5.5 All audit and review findings and any corrective actions that arise from
them shall be documented. The person responsible for quality shall ensure
that these actions are discharged within the agreed timescale.
5.6 In addition to periodic audits the laboratory shall ensure the quality of
results provided to clients by implementing checks. These checks shall be
reviewed and shall include, as appropriate, but not be limited to:
a) internal quality control schemes using whenever possible statistical
techniques;

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

b) participation in proficiency testing or other interlaboratory comparisons;


[attach the last two proficiency testing results for every program in which
the laboratory should be enrolled]
c) regular use of certified reference materials and/or in-house quality control
using secondary reference materials;
d) replicate testings using the same or different methods;
e) re-testing of retained items;
f) correlation of results for different characteristics of an item.
The laboratory meets the A2LA Proficiency Testing Requirements for
Accredited Testing and Calibration Laboratories.
6. PERSONNEL
6.1 The laboratory shall have sufficient personnel, having the necessary
education, training, technical knowledge and experience for their assigned
functions.
6.2 The laboratory shall ensure that the training of its personnel is kept up-
to-date.
6.3 Records on the relevant qualifications, training, skills and experience of
the technical personnel shall be maintained by the laboratory.
5.2.2 The management of the laboratory shall formulate the goals with
respect to the education, training and skills of the laboratory personnel.
The laboratory shall have a policy and procedures for identifying training
needs and providing training of personnel. The training program shall be
relevant to the present and anticipated tasks of the laboratory.
5.2.3 The laboratory shall use personnel who are employed by, or
under contract to, the laboratory. Where contracted and additional
technical and key support personnel are used, the laboratory shall ensure
that such personnel are supervised and competent and that they work in
accordance with the laboratory's quality system.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

5.2.5 The management shall authorize specific personnel to perform


particular types of sampling, test and/or calibration, to issue test reports
and calibration certificates, to give opinions and interpretations and to
operate particular types of equipment. The laboratory shall maintain
records of the relevant authorization(s), competence, educational and
professional qualifications, training, skills and experience of all technical
personnel, including contracted personnel. This information shall be
readily available and shall include the date on which authorization and/or
competence is confirmed.
7. ACCOMMODATION AND ENVIRONMENT
7.1 Laboratory accommodation, test areas, energy sources, lighting, heating
and ventilation shall be such as to facilitate proper performance of tests.
7.2 The environment in which these activities are undertaken shall not
invalidate the results or adversely affect the required accuracy of
measurement. Particular care shall be taken when such activities are
undertaken at sites other than the permanent laboratory premises.
5.3.1 The technical requirements for accommodation and
environmental conditions that can affect the results of tests and
calibrations shall be documented.
7.3 The laboratory shall provide facilities for the effective monitoring,
control and recording of environmental conditions as appropriate. Due
attention shall be paid, for example, to biological sterility, dust,
electromagnetic interference, humidity, mains voltage, temperature, and
sound and vibration levels, as appropriate to the tests concerned.
7.4 There shall be effective separation between neighboring areas when the
activities therein are incompatible.

7.5 Access to and use of all areas affecting the quality of these activities
shall be defined and controlled.
7.6 Adequate measures shall be taken to ensure good housekeeping in the
laboratory.

Supplemental Inquiry. The laboratory should have a chemical hygiene plan


per 29 CFR 1910.1450.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

8. EQUIPMENT AND REFERENCE MATERIALS


8.1 The laboratory shall be furnished all items of equipment (including
reference materials) required for the correct performance of tests. In those
cases where the laboratory needs to use equipment outside its permanent
control it shall ensure that the relevant requirements are met.
8.2 All equipment shall be properly maintained.
Maintenance procedures shall be documented.
Any item of the equipment which has been subjected to overloading or
mishandling, or which gives suspect results, or has been shown by
verification or otherwise to be defective, shall be taken out of service,
clearly identified and wherever possible stored at a specified place until it
has been repaired and shown by calibration, verification or test to perform
satisfactorily. The laboratory shall examine the effect of this defect on
previous tests.
8.3 Each item of equipment [5.5.4 and its software] including reference
materials shall, when appropriate, be labelled, marked or otherwise
identified to indicate its calibration status.
8.4 Records shall be maintained of each major item of equipment [5.5.5 and
its software] and all reference materials significant to the tests performed.
The records shall include:
a) the name of the item of equipment;
b) the manufacturer's name, type identification, and serial number or other
unique identification;
c) date received and date placed in service;
d) current location, where appropriate;
e) condition when received (e.g. new, used, reconditioned);
f) copy of the manufacturer's instructions, where available;
g) dates and results of calibrations and/or verifications and date of the next
calibration and/or verification;
h) details of maintenance carried out to date and planned for the future;

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

i) history of any damage, malfunction, modification or repair.


5.5.5 c) checks that equipment complies with the specification (see 5.5.2)
5.5.9 When, for whatever reason, equipment goes outside the direct
control of the laboratory, the laboratory shall ensure that the function and
calibration status of the equipment are checked and shown to be
satisfactory before the equipment is returned to service.
9. MEASUREMENT TRACEABILITY AND CALIBRATION
9.1 All measuring and testing equipment having an effect on the accuracy or
validity of tests shall be calibrated and/or verified before being put into
service.

The laboratory shall have an established program for the calibration and
verification of its measuring and test equipment.
9.2 The overall program of calibration and/or verification and validation of
equipment shall be designed and operated so as to ensure that, wherever
applicable, measurements made by the laboratory are traceable to national
standards of measurement where available. Calibration certificates shall
wherever applicable indicate the traceability to national standards of
measurement and shall provide the measurement results and associated
uncertainty of measurement and/or a statement of compliance with an
identified metrological specification.
9.3 Where traceability to national standards of measurement is not
applicable, the laboratory shall provide satisfactory evidence of correlation
of results, for example by participation in a suitable program of
interlaboratory comparisons or proficiency testing.
9.4 Reference standards of measurement held by the laboratory shall be
used for calibration only and for no other purpose, unless it can be
demonstrated that their performance as reference standards has not been
invalidated.
9.5 Reference standards of measurement shall be calibrated by a body that
can provide traceability to a national standard of measurement.

There shall be a program of calibration and verification for reference


standards.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

9.6 Where relevant, reference standards and measuring and testing


equipment shall be subjected to in-service checks between calibrations and
verifications.
9.7 Reference materials shall, where possible, be traceable to national or
international standards of measurement, or to national or international
standard reference materials.
5.5.10 When intermediate checks are needed to maintain confidence in
the calibration status of the equipment, these checks shall be carried out
according to a defined procedure.
5.5.11 Where calibrations give rise to a set of correction factors, the
laboratory shall have procedures to ensure that copies (e.g. in computer
software) are correctly updated.
5.5.12 Test and calibration equipment, including both hardware and
software, shall be safeguarded from adjustments which would invalidate
the test and/or calibration results.
5.6.3.4 Transport and storage
The laboratory shall have procedures for safe handling, transport, storage
and use of reference standards and reference materials in order to prevent
contamination or deterioration and in order to protect their integrity.
10.0 TEST METHODS
10.1 The laboratory shall have documented instructions on the use and
operation of all relevant equipment, on the handling and preparation of items
for testing, where the absence of such instructions could jeopardize the tests.

All instructions, standards, manuals and reference data relevant to the work
of the laboratory shall be maintained up-to-date and be readily available to
the staff.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

10.2 The laboratory shall use appropriate methods and procedures for all
tests and related activities within its responsibility (including sampling,
handling, transport and storage, preparation of items, estimation of
uncertainty of measurement and analysis of test data).

They shall be consistent with the accuracy required, and with any standard
specifications relevant to the tests concerned
10.3 Where methods are not specified, the laboratory shall, wherever
possible, select methods that have been published in international or national
standards, those published by reputable technical organizations or in relevant
scientific texts or journals.
10.4 Where it is necessary to employ methods that have not been
established as standard, these shall be subject to agreement with the client,
be fully documented and validated, and be available to the client and other
recipients of the relevant reports.
5.4.2 Laboratory-developed methods
The introduction of test and calibration methods developed by the
laboratory for its own use shall be a planned activity and shall be assigned
to qualified personnel equipped with adequate resources.

Plans shall be updated as development proceeds and effective


communication amongst all personnel involved shall be ensured.
5.4.5 Validation of methods
5.4.5.2 The laboratory shall validate non-standard methods, laboratory-
designed/developed methods, standard methods used outside their intended
scope, and amplifications and modifications of standard methods to
confirm that the methods are fit for the intended use. The validation shall
be as extensive as is necessary to meet the needs of the given application or
field of application.
The laboratory shall record the results obtained, the procedure used for
the validation, and a statement as to whether the method is fit for the
intended use.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

5.4.5.3 The range and accuracy of the values obtainable from validated
methods (e.g. the uncertainty of the results, detection limit, selectivity of
the method, linearity, limit of repeatability and/or reproducibility,
robustness against external influences and/or cross-sensitivity against
interference from the matrix of the sample/test object), as assessed for the
intended use, shall be relevant to the clients' needs.
10.5 Where sampling is carried out as part of the test method, the laboratory
shall use documented procedures and appropriate statistical techniques to
select samples.
5.7.1 The sampling plan as well as the sampling procedure shall be
available at the location where sampling is undertaken.
5.7.2 Where the client requires deviations, additions or exclusions from
the documented sampling procedure, these shall be recorded in detail with
the appropriate sampling data and shall be included in all documents
containing test and/or calibration results, and shall be communicated to
the appropriate personnel.
5.7.3 The laboratory shall have procedures for recording relevant data
and operations relating to sampling that forms part of the testing or
calibration that is undertaken. These records shall include the sampling
procedure used, the identification of the sampler, environmental
conditions (if relevant) and diagrams or other equivalent means to identify
the sampling location as necessary and, if appropriate, the statistics the
sampling procedures are based upon.
10.6 Calculations and data transfers shall be subject to appropriate checks.
10.7 Where computers or automated equipment are used for the capture,
processing, manipulation, recording, reporting, storage or retrieval of test
data, the laboratory shall ensure that:
a) all applicable requirements are complied with;
b) computer software is documented and adequate for use;
c) procedures are established and implemented for protecting the integrity of
data; such procedures shall include, but not be limited to, integrity of data
entry or capture, data storage, data transmission and data processing;

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

d) computer and automated equipment is maintained to ensure proper


functioning and provided with the environmental and operating conditions
necessary to maintain the integrity of test data;
e) it establishes and implements appropriate procedures for the maintenance
of security of data including the prevention of unauthorized access to, and
the unauthorized amendment of, computer records.
10.8 Documented procedures shall exist for the purchase, reception and
storage of consumable materials used for the technical operations of the
laboratory.
5.4.6 Estimation of uncertainty of measurement
5.4.6.1 A calibration laboratory, or a testing laboratory performing its
own calibrations, shall have and shall apply a procedure to estimate the
uncertainty of measurement for all calibrations and types of calibrations.
5.4.6.2 Testing laboratories shall have and shall apply procedures for
estimating uncertainty of measurement. In certain cases the nature of the
test method may preclude rigorous, metrologically and statistically valid,
calculation of uncertainty of measurement. In these cases the laboratory
shall at least attempt to identify all the components of uncertainty and
make a reasonable estimation, and shall ensure that the form of reporting
of the result does not give a wrong impression of the uncertainty.
Reasonable estimation shall be based on knowledge of the performance of
the method and on the measurement scope and shall make use of, for
example, previous experience and validation data.
5.4.6.3 When estimating the uncertainty of measurement, all uncertainty
components which are of importance in the given situation shall be taken
into account using appropriate methods of analysis.
11. HANDLING OF TEST ITEMS
11.1 The laboratory shall have a documented system for uniquely
identifying the items to be tested, to ensure that there can be no confusion
regarding the identity of such items at any time.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

11.2 Upon receipt, the condition of the test item, including any
abnormalities or departures from standard condition as prescribed in the
relevant test method, shall be recorded.

Where there is any doubt as to the item's suitability for test, where the item
does not conform to the description provided, or where the test required is
not fully specified, the laboratory shall consult the client for further
instruction before proceeding.

The laboratory shall establish whether the item has received all necessary
preparation, or whether the client requires preparation to be undertaken or
arranged by the laboratory.
11.3 The laboratory shall have documented procedures and appropriate
facilities to avoid deterioration or damage to the test item, during storage,
handling, preparation, and test; any relevant instructions provided with the
item shall be followed.

Where items have to be stored or conditioned under specific environmental


conditions, these conditions shall be maintained, monitored and recorded
where necessary. Where a test item or portion of an item is to be held secure
(for example, for reasons of record, safety or value, or to enable check tests
to be performed later), the laboratory shall have storage and security
arrangements that protect the condition and integrity of the secured items or
portions concerned.
11.4 The laboratory shall have documented procedures for the receipt,
retention or safe disposal of test items, including all provisions necessary to
protect the integrity of the laboratory.
12. RECORDS
12.1 The laboratory shall maintain a record system to suit its particular
circumstances and comply with any applicable regulations.
It shall retain on record all original observations, calculations and derived
data, calibration records and a copy of the test certificate, or test report for
an appropriate period.
The records for each test shall contain sufficient information to permit their
repetition.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

The records shall include the identity of personnel involved in sampling,


preparation, or testing.
12.2 All records (including those pertaining to test equipment), certificates
and reports shall be safely stored, held secure and in confidence to the client.
4.12.1.1 The laboratory shall establish and maintain procedures for
identification, collection, indexing, access, filing, storage, maintenance
and disposal of quality and technical records. Quality records shall
include reports from internal audits and management reviews as well as
records of corrective and preventive actions.
4.12.2.2 Observations, data and calculations shall be recorded at the time
they are made and shall be identifiable to the specific task.
4.12.2.3 When mistakes occur in records, each mistake shall be crossed
out, not erased, made illegible or deleted, and the correct value entered
alongside. All such alterations to records shall be signed or initialed by
the person making the correction. In the case of records stored
electronically, equivalent measures shall be taken to avoid loss or change
of original data.
13. CERTIFICATES AND REPORTS
13.1 The results of each test, or series of tests carried out by the laboratory
shall be reported accurately, clearly, unambiguously and objectively, in
accordance with any instructions in the test methods.

The results should normally be reported in a test report or test certificate and
should include all the information necessary for the interpretation of the test
results and all information required by the method used.
13.2 Each certificate or report shall include at least the following
information:
a) a title, e.g. "Test Report", or "Test Certificate";
b) name and address of laboratory, and location where the test was carried
out if different from the address of the laboratory;
c) unique identification of the certificate or report (such as serial number)
and of each page, and the total number of pages;
d) name and address of client, where appropriate;
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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

e) description and unambiguous identification of the item tested;


f) characterization and condition of the test item;
g) date of receipt of test item and date(s) of performance of test, where
appropriate;
h) identification of the test method used, or unambiguous description of any
non-standard method used;
i) reference to sampling procedure, where relevant;
5.10.3.2 Test reports containing the results of sampling shall include the
following, where necessary for the interpretation of test results:
5.10.3.2 a) the date of sampling;
5.10.3.2 b) unambiguous identification of the substance, material or
product sampled (including the name of the manufacturer, the model or
type of designation and serial numbers as appropriate);
5.10.3.2 c) the location of sampling, including any diagrams, sketches or
photographs;
5.10.3.2 d) a reference to the sampling plan and procedures used;
5.10.3.2 e) details of any environmental conditions during sampling that
may affect the interpretation of the test results;
5.10.3.2 f) any standard or other specification for the sampling method or
procedure, and deviations, additions to or exclusions from the
specification concerned.
j) any deviations from, additions to or exclusions from the test method, and
any other information relevant to a specific test, such as environmental
conditions;
k) measurements, examinations and derived results, supported by tables,
graphs, sketches and photographs as appropriate, and any failures identified;
l) a statement of the estimated uncertainty of the test result (where relevant);
m) a signature and title, or an equivalent identification of the person(s)
accepting responsibility for the content of the certificate or report (however
produced), and date of issue;

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

n) where relevant, a statement to the effect that the results relate only to the
items tested;
o) a statement that the certificate or report shall not be reproduced except in
full, without the written approval of the laboratory.
5.10.4.2 The calibration certificate shall relate only to quantities and the
results of functional tests. If a statement of compliance with a
specification is made, this shall identify which clauses of the specification
are met or not met.
When a statement of compliance with a specification is made omitting the
measurement results and associated uncertainties, the laboratory shall
record those results and maintain them for possible future reference.
When statements of compliance are made, the uncertainty of measurement
shall be taken into account.
5.10.4.3 When an instrument for calibration has been adjusted or
repaired, the calibration results before and after adjustment or repair, if
available, shall be reported.
5.10.4.4 A calibration certificate (or calibration label) shall not contain
any recommendation on the calibration interval except where this has
been agreed with the client. This requirement may be superseded by legal
regulations.
5.10.1 Any information listed in 5.10.2 to 5.10.4 which is not reported to
the client shall be readily available in the laboratory which carried out the
tests and/or calibrations.
13.3 Where the certificate or report contains results of tests performed by
sub-contractors, these results shall be clearly identified.
5.10.6 The subcontractor shall report the results in writing or
electronically.
5.10.6 When a calibration has been subcontracted, the laboratory
performing the work shall issue the calibration certificate to the
contracting laboratory.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

5.10.5 Opinions and interpretations


When opinions and interpretations are included, the laboratory shall
document the basis upon which the opinions and interpretations have been
made. Opinions and interpretations shall be clearly marked as such in a
test report.
13.4 Particular care and attention shall be paid to the arrangement of the
certificate or report, especially with regard to presentation of the test data
and ease of assimilation by the reader. The format shall be carefully and
specifically designed for each type of test carried out, but the headings shall
be standardized as far as possible.
13.5 Material amendments to a test report or test certificate after issue shall
be made only in the form of a further document, or data transfer including
the statement "Supplement to Test Report [or Test Certificate], serial
number . . . [or as otherwise identified]", or equivalent form of wording.

Such amendments shall meet all the relevant requirements of clause 13.2.
13.6 The laboratory shall notify clients promptly, in writing, of any event
such as the identification of defective measuring or test equipment that casts
doubt on the validity of results given in any test report or test certificate or
amendment to a report or certificate.
13.7 The laboratory shall ensure that, where clients require transmission of
test results by telephone, telex, facsimile or other electronic or
electromagnetic means, staff will follow documented procedures that ensure
that the requirements are met and that confidentiality is preserved.
14. SUB-CONTRACTING OF TESTING
14.1 Where a laboratory sub-contracts any part of the testing, this work
shall be placed with a laboratory complying with these requirements. The
laboratory shall ensure and be able to demonstrate that its sub-contractor is
competent to perform the activities in question and complies with the same
criteria of competence as the laboratory in respect to the work being sub-
contracted. The laboratory shall advise the client in writing of its intention
to sub-contract any portion of the testing to another party.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

14.2 The laboratory shall record and retain details of its investigation of the
competence and compliance of its sub-contractors and maintain a register of
all sub-contracting.
4.5.3 The laboratory is responsible to the client for the subcontractor's
work, except in the case where the client or a regulatory authority specifies
which subcontractor is to be used.
15. OUTSIDE SUPPORT AND SUPPLIES
15.1 Where the laboratory procures outside services and supplies, in support
of tests, the laboratory shall use only those outside support services and
supplies that are of adequate quality to sustain confidence in the laboratory's
tests.
15.2 Where no independent assurance of the quality of outside support
services or supplies is available, the laboratory shall have procedures to
ensure that purchased equipment, materials and services comply with
specified requirements.

The laboratory should, wherever possible, ensure that purchased equipment


and consumable materials are not used until they have been inspected,
calibrated or otherwise verified as complying with any standard
specifications relevant to the tests concerned.
15.3 The laboratory shall maintain records of all suppliers from whom it
obtains support services or supplies required for tests.
4.6.3 Purchasing documents for items affecting the quality of
laboratory output shall contain data describing the services and supplies
ordered. These purchasing documents shall be reviewed and approved for
technical content prior to release.
16. COMPLAINTS
16.1 The laboratory shall have documented policy and procedures for the
resolution of complaints received from clients or other parties about the
laboratory's activities.

A record shall be maintained of all complaints and of the actions taken by


the laboratory.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

16.2 Where a complaint, or any other circumstance, raises doubt concerning


the laboratory's compliance with the laboratory's policies or procedures, or
otherwise concerning the quality of the laboratory's tests, the laboratory shall
ensure that those areas of activity and responsibility involved are promptly
audited in accordance with 5.3.
4.7 Service to the client
The laboratory shall afford clients or their representatives cooperation to
clarify the client's request and to monitor the laboratory's performance in
relation to the work performed, provided that the laboratory ensures
confidentiality to other clients.
4.11 Preventive action
4.11.1 Needed improvements and potential sources of nonconformances,
either technical or concerning the quality system, shall be identified. If
preventive action is required, action plans shall be developed, implemented
and monitored to reduce the likelihood of the occurrence of such
nonconformances and to take advantage of the opportunities for
improvement.
4.11.2 Procedures for preventive actions shall include the initiation of
such actions and application of controls to ensure that they are effective.

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LABORATORY REFERENCE TO A2LA ACCREDITED STATUS – A2LA ADVERTISING POLICY
(ADDENDUM TO THE ASSESSOR CHECKLIST: GENERAL CRITERIA)

(Effective June 1, 2000)

A2LA-accredited laboratories are strongly recommended to use the “A2LA accredited” logo to demonstrate their third party recognition of technical competence. “A2LA
accredited” logo sheets are sent to all accredited laboratories, and an electronic version is available upon request. However, since A2LA laboratory accreditations are issued in a
number of fields, it is the ethical responsibility of accredited laboratories to describe their accredited status in a manner that does not imply accreditation in areas outside their
actual scope of accreditation or for other testing/calibration facilities not covered under the present accreditation. This may be accomplished by adherence to the requirements
noted below. Every circumstance where the principle of accurate representation applies cannot be anticipated and dealt with in this document. Therefore, it is the responsibility of
the accredited laboratory not to misrepresent its accredited status under any circumstances. If there are questions, the laboratory should submit intended uses of the logo, draft
advertisements, and/or any other accreditation claims to A2LA Headquarters for advanced review. (Note: Laboratories initially applying for A2LA accreditation should indicate
"NA" for all items on this checklist addendum for describing the accredited status but must sign the statement on the last page agreeing to abide by this advertising policy once
accredited.)

Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

Laboratory Reference to A2LA Accredited Status – A2LA Advertising Policy


1. Where the A2LA name and/or logo is used on general literature such as
letterhead and advertisements, it shall always be accompanied by at least
the word "accredited".
2. While there are no restrictions on the size and color of the “A2LA-
accredited” logo reproduction, the logo must maintain its form.
3. The “A2LA-accredited” logo may be generated electronically provided
that the prescribed formats and forms are retained.
4. When promoting or providing proof of accreditation, accredited
laboratories should use the scope(s) of accreditation, as this document
details the specific tests or calibrations which are accredited. The
certificate should be used for display purposes and may also accompany the
scope.
5. Where the “A2LA-accredited” logo is used to endorse test or
calibration results, it shall always be accompanied by the A2LA
accreditation number(s). The following conditions also apply:

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

a) The “A2LA-accredited” logo may be displayed on all calibration


certificates, test certificates, and test reports which contain exclusively
results from calibrations and test that have been carried out within the
accredited scope of the laboratory concerned.
b) Non-accredited results may be reported on calibration certificates,
test certificates and test reports with the A2LA logo provided these
results are unambiguously identified as non-accredited. This may be
done by placing an asterisk after each such result, along with a footnote
stating: "This is not covered by our current A2LA accreditation"
c) On reports where results are reported within the field where
accreditation exists but in a technology that is not included in the
scope, they must be so indicated. (For example, if a laboratory is
accredited in the Environmental Field for only wet chemistry and
metals, any gas chromatographic data reported would need to be
identified as non-accredited.
d) As of May 1, 1999, the calibration certificates issued by A2LA-
accredited laboratories shall reference, at a minimum, the A2LA name
(or logo) and the accreditation number when the calibrations contained
in the report are covered under the A2LA-accreditation.
6. When the A2LA name and/or logo is used on a business solicitation
document such as a proposal or quotation form, the laboratory has the
responsibility to distinguish between those proposed tests or calibrations
that fall within the laboratory's scope of accreditation and those that do not.
This is done by attaching a copy of its current A2LA Scope of
Accreditation sheet and Supplement to the Scope, if appropriate, or by
noting which tests or calibrations are non-accredited.
7. The “A2LA-accredited” logo and/or reference to the laboratory’s
accreditation may be made in advertisements provided the requirements of
this document are strictly followed.
8. The “A2LA-accredited” logo shall not be displayed on business cards
in a manner that might imply personnel certification. This may be
accomplished by including the statement “A2LA Accredited Laboratory”.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

9. The “A2LA-accredited” logo shall not be displayed on a test item or


product or used to imply product certification. If the “A2LA accredited”
logo is used in literature relating to a product, the logo must appear directly
adjacent to the reference to the accredited calibration or testing laboratory
and it must be clearly stated that inclusion of the logo does not imply
certification/approval of the products calibrated or tested.
10. Upon suspension or termination of accreditation, a laboratory must
immediately cease to issue calibration certificates, test reports, and test
certificates displaying the logo and shall cease publishing documents
containing the logo.
11. An accredited laboratory owns the right to release A2LA assessor
reports and deficiency reports as long as the reports are reproduced in
whole and not in part. A2LA holds this assessment information in
confidence unless specifically requested in writing by the accredited
laboratory to release this information to another party.

TO BE SIGNED BY THE AUTHORIZED REPRESENTATIVE OF THE LABORATORY:

We understand and agree to abide by the requirements contained in the “Reference to A2LA Accredited Status – A2LA Advertising Policy” once our laboratory becomes A2LA
accredited.

Print Name: _____________________________________ Signature: _________________________________ Date: __________________

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A2LA POLICY ON TRACEABILITY OF MEASUREMENT
(ADDENDUM TO THE ASSESSOR CHECKLIST: GENERAL CRITERIA)

(August 2000)

Accredited laboratories are required to meet the following additional requirements contained in the A2LA Policy on Measurement Traceability

Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

A2LA Policy on Traceability of Measurement


T1. All calibrations and verifications of measuring and test equipment,
reference standards, and reference materials shall be conducted by
accredited calibration laboratories (in some instances an accredited testing
laboratory may also be able to satisfy traceability requirements) or by a
recognized national metrology institute.
T2. Calibrations or verifications must be documented in a calibration
certificate or report endorsed by a recognized accreditation body’s logo, or
otherwise makes reference to accredited status.
T3. Laboratories shall define their policy for achieving measurement
traceability. This policy shall be in compliance with this policy document.
T4. Where uncertainty calculations are applicable, testing and calibration
laboratories shall calculate measurement uncertainty in accordance with the
ISO “Guide to the Expression of Uncertainty in Measurement.” These
uncertainties shall be supported by uncertainty budgets, and they shall be
represented as expanded uncertainties typically using a coverage factor of
k=2 to approximate the 95% confidence level. (Refer to A2LA's Interim Policy
on Measurement Uncertainty for Testing Laboratories, August 2000)

T5. If a calibration certificate or report contains a statement of the


measurement result and the associated uncertainty, then the uncertainty
statement shall be accompanied by an explanation of the meaning of the
uncertainty statement. (For example, “This uncertainty represents an
expanded uncertainty expressed at approximately the 95% confidence level
using a coverage factor of k=2.)
T6. TURs shall be calculated using the expanded uncertainty of the
measurement, not the “collective uncertainty of the measurement
standards”.

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Compliance Comments
Requirement Reference
Y N NA [Reserved for A2LA Assessor]

T7. Implicit uncertainty statements (generally expressed in terms of a TUR)


shall be accompanied by words to the effect that the uncertainty ratio was
calculated using the expanded measurement uncertainty. In addition the
coverage factor and confidence level shall be stated.
T8. Calibration reports and certificates issued by A2LA-accredited
calibration laboratories shall contain a traceability statement.
T9. All in-house calibrations shall be supported by the following minimal
set of elements:
a) The in-house laboratory shall maintain documented procedures for the
in-house calibrations and the in-house calibrations shall be evidenced by a
calibration report, certificate, or sticker, or other suitable method, and
calibration records shall be retained for an appropriate, prescribed time;
b) The in-house laboratory shall maintain training records for calibration
personnel and these records shall demonstrate the technical competence of
the personnel performing the calibrations;
c) The in-house laboratory shall be able to demonstrate traceability to
national or international standards of measurement by procuring calibration
services from accredited calibration labs or a national metrology institute;
d) The in-house laboratory shall have and apply procedures for evaluating
measurement uncertainty. Measurement uncertainty shall be taken into
account when statements of compliance with specifications are made;
e) Reference standards shall be recalibrated at appropriate intervals to
ensure that the reference value is reliable. Policy and procedures for
establishing and changing calibration intervals shall be based on the
historical behavior of the reference standard.

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