ASTM D6808-02(2012)
(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
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.
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.
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 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 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.
General Information
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: D6808 − 02 (Reapproved 2012)
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.
1. Scope ISO/IEC Guide 2:1996 Standardization and Related
Activities—General Vocabulary
1.1 This practice establishes the general requirements with
ISO Guide 30:1992 Terms and Definitions used in Connec-
which a reference materials (RM) producer has to demonstrate
tion with Reference Materials
that it operates, if it is to be recognized as competent to
ISO Guide 31:2000 Contents of Certificates and Labels of
produce RMs used for water analysis.
Reference Materials
1.2 This practice establishes the quality system require-
ISO/IEC Guide 32:1997 Calibration inAnalytical Chemistry
ments in accordance with which waters RMs shall be pro-
and Use of Certified Reference Materials
duced. It is intended to be used as part of a RM producer’s
ISO Guide 34:2000 General Requirements for the Compe-
general QAprocedures. RM producers shall define their scope
tency of Reference Material Producers
in terms of the application, the measurement methods used in
ISO Guide 35:1989 Certification of Reference Materials—
the homogeneity, stability and characterization studies.
General and Statistical Principles
1.3 This standard does not purport to address all of the
ISO 3534 Series: 1993 Statistics—Vocabulary and Symbols
safety concerns, if any, associated with its use. It is the VIM: 1993 International Vocabulary of Basic and General
responsibility of the user of this standard to establish appro-
Terms in Metrology (issued by ISO, IEC, BIPM, IFCC,
priate safety and health practices and determine the applica- IUPAC, IUPAP and OIML)
bility of regulatory limitations prior to use.
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:
3. Terminology
D1129 Terminology Relating to Water
D6362 Practice for Certificates of Reference Materials for
3.1 Definitions:
Water Analysis
3.1.1 For the purposes of this practice, the definitions given
2.2 ISO Documents: inTerminologyD1129,ISO/IECGuide2,ISO/IEC17025,ISO
Guide 30, ISO 8402, ISO 3534, VIM and the following
ISO/IEC 17025:1999 General Requirements for the Compe-
tence of Calibration and Testing Laboratories definitions apply.
3.1.2 collaborator—technically competent body (organiza-
ISO 8402:1994 Quality Management and Quality
Assurance—Vocabulary tion or firm, public or private) that undertakes aspects of the
manufacture, or characterization, of the (certified) RM on
ISO 10012-1:1992 Quality Assurance Requirements for
Measuring Equipment—Part 1: Metrological Confirma- behalf of the RM producer, either on a contractual (as a
sub-contractor) or voluntary basis.
tion Systems for Measuring Equipment
3.1.3 reference material producer—technically competent
body (organization or firm, public or private) that is fully
This practice is under the jurisdiction of ASTM Committee D19 on Water and
responsible for assigning the certified or other property values
is the direct responsibility of Subcommittee D19.02 on Quality Systems,
of the RMs it produces and supplies, which have been
Specification, and Statistics.
produced in accordance with ISO Guide 35, Practice D6362,
Current edition approved June 15, 2012. Published June 2012. Originally
approved in 2002. Last previous edition approved in 2007 as D6808 – 02 (2007).
and ISO Guide 31.
DOI: 10.1520/D6808-02R12.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4. Significance and Use
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
4.1 This practice is for the use by RM producers in the
the ASTM website.
development and implementation of their quality system and
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org. by those concerned with assessing the competence of RM
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D6808 − 02 (2012)
producers. It should be recognized that a RM needs to be produced. Documentation used in this quality system shall be
characterized mainly to the level of accuracy required for its communicatedto,understoodby,availabletoandimplemented
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
candidate RMs;
4.2 This practice is for the use of RM users in the estab-
(b) Preparation procedures;
lishment if a RM producer has a quality system adequate to
(c) Achievement of the required degree of homogeneity of
producehighqualityRMs.Itcanbeusedbyuserstodetermine
the RM;
if the scientific and technical competence of a RMs producer is
(d) 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
(e) Procedures for undertaking characterization;
in ISO Guide 34.
(f) 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
(g) 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.
(h) Arrangements for ensuring adequate storage facilities;
(i) 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
(j) CompliancewithISOGuides30,34and35andPractice
maintain a quality system appropriate to the scope of its
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
5.2.2 The RM producer shall be organized and shall operate
measurement in this context. The policy shall include a
in such a way that it meets all the applicable requirements of
commitment to interact with the appropriate sectors of the
this practice whether carrying out work in its permanent
measurement community in order to prevent working in
facilities or at sites (including associated temporary or mobile
isolation. The policy shall also include a commitment to
facilities) away from its permanent facilities (including work
produce RMs which conform to the definitions given in ISO
undertaken by collaborators).
Guide 30, characterized according to the requirements of ISO
Guide 35 and whose property values are assessed using 5.2.3 The RM producer shall:
accepted statistical techniques. The policy shall, where (a) Have managerial personnel supported by technical
appropriate, include a commitment to comply with Practice personnel with the authority and resources needed to discharge
D6362 for the contents of RM certificates and supply of their duties and to identify the occurrence of departures from
associated information for users. It is important that the policy the quality system or the procedures for the production of RMs
also specifies the intended use of the RMs in order to ensure and to initiate actions to prevent or minimize such departures.
that the RM producer fully advises the user which types of (b) Have arrangements to ensure that its management and
application the materials may be used. personnel are free from any commercial, financial and other
5.1.3 Quality System: internal and external pressures that may adversely affect the
5.1.3.1 The RM producer shall establish, implement and quality of their work;
maintain a documented quality system appropriate to the type, (c) Have policies and procedures to ensure the protection
range and volume of RM production it undertakes. The RM of its client’s confidential information and proprietary rights;
producer shall document all of its policies, systems, programs, (d) Have policies and procedures to avoid involvement in
procedures, instructions, findings, etc., to the extent necessary activities that might diminish confidence in its competence,
to enable the producer to assure the quality of the RMs impartiality, judgement or operational integrity;
D6808 − 02 (2012)
(e) Define, with the aid of organizational charts, the orga- 5.3.3 Document Changes:
nization and management structure of the RM producer, its
5.3.3.1 Changes to documents (including documented pro-
place in any parent organization, and the relations between
cedures) shall be reviewed and approved by designated per-
management, technical operations, support services, collabora-
sonnel performing the same function as that conducted for the
tors and the quality management system;
original review and approval unless specifically decided oth-
(f) Specify the responsibility, authority and inter-
erwise.The designated personnel shall have access to pertinent
relationships of all personnel who manage, perform or verify
background information to base their review and approval.
work affecting the quality of production of RMs;
5.3.3.2 Where practicable, the nature of the change shall be
(g) Have technical management, which has overall respon-
identified in the document with appropriate attachments.
sibility for the technical operations and the provision of the
5.3.3.3 If the RM producer’s documentation control system
resources needed to ensure the required quality of each
allows for the amendment of documents by hand, pending the
operation which forms part of the RM production;
re-issue of the documents, the procedures and authorities for
(h) Appointamemberofstaffasqualitymanager(however
such amendments shall be defined and shall ensure that
named) who, irrespective of other duties and responsibilities,
amendments are initialed and dated. Documents amended by
shallhavedefinedresponsibilityandauthorityforensuringthat
hand shall be marked, signed and dated and shall be formally
therequirementsofthispracticeareimplementedandfollowed
re-issued as soon as practicable.
at all times.The quality manager shall have direct access to the
5.3.3.4 Procedures shall be established to describe how
highest level of management at which decisions are taken on
changes in documents maintained in computerized systems are
production policy or resources; and
made.
(i) Where appropriate, appoint deputies for key managerial
5.4 Request, Tender and Contract Reviews:
personnel such as the technical and quality managers.
5.4.1 When relevant, each request, tender or contract (see
5.3 Document and Information Control:
Note 2) concerning the production of a RM shall be reviewed
5.3.1 General:
by the RM producer to ensure that:
5.3.1.1 The RM producer shall establish and maintain pro-
(a) The requirements are adequately defined, documented
cedures to control all documents (both internally generated and
and understood;
from external sources) and other information that forms part of
(b) The RM producer has the capability (see Note 3) and
its quality documentation. These may include documents of
resources to meet the requirements;
externaloriginsuchasstandards,guides,testand/orcalibration
(c) In the case of external contracts (see Note 4) any
methods as well as specifications, instructions and manuals
differences between the contract or order requirements and
related to the RM under production (see Note 1).
those in a tender are resolved to the satisfaction of the RM
NOTE 1—In this context “document” means any information or instruc-
producer and the customer or client.
tion including policy statements, text books, procedures, specifications,
calibration tables, charts, software, etc. These may be on various media
NOTE 2—The request, tender or contract review should be conducted in
whether hard or electronic and they may be digital, analogue, photo-
a practical and efficient manner and the financial, legal and time schedule
graphic or written.
aspects be taken into account.
NOTE 3—Capability means that the RM producer possesses the neces-
5.3.2 Document Approval and Issue:
sary equipment, intellectual and information resources and that its
5.3.2.1 All documents (including documented procedures)
personnel have the skills and expertise necessary for the production of
issued to personnel as part of the quality system shall be
those RMs in question. The review of the capability may include an
suitably controlled. This shal
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