ASTM D6808-02
(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
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 QA procedures. RM producers shall define their scope in terms of the application, the measurement methods used in the homogeneity, stability and characterization studies.
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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation:D6808–02
Standard Practice for
Competency Requirements of Reference Material Producers
for Water Analysis
This standard is issued under the fixed designation D 6808; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope ISO Guide 30:1992 Terms and Definitions used in Connec-
tion with Reference Materials
1.1 This practice establishes the general requirements with
ISO Guide 31:2000 Contents of Certificates and Labels of
which a reference materials (RM) producer has to demonstrate
Reference Materials
that it operates, if it is to be recognized as competent to
ISO/IEC Guide 32:1997 Calibration in Analytical Chemis-
produce RMs used for water analysis.
try and Use of Certified Reference Materials
1.2 This practice establishes the quality system require-
ISO Guide 34:2000 General Requirements for the Compe-
ments in accordance with which waters RMs shall be pro-
tency of Reference Material Producers
duced. It is intended to be used as part of a RM producer’s
ISO Guide 35:1989 Certification of Reference Materials—
general QAprocedures. RM producers shall define their scope
General and Statistical Principles
in terms of the application, the measurement methods used in
ISO 3534 Series: 1993 Statistics—Vocabulary and Symbols
the homogeneity, stability and characterization studies.
VIM: 1993 International Vocabulary of Basic and General
1.3 This standard does not purport to address all of the
Terms in Metrology (issued by ISO, IEC, BIPM, IFCC,
safety concerns, if any, associated with its use. It is the
IUPAC, IUPAP and OIML)
responsibility of the user of this standard to establish appro-
ISO Guide to the Expression of Uncertainty in Measure-
priate safety and health practices and determine the applica-
ment: 1995 (issued by ISO, IEC, BIPM, IFCC, IUPAC,
bility of regulatory limitations prior to use.
IUPAP and OIML)
2. Referenced Documents
3. Terminology
2.1 ASTM Standards:
3.1 For the purposes of this practice, the definitions given in
D 1129 Terminology Relating to Water
Terminology D 1129, ISO/IEC Guide 2, ISO/IEC 17025, ISO
D 6362 PracticeforCertificatesofRMsforWatersAnalysis
3 Guide 30, ISO 8402, ISO 3534, VIM and the following
2.2 ISO Documents:
definitions apply.
ISO/IEC 17025:1999 General Requirements for the Com-
3.1.1 collaborator—technically competent body (organiza-
petence of Calibration and Testing Laboratories
tion or firm, public or private) that undertakes aspects of the
ISO 8402:1994 Quality Management and Quality
manufacture, or characterization, of the (certified) RM on
Assurance—Vocabulary
behalf of the RM producer, either on a contractual (as a
ISO 10012-1:1992 Quality Assurance Requirements for
sub-contractor) or voluntary basis.
Measuring Equipment—Part 1: Metrological Confirma-
3.1.2 reference material producer—technically competent
tion Systems for Measuring Equipment
body (organization or firm, public or private) that is fully
ISO/IEC Guide 2:1996 Standardization and Related
responsible for assigning the certified or other property values
Activities—General Vocabulary
of the RMs it produces and supplies, which have been
produced in accordance with ISO Guide 35, Practice D 6362,
This practice is under the jurisdiction of ASTM Committee D19 on Water and and ISO Guide 31.
is the direct responsibility of Subcommittee D19.02 on General Specifications,
Technical Resources, and Statistical Methods.
4. Significance and Use
Current edition approved June 10, 2002. Published July 2002.
4.1 This practice is for the use by RM producers in the
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
development and implementation of their quality system and
Standards volume information, refer to the standard’s Document Summary page on
by those concerned with assessing the competence of RM
the ASTM website.
producers. It should be recognized that a RM needs to be
Available from American National Standards Institute, 25 W. 43rd St., 4th
Floor, New York, NY 10036. characterized mainly to the level of accuracy required for its
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D6808–02
intended purpose (that is, appropriate measurement uncer- by all personnel concerned. In particular, the producer shall
tainty). The RM producer shall describe the procedure for have a quality system that covers the following:
establishing the quality of materials as a component of the
(a) Arrangements for ensuring the suitable choice (for
quality system.
example, particle size range, concentration range, etc.) of the
4.2 This practice is for the use of RM users in the estab-
candidate RMs;
lishment if a RM producer has a quality system adequate to
(b) Preparation procedures;
producehighqualityRMs.Itcanbeusedbyuserstodetermine
(c) Achievement of the required degree of homogeneity of
if the scientific and technical competence of a RMs producer is
the RM;
adequate to ensure the quality of RMs. This practice is
(d) Assessment of the stability of the RM; including
consistent with the requirements for RM producers established
on-going assessment of stability where necessary;
in ISO Guide 34.
(e) Procedures for undertaking characterization;
4.3 This practice does not specify specific protocols for the
(f) Practical realization of traceability to national or inter-
contents of RMs certificates of analysis, for calibration in
national standards of measurement;
analytical chemistry and use of certified RMs and for certifi-
(g) Assignment of property values, including preparation
cation of RMs. For this information, users are referred to
of certificates or statements in accordance with Practice
Practice D 6362, ISO Guide 32, and ISO Guide 35.
D 6362 when appropriate;
5. Organization and Management Requirements (h) Arrangements for ensuring adequate storage facilities;
(i) Arrangements for suitable identification, labeling and
5.1 Quality System Requirements:
packaging facilities, packing and delivery procedures and
5.1.1 The RM producer shall establish, implement and
customer service; and
maintain a quality system appropriate to the scope of its
(j)CompliancewithISOGuides30,34and35andPractice
activities including the type, range and magnitude of the RM
D 6362.
production it undertakes.
It is encouraged that the documented quality system specify
5.1.2 Quality Policy:
whichactivitiesareundertakenbytheRMproducerand,where
5.1.2.1 The RM producer shall define and document its
relevant, which activities are undertaken by collaborators and
policy, objectives and commitment to ensuring and maintain-
shall include policies and procedures used by the producer to
ing the quality of all aspects of RM production, including
ensure that all activities conducted by collaborators comply
material quality (that is, homogeneity and stability), character-
with the relevant clauses of this practice.
ization (that is, equipment calibration and measurement
method validation), assignment of property values (that is, use 5.1.3.2 The documented quality system shall define the
of appropriate statistical procedures) and material handling, roles and responsibilities of the technical manager (however
storage and transport procedures. named) and quality manager including their responsibilities for
ensuring compliance with this practice.
5.1.2.2 The quality policy shall, when appropriate, include
use of interlaboratory characterization studies employing labo-
5.2 Organization and Management:
ratories that are active and competent in the respective field of
5.2.1 The RM producer, or the organization of which it is
measurement in this context. The policy shall include a
part, shall be legally identifiable.
commitment to interact with the appropriate sectors of the
5.2.2 The RM producer shall be organized and shall operate
measurement community in order to prevent working in
in such a way that it meets all the applicable requirements of
isolation. The policy shall also include a commitment to
this practice whether carrying out work in its permanent
produce RMs which conform to the definitions given in ISO
facilities or at sites (including associated temporary or mobile
Guide 30, characterized according to the requirements of ISO
facilities) away from its permanent facilities (including work
Guide 35 and whose property values are assessed using
undertaken by collaborators).
accepted statistical techniques. The policy shall, where appro-
5.2.3 The RM producer shall:
priate, include a commitment to comply with Practice D 6362
(a) Have managerial personnel supported by technical
for the contents of RM certificates and supply of associated
personnel with the authority and resources needed to discharge
information for users. It is important that the policy also
their duties and to identify the occurrence of departures from
specifiestheintendeduseoftheRMsinordertoensurethatthe
the quality system or the procedures for the production of RMs
RM producer fully advises the user which types of application
and to initiate actions to prevent or minimize such departures.
the materials may be used.
(b) Have arrangements to ensure that its management and
5.1.3 Quality System:
personnel are free from any commercial, financial and other
5.1.3.1 The RM producer shall establish, implement and
internal and external pressures that may adversely affect the
maintain a documented quality system appropriate to the type,
quality of their work;
range and volume of RM production it undertakes. The RM
(c)Havepoliciesandprocedurestoensuretheprotectionof
producer shall document all of its policies, systems, programs,
its client’s confidential information and proprietary rights;
procedures, instructions, findings, etc., to the extent necessary
to enable the producer to assure the quality of the RMs (d) Have policies and procedures to avoid involvement in
produced. Documentation used in this quality system shall be activities that might diminish confidence in its competence,
communicatedto,understoodby,availabletoandimplemented impartiality, judgement or operational integrity;
D6808–02
(e) Define, with the aid of organizational charts, the 5.3.3.1 Changes to documents (including documented pro-
organizationandmanagementstructureoftheRMproducer,its cedures) shall be reviewed and approved by designated per-
place in any parent organization, and the relations between sonnel performing the same function as that conducted for the
management, technical operations, support services, collabora- original review and approval unless specifically decided oth-
tors and the quality management system; erwise.The designated personnel shall have access to pertinent
background information to base their review and approval.
(f) Specify the responsibility, authority and inter-
5.3.3.2 Where practicable, the nature of the change shall be
relationships of all personnel who manage, perform or verify
identified in the document with appropriate attachments.
work affecting the quality of production of RMs;
5.3.3.3 If the RM producer’s documentation control system
(g) Have technical management, which has overall respon-
allows for the amendment of documents by hand, pending the
sibility for the technical operations and the provision of the
re-issue of the documents, the procedures and authorities for
resources needed to ensure the required quality of each
such amendments shall be defined and shall ensure that
operation which forms part of the RM production;
amendments are initialed and dated. Documents amended by
(h)Appointamemberofstaffasqualitymanager(however
hand shall be marked, signed and dated and shall be formally
named) who, irrespective of other duties and responsibilities,
re-issued as soon as practicable.
shallhavedefinedresponsibilityandauthorityforensuringthat
5.3.3.4 Procedures shall be established to describe how
therequirementsofthispracticeareimplementedandfollowed
changes in documents maintained in computerized systems are
at all times.The quality manager shall have direct access to the
made.
highest level of management at which decisions are taken on
5.4 Request, Tender and Contract Reviews:
production policy or resources; and
5.4.1 When relevant, each request, tender or contract (see
(i) Where appropriate, appoint deputies for key managerial
Note 2) concerning the production of a RM shall be reviewed
personnel such as the technical and quality managers.
by the RM producer to ensure that:
5.3 Document and Information Control
(a) The requirements are adequately defined, documented
5.3.1 General:
and understood;
5.3.1.1 The RM producer shall establish and maintain pro-
(b) The RM producer has the capability (see Note 3) and
cedures to control all documents (both internally generated and
resources to meet the requirements;
from external sources) and other information that forms part of
(c) In the case of external contracts (see Note 4) any
its quality documentation. These may include documents of
differences between the contract or order requirements and
externaloriginsuchasstandards,guides,testand/orcalibration
those in a tender are resolved to the satisfaction of the RM
methods as well as specifications, instructions and manuals
producer and the customer or client.
related to the RM under production (see Note 1).
NOTE 2—The request, tender or contract review should be conducted in
NOTE 1—In this context “document” means any information or instruc-
a practical and efficient manner and the financial, legal and time schedule
tion including policy statements, text books, procedures, specifications,
aspects be taken into account.
calibration tables, charts, software, etc. These may be on various media
NOTE 3—Capability means that the RM producer possesses the neces-
whether hard or electronic and they may be digital, analogue, photo-
sary equipment, intellectual and information resources and that its
graphic or written.
personnel have the skills and expertise necessary for the production of
those RMs in question. The review of the capability may include an
5.3.2 Document Approval and Issue:
assessment of previous RM production and/or the organization of inter-
5.3.2.1 All documents (including documented procedures)
laboratory characterization programs using samples of similar composi-
issued to personnel as part of the quality system shall be
tion to the RMs to be produced.
suitably controlled. This shall include review and approval for
NOTE 4—Acontract may be any
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