ISO 15560:1998

INTERNATIONAL IS0
STANDARD 15560
First edition
1998-12-15
Practice for characterization and
performance of a high-dose radiation
dosimetry calibration laboratory
Pratique de caractkrisation et exploitation d ’un laboratoire d ’ktalonnage de
dosimdtrie d ’irradiations 2 hautes doses
Reference number
IS0 15560: 1998(E)

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IS0 15560:1998(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies
(IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. IS0 collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
International Standard IS0 15560 was prepared by the American Society for Testing and Materials (ASTM)
Subcommittee E1O.O1 (as E 1400-95a) and was adopted, under a special “fast-track procedure ”, by Technical
Committee ISOTT ’C 85, Nuclear energy, in parallel with its approval by the IS0 member bodies.
A new ISOfTC 85 Working Group WG 3, High-level dosimetry for radiation processing, was formed to review the
and to maintain these standards. The USA holds the
voting comments from the IS0 “Fast-track procedure”
convenership of this working group.
International Standard IS0 15560 is one of 20 standards developed and published by ASTM. The 20 fast-tracked
standards and their associated ASTM designations are listed below:
IS0 Designation ASTM Designation Title
E 1204-93 Practice for dosimetry in gamma irradiation facilities for food
15554
processing
E 1205-93 Practice for use of a ceric-cerous sulfate dosimetty system
15555
15556 E 1261-94 Guide for selection and calibration of dosimetry systems for
radiation processing
15557 E 1275-93 Practice for use of a radiochromic film dosimetry system
E 1276-96 Practice for use of a polymethylmethacrylate dosimetry system
15558
15559 E 1310-94 Practice for use of a radiochromic optical waveguide dosimetry
sys tern
15560 E 1400-95a Practice for characterization and performance of a high-dose
radiation dosimetry calibration labora tory
E 1401-96 Practice for use of a dichromate dosimetry system
15561
0 IS0 1998
no pa rt of this publication may be reproduced or utilized in any form or by any means, electronic
All rights reserved. Unless otherwise specified,
or mechanical, incl uding photocopying and mic rofilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 l CH-1211 Geneve 20 l Switzerland
Internet iso @I iso.ch
Printed in Switzerland
ii

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IS0 15560:1998(E)
@ IS0
Practice for dosimetry in electron irradiation
15562 E 1431-91 and bremss tra hlung
facilities for food processing
15563 E 1538-93 Practice for use of the ethanol-chlorobenzene dosimetry system
E 1539-93 Guide for use of radiation-sensitive indicators
15564
15565 E 1540-93 Practice for use of a radiochromic liquid dosimetry system
E 1607-94
15566 Practice for use of the alanine-EPR dosimetry system
15567 E 1608-94 Practice for dosimetry in an X-ray (bremsstrahlung) facility for
radiation processing
Practice for use of calorimetric dosimetry systems for electron
15568 E 1631-96
beam dose measurements and dosimeter calibrations
Practice for dosimetry in an electron-beam facility for radiation
15569 E1649-94
processing at energies between 300 keV and 25 MeV
Practice for use of cellulose acetate dosimetry system
15570 E 1650-94
facility for radiation
15571 E 1702-95 Practice for dosimetry in a gamma irradiation
processing
15572 E 1707-95 Guide for es tima ting uncertainties in dosimetry for radiation
processing
15573 E1818-96 Practice for dosimetry in an electron-beam facility for radiation
processing at energies between 80 keV and 300 keV
. . .
III

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0 IS0 IS0 15560:1998(E)
AMERICAN SOCIETY FOR TEST!NG AN!2 MATERIALS
Designation: E 1400 - 95a 19: 6 Race St. Philadelphia, Pa 19103
Reprinted from the Annual Book cf ASTM Standards. Copyright ASTM
If not listed in the current combined index, will appear in the next edition.
Standard Practice for
Characterization and Performance of a High-Dose Radiation
Dosimetry Calibration Laboratory’
This standard is issued under the fixed designation E 1400; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (f) indicates an editorial change since the last revision or reapproval.
1. scope and consistent with, a national standard.
3.1.3 dosimetry system -a system used for determining
1.1 This practice contains the characterization and perfor-
absorbed dose, consisting of dosimeters, measurement in-
mance criteria to be met by a high-dose radiation dosimetry
struments and their associated reference standards, and
calibration laboratory. By meeting these criteria, the labora-
procedures for the system ’s use.
tory may be accredited by a recognized accreditation organi-
zation. Adherence to these criteria will ensure high standards
DIscussIoN-The types of dosimeters include reference standard
of performance and instill confidence that the accredited
dosimcrers, lransfer standard dosimelers, and rottbne dosimc~ers. See
laboratory is competent to provide reliable, accurate services.
Guide E 1261 for guidance on the selection and calibration of the
various dosimetry systems.
2. Referenced Documents
3.1.4 laboratory-high-dose calibration laboratory that
2.1 ASTM Stundards.
includes pertinent radiation calibration facilities, services,
E 170 Terminology Relating to Radiation Measurements
personnel, and equipment.
and Dosimetry*
3.1.5 laboratory accreditation-formal recognition that a
E 177 Practice for Use of the Terms Precision and Bias in
laboratory is competent to carry out specific calibrations in
ASTM Test Methods3
accordance with documented requirements of a recognized
E 456 Terminology Relating to Quality and Statistics3
accrediting organization.
E 1249 Practice for Minimizing Dosimetry Errors in
3.1.6 measurement quality assurance plan-a docu-
Radiation Hardness Testing of Silicon Electronic De-
mented program for the measurement process that quanti-
vices Using Co-60 Sources”
fies, on a continuing basis, the overall uncertainty of the
E. 1250 Test Method for Application of Ionization Cham-
measurements. This plan requires traceability to and consis-
bers to Assess the Low Energy Gamma Component of
tency with national or international standards, and shall
Cobalt-60 Irradiators Used in Radiation-Hardness
ensure that the overall uncertainty meets the requirements of
Testing of Silicon Electronic Devices”
the specific application.
E 126 1 Guide for Selection and Calibration of Dosimetry
3.1.7 measurement traceability-the ability to demon-
Systems for Radiation Processing’
strate and document periodically that the measurement
E 1707 Guide for Estimating Uncertainties in Dosimetry
results from a particular measurement system are in agree-
for Radiation Processing’
ment with comparable measurement results obtained with a
2.2 Intcrm~liot~ctl Orgwizlrriorz jbr* Stunhrdizutiora D~I-
national standard (or some identifiable and accepted stan-
i??UllS**
dard) to a specified uncertainty.
ISO/IEC Guide 25 (1990) General Requirements for the
Competence of Calibration and Testing Laboratories4 3.1.8 primary standard dosimeter-a dosimeter of the
highest metrological quality, established and maintained as
an absorbed dose standard by a national or international
3. Terminology
standards organization.
3. I Descriptions of Tmns SpcciJic* to This Standard.
3.1.9 proficiency testing-evaluation of the measurement
3.1 . 1 UCCllI ’UC~~ g&Is -the maximum acceptable deviation
capability of a calibration laboratory and demonstration of
from the accepted reference value of a measured quantity,
consistency with appropriate national standards.
where the accepted reference value is defined by the appro-
3.1.10 quality assurance
-all systematic actions necessary
priate national standard.
to provide adequate confidence that a calibration or mea-
3.1.2 culihration-the process whereby the response of a
surement is performed to a predefined level of quality.
dosimeter or measuring instrument is characterized through
3.1.11 quality control---the operational techniques and
comparison with an appropriate standard that is traceable to,
procedures that are employed routinely to achieve and
sustain a predefined level of quality.
* This practice is under the jurisdiction of ASTM Committee E-10 on Nuclear
3.1.12 quality rnantlakdocument stating the quality
Technology and Applications and is the direct responsibility of Subcommittee
policy, quality system, and quality practices of an organiza-
E IO.01 on Dosimctry for Radiation Processing.
tion
Current edition approved Sept. IO, 1995. Published November 1995. Originally
published as E 1400 - 9 I. Last prcvicaus edition E 1400 - OS.
3.1.13 quality system -organizational structure, responsi-
2 :ltllrlrirl l!h)ii ~~~ ‘/lSTAl ,9mh-& Vol 12.02.
bilities, procedures, processes, and resources for imple-
3 ht~d IJook c&C2Yl S~trtrclcrrds, Vol 14.02.
menting quality management.
d Available from International Organization for Standardization, I Rut de
V:mmbe, Cast Postalc 56, CH-I 2 I I Gcncva 20, Switzerland. 3.1.14 radiation processing- the intentional irradiation of

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0 IS0
IS0 15560:1998(E)
satisfied by each laboratory seeking accreditation. These
products or materials to preserve, modify, or improve their
characteristics.
general criteria are completely consistent with ISO/IEC
3.1. I 5 . recognized uccreditution or~ganizu~iort-organiza-
Guide 25. Laboratories that meet these general requirements
tion, operating in conformance with national regulations or
comply, for calibration activities, with Guide 25 and the
requirements, that conducts and administers a laboratory
relevant requirements of the IS0 9000 series of standards,
accreditation program and grants accreditation to calibration
including those of the model described in IS0 9002 when
laboratories.
they are acting as suppliers producing calibration results.
3.1.16 re$f?ence stundurd dosimeter-a dosimeter of high
4.5 For laboratories engaged in specific fields of calibra-
metrological quality used as a standard to provide measure-
tion, the general requirements of ISO/IEC Guide 25 need
ments traceable to, and consistent with, measurements made
amplification and interpretation. Section 6 of this practice
using primary standard dosimeters.
contains specific criteria which provide that amplification
3.1.17 routine dosimeter-a dosimeter calibrated against
and interpretation for ionizing radiation. Section 7 contains
a primary-, reference-, or transfer-standard dosimeter and
specific criteria for particular types of ionizing radiation, that
used for routine absorbed dose measurement.
is, gamma rays, electron beams and X-ray (bremsstrahlung)
3.1.18 lransfer standard dosirneter-a dosimeter, often a
. beams.
reference standard dosimeter, suitable for transport between
4.6 For ease of use, all sections of this document after
different locations for use as an intermediary to compare
Section 5 employ the format established in Section 5. It is
absorbed dose measurements.
therefore readily apparent how the subsequent sections
confirmation by examination of ob-
3.1 . 19 vcri/icut io+--
amplify and interpret the general requirements contained in
jective evidence that specified requirements have been met.
Section 5.
DISCUSSION -In the case of measuring equipment, the result of
5. General Criteria
verification Icads to a decision cithcr to restore to scrvicc or to perform
5.1 This section sets forth the general requirements that
adjustments, or to repair, or to downgrade, or to declare obsolete. In all
shall be satisfied by each laboratory seeking accreditation. In
cases it is required that a written trace of the verification performed be
kept on the instrument ’s individual record. addition to satisfying the general criteria of this section, a
laboratory shall also satisfy the specific criteria contained in
3.1.20 working stundurd-a standard, usually calibrated
Section 6 and in those parts of Section 7 relevant to each
against a reference standard, used routinely to calibrate or
calibration service for which accreditation is sought (see 4.4
check measuring instruments or devices.
and 4.5).
3.2 Also see Terminology E 170.
5.2 This section may also be used by calibration laborato-
ries in the development and implementation of their quality
4. Significance and Use
systems, and by others concerned with evaluating the com-
4.1 The radiation industry needs a source of reliable,
petence of laboratories.
prompt dosimeter calibration services to support accurate
e
5.3 Organization and Management.
measurements of absorbed dose during radiation processing.
5.3.1 The laboratory shall be organized and shall operate
Those measurements, made routinely in industrial facilities,
in such a way that its facilities meet the requirements of this
should be consistent with and traceable to the physical
section.
measurement standards maintained by an appropriate na-
5.3.2 The laboratory shall:
tional or international standards laboratory. Organizations
5.3.2.1 Have managerial staff with the authority and
that might provide calibration services and thereby serve as a
resources needed to discharge their duties,
link to national standards include universities, government-
5.3.2.2 Have arrangements to ensure that its personnel are
owned laboratories, and private companies.
free from any commercial, financial, and other conflicts
4.2 To ensure the provision of adequate services, a
which might adversely affect the quality of their work,
calibration laboratory should be operating with a full mea-
5.3.2.3 Be organized in such a way that confidence in its
surement quality assurance (MQA) program. The funda-
independence ofjudgement and integrity is maintained at all
mental requirements for such a program include: (I) compli-
times,
ance with operational requirements of this practice; (2)
5.3.2-4 Specify and document the responsibility, au-
documented procedures and in-house quality assurance
thority, and interrelation of all personnel who manage,
(QA) program specific to the calibration services provided;
perform, or verify work affecting the quality of calibrations,
and (3) periodic performance evaluations, including profi-
5.3.2.5 Provide adequate supervision by persons familiar
ciency tests and on-site expert assessments. ( 1,2)5
with the calibration methods and procedures, the objective of
4.3 When a potential calibration laboratory applies for
the calibration, and the assessment of the results,
accreditation, the accrediting organization (see Appendix)
5.3.2.6 Have a technical manager (however named) who
determines whether the laboratory ’s quality documentation
has overall responsibility for the technical operations,
is satisfactory, performs proficiency tests for each calibration
5.3.2.7 Have a quality manager (however named) who has
category for which accreditation is requested, and provides
responsibility for the quality system and its implementation.
technical experts for on-site assessments to determine
The quality manager shall have direct access to the highest
whether the laboratory meets the criteria of this practice.
level of management at which decisions are made on
4.4 Section 5 sets forth general criteria that shall be
calibration laboratory policy or resources, and to the tech-
nical manager. In some laboratories, the quality manager
may also be the technical manager or deputy technical
5 The boldface numbers in parentheses refer to a list of references at the end of
this practice. manager of the calibration laboratory,
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0 IS0 IS0 15560:1998(E)
5.4.2.16 The laboratory management arrangements for
5.3.2.8 Nominate deputies in case of absence of the
technical or quality manager, exceptionally permitted departures from documented poli-
5.3.2.9 Where relevant, have documented policy and cies and procedures or from standard specifications,
procedures to ensure the protection of clients’ confidential 5.4.2.17 Procedures for dealing with complaints,
information and proprietary rights, and 5.4.2.18 Procedures for protecting confidentiality and
5.3.2. IO Where appropriate, participate in inter-laboratory proprietary rights, and
comparisons and proficiency testing programs. 5.4.2.19 Procedures for audit and review.
5.4 Qrrality System, Audit, and -Review. 5.4.3 The laboratory shall arrange for audits of its activi-
5.4.1 The laboratory shall establish and maintain a ties at appropriate intervals to verify that its operations
quality system appropriate to the type, range, and volume of continue to comply with the requirements of the quality
calibration activities it undertakes. The elements of this system. Such audits shall be carried out by trained and
system shall be documented. The quality documentation qualified staff who are, wherever possible, independent of the
shall be available for use by the laboratory personnel. The activity to be audited. Where the audit findings cast doubt on
laboratory shall define and document its policies and objec- the correctness or validity of the laboratory ’s calibration
tives for, and its commitment to, good laboratory practice results, the laboratory shall take corrective action and shall
and quality of calibration services. The laboratory manage- notify, in writing, as soon as practically possible, any client
ment shall ensure that these policies and objectives are whose work may have been affected.
documented in a quality manual and communicated to, 5.4.4 The quality system adopted to satisfy the require-
understood, and implemented by all laboratory personnel ments of this section shall be reviewed at least once a year by
concerned. The quality manual shall be maintained current the management to ensure its continuing suitability and
under the responsibility of the quality manager. effectiveness and to introduce any necessary changes or
5.4.2 The quality manual, and related quality documen- improvements. Any changes in the quality system shall be
tation, shall state the laboratory ’s policies and operational approved by the accrediting organization prior to implemen-
procedures established in order to meet the requirements of tation.
this section. The quality manual and related quality docu- 5.4.5 All audit and review findings and any corrective
mentation shall also contain: actions that arise from them shall be documented. The
5 4 7 1 A quality policy statement, including objectives person responsible for quality shall ensure that these actions
and’ commitments, by top management, are discharged within the agreed time scale.
5.4.2.2 The organization and management structure of 5.4.6 In addition to periodic audits the laboratory shall
the laboratory, its place in any parent organization, and ensure the quality of results provided to clients by imple-
relevant organizational charts, menting and documenting checks. These checks shall be
5.4.2.3 The relations between management, technical op- reviewed by management and shall include, as appropriate,
erations,; support services, and the quality system, but not be limited to:
5.4.2.4 Procedures for control and maintenance of docu- 5.4.6.1 Internal quality control schemes using, whenever
mentation, practical, statistical techniques,
5 . 4.2.5 Job descriptions of key staff and reference to the 5.4.6.2 Participation in proficiency testing or other
job descriptions of other staff, interlaboratory comparisons,
5.4.2.6 Identification of the laboratory ’s approved signa- 5.4.6.3 Replicate calibrations using the same or different
tories, methods, and.
5.4.2.7 The laboratory ’s procedures for achieving trace- 5.4.6.4 Re-calibration of retained instruments and dosim-
ability of measurements, eters.
5.4.2.8 The laboratory ’s scope of calibrations, 5.5 Personnel:
5.4.2.9 Arrangements for ensuring that the laboratory 5.5.1 The laboratory shall have sufficient personnel
reviews all new work to ensure that it has the appropriate having the necessary education, training, technical knowl-
facilities and resources before commencing such work, edge, and experience to carry out their assigned functions.
5.4.2.10 Reference to the calibration and verification 5.5.2 The laboratory shall ensure that the training of its
procedures used, . personnel is kept up-to-date (see Section 6).
5.4.2.11 Procedures for handling calibration and test 5.5.3 Records on the relevant qualifications, training,
items, skills, and experience of the technical personnel shall be
5.4.2.12 Reference to the major equipment and reference maintained by the laboratory.
measurement standards used, 5.6 Facilities and Environment.
5.4.2.13 Reference to procedures for calibration, verifica- 56.1 Laboratory facilities including calibration areas,
tion, and maintenance of equipment, electrical power sources, lighting, heating, and ventilation
5.4.2.14 Reference to verification practices including shall be adequate to facilitate proper performance of calibra-
interlaboratory comparisons, proficiency testing programs, tions.
use of reference materials, and internal quality control 5.6.2 The environment in which calibrations and related
schemes, activities are undertaken shall not invalidate the results or
5.4.2.15 Procedures to be followed for consultation and compromise the specified uncertainty of measurement.
5.6.3 The laboratory shall provide facilities for the effec-
corrective action whenever discrepancies in proficiency
tive monitoring, control, and recording of environmental
testing are detected or departures from documented policies
and procedures occur, conditions as appropriate. Due attention shall be paid, for
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IS0 15560:1998(E)
ments made by the laboratory are traceable to national or
example, to dust, electromagnetic interference, humidity,
international standards of measurement where available.
electrical power stability, temperature, and sound and vibra-
Calibration certificates ,shall, wherever applicable, indicate
tion levels, as appropriate to the calibrations performed.
the traceability to national standards of measurement, and
5.64 The laboratory design shall provide adequate protec-
shall provide the measurement results and associated uncer-
tion between areas where the activities are incompatible.
tainty of measurement or a statement of compliance, or
5.65 Access to and use of all areas affecting the quality of
both, with an identified metrological specification. .
calibration and related activities shall be defined and con-
5.8.3 Where traceability to national or international stan-
trolled.
dards of measurement is either not available or not appli-
56.6 Adequate measures shall be taken to ensure good
cable, the laboratory shall provide satisfactory evidence of
housekeeping.
correlation of results, for example by participation in a
5.6.7 The laboratory shall comply with all relevant health
suitable program of interlaboratory comparisons or profi-
and safety requirements.
ciency testing.
5.7 Eqtlipment.
5.7.1 The laboratory shall be furnished with all items of 5.8.4 Reference standards of measurement held by the
laboratory shall be used for calibration only and for no other
equipment required for the correct performance of calibra-
tions. In those cases where the laboratory needs to use purpose, unless it can be demonstrated that use for other
purposes will not invalidate their performance as reference
equipment outside its permanent control, it shall ensure that
the relevant requirements of this section are met. standards.
5.8.5 Reference standards of measurement shall be cali-
5.7.2 All equipment shall be properly maintained. Main-
tenance procedures shall be documented. Any item of brated by a body that can provide traceability to a national
equipment which has been subjected to overloading or or international standard of measurernent. There shall be a
mishandling, or which gives suspect results, or has been program of calibration and verification for reference stan-
shown by verification or during calibration or use to be dards.
defective, shall be taken out of service, clearly identified, and 5.8.6 Where relevant, reference standards and measuring
wherever possible stored at a specified place until it has been equipment shall be subjected to in-service checks (constancy
repaired and shown by calibration, verification, or test to checks) between calibrations and verifications.
perform satisfactorily. The laboratory shall examine the 5.9 Culibrulion Methods.
effect of this defect on previous calibrations. 5.9.1 The laboratory shall have documented instructions
5.7.3 Each item of equipment shall, when appropriate, be for using and operating all relevant equipment, for handling
labelled, marked, or otherwise identified to indicate its and preparing dosimeters, and for performing calibrations,
calibration status. where the absence of such instructions could jeopardize the
5.7.4 Records shall be maintained for each item of calibrations. All instructions, standards, manuals, and refer-
equipment significant to the calibrations performed. The ence data relevant to the work of the laboratory shall be
records shall include: maintained up-to-date and be readily available to the staff.
5.7.4.1 The name of the item of equipment, 5.9.2 The laboratory shall use appropriate methods and
5.7.4.2 The manufacturer ’s name, type identification, and procedures for all calibrations and related activities within its
serial number or other unique identification, responsibility (including handling, transport, storage, and
5.7.4.3 The date received and the date placed in service, preparation of dosimeters, estimation of uncertainty of
5.7.4.4 The current location, where appropriate, measurement, and analysis of calibration data). (4,§) The
5.7.4.5 The condition when received (for example, new, methods and procedures shall be consistent with the accu-
used, reconditioned), racy required, and with any standard specifications relevant
I nanufacturer ’s instructions, where
5.7.4.6 A copy of the to the calibrations concerned.
available,
5.9.3 Where methods and procedures are not specified,
5.7.4.7 The dates and results of calibrations or verifica-
the laboratory shall, wherever possible, use those that have
tions, or both, and the date of the next calibration or been published in international or national standards, pub-
verification, or both, lished by reputable technical organizations, or published in
5.7.4.8 The name and signature of the person who per-
relevant scientific texts or journals,
formed the calibrations or verifications, or both, 5.9.4 Where it is necessary to employ methods and
5.7.4.9 The details of maintenance carried out to date and procedures that have not been established as standard, these
planned for the future, and shall be subject to agreement with the client, be fully
5.7.4.10 The history of any damage, malfunction, modifi- validated and documented, and be available to the client and
cation, or repair. other recipients of the relevant reports.
5.8 Mcuswcmen~ Truceubilil v und Culibrut ion.
5.9.5 Calculations and data transfers shall be subject to
5.8.1 All measuring equipment having an effect on the appropriate checks.
accuracy or validity of calibrations shall be calibrated or 5.9.6 Where computers or automated equipment are used
verified, or both, before being put into service. The labora-
to capture, process, manipulate, record, report, store, or
tory shall have an established program for the calibration retrieve calibration data, the laboratory shall ensure that:
and verification of its measuring equipment. (3)
5.9.6.1 Computer software is validated and documented
5 8 2 The overall program of calibration or verification, or
where the software provides operational control or contrib-
both, “and validation of equipment shall be designed and
utes to a quality management decision process,
operated so as to ensure that, wherever applicable, measure-
5.9.6.2 Procedures are established and implemented for
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IS0 15560: 1998(E)
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'!m El400
protecting the integrity of data; such procedures shall in- 5.12 Certificates and Reporzs.
clude, but not be limited to, integrity of data entry or 5.12.1 The results of each calibration or series of calibra-
capture, data storage, data transmission, and data processing, tions carried out by the laboratory shall be reported accu-
rately, clearly, unambiguously, and objectively in accordance
5.9.6.3 Computer an
...