1、Designation: D6808 02 (Reapproved 2018)1Standard Practice forCompetency Requirements of Reference Material Producersfor Water Analysis1This standard is issued under the fixed designation D6808; the number immediately following the designation indicates the year oforiginal adoption or, in the case of
2、 revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTEThe Keywords section was added editorially in August 2018.1. Scope1.1 This practice establishes the ge
3、neral requirements withwhich a reference materials (RM) producer has to demonstratethat it operates, if it is to be recognized as competent toproduce RMs used for water analysis.1.2 This practice establishes the quality system require-ments in accordance with which waters RMs shall be pro-duced. It
4、is intended to be used as part of a RM producersgeneral quality assurance (QA) procedures. RM producersshall define their scope in terms of the application, themeasurement methods used in the homogeneity, stability, andcharacterization studies.1.3 The values stated in SI units are to be regarded ass
5、tandard. No other units of measurement are included in thisstandard.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, health, and environmental practices and
6、 deter-mine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-m
7、endations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D1129 Terminology Relating to WaterD6362 Practice for Certificates of Reference Materials forWater Analysis2.2 ISO Documents:3ISO/IEC 17025:1999 General Requirements
8、 for the Compe-tence of Calibration and Testing LaboratoriesISO 8402:1994 Quality Management and QualityAssuranceVocabularyISO 10012-1:1992 Quality Assurance Requirements forMeasuring EquipmentPart 1: Metrological Confirma-tion Systems for Measuring EquipmentISO/IEC Guide 2:1996 Standardization and
9、RelatedActivitiesGeneral VocabularyISO Guide 30:1992 Terms and Definitions used in Connec-tion with Reference MaterialsISO Guide 31:2000 Contents of Certificates and Labels ofReference MaterialsISO/IEC Guide 32:1997 Calibration inAnalytical Chemistryand Use of Certified Reference MaterialsISO Guide
10、34:2000 General Requirements for the Compe-tency of Reference Material ProducersISO Guide 35:1989 Certification of Reference MaterialsGeneral and Statistical PrinciplesISO 3534 Series: 1993 StatisticsVocabulary and SymbolsVIM: 1993 International Vocabulary of Basic and GeneralTerms in Metrology (iss
11、ued by ISO, IEC, BIPM, IFCC,IUPAC, IUPAP and OIML)ISO Guide to the Expression of Uncertainty in Measure-ment: 1995 (issued by ISO, IEC, BIPM, IFCC, IUPAC,IUPAP and OIML)3. Terminology3.1 Definitions:3.1.1 For the purposes of this practice, the definitions givenin Terminology D1129, ISO/IEC Guide 2,
12、ISO/IEC 17025, ISOGuide 30, ISO 8402, ISO 3534, VIM, and the followingdefinitions apply.1This practice is under the jurisdiction of ASTM Committee D19 on Water andis the direct responsibility of Subcommittee D19.02 on Quality Systems,Specification, and Statistics.Current edition approved Aug. 1, 201
13、8. Published September 2018. Originallyapproved in 2002. Last previous edition approved in 2012 as D6808 02 (2012).DOI: 10.1520/D6808-02R18E01.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards vo
14、lume information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 194
15、28-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Techn
16、ical Barriers to Trade (TBT) Committee.13.2 Definitions of Terms Specific to This Standard:3.2.1 collaborator, ntechnically competent body (organi-zation or firm, public or private) that undertakes aspects of themanufacture, or characterization, of the (certified) RM onbehalf of the RM producer, eit
17、her on a contractual (as asub-contractor) or voluntary basis.3.2.2 reference material producer, ntechnically competentbody (organization or firm, public or private) that is fullyresponsible for assigning the certified or other property valuesof the RMs it produces and supplies, which have beenproduc
18、ed in accordance with ISO Guide 35, Practice D6362,and ISO Guide 31.4. Significance and Use4.1 This practice is for the use by RM producers in thedevelopment and implementation of their quality system andby those concerned with assessing the competence of RMproducers. It should be recognized that a
19、RM needs to becharacterized mainly to the level of accuracy required for itsintended purpose (that is, appropriate measurement uncer-tainty). The RM producer shall describe the procedure forestablishing the quality of materials as a component of thequality system.4.2 This practice is for the use of
20、RM users in the estab-lishment if a RM producer has a quality system adequate toproduce high quality RMs. It can be used by users to determineif the scientific and technical competence of a RMs producer isadequate to ensure the quality of RMs. This practice isconsistent with the requirements for RM
21、producers establishedin ISO Guide 34.4.3 This practice does not specify specific protocols for thecontents of RMs certificates of analysis, for calibration inanalytical chemistry and use of certified RMs and for certifi-cation of RMs. For this information, users are referred toPractice D6362, ISO Gu
22、ide 32, and ISO Guide 35.5. Organization and Management Requirements5.1 Quality System Requirements:5.1.1 The RM producer shall establish, implement, andmaintain a quality system appropriate to the scope of itsactivities including the type, range, and magnitude of the RMproduction it undertakes.5.1.
23、2 Quality Policy:5.1.2.1 The RM producer shall define and document itspolicy, objectives, and commitment to ensuring and maintain-ing the quality of all aspects of RM production, includingmaterial quality (that is, homogeneity and stability), character-ization (that is, equipment calibration and mea
24、surementmethod validation), assignment of property values (that is, useof appropriate statistical procedures), and material handling,storage, and transport procedures.5.1.2.2 The quality policy shall, when appropriate, includeuse of interlaboratory characterization studies employing labo-ratories th
25、at are active and competent in the respective field ofmeasurement in this context. The policy shall include acommitment to interact with the appropriate sectors of themeasurement community in order to prevent working inisolation. The policy shall also include a commitment toproduce RMs which conform
26、 to the definitions given in ISOGuide 30, characterized according to the requirements of ISOGuide 35, and whose property values are assessed usingaccepted statistical techniques. The policy shall, whereappropriate, include a commitment to comply with PracticeD6362 for the contents of RM certificates
27、 and supply ofassociated information for users. It is important that the policyalso specifies the intended use of the RMs in order to ensurethat the RM producer fully advises the user which types ofapplication the materials may be used.5.1.3 Quality System:5.1.3.1 The RM producer shall establish, im
28、plement, andmaintain a documented quality system appropriate to the type,range, and volume of RM production it undertakes. The RMproducer shall document all of its policies, systems, programs,procedures, instructions, findings, etc., to the extent necessaryto enable the producer to assure the qualit
29、y of the RMsproduced. Documentation used in this quality system shall becommunicated to, understood by, available to and implementedby all personnel concerned. In particular, the producer shallhave a quality system that covers the following:(1) Arrangements for ensuring the suitable choice (forexamp
30、le, particle size range, concentration range, etc.) of thecandidate RMs;(2) Preparation procedures;(3) Achievement of the required degree of homogeneity ofthe RM;(4) Assessment of the stability of the RM; includingon-going assessment of stability where necessary;(5) Procedures for undertaking charac
31、terization;(6) Practical realization of traceability to national or inter-national standards of measurement;(7) Assignment of property values, including preparationof certificates or statements in accordance with Practice D6362when appropriate;(8) Arrangements for ensuring adequate storage facilitie
32、s;(9) Arrangements for suitable identification, labeling andpackaging facilities, packing and delivery procedures, andcustomer service; and(10) Compliance with ISO Guides 30, 34, and 35, andPractice D6362.It is encouraged that the documented quality system specifywhich activities are undertaken by t
33、he RM producer and, whererelevant, which activities are undertaken by collaborators andshall include policies and procedures used by the producer toensure that all activities conducted by collaborators complywith the relevant clauses of this practice.5.1.3.2 The documented quality system shall defin
34、e theroles and responsibilities of the technical manager (howevernamed) and quality manager including their responsibilities forensuring compliance with this practice.5.2 Organization and Management:5.2.1 The RM producer, or the organization of which it ispart, shall be legally identifiable.5.2.2 Th
35、e RM producer shall be organized and shall operatein such a way that it meets all the applicable requirements ofthis practice whether carrying out work in its permanentfacilities or at sites (including associated temporary or mobileD6808 02 (2018)12facilities) away from its permanent facilities (inc
36、luding workundertaken by collaborators).5.2.3 The RM producer shall:(1) Have managerial personnel supported by technicalpersonnel with the authority and resources needed to dischargetheir duties and to identify the occurrence of departures fromthe quality system or the procedures for the production
37、of RMsand to initiate actions to prevent or minimize such departures;(2) Have arrangements to ensure that its management andpersonnel are free from any commercial, financial, and otherinternal and external pressures that may adversely affect thequality of their work;(3) Have policies and procedures
38、to ensure the protectionof its clients confidential information and proprietary rights;(4) Have policies and procedures to avoid involvement inactivities that might diminish confidence in its competence,impartiality, judgement, or operational integrity;(5) Define, with the aid of organizational char
39、ts, the orga-nization and management structure of the RM producer, itsplace in any parent organization, and the relations betweenmanagement, technical operations, support services,collaborators, and the quality management system;(6) Specify the responsibility, authority, and inter-relationships of a
40、ll personnel who manage, perform, or verifywork affecting the quality of production of RMs;(7) Have technical management, which has overall respon-sibility for the technical operations and the provision of theresources needed to ensure the required quality of eachoperation which forms part of the RM
41、 production;(8) Appoint a member of staff as quality manager (howevernamed) who, irrespective of other duties and responsibilities,shall have defined responsibility and authority for ensuring thatthe requirements of this practice are implemented and followedat all times. The quality manager shall ha
42、ve direct access to thehighest level of management at which decisions are taken onproduction policy or resources; and(9) Where appropriate, appoint deputies for key managerialpersonnel such as the technical and quality managers.5.3 Document and Information Control:5.3.1 General:5.3.1.1 The RM produc
43、er shall establish and maintain pro-cedures to control all documents (both internally generated andfrom external sources) and other information that forms part ofits quality documentation. These may include documents ofexternal origin such as standards, guides, or test or calibrationmethods, or comb
44、ination thereof, as well as specifications,instructions, and manuals related to the RM under production(see Note 1).NOTE 1In this context “document” means any information or instruc-tion including policy statements, text books, procedures, specifications,calibration tables, charts, software, etc. Th
45、ese may be on various mediawhether hard or electronic and they may be digital, analogue,photographic, or written.5.3.2 Document Approval and Issue:5.3.2.1 All documents (including documented procedures)issued to personnel as part of the quality system shall besuitably controlled. This shall include
46、review and approval foruse by authorized personnel prior to issue. A master list orequivalent identifying the current revision status of documentsin the quality system shall be established and be readilyavailable to preclude the use of invalid or obsolete documents,or both.5.3.2.2 The procedures ado
47、pted shall also ensure that:(1) Authorized editions of appropriate documents are avail-able at all locations where operations essential to the effectiveproduction of RMs are performed;(2) Documents are periodically reviewed and, wherenecessary, revised to ensure continuing suitability and compli-anc
48、e with applicable requirements;(3) Invalid or obsolete documents are promptly removedfrom all points of issue or use, or otherwise assured againstunintended use; and(4) Obsolete documents retained for legal or informationalpurposes are suitably marked.5.3.3 Document Changes:5.3.3.1 Changes to docume
49、nts (including documented pro-cedures) shall be reviewed and approved by designated per-sonnel performing the same function as that conducted for theoriginal review and approval unless specifically decided oth-erwise. The designated personnel shall have access to pertinentbackground information to base their review and approval.5.3.3.2 Where practicable, the nature of the change shall beidentified in the document with appropriate attachments.5.3.3.3 If the RM producers documentation control systemallows for the amendment of documents by hand, pending there-issue of t
