ASTM D6808-02(2018)e1

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

• Status: Published
• Publication Date: 31-Jul-2018
• ICS: 71.040.40 - Chemical analysis
• Technical Committee: D19 - Water
• Drafting Committee: D19.02 - Quality Systems, Specification, and Statistics

Relations

• Replaces: ASTM D6808-02(2012) - Standard Practice for Competency Requirements of Reference Material Producers for Water Analysis
• Effective Date: 01-Aug-2018
• Refers: ASTM D1129-13(2020)e2 - Standard Terminology Relating to Water
• Effective Date: 01-May-2020
• Refers: ASTM D6362-98(2018) - Standard Practice for Certificates of Reference Materials for Water Analysis
• Effective Date: 15-Oct-2018
• Refers: ASTM D6362-98(2013) - Standard Practice for Certificates of Reference Materials for Water Analysis
• Effective Date: 01-Jan-2013
• Refers: ASTM D1129-10 - Standard Terminology Relating to Water
• Effective Date: 01-Mar-2010
• Refers: ASTM D6362-98(2008) - Standard Practice for Certificates of Reference Materials for Water Analysis
• Effective Date: 15-Jul-2008
• Refers: ASTM D1129-06ae1 - Standard Terminology Relating to Water
• Effective Date: 01-Sep-2006
• Refers: ASTM D1129-06a - Standard Terminology Relating to Water
• Effective Date: 01-Sep-2006
• Refers: ASTM D1129-06 - Standard Terminology Relating to Water
• Effective Date: 15-Feb-2006
• Refers: ASTM D1129-04e1 - Standard Terminology Relating to Water
• Effective Date: 01-Mar-2004
• Refers: ASTM D1129-04 - Standard Terminology Relating to Water
• Effective Date: 01-Mar-2004
• Refers: ASTM D6362-98(2003) - Standard Practice for Certificates of Reference Materials for Water Analysis
• Effective Date: 10-Aug-2003
• Refers: ASTM D1129-03a - Standard Terminology Relating to Water
• Effective Date: 10-Aug-2003
• Refers: ASTM D1129-03 - Standard Terminology Relating to Water
• Effective Date: 10-Mar-2003
• Refers: ASTM D1129-01 - Standard Terminology Relating to Water
• Effective Date: 10-Jul-2002

Overview

ASTM D6808-02(2018)e1 - Standard Practice for Competency Requirements of Reference Material Producers for Water Analysis defines the essential requirements for organizations that produce reference materials (RMs) used in the analysis of water. Developed by ASTM International, this standard is designed both for RM producers establishing or improving their quality systems, and for users or assessors evaluating the competence and reliability of such producers. The standard emphasizes that RMs must meet accuracy requirements specific to their intended analytical purposes and that producers maintain robust procedures and systems to ensure the consistency, homogeneity, and reliability of their RMs.

Key Topics

• Competency of Reference Material Producers: Outlines how RM producers must demonstrate technical and scientific proficiency, including the ability to assign accurate property values and adhere to recognized protocols such as those detailed in ISO Guide 34.
• Quality System Requirements: Establishes the need for a documented and implemented quality management system that covers all aspects of RM production, from material selection and preparation to homogeneity assessment, stability testing, and traceability to international standards.
• Roles and Responsibilities: Details required qualifications for managerial and technical personnel, mandates clear assignment of responsibilities, and emphasizes impartiality and the avoidance of conflicts of interest.
• Collaborators and Subcontractors: Specifies requirements for oversight and competency of subcontracted collaborators, ensuring their compliance with relevant sections of the practice.
• Document and Information Control: Requires formal procedures for managing all documentation related to production and quality, ensuring control, updates, and secure record-keeping.
• Corrective and Preventive Actions: Mandates the establishment of processes for handling non-conforming RMs, client complaints, and ongoing quality improvements.
• Internal Audits and Management Review: Regular audits and senior management reviews support continued compliance and process optimization.
• Technical Production Controls: Covers areas such as equipment calibration, environmental conditions for storage and transport, labeling, and packaging.

Applications

This standard delivers practical value in several water analysis settings, including:

• Quality Assurance in Laboratories: Water testing laboratories and RM producers can implement ASTM D6808 to structure their quality assurance protocols, ensuring all reference materials produced are consistent, traceable, and fit for intended analytical techniques.
• Accreditation and Assessment: Organizations seeking accreditation or recognition for their RM production processes can use this standard as a benchmark to demonstrate competency to external auditors and customers.
• Regulatory and Compliance Efforts: Regulatory agencies and other oversight bodies may reference this standard when specifying requirements for RMs in water testing to safeguard public health and environmental standards.
• Purchaser Confidence: Laboratories or facilities using RMs can reference ASTM D6808 during procurement to ensure the selected RM producer operates a quality system capable of delivering high-quality reference materials that meet international best practices.
• International Harmonization: By aligning with ISO and related guides, the standard reinforces compatibility and acceptance across international borders, aiding in global water quality initiatives and proficiency testing.

Related Standards

ASTM D6808-02(2018)e1 references or aligns with several key international and ASTM standards, such as:

• ISO Guide 34: General requirements for the competence of reference material producers.
• ISO Guide 35: Certification of reference materials-General and statistical principles.
• ISO Guide 31: Contents of certificates and labels for reference materials.
• ISO Guide 32: Calibration in analytical chemistry and the use of certified reference materials.
• ASTM D6362: Practice for certificates of reference materials for water analysis.
• ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories.
• ISO 10012-1 & ISO 8402: Requirements and vocabulary relating to quality assurance and measurement.
• VIM (International Vocabulary of Metrology): Defining key measurement terms for uniformity.

Conclusion

ASTM D6808-02(2018)e1 is an essential resource for producers and users of reference materials in water analysis, promoting high standards of quality, traceability, and accuracy. By adhering to its guidelines, organizations can facilitate reliable analytical results, ensure customer confidence, and meet international expectations for water quality testing. For entities involved in the production, certification, or use of water reference materials, compliance with this standard is a mark of technical competence and commitment to excellence.

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.
´1
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 [e-mail]. 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
´1
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
´1
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 pro-
(2) The RM producer has the capability (see Note 3) and
cedures to control all documents (both internally generated and
resources to meet the requirements; and
from external sources) and other information that forms part of
(3) 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
external origin such as standards, guides, or test or calibration
those in a tender are resolved to the satisfaction of the RM
methods, or combination thereof, as well as specifications,
producer and the customer or client.
instructions, and manuals related to the RM under production
(see Note 1).
NOTE2—Therequest,tender,orcontractreviewshouldbeconductedin
a practical and efficient manner and the financial, legal, and time schedule
NOTE 1—In this context “document” means any information or instruc-
aspects be taken into account.
tion including policy statements, text books, procedures, specifications,
NOTE 3—Capability means that the RM producer possesses the neces-
calibration tables, charts, software, etc. These may be on various media
sary equipment, intellectual, and information resources and that its
whether hard or electronic and they may be digital, analogue,
personnel have the skills and expertise necessary for the production of
photographic, or written.
those RMs in question. The review of the capability may include an
assessment of previous RM production or the organization of inter-
5.3.2 Document Approval and Issue:
laboratory characterization programs, or both, using samples of similar
5.3.2.1 All documents (including documented procedures)
composition to the RMs to be produced.
issued to personnel as part of the quality system shall be
NOTE 4—Acontract may be any written or verbal agreement to provide
suitably controlled. This shall include review and approval for
a customer or client with RMs from stock or custom-produced respec-
use by authorized personnel prior to issue. A master list or tively.
´1
D6808 − 02 (2018)
5.4.2 Records of such reviews including any changes shall tainedofallcomplaintsandoftheinvestigationsandcorrective
be maintained. Records shall also be maintained of pertinent actions taken by the RM producer.
discussions with a customer relating to the customer’s require-
5.8 Control of Nonconforming (Poor Quality) RMs:
ments or the results of the work during the period of execution
5.8.1 The RM producer shall have a policy and procedures
of the contract or request.
thatshallbeimplementedwhenitestablishesthatanyaspectof
5.4.3 The review shall include any work that has to be
its production activities do not conform with its own specified
sub-contracted by the RM producer.
production procedures (see Note 6).The policy and procedures
5.5 Use of Collaborators:
shall ensure that:
(1) Responsibilities and authorities for the management of
5.5.1 The RM producer shall establish and maintain proce-
dures to ensure that all tasks performed by collaborators non-conforming work are designated;
comply with specifications set by the RM producer for such (2) The actions which must be taken when any non-
tasks. The RM producer shall ensure also that collaborators conforming RMs are identified are defined, together with a
comply with any clauses of this practice relevant to the tasks system which ensures they are implemented;
performed by them for the RM producer. (3) An evaluation of the significance of the non-
conforming work is made;
5.5.2 The RM producer shall select collaborators based on
(4) Work is halted and, if appropriate, certificates withheld
their ability to meet sub-contracted requirements in terms of
as necessary;
both their technical competence and any specific quality
(5) Remedial actions are taken within a defined timeframe;
assurance requirements relevant to their tasks. The technical
(6) Where necessary, the results of non-conforming RMs
requirementstobesatisfiedbycollaboratorsshallbeequivalent
already distributed to customers are recalled; and
to the technical requirements specified in Section 5 of this
(7) The responsibility for authorization of the resumption
practice.
of work is defined.
5.5.3 The RM producer shall maintain a register of all
collaborators used in the production process, and include a
NOTE 6—The identification of non-conforming RMs or problems with
record of any assessments made of their abilities to carry out
the quality system or with certification activities can occur at various
sub-contracted tasks according to the requirements of this places within the quality system such as: customer complaints, quality
control, checking of consumable materials, staff observations or
practice (see Note 5).
supervision, certificate checking, management reviews, and internal or
NOTE 5—The RM producer is always responsible for ensuring that a external audits.
collaborator is competent. The collaborator should be able to demonstrate
5.8.2 Where the evaluation indicates that the supply of
compliance with the requirements of this practice for all sub-contracted
non-conforming RMs could recur or that there is doubt about
work.
the RM producer’s compliance with its own policies and
5.6 Procurement of Services and Supplies:
procedures, the corrective action procedures in 5.9 shall be
5.6.1 The RM producer shall have policies and procedures
promptly followed to identify the causes of the problem and to
for the selection of services and supplies that affect the quality
eliminate them.
of its RMs.
5.9 Corrective Action:
5.6.2 The RM producer shall use only those services and
5.9.1 General:
supplies that are of adequate specification to ensure the quality
of its RMs. 5.9.1.1 The RM producer shall establish a policy and
5.6.3 When no formal approval of the quality of services procedures and shall designate appropriate authorities for
and supplies is available, the RM producer shall have proce- implementing corrective action when non-conforming RMs or
departures from the policies and procedures in the quality
dures to ensure that purchased materials and services comply
with specified requirements and records of actions taken shall system have been identified (see Note 7).
be maintained.
NOTE 7—A problem with the quality system or with technical opera-
5.6.4 The RM producer shall ensure that purchased equip-
tions may be identified through a variety of activities within the quality
ment and consumable materials are not used until they have
system such as control of non-conforming RMs, internal or external
audits, management reviews, feedback from clients, or staff observations.
been inspected, calibrated, or otherwise verified as complying
with standard specifications or requirements defined in speci-
5.9.1.2 Any corrective action taken to eliminate the causes
fications for production, characterization, and certification of
of non-conformances or other departures shall be to a degree
its RMs.
appropriate to the magnitude of the problems and commensu-
5.6.5 The RM producer shall maintain records of the main
rate with the risks encountered.
suppliers and collaborators from whom it obtains supplies
5.9.1.3 The RM producer shall document and implement
required for the production of RMs. These records should
any required changes to the operational procedures resulting
include any quality assurance approval the suppliers or col-
from corrective action investigations as described in this
laborators hold, or both.
section.
5.9.2 Cause Analysis:
5.7 Client Feedback:
5.7.1 The RM producer shall have a policy and procedures 5.9.2.1 Corrective action procedures shall include an inves-
for the resolution of complaints or other feedback received tigation process to determine the causes of the problem (see
from its customers or other parties. Records shall be main- Note 8).
´1
D6808 − 02 (2018)
NOTE 8—This is sometimes the most difficult, but the key part in the
damage,deterioration,orloss(seeNote12).Retentiontimesof
corrective action procedure. Often the root cause is not obvious and thus
records shall be established and recorded.
a careful analysis of all potential causes of the problem is required.
Potential causes could include, inter alia, the nature of the RM and its
NOTE 12—Records may be in the form of any type of media, such as
specification, methods, and procedures used for characterization, staff
hard copy or electronic media.
skills, and training, and the materials and equipment (or its calibration, or
5.11.1.3 All records shall be held secure and, where
both) used in the production processes.
appropriate, in confidence to the client.
5.9.3 Corrective Actions:
5.11.1.4 The RM producer shall have procedures to protect
5.9.3.1 The RM producer shall identify possible causes and
electronically-held data at all times and to prevent unauthor-
potential corrective actions. It shall select the actions most
ized access to, or amendment of, such data.
likely to eliminate the problem and to prevent it recurring.
5.11.2 Records and Reports:
5.9.4 Monitoring of Corrective Actions:
5.11.2.1 The RM producer shall establish and maintain a
5.9.4.1 After having implemented the action plans, the RM
recordsystemtosuititsparticularcircumstancesandtocomply
producer shall monitor the results to ensure that the actions
with any applicable regulations. The RM producer shall
taken have been effective in overcoming the problems origi-
arrange for all individual measurement observations, appropri-
nally identified.
ate calculations and derived data (for example, statistical
5.9.5 Management Review:
treatments and uncertainty budgets), calibration records and
5.9.5.1 The results of corrective action shall be submitted
preparation reports to be retained for a defined period beyond
for management review.
which it is no longer probable that they will be referred to,
5.10 Preventative Action:
taking into account the period for which the RM remains valid.
5.10.1 All operational procedures shall be systematically
5.11.2.2 The results of each calibration or measurement (or
reviewed at regular intervals to identify any potential sources
series of either) carried out by the RM producer and, where
of non-conformances and any opportunities for improvement,
appropriate, its collaborators, shall be reported unambiguously
either technical or with the quality system. Action plans shall
and objectively, in accordance with any instructions in the
be developed, implemented, and monitored, to reduce the
calibration or measurement methods. The results shall nor-
likelihood of occurrence of such non-conformances and to take
mally be reported in a calibration or measurement report and
advantage of the improvement opportunities (see Note 9).
shall include all information necessary for interpretation of the
calibration or measurement results and a summary of the
NOTE 9—Preventative action is a pro-active process to identify im-
method employed (see Note 13).
provement opportunities, rather than a reaction to the identification of
problems or complaints. Total quality management (TQM) tools such as
NOTE 13—This is for internal reports of the RM producer and should
brainstorming, flowcharting, mind-mapping, and parieto charts will assist
not be confused with a certificate of analysis or certification report which
this process.
is supplied with a RM to the customer or client.
5.10.2 After the implementation of the preventative actions,
5.12 Internal Audits:
the RM producer shall monitor the results to establish any
5.12.1 The RM producer shall, periodically and in accor-
reduction in deficiencies or other improvements in this opera-
dance with a predetermined schedule and procedure (see Note
tional area, thereby establishing the effectiveness of the pre-
14), conduct internal audits of its activities to verify that its
ventative action.
operations continue to comply with the requirements of the
5.10.3 The results of preventative actions shall be submitted
quality system and the requirements of this practice. The
for management review.
internal audit program shall address all elements of the quality
5.11 Records:
system, including the technical and production activities lead-
5.11.1 General:
ing to the finished product (RM). It is the responsibility of the
5.11.1.1 The RM producer shall establish and maintain
quality manager to plan and organize audits as required by the
procedures for identification, collection, indexing, access,
schedule and requested by management. Such audits shall be
storage,maintenanceanddisposalofquality(seeNote10),and
carried out by trained and qualified personnel who are, wher-
technical records (see Note 11).
everresourcespermit,independentoftheactivitytobeaudited.
Personnel shall not audit their own activities except where it is
NOTE 10—Quality records are records providing objective evidence of
necessaryanditcanbedemonstratedthataneffectiveaudithas
the extent of the fulfillment of the requirements for quality or the
effectiveness of the operation of the quality system. For example, they
been carried out.
include reports from internal audits and management reviews and correc-
tive and preventative action records.
NOTE 14—The schedule for internal auditing should normally be
NOTE 11—Technical records are accumulations of data and information completed in one year.
which result from carrying out testing and calibration procedures and
5.12.2 When audit findings cast doubt on the effectiveness
which indicate whether specified quality or process parameters are
of the operations or on the correctness or validity of its RMs,
achieved. They include forms, contracts, work sheets, work books, check
sheets, control charts/graphs, calibration reports/certificates, and papers,
the RM producer shall take timely corrective action and shall
reports, and certificates to customers and clients.
notify,inwriting,itscustomerswhoseactivitiesmayhavebeen
adversely affected.
5.11.1.2 All records shall be legible and shall be stored and
retained in such a way that they are readily retrievable, and in 5.12.3 All audit findings and corrective actions that arise
facilities that provide a suitable environment to prevent from them shall be recorded. The RM producer’s management
´1
D6808 − 02 (2018)
shall ensure that these actions are discharged within an complete particular types of material preparation and measure-
appropriate and agreed timescale. ment has been assessed.
5.13 Management Reviews: 6.2 Collaborators:
5.13.1 The RM producer’s senior management shall peri- 6.2.1 Where a RM producer undertakes any part of the
odically (see Note 15) conduct a review of its quality system procedure for the production or characterization of a RM on an
and production processes to ensure their continuing suitability interlaboratory basis, the producer shall be able to demonstrate
and effectiveness and to introduce any necessary changes or that the experience of any collaborators is sufficient, and that
improvements. The review shall take account of reports from theresultsproducedareoftherequiredquality.Inassessingthe
managerial and supervisory personnel, the outcome of recent competence of a collaborator, the RM producer shall require
internal audits, assessments by external bodies, feedback from information on the collaborator’s knowledge of the subject and
customers, including complaints and other relevant factors. detailsofpastexperienceinthefield(forexample,validresults
for comparable measurements). In the latter context, the
NOTE 15—A typical period for conducting a management review is
producer may consider distributing materials of a comparable
once every year. Results should feed into the corporate planning program
matrix whose property values are well established and at
and should include the goals, objectives, and action plans for the coming
year.
appropriate concentration levels, ranges, etc., prior to distrib-
uting any candidate RM samples. Evidence of collaborators
5.13.2 Findings from management reviews and the actions
being accredited to ISO/IEC 17025 when testing is carried out,
that arise from them shall be recorded. The management shall
or registered to the ISO 9000 series for other activities, will
ensure that these actions are discharged within an appropriate
generally be appropriate. Evidence of collaborators participat-
and agreed timescale.
ing in a relevant proficiency testing scheme and producing
6. Technical and Production Requirements acceptable results on well-characterized materials of similar or
equivalent nature to that of the RM would also be considered
6.1 Management, Staffıng, and Training:
appropriate. In the limit, the RM producer may have no
6.1.1 The production of RMs should, where possible, only
laboratories facilities, but shall ensure that all scientific work
be undertaken by organizations having experience in the
carried out by collaborators which may contribute to the
productionoftheparticulartypeofRM(orrelatedmaterial),as
assignment of the property values of interest is fit for that
well as having experience in the measurement of the properties
purpose and in compliance with the above requirements.
being determined. The RM producer and any associated
6.2.2 The RM producer shall ensure that all details of the
collaborators shall have managerial staff with the necessary
methodology, results, and all the performance procedures of
authority, resources, and technical competence required to
any collaborators are available, if required, and that a register/
discharge their duties. Measurement of the property of interest
database of all collaborators and their accreditation/quality
shallbecompletedby,orunderthesupervisionofatechnically
system/other forms of competence status is maintained.
competent manager qualified either in terms of suitable aca-
demic qualifications or relevant work experience. The RM
6.3 Production Planning:
producer’s management shall define the minimum levels of 6.3.1 The RM producer shall identify and plan those pro-
qualification and experience necessary for the key posts within cesses which directly affect the quality of RM production and
its body. shall ensure that they are carried out in accordance with
6.1.2 The RM producer shall have sufficient personnel prescribed procedures.
having the necessary education, training, technical knowledge, 6.3.2 Organizational and technical input of the different
and experience for their assigned functions (see Note 16). collaborators involved shall be identified and the necessary
information documented and regularly reviewed (see Note 18).
NOTE 16—For example, a staff member undertaking thermal expansion
A mechanism (for example, a management/technical advisory
measurements should have a degree or appropriate level qualification,
together with adequate experience in the field working with a more senior group) shall be established to make recommendations on how
scientist making measurements at an equivalent level of accuracy.
to plan the production processes.
6.1.3 The RM producer shall also ensure that staff receive
NOTE 18—These could include recommendations for production, set-
additional training, when necessary, to ensure competent per-
ting up a monitoring system (to ensure timeliness and quality for each
formance of measurements, operation of equipment, and any production phase) and having an evaluation procedure to assess the
production processes retrospectively.
other activities which affect quality (see Note 17). Where
possible, objective measures should be used to assess the 6.3.3 In planning the production processes, the RM pro-
attainment of competence during training. ducerwillneedtohaveproceduresandservicefacilities,where
appropriate, for:
NOTE 17—The need to retrain staff periodically should be considered
(1) Material selection (including, where appropriate, sam-
(forexample,theRMproducershouldhaveinplaceapolicyforretraining
pling);
staff when a method or measurement technique is not in regular use). Staff
training and retraining policies should take account of technological
(2) Maintaining suitable environments for all aspects of
change and aim at continuous skill upgrading.
production;
6.1.4 The RM producer shall maintain an up-to-date record (3) Material preparation;
of the training that each staff member has received. These (4) Measuring/testing;
records shall provide evidence that individual staff members (5) Calibration/validation of equipment/measurement
have been adequately trained and that their competence to methods;
´1
D6808 − 02 (2018)
(6) Assessing material homogeneity; 6.6.3 The condition of all stored/stocked items and materi-
(7) Assessing material stability; als shall be assessed at appropriate intervals throughout their
(8) Organizing interlaboratory studies with its collabora- storage life in order to detect possible deterioration.
tors; 6.6.4 The RM producer shall control packing and marking
(9) Assigning property values based on the results of
processes to the extent necessary to ensure conformity with the
measurements; safety and transport requirements (see Notes 20 and 21).
(10) Producing uncertainty budgets and uncertainty inter-
NOTE 20—The proper distribution of samples, for example, can present
vals to the assigned property values;
a severe problem for some types of material which require uninterrupted
(11) Ensuring adequate storage facilities and conditions;
storage in a freezer or which should not be exposed to X-rays, shocks, or
(12) Ensuring adequate packaging facilities; vibrations. Most types of chemical materials would benefit from air-tight
packaging to avoid contamination by atmospheric contaminants (for
(13) Ensuring appropriate transport arrangements; and
example, fuel vapors or engine exhaust gases) which may be encountered
(14) Ensuring an adequate post-distribution service;
during transport.
6.4 Production Control: NOTE 21—The RM producer has a responsibility to ensure that the
integrity of the RM is maintained until the seal has been broken or up to
6.4.1 The RM producer shall identify the verification pro-
the point when presented for analysis. The producer cannot be held
cedures necessary to ensure the quality of each stage of RM
responsible for the material once its seal has been broken. This may
production, and shall assign adequate resources and personnel
require, in some cases, that the RM be packaged in unit quantities
for such activities. These activities should include inspection,
sufficient for a single use.
testing, and monitoring of all stages of production.
6.6.5 TheRMlabelshallbesecurelyattachedtotheproduct
6.5 Environment:
packaging of an individual RM unit, and shall be designed to
6.5.1 The RM producer shall ensure that all laboratory
remain legible and intact within the period of validity of the
accommodation, calibration and measurement arm, material
material (that is, the expiration date). The label shall identify
preparation and packaging areas, energy sources, lighting,
the material, the producer, its batch and catalogue numbers,
temperature, pressure, and ventilation are such as to facilitate
and any other information necessary to enable the material to
proper material preparation and packaging as well as proper
be uniquely distinguished and referenced, where appropriate,
performance of calibration and measurements (see Note 19).
to its statement or certificate.
6.6.6 The RM producer shall make arrangements to ensure
NOTE19—Itisimperativethatallpossibleprecautionsaretakenagainst
the integrity of each RM throughout the entire production
possible contamination of the RM during its production and certification.
All RM production and testing areas, in addition to satisfying require-
process. Where contractually specified, this protection shall be
ments for humidity and temperature, should be protected from vibration,
extended to include delivery to destination.
airborne dust and microbiological contamination, magnetic fields, and
electromagnetic radiation (as appropriate). For example, the packaging of 6.7 Post-Distribution Service:
a cement material will require conditions of low humidity, and the
6.7.1 The RM producer shall establish, document, and
preparation and characterization of a material in which the content of
maintain procedures for ensuring that corrective action is
traces of lead is to be measured will require clean-room conditions to
undertaken whenever a product is found not to conform to the
prevent contamination from airborne lead particulates due to car emis-
specified requirements.Any resultant changes (for example, in
sions. Clean-room conditions may also be required for other types of trace
analysis.
procedures or data) should be recorded, and all purchasers of
the RM notified if there is a change to its assigned property
6.5.2 The RM producer shall also ensure that all environ-
values (for example, as a result of additional measurement
mental requirements are also met by any collaborator involved
studies) within the period of the validity of the material.
in any production process.
6.7.2 The RM producer should also provide an advisory
6.5.3 Where appropriate to do so, the environment in which
service to offer guidance (including a complaints procedure)
these activities are undertaken shall be monitored with appro-
and technical services to users. Where the goods are subject to
priately calibrated equipment, controlled and recorded, such
resale through a distributor, the RM producer should make
that results and processes are not adversely affected.
arrangements with the distributor to keep records of purchasers
6.5.4 Appropriate health, safety, and environmental protec-
of the RMs.
tion precautions shall also be implemented where necessary
(for example, when handling pesticides or serum).
6.8 Material Preparation:
6.6 Material Handling and Storage: 6.8.1 The RM producer shall establish whether the item or
6.6.1 In order to avoid any contamination, the RM producer material has received adequate preparation for its intended use.
shall identify, preserve, and segregate (that is, from other Procedures for material preparation should include, where
chemicals and samples) all candidate materials and RMs from appropriate:
the time of preparation through to their distribution to users. (1) Qualitative analysis for verification of material type;
6.6.2 The RM producer shall ensure adequate packaging of (2) Machining, grinding, blending, sieving, and riffling
all RMs (for example, where appropriate, use air-free, (that is, dividing into representative samples);
moisture-free or inert gas packaging) and provide secure (3) Determination of particle size distribution;
storage areas/stock rooms which prevent damage or deteriora- (4) Cleaning of sample containers;
tion of any item or material between characterization and (5) Drying (including lyophilisation) and sterilization;
distribution. Appropriate methods for authorizing dispatch to, (6) Packaging (for example, bottling, etc.) representative
and receipt from, such areas should be stipulated. samples from the batch;
´1
D6808 − 02 (2018)
(7) Homogeneity testing; and supplied by the RM producer. It is encouraged that this
(8) Stability testing over a range of conditions which may documentation also state the minimum sample size for use.
affectthepropertyvaluesormatrixcomposition,orboth,ofthe
6.9.3 Where appropriate, an assessment of the stability of
RMsbeingproduced(forexample,differentlevelsofhumidity, the assigned property values of the RM performed at periodic
temperature, light. magnetic fields, etc.).
intervals after characterization to confirm that all values are
maintained from production until its expiry date (see Note 26).
6.8.2 The RM producer shall be able to demonstrate that the
Wherever appropriate, the RM producer shall provide an
candidate RM is sufficiently homogeneous, that is, the
expiry date for the usable life of the RMs produced, based on
difference, if any, between units must be smaller than the
initial and on-going stability studies in compliance with ISO
uncertainty limits stated in the certificate (see Note 22).
Guide 35. It is encouraged that it be made clear on the
NOTE 22—A relatively inhomogeneous material may be the best
certificate of analysis on what criteria the expiry date is based
available, and may therefore still be useful as a RM provided the
(for example, the date of certification, the date of shipment or
uncertainties of the assigned property values take due account of this.
the date of opening the packaging).
6.9 Assessment of Homogeneity and Stability:
NOTE 26—Some certificates may have more than one expiry date. For
6.9.1 Whereappropriate,theRMproducershallcarryoutan
example,adatefromcertification,oradatefromopeningthecontainerby
assessment of the homogeneity of any candidate RM by
the user.
analyzing a representative number of randomly, systematically,
6.9.4 The RM producer shall provide details of the homo-
or stratified randomly chosen units appropriate to the size of
geneity and stability studies carried out in accordance with the
the lot being produced (see Note 23). This should be done by
requirements of ISO Guide 35 and Practice D6362.
means of a measurement method, the repeatability of which is
fit for the purpose required (that is, good enough to not
6.10 Measurement Methods:
contribute significantly to the combined uncertainty). The
6.10.1 The RM producer and its collaborators shall use
assessment procedure shall be documented and conducted in
appropriate documented methods or procedures, which include
accordance with acceptable statistical procedures.
protocols defining approaches to be adopted for different
analyses, calibrations, measurements, and related activities
NOTE 23—For RMs that are expected to be homogeneous on physical
within their responsibility (inclu
...