ASTM D6808-2002(2012) 0625 Standard Practice for Competency Requirements of Reference Material Producers for Water Analysis《水分析参考材料生产者合格性要求的标准实施规程》.pdf

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1、Designation: D6808 02 (Reapproved 2012)Standard 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.1. Scope1.1 This practice establishes the general requirements withwhich a reference materials (RM) producer

3、 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 is intended to be used as part of a RM producersgeneral QA proce

4、dures. RM producers shall define their scopein terms of the application, the measurement methods used inthe homogeneity, stability and characterization studies.1.3 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the use

5、r of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D1129 Terminology Relating to WaterD6362 Practice for Certificates of Reference Materials forWater Analysis2.2 I

6、SO Documents:3ISO/IEC 17025:1999 General Requirements for the Com-petence 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 Measuri

7、ng EquipmentISO/IEC Guide 2:1996 Standardization and 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 in Analytical Chemi

8、s-try and Use of Certified Reference MaterialsISO Guide 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 Internationa

9、l Vocabulary of Basic and GeneralTerms in Metrology (issued 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 For the purposes of this practice, the definitions given

10、inTerminology D1129, ISO/IEC Guide 2, ISO/IEC 17025, ISOGuide 30, ISO 8402, ISO 3534, VIM and the followingdefinitions apply.3.1.1 collaboratortechnically competent body (organiza-tion or firm, public or private) that undertakes aspects of themanufacture, or characterization, of the (certified) RM o

11、nbehalf of the RM producer, either on a contractual (as asub-contractor) or voluntary basis.3.1.2 reference material producertechnically competentbody (organization or firm, public or private) that is fullyresponsible for assigning the certified or other property valuesof the RMs it produces and sup

12、plies, which have beenproduced 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

13、should be recognized that a RM needs to be1This practice is under the jurisdiction of ASTM Committee D19 on Water andis the direct responsibility of Subcommittee D19.02 on Quality Systems, Specifi-cation, and Statistics.Current edition approved June 15, 2012. Published June 2012. Originallyapproved

14、in 2002. Last previous edition approved in 2007 as D6808 02(2007).DOI: 10.1520/D6808-02R12.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Su

15、mmary 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.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.characterized mainly to the

16、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 RM users in the estab-lishment if a RM pro

17、ducer 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 producers establishedin ISO Guide 34.4.3 T

18、his 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 Guide 32, and ISO Guide 35.5. Organization a

19、nd 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.5.1.2 Quality Policy:5.1.2.1 The RM producer sha

20、ll 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 measurementmethod validation), assignment of pro

21、perty 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 that are active and competent in the respective f

22、ield 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 to the definitions given in ISOGuide 30, chara

23、cterized according to the requirements of ISOGuide 35 and whose property values are assessed usingaccepted statistical techniques. The policy shall, where appro-priate, include a commitment to comply with Practice D6362for the contents of RM certificates and supply of associatedinformation for users

24、. It is important that the policy alsospecifies the intended use of the RMs in order to ensure that theRM producer fully advises the user which types of applicationthe materials may be used.5.1.3 Quality System:5.1.3.1 The RM producer shall establish, implement andmaintain a documented quality syste

25、m 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 quality of the RMsproduced. Documentation used in this

26、 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:(a) Arrangements for ensuring the suitable choice (forexample, particle size range, concentration range, et

27、c.) of thecandidate RMs;(b) Preparation procedures;(c) Achievement of the required degree of homogeneity ofthe RM;(d) Assessment of the stability of the RM; includingon-going assessment of stability where necessary;(e) Procedures for undertaking characterization;(f) Practical realization of traceabi

28、lity to national or inter-national standards of measurement;(g) Assignment of property values, including preparationof certificates or statements in accordance with Practice D6362when appropriate;(h) Arrangements for ensuring adequate storage facilities;(i) Arrangements for suitable identification,

29、labeling andpackaging facilities, packing and delivery procedures andcustomer service; and(j) Compliance with ISO Guides 30, 34 and 35 and PracticeD6362.It is encouraged that the documented quality system specifywhich activities are undertaken by the RM producer and, whererelevant, which activities

30、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 define theroles and responsibilities of the technical man

31、ager (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 The RM producer shall be organized and shall operatein

32、 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 mobilefacilities) away from its permanent facilities (including workundertaken by collaborators).5.2.3 The RM producer shall:(

33、a) 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 of RMsand to initiate actions to prevent or minimize such departures.

34、(b) 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;(c) Have policies and procedures to ensure the protection ofits clients confidential information and pr

35、oprietary rights;(d) Have policies and procedures to avoid involvement inactivities that might diminish confidence in its competence,impartiality, judgement or operational integrity;D6808 02 (2012)2(e) Define, with the aid of organizational charts, theorganization and management structure of the RM

36、producer, itsplace in any parent organization, and the relations betweenmanagement, technical operations, support services, collabora-tors and the quality management system;(f) Specify the responsibility, authority and inter-relationships of all personnel who manage, perform or verifywork affecting

37、the quality of production of RMs;(g) 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 production;(h) Appoint a member of staff as quality manag

38、er (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 have direct access to thehighest level of management at whic

39、h decisions are taken onproduction policy or resources; and(i) Where appropriate, appoint deputies for key managerialpersonnel such as the technical and quality managers.5.3 Document and Information Control5.3.1 General:5.3.1.1 The RM producer shall establish and maintain pro-cedures to control all

40、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, test and/or calibrationmethods as well as specifications, instructions and manualsrelated to the

41、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. These may be on various mediawhether hard or electronic and they may be digital, anal

42、ogue, photo-graphic 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 review and approval foruse by authorized personnel prior to issue. A master list o

43、requivalent identifying the current revision status of documentsin the quality system shall be established and be readilyavailable to preclude the use of invalid and/or obsoletedocuments.5.3.2.2 The procedures adopted shall also ensure that:(a) Authorized editions of appropriate documents areavailab

44、le at all locations where operations essential to theeffective production of RMs are performed;(b) Documents are periodically reviewed and, where nec-essary, revised to ensure continuing suitability and compliancewith applicable requirements;(c) Invalid or obsolete documents are promptly removedfrom

45、 all points of issue or use, or otherwise assured againstunintended use; and(d) Obsolete documents retained for legal or informationalpurposes are suitably marked.5.3.3 Document Changes:5.3.3.1 Changes to documents (including documented pro-cedures) shall be reviewed and approved by designated per-s

46、onnel 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 b

47、eidentified 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 the documents, the procedures and authorities forsuch amendments shall be defined and shall ensure thatamendments are

48、 initialed and dated. Documents amended byhand shall be marked, signed and dated and shall be formallyre-issued as soon as practicable.5.3.3.4 Procedures shall be established to describe howchanges in documents maintained in computerized systems aremade.5.4 Request, Tender and Contract Reviews:5.4.1

49、 When relevant, each request, tender or contract (seeNote 2) concerning the production of a RM shall be reviewedby the RM producer to ensure that:(a) The requirements are adequately defined, documentedand understood;(b) The RM producer has the capability (see Note 3) andresources to meet the requirements;(c) In the case of external contracts (see Note 4) anydifferences between the contract or order requirements andthose in a tender are resolved to the satisfaction of the RMproducer and the customer or client.NOTE 2The request, tender or contract review should be conduct