ASTM D6808-02(2018)e1
(Practice)Standard Practice for Competency Requirements of Reference Material Producers for Water Analysis
Standard Practice for Competency Requirements of Reference Material Producers for Water Analysis
SIGNIFICANCE AND USE
4.1 This practice is for the use by RM producers in the development and implementation of their quality system and by those concerned with assessing the competence of RM producers. It should be recognized that a RM needs to be characterized mainly to the level of accuracy required for its intended purpose (that is, appropriate measurement uncertainty). The RM producer shall describe the procedure for establishing the quality of materials as a component of the quality system.
4.2 This practice is for the use of RM users in the establishment if a RM producer has a quality system adequate to produce high quality RMs. It can be used by users to determine if the scientific and technical competence of a RMs producer is adequate to ensure the quality of RMs. This practice is consistent with the requirements for RM producers established in ISO Guide 34.
4.3 This practice does not specify specific protocols for the contents of RMs certificates of analysis, for calibration in analytical chemistry and use of certified RMs and for certification of RMs. For this information, users are referred to Practice D6362, ISO Guide 32, and ISO Guide 35.
SCOPE
1.1 This practice establishes the general requirements with which a reference materials (RM) producer has to demonstrate that it operates, if it is to be recognized as competent to produce RMs used for water analysis.
1.2 This practice establishes the quality system requirements in accordance with which waters RMs shall be produced. It is intended to be used as part of a RM producer’s general quality assurance (QA) procedures. RM producers shall define their scope in terms of the application, the measurement methods used in the homogeneity, stability, and characterization studies.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
Relations
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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Designation: D6808 − 02 (Reapproved 2018)
Standard Practice for
Competency Requirements of Reference Material Producers
for Water Analysis
This standard is issued under the fixed designation D6808; 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 (´) indicates an editorial change since the last revision or reapproval.
ε NOTE—The Keywords section was added editorially in August 2018.
1. Scope D6362 Practice for Certificates of Reference Materials for
Water Analysis
1.1 This practice establishes the general requirements with
2.2 ISO Documents:
which a reference materials (RM) producer has to demonstrate
ISO/IEC 17025:1999 General Requirements for the Compe-
that it operates, if it is to be recognized as competent to
tence of Calibration and Testing Laboratories
produce RMs used for water analysis.
ISO 8402:1994 Quality Management and Quality
1.2 This practice establishes the quality system require-
Assurance—Vocabulary
ments in accordance with which waters RMs shall be pro-
ISO 10012-1:1992 Quality Assurance Requirements for
duced. It is intended to be used as part of a RM producer’s
Measuring Equipment—Part 1: Metrological Confirma-
general quality assurance (QA) procedures. RM producers
tion Systems for Measuring Equipment
shall define their scope in terms of the application, the
ISO/IEC Guide 2:1996 Standardization and Related
measurement methods used in the homogeneity, stability, and
Activities—General Vocabulary
characterization studies.
ISO Guide 30:1992 Terms and Definitions used in Connec-
1.3 The values stated in SI units are to be regarded as
tion with Reference Materials
standard. No other units of measurement are included in this
ISO Guide 31:2000 Contents of Certificates and Labels of
standard.
Reference Materials
1.4 This standard does not purport to address all of the ISO/IEC Guide 32:1997 Calibration inAnalytical Chemistry
safety concerns, if any, associated with its use. It is the
and Use of Certified Reference Materials
responsibility of the user of this standard to establish appro- ISO Guide 34:2000 General Requirements for the Compe-
priate safety, health, and environmental practices and deter-
tency of Reference Material Producers
mine the applicability of regulatory limitations prior to use. ISO Guide 35:1989 Certification of Reference Materials—
1.5 This international standard was developed in accor-
General and Statistical Principles
dance with internationally recognized principles on standard- ISO 3534 Series: 1993 Statistics—Vocabulary and Symbols
ization established in the Decision on Principles for the
VIM: 1993 International Vocabulary of Basic and General
Development of International Standards, Guides and Recom- Terms in Metrology (issued by ISO, IEC, BIPM, IFCC,
mendations issued by the World Trade Organization Technical
IUPAC, IUPAP and OIML)
Barriers to Trade (TBT) Committee.
ISO Guide to the Expression of Uncertainty in Measure-
ment: 1995 (issued by ISO, IEC, BIPM, IFCC, IUPAC,
2. Referenced Documents
IUPAP and OIML)
2.1 ASTM Standards:
D1129 Terminology Relating to Water
3. Terminology
3.1 Definitions:
This practice is under the jurisdiction ofASTM Committee D19 on Water and
3.1.1 For the purposes of this practice, the definitions given
is the direct responsibility of Subcommittee D19.02 on Quality Systems,
inTerminologyD1129,ISO/IECGuide2,ISO/IEC17025,ISO
Specification, and Statistics.
Current edition approved Aug. 1, 2018. Published September 2018. Originally
Guide 30, ISO 8402, ISO 3534, VIM, and the following
approved in 2002. Last previous edition approved in 2012 as D6808 – 02 (2012).
definitions apply.
DOI: 10.1520/D6808-02R18E01.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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D6808 − 02 (2018)
3.2 Definitions of Terms Specific to This Standard: produce RMs which conform to the definitions given in ISO
3.2.1 collaborator, n—technically competent body (organi- Guide 30, characterized according to the requirements of ISO
zation or firm, public or private) that undertakes aspects of the Guide 35, and whose property values are assessed using
manufacture, or characterization, of the (certified) RM on accepted statistical techniques. The policy shall, where
behalf of the RM producer, either on a contractual (as a appropriate, include a commitment to comply with Practice
sub-contractor) or voluntary basis. D6362 for the contents of RM certificates and supply of
associated information for users. It is important that the policy
3.2.2 reference material producer, n—technicallycompetent
also specifies the intended use of the RMs in order to ensure
body (organization or firm, public or private) that is fully
that the RM producer fully advises the user which types of
responsible for assigning the certified or other property values
application the materials may be used.
of the RMs it produces and supplies, which have been
5.1.3 Quality System:
produced in accordance with ISO Guide 35, Practice D6362,
5.1.3.1 The RM producer shall establish, implement, and
and ISO Guide 31.
maintain a documented quality system appropriate to the type,
4. Significance and Use
range, and volume of RM production it undertakes. The RM
4.1 This practice is for the use by RM producers in the producer shall document all of its policies, systems, programs,
procedures, instructions, findings, etc., to the extent necessary
development and implementation of their quality system and
by those concerned with assessing the competence of RM to enable the producer to assure the quality of the RMs
produced. Documentation used in this quality system shall be
producers. It should be recognized that a RM needs to be
communicatedto,understoodby,availabletoandimplemented
characterized mainly to the level of accuracy required for its
by all personnel concerned. In particular, the producer shall
intended purpose (that is, appropriate measurement uncer-
have a quality system that covers the following:
tainty). The RM producer shall describe the procedure for
(1) Arrangements for ensuring the suitable choice (for
establishing the quality of materials as a component of the
example, particle size range, concentration range, etc.) of the
quality system.
candidate RMs;
4.2 This practice is for the use of RM users in the estab-
(2) Preparation procedures;
lishment if a RM producer has a quality system adequate to
(3) Achievement of the required degree of homogeneity of
producehighqualityRMs.Itcanbeusedbyuserstodetermine
the RM;
if the scientific and technical competence of a RMs producer is
(4) Assessment of the stability of the RM; including
adequate to ensure the quality of RMs. This practice is
on-going assessment of stability where necessary;
consistent with the requirements for RM producers established
(5) Procedures for undertaking characterization;
in ISO Guide 34.
(6) Practical realization of traceability to national or inter-
4.3 This practice does not specify specific protocols for the
national standards of measurement;
contents of RMs certificates of analysis, for calibration in
(7) Assignment of property values, including preparation
analytical chemistry and use of certified RMs and for certifi-
of certificates or statements in accordance with Practice D6362
cation of RMs. For this information, users are referred to
when appropriate;
Practice D6362, ISO Guide 32, and ISO Guide 35.
(8) Arrangements for ensuring adequate storage facilities;
(9) Arrangements for suitable identification, labeling and
5. Organization and Management Requirements
packaging facilities, packing and delivery procedures, and
5.1 Quality System Requirements:
customer service; and
5.1.1 The RM producer shall establish, implement, and
(10) Compliance with ISO Guides 30, 34, and 35, and
maintain a quality system appropriate to the scope of its
Practice D6362.
activities including the type, range, and magnitude of the RM
It is encouraged that the documented quality system specify
production it undertakes.
whichactivitiesareundertakenbytheRMproducerand,where
5.1.2 Quality Policy:
relevant, which activities are undertaken by collaborators and
5.1.2.1 The RM producer shall define and document its
shall include policies and procedures used by the producer to
policy, objectives, and commitment to ensuring and maintain-
ensure that all activities conducted by collaborators comply
ing the quality of all aspects of RM production, including
with the relevant clauses of this practice.
material quality (that is, homogeneity and stability), character-
5.1.3.2 The documented quality system shall define the
ization (that is, equipment calibration and measurement
roles and responsibilities of the technical manager (however
method validation), assignment of property values (that is, use
named) and quality manager including their responsibilities for
of appropriate statistical procedures), and material handling,
ensuring compliance with this practice.
storage, and transport procedures.
5.2 Organization and Management:
5.1.2.2 The quality policy shall, when appropriate, include
5.2.1 The RM producer, or the organization of which it is
use of interlaboratory characterization studies employing labo-
part, shall be legally identifiable.
ratories that are active and competent in the respective field of
measurement in this context. The policy shall include a 5.2.2 The RM producer shall be organized and shall operate
commitment to interact with the appropriate sectors of the in such a way that it meets all the applicable requirements of
measurement community in order to prevent working in this practice whether carrying out work in its permanent
isolation. The policy shall also include a commitment to facilities or at sites (including associated temporary or mobile
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D6808 − 02 (2018)
facilities) away from its permanent facilities (including work equivalent identifying the current revision status of documents
undertaken by collaborators). in the quality system shall be established and be readily
available to preclude the use of invalid or obsolete documents,
5.2.3 The RM producer shall:
or both.
(1) Have managerial personnel supported by technical
5.3.2.2 The procedures adopted shall also ensure that:
personnel with the authority and resources needed to discharge
(1) Authorizededitionsofappropriatedocumentsareavail-
their duties and to identify the occurrence of departures from
able at all locations where operations essential to the effective
the quality system or the procedures for the production of RMs
and to initiate actions to prevent or minimize such departures; production of RMs are performed;
(2) Documents are periodically reviewed and, where
(2) Have arrangements to ensure that its management and
personnel are free from any commercial, financial, and other necessary, revised to ensure continuing suitability and compli-
ance with applicable requirements;
internal and external pressures that may adversely affect the
quality of their work; (3) Invalid or obsolete documents are promptly removed
from all points of issue or use, or otherwise assured against
(3) Have policies and procedures to ensure the protection
of its client’s confidential information and proprietary rights; unintended use; and
(4) Obsolete documents retained for legal or informational
(4) Have policies and procedures to avoid involvement in
activities that might diminish confidence in its competence, purposes are suitably marked.
5.3.3 Document Changes:
impartiality, judgement, or operational integrity;
(5) Define, with the aid of organizational charts, the orga- 5.3.3.1 Changes to documents (including documented pro-
cedures) shall be reviewed and approved by designated per-
nization and management structure of the RM producer, its
place in any parent organization, and the relations between sonnel performing the same function as that conducted for the
original review and approval unless specifically decided oth-
management, technical operations, support services,
collaborators, and the quality management system; erwise.The designated personnel shall have access to pertinent
background information to base their review and approval.
(6) Specify the responsibility, authority, and inter-
relationships of all personnel who manage, perform, or verify 5.3.3.2 Where practicable, the nature of the change shall be
identified in the document with appropriate attachments.
work affecting the quality of production of RMs;
(7) Have technical management, which has overall respon- 5.3.3.3 If the RM producer’s documentation control system
sibility for the technical operations and the provision of the allows for the amendment of documents by hand, pending the
resources needed to ensure the required quality of each re-issue of the documents, the procedures and authorities for
operation which forms part of the RM production; such amendments shall be defined and shall ensure that
(8) Appointamemberofstaffasqualitymanager(however amendments are initialed and dated. Documents amended by
named) who, irrespective of other duties and responsibilities, hand shall be marked, signed, and dated and shall be formally
shallhavedefinedresponsibilityandauthorityforensuringthat re-issued as soon as practicable.
therequirementsofthispracticeareimplementedandfollowed 5.3.3.4 Procedures shall be established to describe how
at all times.The quality manager shall have direct access to the changes in documents maintained in computerized systems are
highest level of management at which decisions are taken on made.
production policy or resources; and
5.4 Request, Tender, and Contract Reviews:
(9) Whereappropriate,appointdeputiesforkeymanagerial
5.4.1 When relevant, each request, tender, or contract (see
personnel such as the technical and quality managers.
Note 2) concerning the production of a RM shall be reviewed
by the RM producer to ensure that:
5.3 Document and Information Control:
(1) The requirements are adequately defined, documented,
5.3.1 General:
and understood;
5.3.1.1 The RM producer shall establish and maintain pr
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