ASTM E548-94e1
(Guide)Standard Guide for General Criteria Used for Evaluating Laboratory Competence
Standard Guide for General Criteria Used for Evaluating Laboratory Competence
SCOPE
1.1 This standard sets forth general criteria (harmonized with ISO/IEC Guide 25-1990) for evaluating the competence of calibration laboratories or testing laboratories.
General Information
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Please contact ASTM International (www.astm.org) for the latest information.
An American National Standard
´1
Designation:E548–94
Standard Guide for
General Criteria Used for Evaluating Laboratory
Competence
This standard is issued under the fixed designation E548; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
´ NOTE—The scope was corrected editorially in June 1995.
1. Scope 3. Terminology
1.1 This standard sets forth general criteria (harmonized 3.1 Definitions—The following definitions of terms are
with ISO/IEC Guide25-1990) for evaluating the competence applicable to this standard. When the terms are taken from
of calibration laboratories or testing laboratories. other documents such as ISO/IEC Guide 2, Guide30, 8402 or
the International vocabulary of basic and general terms in
2. Referenced Documents
metrology (VIM) appropriate reference is made.
2.1 ASTM Standards:
3.1.1 laboratory—body that calibrates and/or tests.
E994 Guide for Laboratory Accreditation Systems 3.1.1.1 Discussion—In cases where a laboratory forms part
E1187 Terminology Relating to Laboratory Accreditation
of an organization that carries out other activities besides
2.2 ISO Standards: calibration and testing, the term“ laboratory” refers only to
8402 Quality-Vocabulary
those parts of that organization that are involved in the
9000 Quality Management and Quality Assurance Stan- calibration and testing process.
dards, Guidelines for Selection and Use
3.1.1.2 As used herein, the term “laboratory” refers to a
9001 Quality Systems—Model for Quality Assurance In body that carries out calibration or testing—at or from a
Design/Development, Production, Installation and Servic-
permanentlocation,—atorfromatemporaryfacility,or—inor
ing from a mobile facility.
9002 Quality Systems—Model for Quality Assurance In
3.1.2 testing laboratory—laboratory that performs tests.
Production and Installation [ISO/IEC Guide2—12.4]
9003 Quality Systems—Model for Quality Assurance In 3.1.3 calibration laboratory—laboratory that performs cali-
Final Inspection and Test
bration.
9004 Quality Management and Quality System Elements— 3.1.4 calibration—the set of operations which establish,
Guidelines
under specified conditions, the relationship between values
Guide2—General Terms and their Definitions Concerning indicated by a measuring instrument or measuring system, or
Standardization and Related Activities
values represented by a material measure, and the correspond-
Guide25—General Requirements for the Competence of ing known values of a measurand.
Calibration and Testing Laboratories
3.1.4.1 Discussion—The results of a calibration permits the
Guide30 Terms and Definitions Used in Connection with estimation of errors of indication of the measuring instrument,
Reference Materials
measuring system or material measure, or the assignment of
values to marks on arbitrary scales.
3.1.4.2 Acalibration may also determine other metrological
properties.
ThispracticeisunderthejurisdictionofASTMCommitteeE-36onLaboratory
3.1.4.3 The result of a calibration may be recorded in a
and InspectionAgency Evaluation andAccreditation and is the direct responsibility
document, sometimes called a calibration certificate or calibra-
of Subcommittee E36.10 on Generic Criteria.
Current edition approved April 15, 1994. Published August 1994. Originally
tion report.
published as E548–93. Last previous edition E54–93.
3.1.4.4 Theresultofacalibrationissometimesexpressedas
Annual Book of ASTM Standards, Vol 14.02.
a calibration factor, or as a series of calibration factors in the
Available from ISO, 1 Rue deVarembe, Case Postale 56, Crt 1221, Geneva 20,
Switzerland. form of a calibration curve. [VIM—6.13]
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Please contact ASTM International (www.astm.org) for the latest information.
´1
E548–94
3.1.5 test—a technical operation that consists of the deter- specific technical field. The requirements developed should
mination of one or more characteristics or performance of a provide the specificity in each subject area describing in detail
given product, material, equipment, organism, physical phe- what a laboratory in that specific technical field must have to
nomenon, process or service according to a specified proce- perform,haveonhand,beawareof,orisotherwiseessentialto
dure. conduct testing on a specific product, class of products or
3.1.5.1 Discussion—The result of a test is normally re- material.
corded in a document sometimes called a test report or a test
4.3 This guide should be particularly useful as a guide to
certificate. [ISO/IEC Guide2—12.1, amended] ASTM technical committees which are developing standard
3.1.6 calibration method—defined technical procedure for
test methods, and need to include specific information that can
performing a calibration. be used to evaluate a laboratory’s ability to conduct the test.
3.1.7 test method—definedtechnicalprocedureforperform-
4.4 Thisguideshouldalsobeausefulguidetoaccreditation,
ing a test. or other types of evaluation bodies, in developing specific
3.1.8 verification—confirmation by examination and provi-
technical evaluation requirements.
sion of evidence that specified requirements have been met.
4.5 Using this guide should promote the development of
3.1.8.1 Discussion—In connection with the management of
documents that are more uniform in content and style, and
measuringequipment,verificationprovidesameansforcheck-
therefore should be much more universally useful to bodies
ing that the deviations between values indicated by a measur-
who perform evaluations of many different types of laborato-
ing instrument and corresponding known values of a measured
ries in different technical fields.
quantity are consistently smaller than the maximum allowable
4.6 An accrediting body may also impose other non-
error defined in a standard, regulation or specification peculiar
technical requirements such as payment of fees or submittal of
to the management of the measuring equipment.
quality documentation for review.
3.1.8.2 Theresultofverificationleadstoadecisioneitherto
restore to service, or to perform adjustments, or to repair, or to
5. Organization and Management
downgrade,ortodeclareobsolete.Inallcasesitisrequiredthat
5.1 The laboratory shall be legally identifiable. It shall be
a written trace of the verification performed be kept on the
organized and shall operate in such a way that its permanent,
measuring instrument’s individual record.
temporary and mobile facilities meet the requirements of this
3.1.9 quality system—the organizational structure, respon-
standard.
sibilities, procedures, processes and resources for implement-
5.2 The laboratory shall:
ing quality management. [ISO 8402—3.8 without the notes]
5.2.1 have managerial staff with the authority and resources
3.1.10 quality manual—a document stating the quality
needed to discharge their duties;
policy, quality system and quality practices of an organization.
5.2.2 havearrangementstoensurethatitspersonnelarefree
3.1.10.1 Discussion—The quality manual may call up other
from any commercial, financial and other pressures which
documentation relating to the laboratory’s quality arrange-
might adversely affect the quality of their work;
ments.
5.2.3 be organized in such a way that confidence in its
3.1.11 reference standard—A standard, generally of the
independence of judgment and integrity is maintained at all
highest metrological quality available at a given location, from
times;
which measurements made at that location are derived.
5.2.4 specifyanddocumenttheresponsibility,authority,and
[VIM—6.08]
interrelation of all personnel who manage, perform or verify
3.1.12 reference material—A material or substance one or
work affecting the quality of calibrations and tests;
more properties of which are sufficiently well established to be
5.2.5 provide supervision by persons familiar with the
used for the calibration of an apparatus, the assessment of a
calibrationortestmethodsandprocedures,theobjectiveofthe
measurement, or for assigning values to materials. [ISO
calibration or test and the assessment of the results. The ratio
Guide30—2.1]
ofsupervisorytonon-supervisorypersonnelshallbesuchasto
4. Significance and Use
ensure adequate supervision;
5.2.6 have a technical manager (however named) who has
4.1 Laboratories meeting the requirements of this standard
overall responsibility for the technical operations;
comply, for calibration and testing activities, with the relevant
5.2.7 have a quality manager (however named) who has
requirements of the ISO 9000 series of standards, including
responsibility for the quality system and its implementation.
thoseofthemodeldescribedinISO9002whentheyareacting
The quality manager shall have direct access to the highest
as suppliers producing calibration or test results.
level of management at which decisions are taken on labora-
4.2 Since laboratories provide services in many diverse
tory policy or resources, and to the technical manager. In some
technical areas, the generic statements contained in this docu-
laboratories, the quality manager may also be the technical
ment will need to be interpreted for the specific technical areas
manager or deputy technical manager;
or type of testing which will require evaluation. Each indi-
vidual test, class of tests, or technical field will generally have 5.2.8 nominate deputies in case of absence of the technical
or quality manager;
unique requirements that must be satisfied in order to properly
conduct the test(s). 5.2.9 where relevant, have documented policy and proce-
4.2.1 The interpretations and specific requirements should dures to ensure the protection of clients’ confidential informa-
be developed by persons technically knowledgeable in the tion and proprietary rights;
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Please contact ASTM International (www.astm.org) for the latest information.
´1
E548–94
5.2.10 where appropriate, participate in interlaboratory 6.2.18 procedures for protecting confidentiality and propri-
comparisons and proficiency testing programs. etary rights;
6.2.19 procedures for audit and review.
6. Quality System, Audit and Review 6.3 Thelaboratoryshallarrangeforauditsofitsactivitiesat
appropriate intervals to verify that its operations continue to
6.1 The laboratory shall establish and maintain a quality
comply with the requirements of the quality system. Such
systemappropriatetothetype,rangeandvolumeofcalibration
audits shall be carried out by trained and qualified staff who
andtestingactivitiesitundertakes.Theelementsofthissystem
are, wherever possible, independent of the activity to be
shall be documented. The quality documentation shall be
audited.Where the audit findings cast doubt on the correctness
available for use by the laboratory personnel. The laboratory
or validity of the laboratory’s calibrations or test results, the
shall define and document its policies and objectives for, and
laboratory shall take immediate corrective action and shall
its commitment to good laboratory practice and quality of
immediately notify, in writing, any client whose work may
calibration or testing services. The laboratory management
have been affected.
shall ensure that these policies and objectives are documented
6.4 The quality system adopted to satisfy the requirements
in a quality manual and communicated to, understood, and
of this standard shall be reviewed at least once a year by the
implemented by all laboratory personnel concerned. The qual-
management to ensure its continuing suitability and effective-
ity manual shall be maintained current under the responsibility
ness and to introduce any necessary changes or improvements.
of the quality manager.
6.5 All audit and review findings and any corrective actions
6.2 The quality manual, and related quality documentation,
that arise from them shall be documented. The person respon-
shall state the laboratory’s policies and operational procedures
sible for quality shall ensure that these actions are discharged
established in order to meet the requirements of this standard.
within the agreed timescale.
The quality manual and related quality documentation shall
6.6 In addition to periodic audits the laboratory shall ensure
also contain:
the quality of results provided to clients by implementing
6.2.1 a quality policy statement, including objectives and
checks. These checks shall be reviewed and shall include, as
commitments, by top management;
appropriate, but not be limited to:
6.2.2 the organization and management structure of the
6.6.1 internal quality control schemes using whenever pos-
laboratory, its place in any parent organization and relevant
sible statistical techniques;
organizational charts;
6.6.2 participation in proficiency testing or other interlabo-
6.2.3 the relations between management, technical opera-
ratory comparisons;
tions, support services and the quality system;
6.6.3 regular use of certified reference materials and/or
6.2.4 procedures for control and maintenance of documen-
in-house quality control using secondary reference materials;
tation;
6.6.4 replicate testings using the same or different methods;
6.2.5 job descriptions of key staff and reference to the job
6.6.5 re-testing of retained items;
descriptions of other staff;
6.6.6 correlation of results for different characteristics of an
6.2.6 identification of the laboratory’s approved signatories
item.
(where this concept is appropriate);
6.2.7 the laboratory’s procedures for achieving traceability
7. Personnel
of measurements;
7.1 The laboratory shall have sufficient personnel, having
6.2.8 the laboratory’s scope of calibrations and/or tests;
the necessary education, training, technical knowledge and
6.2.9 arrangements for ensuring that the laboratory reviews
experience for their assigned functions.
all new work to ensure that it has the appropriate facilities and
7.2 The laboratory shall ensure that the training of its
resources before commencing such work;
personnel is kept up-to-date.
6.2.10 reference to the calibration, verification and/or test
7.3 Records on the relevant qualifications, training, skills
procedures used;
and experience of the technical personnel shall be maintained
6.2.11 procedures for handling calibrations and test items;
by the laboratory.
6.2.12 reference to the major equipm
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