实验室会声会影12序列号

FINALDRAFTINTERNATIONALSTANDARDISO/IECFDIS17025ISO/CASCOSecretariat:ISOVotingbeginon:2017-08-14Votingterminateson:2017-10-09Generalrequirementsforthecompetenceoftestingandcalibrationlaboratories检测和校准实验室能力的通用要求翻译及认可交流联系方式Tel.
:18657856588(微信同号)ReferencenumberISO/IECFDIS17025:2017(E)ThisdraftissubmittedtoaparallelvoteinISOandinIEC.
ISO/CENPARALLELPROCESSINGISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码PageI/ⅡForeword前言ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).
TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.
Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.
Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.
Inthefieldofconformityassessment,ISOandtheInternationalElectrotechnicalCommission(IEC)developjointISO/IECdocumentsunderthemanagementoftheISOCommitteeonConformityassessment(ISO/CASCO).
ISO(国际标准化组织)是一个世界性的国家标准机构联合会(ISO成员机构).
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国际组织、政府和非政府组织以及ISO,也参与了这项工作.
在符合性评估领域,ISO和国际电工委员会(IEC)在符合性评估委员会(ISO/CASCO)的管理下制定了ISO/IEC联合文件.
TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.
InparticularthedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentsshouldbenoted.
ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(seewww.
iso.
org/directives).
在ISO/IEC指示第1部分中描述了用于开发本文件的程序和用于进一步维护的程序.
特别需要注意的是不同类型的ISO文件需要不同的审批标准.
本文件是根据ISO/IEC指令,第2部分(见www.
iso.
org/指令)的编辑规则起草的.
Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.
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iso.
org/patents).
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在本文件的开发过程中所确定的任何专利权的细节,将在所收到的专利声明的ISO列表中介绍(见www.
iso.
org/专利).
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本文件所使用的任何商业名称都是为方便用户而提供的信息,不构成背书.
Foranexplanationonthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO'sadherencetotheWorldTradeOrganization(WTO)principlesintheTechnicalBarrierstoTrade(TBT)seethefollowingURL:www.
iso.
org/iso/foreword.
html.
对于标准的自愿性质说明,ISO特定术语的含义与符合性评估有关的表达,以及ISO在贸易技术壁垒中遵守世界贸易组织(WTO)原则的信息,请参阅以下网址:www.
iso.
org/iso/foreword.
htmlThisdocumentwaspreparedbytheISOCommitteeonConformityAssessment(CASCO)andcirculatedforvotingtothenationalbodiesofbothISOandIEC,andwasapprovedbybothorganizations.
该文件由ISO评定委员会(CASCO)编写,并分发给ISO和IEC的国家机构投票,并得到两个组织的批准.
Themainchangescomparedtothepreviouseditionareasfollows:—therisk-basedthinkingappliedinthiseditionhasenabledsomereductioninprescriptiverequirementsandtheirreplacementbyperformance-basedrequirements;—thereisgreaterflexibilitythaninthepreviouseditionintherequirementsforprocesses,procedures,documentedinformationandorganizationalresponsibilities;—adefinitionof"laboratory"hasbeenadded(see3.
6).
与上一版相比,主要变化如下:——本版所采用的基于风险的思想,使一些规定性的需求减少,并以基于业绩的要求取代它们;——在过程、程序、成文信息和组织责任方面,比以前的版本有更大的灵活性;——增加了"实验室"的定义(见3.
6).
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码PageII/ⅡIntroduction引言Thisdocumenthasbeendevelopedwiththeobjectiveofpromotingconfidenceintheoperationoflaboratories.
Thisdocumentcontainsrequirementsforlaboratoriestoenablethemtodemonstratetheyoperatecompetently,andareabletogeneratevalidresults.
LaboratoriesthatconformtothisdocumentwillalsooperategenerallyinaccordancewiththeprinciplesofISO9001.
制定本标准的目的是增强对实验室运作的信任.
本标准包含了实验室能够证明其运作能力,并且能够产生出有效结果的要求.
符合本标准的实验室通常也是依据ISO9001的原则来运作的.
Thisdocumentrequiresthelaboratorytoplanandimplementactionstoaddressrisksandopportunities.
Addressingbothrisksandopportunitiesestablishesabasisforincreasingtheeffectivenessofthemanagementsystem,achievingimprovedresultsandpreventingnegativeeffects.
Thelaboratoryisresponsiblefordecidingwhichrisksandopportunitiesneedtobeaddressed.
本标准要求实验室计划并采取措施应对风险和机遇.
同时应对风险和机遇是提升管理体系有效性、取得改进效果、以及预防负面效应的基础.
实验室有责任确定要应对哪些风险和机遇.
Theuseofthisdocumentwillfacilitatecooperationbetweenlaboratoriesandotherbodies,andassistintheexchangeofinformationandexperience,andintheharmonizationofstandardsandprocedures.
Theacceptanceofresultsbetweencountriesisfacilitatediflaboratoriesconformtothisdocument.
使用本标准将促进实验室与其他机构的合作,有助于相互间信息和经验的交流,也有助于标准和程序的协调统一.
如果实验室符合本标准,将促进结果的国际互认.
Inthisdocument,thefollowingverbalformsareused:—"shall"indicatesarequirement;—"should"indicatesarecommendation;—"may"indicatesapermission;—"can"indicatesapossibilityoracapability.
FurtherdetailscanbefoundintheISO/IECDirectives,Part2.
在本标准中,使用了以下动词形式:——"应"表示要求;——"应当"表示建议;——"可"表示可以;——"能"表示可能或能力.
ISO/IEC工作导则第2部分中对这些动词做了更详细的说明.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page1/35ISOIEC17025:2017GeneralrequirementsforthecompetenceoftestingandcalibrationlaboratoriesISOIEC17025:2017检测和校准实验室能力的通用要求1SCOPE1范围Thisdocumentspecifiesthegeneralrequirementsforcompetence,impartialityandconsistentoperationoflaboratories.
本标准规定了实验室能力、公正性以及持续运作的通用要求.
Thisdocumentisapplicabletoallorganizationsperforminglaboratoryactivities,regardlessofthenumberofpersonnel本标准适用于所有从事实验室活动的组织,不论其人员数量多少.
Laboratorycustomers,regulatoryauthorities,organizationsandschemesusingpeer-assessment,accreditationbodies,andothersusethisdocumentinconfirmingorrecognizingthecompetenceoflaboratories实验室的客户、法定管理机构、采用同行评审的组织和制度、认可机构及其他机构使用本标准确认或认可实验室能力.
2Normativereferences2规范性引用文件Thefollowingdocumentsarereferredtointhetextinsuchawaythatsomeoralloftheircontentconstitutesrequirementsofthisdocument.
Fordatedreferences,onlytheeditioncitedapplies.
Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.
本标准引用了下列文件,这些文件的部分或全部内容构成了本标准的要求.
对注明日期的参考文件,只采用引用的版本;对没有注明日期的参考文件,采用最新的版本(包括任何的修订).
ISO/IECGuide991),Internationalvocabularyofmetrology—Basicandgeneralconceptsandassociatedterms(VIM)ISO/IEC17000,Conformityassessment—VocabularyandgeneralprinciplesISO/IEC指南99国际计量学词汇—基本和通用概念及相关术语ISO/IEC17000合格评定—词汇和通用原则3Termsanddefinitions3术语和定义Forthepurposesofthisdocument,thetermsanddefinitionsgiveninISO/IECGuide99andISO/IEC17000andthefollowingapply.
ISO/IEC指南99和ISO/IEC17000中界定的以及下述术语和定义适用于本标准.
ISOandIECmaintainterminologicaldatabasesforuseinstandardizationatthefollowingaddresses:—ISOOnlinebrowsingplatform:availableathttps://www.
iso.
org/obp—IECElectropedia:availableathttp://www.
electropedia.
org/ISO和IEC维护的用于标准化的术语数据库地址如下:——ISO在线浏览平台:http://www.
iso.
org/obp——IEC电子开放平台:http://www.
electropedia.
org/3.
1impartiality3.
1公正性presenceofobjectivity客观性的存在.
Note1toentry:Objectivitymeansthatconflictsofinterestdonotexist,orareresolvedsoasnottoadverselyinfluencesubsequentactivitiesofthelaboratory(3.
6).
注1:客观性意味着利益冲突不存在或已解决,不会对实验室(3.
6)的活动产生不利影响.
Note2toentry:Othertermsthatareusefulinconveyingtheelementofimpartialityinclude"independence","freedomfromconflictofinterests","freedomfrombias","lackofprejudice","neutrality","fairness","open-mindedness","even-handedness","detachment","balance".
注2:其他可用于表示公正性的要素的术语有:客观、独立、无利益冲突、没有成见、没有偏见、中立、公平、思想开明、不偏不倚、不受他人影响、平衡.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page2/35[SOURCE:ISO/IEC17021-1:2015,3.
2,modified—Thewords"thecertificationbody"havebeenreplacedby"thelaboratory"inNote1toentry.
][源自:ISO/IEC17021-1:2015,3.
2,修改—在注1中以"实验室"代替"认证机构"]3.
2Complaint3.
2投诉expressionofdissatisfactionbyanypersonororganizationtoalaboratory(3.
6),relatingtotheactivitiesorresultsofthatlaboratory,wherearesponseisexpected任何人员或组织向实验室(3.
6)就其活动或结果表达不满意,并期望得到回复的行为.
[SOURCE:ISO/IEC17000:2004,6.
5,modified—Thewords"otherthanappeal"havebeendeleted,andthewords"aconformityassessmentbodyoraccreditationbody,relatingtotheactivitiesofthatbody"havebeenreplacedby"alaboratory,relatingtotheactivitiesorresultsofthatlaboratory".
][源自:ISO17000:2004,6.
5修改—删除了"除申诉外",以"实验室就其活动或结果"代替"合格评定机构或认可机构就其活动"]3.
3interlaboratorycomparison3.
3实验室间比对organization,performanceandevaluationofmeasurementsortestsonthesameorsimilaritemsbytwoormorelaboratoriesinaccordancewithpredeterminedconditions按照预先规定的条件,由两个或多个实验室对相同或类似的物品进行测量或检测的组织、实施和评价.
[SOURCE:ISO/IEC17043:2010,3.
4][源自:ISO/IEC17043:2010,3.
4]3.
4intralaboratorycomparison3.
4实验室内比对organization,performanceandevaluationofmeasurementsortestsonthesameorsimilaritems,withinthesamelaboratory(3.
6),inaccordancewithpredeterminedconditions按照预先规定的条件,在同一实验室(3.
6)内部对相同或类似的物品进行测量或检测的组织、实施和评价.
3.
5proficiencytesting3.
5能力验证evaluationofparticipantperformanceagainstpre-establishedcriteriabymeansofinterlaboratorycomparisons(3.
3)利用实验室间比对,按照预先制定的准则评价参加者的能力.
[SOURCE:ISO/IEC17043:2010,3.
7,modified—Notestoentryhavebeendeleted.
][源自:ISO/IEC17043:2010,3.
7—修改:删除了注]3.
6Laboratory3.
6实验室bodythatperformsoneormoreofthefollowingactivities:—testing—calibration—sampling,associatedwithsubsequenttestingorcalibration从事下列一个或多个活动的机构——检测——校准——与后续检测或校准相关的抽样Note1toentry:Inthecontextofthisdocument,"laboratoryactivities"refertothethreeabove-mentionedactivities.
注1:在本标准中,"实验室活动"指上述三种活动.
3.
7decisionrule3.
7判定规则rulethatdescribeshowmeasurementuncertaintyisaccountedforwhenstatingconformitywithaspecifiedrequirement当声明符合规定要求时,描述如何考虑测量不确定度的规则.
3.
8Verification3.
8验证provisionofobjectiveevidencethatagivenitemfulfilsspecifiedrequirements提供客观证据证明给定项目满足规定要求.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page3/35EXAMPLE1Confirmationthatagivenreferencematerialasclaimedishomogeneousforthequantityvalueandmeasurementprocedureconcerned,downtoameasurementportionhavingamassof10mg.
EXAMPLE2Confirmationthatperformancepropertiesorlegalrequirementsofameasuringsystemareachieved.
EXAMPLE3Confirmationthatatargetmeasurementuncertaintycanbemet.
例1:证实在测量取样量小至10mg时,对于相关量值和测量程序而言,给定标准物质的均匀性与其声称的一致.
例2:证实已达到测量系统的性能或法定要求.
例3:证实满足目标测量不确定度.
Note1toentry:Whenapplicable,measurementuncertaintyshouldbetakenintoconsideration.
Note2toentry:Theitemmaybe,forexample,aprocess,measurementprocedure,material,compound,ormeasuringsystem.
Note3toentry:Thespecifiedrequirementsmaybe,forexample,thatamanufacturer'sspecificationsaremet.
Note4toentry:Verificationinlegalmetrology,asdefinedinVIML,andinconformityassessmentingeneral,pertainstotheexaminationandmarkingand/orissuingofaverificationcertificateforameasuringsystem.
Note5toentry:Verificationshouldnotbeconfusedwithcalibration.
Noteveryverificationisavalidation(3.
9).
Note6toentry:Inchemistry,verificationoftheidentityoftheentityinvolved,orofactivity,requiresadescriptionofthestructureorpropertiesofthatentityoractivity.
[SOURCE:ISO/IECGuide99:2007,2.
44]注1:适用时,应当考虑测量不确定度.
注2:项目可以是,例如一个过程、测量程序、物质、化合物或测量系统.
注3:规定要求可以是如满足生产商的规定.
注4:法制计量中的验证,如在VIML和通常的合格评定中的定义,是指对测量系统的检查并加标记和/或出具验证证书.
(译者注:在我国的法制计量领域,"verification"翻译为"检定")注5:验证不应当与校准混淆.
不是每个验证都是确认.
注6:在化学中,验证活性或所含实体的特性时,需要描述该实体或活性的结构或特性.
[源自:ISO/IEC指南99:2007,2.
44]3.
9Validation3.
9确认verification(3.
8),wherethespecifiedrequirementsareadequateforanintendeduse对规定要求满足预期用途的验证(3.
8).
EXAMPLEAmeasurementprocedure,ordinarilyusedforthemeasurementofmassconcentrationofnitrogeninwater,maybevalidatedalsoformeasurementofmassconcentrationofnitrogeninhumanserum.
示例:一个通常用于测量水中氮的质量浓度的测量程序,也可被确认为可用于测量人体血清中氮的质量浓度.
[SOURCE:ISO/IECGuide99:2007,2.
45][源自:ISO/IEC指南99:2007,2.
45]4Generalrequirements4通用要求4.
1Impartiality4.
1公正性4.
1.
1Laboratoryactivitiesshallbeundertakenimpartiallyandstructuredandmanagedsoastosafeguardimpartiality.
4.
1.
1实验室活动应公正地实施,并从组织结构和管理上保证公正性.
4.
1.
2Thelaboratorymanagementshallbecommittedtoimpartiality.
4.
1.
2实验室管理层做出公正性承诺.
4.
1.
3Thelaboratoryshallberesponsiblefortheimpartialityofitslaboratoryactivitiesandshallnotallowcommercial,financialorotherpressurestocompromiseimpartiality.
4.
1.
3实验室应对其实验室活动的公正性负责,不允许商业、财务或其他方面的压力损害其公正性.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page4/354.
1.
4Thelaboratoryshallidentifyriskstoitsimpartialityonanon-goingbasis.
Thisshallincludethoserisksthatarisefromitsactivities,orfromitsrelationships,orfromtherelationshipsofitspersonnel.
However,suchrelationshipsdonotnecessarilypresentalaboratorywitharisktoimpartiality.
4.
1.
4实验室应持续识别影响公正性的风险.
这些风险来源应来自其活动、实验室的各种关系,或者源于实验室人员的关系.
然而,这些关系并非一定会对实验室的公正性产生风险.
NOTEArelationshipthatthreatenstheimpartialityofthelaboratorycanbebasedonownership,governance,management,personnel,sharedresources,finances,contracts,marketing(includingbranding),andpaymentofasalescommissionorotherinducementforthereferralofnewcustomers,etc.
注:危及实验室公正性的关系可能基于所有权、控制权、管理、人员、共享资源、财务、合同、市场营销(包括品牌)、支付销售佣金或其它引荐新客户的奖酬等.
4.
1.
5Ifarisktoimpartialityisidentified,thelaboratoryshallbeabletodemonstratehowiteliminatesorminimizessuchrisk.
4.
1.
5如果识别出公正性风险,实验室应能够证明如何消除或最大程度减小这种风险.
4.
2Confidentiality4.
2保密性4.
2.
1Thelaboratoryshallberesponsible,throughlegallyenforceablecommitments,forthemanagementofallinformationobtainedorcreatedduringtheperformanceoflaboratoryactivities.
Thelaboratoryshallinformthecustomerinadvance,oftheinformationitintendstoplaceinthepublicdomain.
Exceptforinformationthatthecustomermakespubliclyavailable,orwhenagreedbetweenthelaboratoryandthecustomer(e.
g.
forthepurposeofrespondingtocomplaints),allotherinformationisconsideredproprietaryinformationandshallberegardedasconfidential.
4.
2.
1实验室应通过做出具有法律效力的承诺,对在实验室活动中获得或产生的信息承担管理责任.
实验室应将其准备公开的信息事先通知客户.
除非客户公开的信息,或实验室与客户有约定(例如:为回应投诉的目的),其他所有信息都被视为专利信息,应予保密.
4.
2.
2Whenthelaboratoryisrequiredbylaworauthorizedbycontractualarrangementstoreleaseconfidentialinformation,thecustomerorindividualconcernedshall,unlessprohibitedbylaw,benotifiedoftheinformationprovided.
4.
2.
2实验室依据法律要求或合同授权透露保密信息时,除法律禁止外,所提供的信息应通知到相关客户或个人.
4.
2.
3Informationaboutthecustomerobtainedfromsourcesthanthecustomer(e.
g.
complainant,regulators)shallbeconfidentialbetweenthecustomerandlaboratory.
Theprovider(source)ofthisinformationshallbeconfidentialbetweenthecustomerandlaboratory.
Theprovider(source)ofthisinformationshallbeconfidentialtothelaboratoryandshallnotbesharedwithcustomer,unlessagreedbysource.
4.
2.
3从客户以外渠道(如投诉人、监管机构)获取有关客户的信息,应在客户和实验室间保密.
除非信息的提供方同意,实验室不应告知客户信息的提供方(来源)4.
2.
4Personnel,includinganycommitteemembers,contractors,personnelofexternalbodies,orindividualsactingonthelaboratory'sbehalf,shallkeepconfidentialallinformationobtainedorcreatedduringtheperformanceoflaboratoryactivities.
4.
2.
4人员,包括委员会委员、合同方、外部机构人员、或代表实验室的个人,应对在实施实验室活动过程中所获得或产生的所有信息保密.
5Structuralrequirements5结构要求5.
1Thelaboratoryshallbealegalentity,oradefinedpartofalegalentity,thatislegallyresponsibleforitslaboratoryactivities.
5.
1实验室应为法律实体,或法律实体中被明确界定的一部分,该实体对实验室活动承担法律责任.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page5/35NOTEForthepurposesofthisdocument,agovernmentallaboratoryisdeemedtobealegalentityonthebasisofitsgovernmentalstatus.
注:在本标准中,政府实验室基于其政府地位被视为法律实体.
5.
2Thelaboratoryshallidentifymanagementthathasoverallresponsibilityforthelaboratory.
5.
2实验室应确定对实验室全权负责的管理层.
5.
3Thelaboratoryshalldefineanddocumenttherangeoflaboratoryactivitiesforwhichitconformswiththisdocument.
Thelaboratoryshallonlyclaimconformitywiththisdocumentforthisrangeoflaboratoryactivities,whichexcludesexternallyprovidedlaboratoryactivitiesonanongoingbasis.
5.
3实验室应规定符合本标准的实验室活动范围并制定文件.
实验室声明符合本标准的实验室活动不应包括持续从外部获得的实验室活动.
5.
4Laboratoryactivitiesshallbecarriedoutinsuchawayastomeettherequirementsofthisdocument,thelaboratory'scustomers,regulatoryauthoritiesandorganizationsprovidingrecognition.
Thisshallincludelaboratoryactivitiesperformedinallitspermanentfacilities,atsitesawayfromitspermanentfacilities,inassociatedtemporaryormobilefacilitiesoratacustomer'sfacility.
5.
4实验室应以满足本标准、实验室客户、法定管理机构和提供承认的组织要求的方式开展活动,这包括实验室在固定设施、固定设施以外的地点,或在临时或移动设施、客户的设施中实施的实验室活动.
5.
5Thelaboratoryshall:a)definetheorganizationandmanagementstructureofthelaboratory,itsplaceinanyparentorganization,andtherelationshipsbetweenmanagement,technicaloperationsandsupportservices;b)specifytheresponsibility,authorityandinterrelationshipofallpersonnelwhomanage,performorverifyworkaffectingtheresultsoflaboratoryactivities;c)documentitsprocedurestotheextentnecessarytoensuretheconsistentapplicationofitslaboratoryactivitiesandthevalidityoftheresults.
5.
5实验室应:a)确定实验室的组织和管理结构、其在母体组织中的位置,以及管理、技术运作和支持服务间的关系;b)规定对实验室活动结果有影响的所有管理、操作和验证人员的职责、权力和相互关系;c)将程序制定成文件,形成文件的程度以确保实验室活动应用的一致性和结果有效性为原则.
5.
6Thelaboratoryshallhavepersonnelwho,irrespectiveofotherresponsibilities,havetheauthorityandresourcesneededtocarryouttheirduties,including:a)implementation,maintenanceandimprovementofthemanagementsystem;b)identificationofdeviationsfromthemanagementsystemorfromtheproceduresforperforminglaboratoryactivities;c)initiationofactionstopreventorminimizesuchdeviations;d)reportingtolaboratorymanagementontheperformanceofthemanagementsystemandanyneedforimprovement;e)ensuringtheeffectivenessoflaboratoryactivities.
5.
6实验室应有人员具有履行职责所需的权利和资源(不论其他职责),包括:a)实施、保持和改进管理体系;b)识别与管理体系或实验室活动程序的偏离;c)采取预防或最大程度减少这类偏离的措施;d)向实验室管理层报告管理体系运行状况和改进的需求;e)确保实验室活动的有效性.
5.
7Laboratorymanagementshallensurethat:a)communicationtakesplaceregardingtheeffectivenessofthemanagementsystemandtheimportanceofmeetingcustomers'andotherrequirements;b)theintegrityofthemanagementsystemis5.
7实验室管理层应确保:a)在管理体系有效性、以及满足客户和其他要求的重要性方面进行沟通;b)当策划和实施管理体系的变更时,保持管理体系的完整性.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page6/35maintainedwhenchangestothemanagementsystemareplannedandimplemented.
6Resourcerequirements6资源要求6.
1General6.
1总则Thelaboratoryshallhaveavailablethepersonnel,facilities,equipment,systemsandsupportservicesnecessarytomanageandperformitslaboratoryactivities.
实验室应配备管理和从事实验室活动所需的人员、设施、设备、系统及支持服务.
6.
2Personnel6.
2人员6.
2.
1Allpersonnelofthelaboratory,eitherinternalorexternal,thatcouldinfluencethelaboratoryactivitiesshallactimpartially,becompetentandworkinaccordancewiththelaboratory'smanagementsystem.
6.
2.
1所有可能影响实验室活动的人员,无论是内部人员还是外部人员,应行为公正、有能力、并按照实验室管理体系要求工作.
6.
2.
2Thelaboratoryshalldocumentthecompetencerequirementsforeachfunctioninfluencingtheresultsoflaboratoryactivities,includingrequirementsforeducation,qualification,training,technicalknowledge,skillsandexperience.
6.
2.
2实验室应将影响实验室活动结果的各职能的能力要求制定成文件,包括对教育、资格、培训、技术知识、技能和经验等要求.
6.
2.
3Thelaboratoryshallensurethatthepersonnelhavethecompetencetoperformlaboratoryactivitiesforwhichtheyareresponsibleandtoevaluatethesignificanceofdeviations.
6.
2.
3实验室应确保人员具备其负责的实验室活动的能力,并能够评估偏离的影响程度.
6.
2.
4Themanagementofthelaboratoryshallcommunicatetopersonneltheirduties,responsibilitiesandauthorities.
6.
2.
4实验室管理层应与实验室人员就其职责、责任和权限进行沟通.
6.
2.
5Thelaboratoryshallhaveprocedure(s)andretainrecordsfor:a)determiningthecompetencerequirements;b)selectionofpersonnel;c)trainingofpersonnel;d)supervisionofpersonnel;e)authorizationofpersonnel;f)monitoringofcompetenceofpersonnel.
6.
2.
5实验室应有以下程序并保存记录:a)确定能力要求b)人员选择c)人员培训d)人员监督e)人员授权f)人员能力监控.
6.
2.
6Thelaboratoryshallauthorizepersonneltoperformspecificlaboratoryactivities,includingbutnotlimitedto,thefollowing:a)development,modification,verificationandvalidationofmethods;b)analysisofresults,includingstatementsofconformityoropinionsandinterpretations;c)report,reviewandauthorizationofresults.
6.
2.
6实验室应对从事特定实验室活动的人员授权,包括但不限于下列活动:a)开发、修改、验证和确认方法b)分析结果,包括符合性声明或意见和解释c)报告、审查和批准结果.
6.
3Facilitiesandenvironmentalconditions6.
3设施和环境条件6.
3.
1Thefacilitiesandenvironmentalconditionsshallbesuitableforthelaboratoryactivitiesandshallnotadverselyaffectthevalidityofresults.
6.
3.
1设施和环境条件应适合于实验室活动,不应对结果有效性产生不良影响.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page7/35NOTEInfluencesthatcanadverselyaffectthevalidityofresultscaninclude,butarenotlimitedto,microbialcontamination,dust,electromagneticdisturbances,radiation,humidity,electricalsupply,temperature,soundandvibration.
注:对结果有效性有不良影响的因素包括但不限于:微生物污染、灰尘、电磁干扰、辐射、湿度、供电、温度、声音和振动.
6.
3.
2Therequirementsforfacilitiesandenvironmentalconditionsnecessaryfortheperformanceofthelaboratoryactivitiesshallbedocumented.
6.
3.
2应将从事实验室活动所必需的设施及环境条件的要求制定成文件.
6.
3.
3Thelaboratoryshallmonitor,controlandrecordenvironmentalconditionsinaccordancewithrelevantspecifications,methodsorproceduresorwheretheyinfluencethevalidityoftheresults.
6.
3.
3当相关规范、方法或程序对环境条件有要求时,或环境条件影响结果的有效性时,实验室应监测、控制和记录环境条件.
6.
3.
4Measurestocontrolfacilitiesshallbeimplemented,monitoredandperiodicallyreviewedandshallinclude,butnotbelimitedto:a)accesstoanduseofareasaffectinglaboratoryactivities;b)preventionofcontamination,interferenceoradverseinfluencesonlaboratoryactivities;c)effectiveseparationbetweenareaswithincompatiblelaboratoryactivities.
6.
3.
4应实施、监控并定期评审控制设施的措施,这些措施应包括但不限于:a)进入和使用影响实验室活动的区域;b)预防对实验室活动的污染、干扰或不良影响;c)有效隔离不相容实验室活动的区域.
6.
3.
5Whenthelaboratoryperformslaboratoryactivitiesatsitesorfacilitiesoutsideitspermanentcontrol,itshallensurethattherequirementsrelatedtofacilitiesandenvironmentalconditionsofthisdocumentaremet.
6.
3.
5当实验室在永久控制之外的地点或设施中从事实验室活动时,应确保满足本标准中有关设施及环境条件的要求.
6.
4Equipment6.
4设备6.
4.
1Thelaboratoryshallhaveaccesstoequipmentincluding,butnotlimitedto,measuringinstruments,software,measurementstandards,referencematerials,referencedata,reagents,consumablesorauxiliaryapparatuswhichisrequiredforthecorrectperformanceoflaboratoryactivitiesandwhichcaninfluencetheresult.
6.
4.
1实验室应配置正确开展实验室活动所需的并能影响结果的设备,包括但不限于:测量仪器、软件、测量标准、标准物质、参考数据、试剂、消耗品或辅助装置.
NOTE1Amultitudeofnamesexistforreferencematerialsandcertifiedreferencematerials,includingreferencestandards,calibrationstandards,standardreferencematerialsandqualitycontrolmaterials.
ReferencematerialsfromproducersmeetingtherequirementsofISO17034comewithaproductinformationsheet/certificatethatspecifies,amongstothercharacteristics,homogeneityandstabilityforspecifiedpropertiesand,forcertifiedreferencematerials,specifiedpropertieswithcertifiedvalues,theirassociatedmeasurementuncertaintyandmetrologicaltraceability.
ReferencematerialsshouldbeusedfromproducersthatmeetISO17034.
注1:标准物质和有证标准物质有多种名称,包括标准样品、参考标准、校准标准、标准参考物质和质量控制物质.
满足ISO17034要求的标准物质生产者提供的标准物质会附有产品信息单/证书,除其他特性外至少包含规定特性的均匀性及稳定性,对于有证标准物质,信息中包含规定特性的标准值、相关的测量不确定度和计量溯源性.
(译者注:考虑我国也将标准物质称为标准样品,因此增加"标准样品".
)应当使用满足ISO17034的标准物质生产者提供的标准物质.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page8/35NOTE2ISOGuide33providesguidanceontheselectionanduseofreferencematerials.
ISOGuide80providesguidancetoproduceinhousequalitycontrolmaterials.
注2:ISO指南33给出了标准物质选择和使用的指南.
ISO指南80给出了内部制备质量控制物质的指南.
6.
4.
2Inthosecaseswherethelaboratoryusesequipmentoutsideitspermanentcontrol,itshallensurethattherequirementsforequipmentofthisdocumentaremet.
6.
4.
2实验室使用永久控制以外的设备时,应确保满足本标准对设备的要求.
6.
4.
3Thelaboratoryshallhaveaprocedureforhandling,transport,storage,useandplannedmaintenanceofequipmentinordertoensureproperfunctioningandtopreventcontaminationordeterioration.
6.
4.
3实验室应有处理、运输、储存、使用和按计划维护设备的程序,以确保其功能正常运行并防止污染或性能退化.
6.
4.
4Thelaboratoryshallverifythatequipmentconformstospecifiedrequirementsbeforebeingplacedorreturnedintoservice.
6.
4.
4当设备投入使用或重新投入使用前,实验室应验证其符合规定的要求.
6.
4.
5Theequipmentusedformeasurementshallbecapableofachievingthemeasurementaccuracyormeasurementuncertaintyrequiredtoprovideavalidresult.
6.
4.
5用于测量的设备应能够达到所需的测量准确度或测量不确定度,以提供有效的结果.
6.
4.
6Measuringequipmentshallbecalibratedwhen:—themeasurementaccuracyormeasurementuncertaintyaffectsthevalidityofthereportedresults,or—calibrationoftheequipmentisrequiredtoestablishthemetrologicaltraceabilityofthereportedresult.
NOTETypesofequipmenthavinganeffectonthevalidityofthereportedresultscaninclude:—thoseusedforthedirectmeasurementofthemeasurand,e.
g.
useofabalancetoperformamassmeasurement;—thoseusedtomakecorrectionstothemeasuredvalue,e.
g.
temperaturemeasurements;—thoseusedtoobtainameasurementresultcalculatedfrommultiplequantities.
6.
4.
6在下列情况下,测量设备应进行校准:——当测量准确度或测量不确定度影响报告结果的有效性,或——为建立所报告结果的计量溯源性,要求对设备进行校准.
注:影响报告结果有效性的设备类型可能包括:——用于直接测量被测量的设备,例如,使用天平测量质量;——用于修正测量值的设备,例如温度测量;——用于从多个测量值计算获得测量结果的设备.
6.
4.
7Thelaboratoryshallestablishacalibrationprogramme,whichshallbereviewedandadjustedasnecessaryinordertomaintainconfidenceinthestatusofcalibration.
6.
4.
7实验室应制定校准方案,并进行复审和必要的调整,以保持对校准状态的信心.
6.
4.
8Allequipmentrequiringcalibrationorwhichhasadefinedperiodofvalidityshallbelabelled,codedorotherwiseidentifiedtoallowtheuseroftheequipmenttoreadilyidentifythestatusofcalibrationorperiodofvalidity.
6.
4.
8所有需要校准或具有规定有效期的设备应使用标签,编码或以其他方式标识,方便设备使用人能够迅速识别校准的状态或有效期.
6.
4.
9Equipmentthathasbeensubjectedtooverloadingormishandling,givesquestionableresults,orhasbeenshowntobedefectiveoroutsidespecifiedrequirements,shallbetakenoutofservice.
Itshallbeisolatedtopreventitsuseorclearlylabelledormarkedasbeingoutofserviceuntilithasbeenverifiedtoperformcorrectly.
Thelaboratoryshallexaminetheeffectofthedefectordeviationfromspecifiedrequirementsandshallinitiatethe6.
4.
9如果设备有过载或处置不当、给出可疑结果、或已显示有缺陷或超出规定限度时,应停止使用.
这些设备应予以隔离以防误用,或加贴标签或标记以清晰表明该设备已停用,直至经过验证表明能正常工作.
实验室应核查设备缺陷或偏离规定要求的影响,ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page9/35managementofnonconformingworkprocedure(see7.
10).
并应启动不符合工作管理程序(见7.
10).
6.
4.
10Whenintermediatechecksarenecessarytomaintainconfidenceintheperformanceoftheequipment,thesechecksshallbecarriedoutaccordingtoaprocedure.
6.
4.
10当需要利用期间核查以保持设备性能的信心时,应按程序进行核查.
6.
4.
11Whencalibrationandreferencematerialdataincludereferencevaluesorcorrectionfactors,thelaboratoryshallensurethereferencevaluesandcorrectionfactorsareupdatedandimplemented,asappropriate,tomeetspecifiedrequirements.
6.
4.
11如果校准和标准物质数据中包含参考值或修正因子,实验室应确保该参考值和修正因子得到适当的更新和应用,以满足规定要求.
6.
4.
12Thelaboratoryshalltakepracticablemeasurestopreventunintendedadjustmentsofequipmentfrominvalidatingresults.
6.
4.
12实验室应有切实可行的措施,防止设备被意外调整而导致结果无效.
6.
4.
13Recordsshallberetainedforequipmentwhichcaninfluencelaboratoryactivities.
Therecordsshallincludethefollowing,whereapplicable:a)theidentityofequipment,includingsoftwareandfirmwareversion;b)themanufacturer'sname,typeidentification,andserialnumberorotheruniqueidentification;c)evidenceofverificationthatequipmentconformswithspecifiedrequirements;d)thecurrentlocation;e)calibrationdates,resultsofcalibrations,adjustments,acceptancecriteria,andtheduedateofthenextcalibrationorthecalibrationinterval;f)documentationofreferencematerials,results,acceptancecriteria,relevantdatesandtheperiodofvalidity;g)themaintenanceplanandcarriedouttodate,whererelevantperformanceofequipment;h)detailsofanydamage,malfunction,modificationto,orrepairof,theequipment.
6.
4.
13应保存对实验室活动有影响的设备的记录.
记录应包括以下适用的内容:a)设备的识别,包括软件和硬件版本;b)制造商名称、型号、系列号或其他唯一性标识;c)设备符合规定要求的验证证据;d)当前的位置;e)校准日期、校准结果、设备调整、验收准则以用下次校准的预定日期或校准周期;f)标准物质的文件、结果、验收准则、相关数据和有效期;g)与设备性能相关的维护计划和已进行的维护.
h)设备的损坏、故障、改装或维修的详细信息.
6.
5Metrologicaltraceability6.
5计量溯源性6.
5.
1Thelaboratoryshallestablishandmaintainmetrologicaltraceabilityofitsmeasurementresultsbymeansofadocumentedunbrokenchainofcalibrations,eachcontributingtothemeasurementuncertainty,linkingthemtoanappropriatereference.
6.
5.
1为建立并保持测量结果的计量溯源性,实验室应通过形成文件的不间断的校准链与适当参考标准相链接,其中每次校准对测量不确定度均有贡献.
NOTE1InISO/IECGuide99,metrologicaltraceabilityisdefinedasthe"propertyofameasurementresultwherebytheresultcanberelatedtoareferencethroughadocumentedunbrokenchainofcalibrations,eachcontributingtothemeasurementuncertainty".
NOTE2SeeAnnexAforadditionalinformationonmetrologicaltraceability.
注1:在ISO/IEC指南99中,计量溯源性定义为"测量结果的特性,结果可以通过形成文件的不间断的校准链与参考标准相关连,每次校准均会引入测量不确定度"注2:关于计量溯源性的进一步ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page10/35信息见附录A.
6.
5.
2ThelaboratoryshallensurethatmeasurementresultsaretraceabletotheInternationalSystemofUnits(SI)throughoneofthefollowing:a)calibrationprovidedbyacompetentlaboratory;NOTE1Laboratoriesfulfillingtherequirementsofthisdocumentareconsideredtobecompetent.
b)certifiedvaluesofcertifiedreferencematerialsprovidedbyacompetentproducerwithstatedmetrologicaltraceabilitytotheSI;NOTE2ReferencematerialproducersfulfillingtherequirementsofISO17034areconsideredtobecompetent.
c)directrealizationoftheSIunitsensuredbycomparison,directlyorindirectly,withnationalorinternationalstandards.
NOTE3DetailsofpracticalrealizationofthedefinitionsofsomeimportantunitsaregivenintheSIbrochure.
6.
5.
2实验室应通过以下方式确保测量结果可溯源到国际单位制(SI):a)具备能力的实验室提供的校准;注1:满足本标准要求的实验室可视为是有能力的.
b)具备能力的标准物质生产者提供并声明计量溯源至SI的有证标准物质的标准值;注2:满足ISO17034要求的标准物质生产者被认为是有能力的.
c)SI单位的直接复现,并通过直接或间接与国家或国际标准比对来保证.
注3:SI手册给出了一些重要单位定义的实际复现的详细信息.
6.
5.
3WhenmetrologicaltraceabilitytotheSIunitsisnottechnicallypossible,thelaboratoryshalldemonstratemetrologicaltraceabilitytoanappropriatereference,e.
g.
a)certifiedvaluesofcertifiedreferencematerialsprovidedbyacompetentproducer;b)resultsofreferencemeasurementprocedures,specifiedmethodsorconsensusstandardsthatareclearlydescribedandacceptedasprovidingmeasurementresultsfitfortheirintendeduseandensuredbysuitablecomparison.
6.
5.
3技术上不可能计量溯源到SI单位时,实验室应通过下列方式证明可溯源至适当的参考标准,如:a)具备能力的标准物质生产者提供的有证标准物质的标准值;b)使用参考测量程序、规定方法或描述清晰的协议标准,其测量结果满足预期用途,并通过适当比对予以保证.
6.
6Externallyprovidedproductsandservices6.
6外部提供的产品和服务6.
6.
1Thelaboratoryshallensurethatonlysuitableexternallyprovidedproductsandservicesthataffectlaboratoryactivitiesareused,whensuchproductsandservices:a)areintendedforincorporationintothelaboratory'sownactivities;b)areprovided,inpartorinfull,directlytothecustomerbythelaboratory,asreceivedfromtheexternalprovider;c)areusedtosupporttheoperationoflaboratory.
NOTEProductscaninclude,forexample,measurementstandardsandequipment,auxiliaryequipment,consumablematerialsandreferencematerials.
Servicescaninclude,forexample,calibrationservices,samplingservices,testingservices,facilityandequipmentmaintenanceservices,proficiencytestingservicesandassessmentandauditingservices.
6.
6.
1实验室应确保影响实验室活动的外部产品和服务的适用性,包括:a)将外部提供的产品和服务用于实验室自身的活动;b)将外部提供的部分或全部产品和服务直接提供给客户时;c)用于支持实验室的运作.
注:产品可包括测量标准和设备、辅助设备、消耗材料和标准物质.
服务可包括校准服务、抽样服务、检测服务、设施和设备维护服务,能力验证服务以及评审和审核服务.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page11/356.
6.
2Thelaboratoryshallhaveaprocedureandretainrecordsfor:a)defining,reviewingandapprovingthelaboratory'srequirementsforexternallyprovidedproductsservices;b)definingthecriteriaforevaluation,selection,monitoringofperformanceandre-evaluationoftheexternalproviders;c)ensuringthatexternallyprovidedproductsandservicesconformtothelaboratory'sestablishedrequirements,orwhenapplicable,totherelevantrequirementsofthisdocument,beforetheyareusedordirectlyprovidedtothecustomer;d)takinganyactionsarisingfromevaluations,monitoringofperformanceandre-evaluationsoftheexternalproviders.
6.
6.
2实验室应有以下活动的程序和记录:a)确定、审查和批准实验室对外部产品和服务的要求;b)确定对外部供应商的评价、选择、表现监控和重新评价标准;c)在使用外部提供的产品和服务前,或直接提供给客户之前,应确保符合实验室规定的要求,或适用时,满足本标准的相关要求;d)根据对外部供应商的评价、监控和重新评价结果采取措施.
6.
6.
3Thelaboratoryshallcommunicateitsrequirementstoexternalprovidersfor:a)theproductsandservicestobeprovided;b)theacceptancecriteria;c)competence,includinganyrequiredqualificationofpersonnel;d)activitiesthatthelaboratory,oritscustomer,intendstoperformattheexternalprovider'spremises.
6.
6.
3实验室应与外部供应商沟通以明确以下要求:a)需提供的产品和服务;b)验收准则;c)能力,包括人员所具备的资格;d)实验室或其客户拟在外部供应商的场所进行的活动.
7Processrequirements7过程要求7.
1Reviewofrequests,tendersandcontracts7.
1要求、标书和合同的评审7.
1.
1Thelaboratoryshallhaveaprocedureforthereviewofrequests,tendersandcontracts.
Theprocedureshallensurethat:a)therequirementsareadequatelydefined,documentedandunderstood;b)thelaboratoryhasthecapabilityandresourcestomeetrequirements;c)whereexternalprovidersareused,therequirementsof6.
6areappliedandthelaboratoryadvisesthecustomerofthespecificlaboratoryactivitiestobeperformedbytheexternalproviderandgainsthecustomer'sapproval;NOTE1Itisrecognizedthatexternallyprovidedlaboratoryactivitiescanoccurwhen:—thelaboratoryhastheresourcesandcompetencetoperformtheactivities,however,forunforeseenreasonsisunabletoundertaketheseinpartorfull;—thelaboratorydoesnothavetheresourcesorcompetencetoperformtheactivities.
d)theappropriatemethodsorproceduresareselectedandarecapableofmeetingthecustomers'requirements.
NOTE2Forinternalorroutinecustomers,reviewsofrequests,tendersandcontractscanbeperformedinasimplifiedway.
7.
1.
1实验室应有评审要求、标书和合同的程序.
该程序应确保:a)明确规定要求,形成文件,并被理解;b)实验室有能力和资源满足这些要求;c)当使用外部提供者时,应满足6.
6的要求,实验室应告知客户由外部提供者实施的实验室活动,并获得客户同意;注1:在下列情况下可能使用外部提供的实验室活动:——实验室有开展活动的资源和能力,然而由于不可预见的原因不能承担部分或全部活动;——实验室没有开展活动的资源和能力.
d)选择适当的方法或程序,并能满足客户的要求.
注2:对内部或例行客户,要求、标书和合同的评审可简化进行.
7.
1.
2Thelaboratoryshallinformthecustomerwhenthemethodrequestedbythecustomerisconsideredto7.
1.
2当客户要求的方法不合适或是过时的,实验室应通知客户.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page12/35beinappropriateoroutofdate.
7.
1.
3Whenthecustomerrequestsastatementofconformitytoaspecificationorstandardforthetestorcalibration(e.
g.
pass/fail,in-tolerance/out-of-tolerance)thespecificationorstandard,andthedecisionruleshallbeclearlydefined.
Unlessinherentintherequestedspecificationorstandard,thedecisionruleselectedshallbecommunicatedto,andagreedwith,thecustomer.
7.
1.
3当客户要求针对检测或校准做出与规范或标准符合性的声明(如通过/未通过,在允许限内/超出允许限)时,应明确规定判定规则.
选择的判定规则应与客户沟通并得到同意,除非规范或标准本身已包含判定规则.
NOTEForfurtherguidanceonstatementsofconformity,seeISO/IECGuide98-4.
注:符合性声明的进一步指南见ISO/IEC98-4.
7.
1.
4Anydifferencesbetweentherequestortenderandthecontractshallberesolvedbeforelaboratoryactivitiescommence.
Eachcontractshallbeacceptablebothtothelaboratoryandthecustomer.
Deviationsrequestedbythecustomershallnotimpacttheintegrityofthelaboratoryorthevalidityoftheresults.
7.
1.
4要求或标书与合同之间的任何差异,应在实验室活动开展前解决.
每项合同应被实验室和客户双方接受.
客户要求的偏离不应影响实验室的诚信或结果的有效性.
7.
1.
5Thecustomershallbeinformedofanydeviationfromthecontract.
7.
1.
5与合同的任何偏离应通知客户.
7.
1.
6Ifacontractisamendedafterworkhascommenced,thecontractreviewshallberepeatedandanyamendmentsshallbecommunicatedtoallaffectedpersonnel.
7.
1.
6如果工作开始后修改合同,应重复进行合同评审,并将修改内容通知所有受影响的人员.
7.
1.
7Thelaboratoryshallcooperatewithcustomersortheirrepresentativesinclarifyingthecustomer'srequestandinmonitoringthelaboratory'sperformanceinrelationtotheworkperformed.
7.
1.
7在澄清客户要求和允许客户监视其相关工作表现方面,实验室应与客户或其代表合作.
NOTESuchcooperationcaninclude:a)providingreasonableaccesstorelevantareasofthelaboratorytowitnesscustomer-specificlaboratoryactivities;b)preparation,packaging,anddispatchofitemsneededbythecustomerforverificationpurposes.
注:这种合作可包括:a)允许适当进入实验室相关区域,以观察与该客户相关的实验室活动.
b)客户出于验证目的所需的物品的准备、包装和发送.
7.
1.
8Recordsofreviews,includinganysignificantchanges,shallberetained.
Recordsshallalsoberetainedofpertinentdiscussionswithacustomerrelatingtothecustomer'srequirementsortheresultsofthelaboratoryactivities.
7.
1.
8应保存评审记录,包括任何重大的变化.
针对客户要求或实验室活动结果与客户的讨论也应作为记录予以保存.
7.
2Selection,verificationandvalidationofmethods7.
2方法的选择、验证和确认7.
2.
1Selectionandverificationofmethods7.
2.
1方法的选择和验证7.
2.
1.
1Thelaboratoryshalluseappropriatemethodsandproceduresforalllaboratoryactivitiesand,whereappropriate,forevaluationofthemeasurementuncertaintyaswellasstatisticaltechniquesforanalysisofdata.
7.
2.
1.
1实验室应使用适当的方法和程序开展实验室活动和(适当时)评定测量不确定度,以及使用统计技术进行数据分析.
NOTE"Method"asusedinthisdocumentcanbeconsideredsynonymouswiththeterm"measurementprocedure"asdefinedinISO/IECGuide99.
注:本标准所用"方法"可视为是ISO/IEC指南99定义的"测量程序"的同义词.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page13/357.
2.
1.
2Allmethods,proceduresandsupportingdocumentation,suchasinstructions,standards,manualsandreferencedatarelevanttothelaboratoryactivities,shallbekeptuptodateandshallbemadereadilyavailabletopersonnel(see8.
3).
7.
2.
1.
2所有方法、程序和支持文件应保持现行有效并易于人员取阅,例如与实验室活动相关的指导书、标准、手册和参考数据(见8.
3)Thelaboratoryshallensurethatitusesthelatestvalidversionofamethodunlessitisnotappropriateorpossibletodoso.
Whennecessary,theapplicationofthemethodshallbesupplementedwithadditionaldetailstoensureconsistentapplication.
实验室应确保使用最新有效版本的方法,除非不合适或不可能做到.
必要时,应补充方法使用的细节以确保应用的一致性.
NOTEInternational,regionalornationalstandardsorotherrecognizedspecificationsthatcontainsufficientandconciseinformationonhowtoperformlaboratoryactivitiesdonotneedtobesupplementedorrewrittenasinternalproceduresifthesestandardsarewritteninawaythattheycanbeusedbytheoperatingpersonnelinalaboratory.
Itcanbenecessarytoprovideadditionaldocumentationforoptionalstepsinthemethodoradditionaldetails.
注:如果国际的、区域的或国家的标准,或其他公认的规范已包含了如何进行实验室活动的简明和充分信息,并且这些标准是以可被实验室操作人员使用的方式书写时,则不需再进行补充或改写为内部程序.
对方法中的可选择步骤,可能有必要制定附加细则或补充文件.
7.
2.
1.
4Whenthecustomerdoesnotspecifythemethodtobeused,thelaboratoryshallselectanappropriatemethodandinformthecustomerofthemethodchosen.
Methodspublishedeitherininternational,regionalornationalstandards,orbyreputabletechnicalorganizations,orinrelevantscientifictextsorjournals,orasspecifiedbythemanufactureroftheequipment,arerecommended.
Laboratory-developedormodifiedmethodscanalsobeused.
7.
2.
1.
4当客户未指定所用的方法时,实验室应选择适当的方法并通知客户.
推荐使用以国际标准、区域标准或国家标准发布的方法,或由知名技术组织或由有关科技书籍或期刊中公布的方法,或设备制造商规定的方法,也可使用实验室开发或修改的方法.
7.
2.
1.
5Thelaboratoryshallverifythatitcanproperlyperformmethodsbeforeintroducingthembyensuringthatitcanachievetherequiredperformance.
Recordsoftheverificationshallberetained.
Ifthemethodisrevisedbytheissuingbody,verificationshallberepeatedtotheextentnecessary.
7.
2.
1.
5实验室在引入方法前,应验证能够正确运用该方法,以确保能实现所需的方法性能.
应保存验证记录.
如果发布机构修订了方法,应在所需的程度上重新进行验证.
7.
2.
1.
6Whenmethoddevelopmentisrequired,thisshallbeaplannedactivityandshallbeassignedtocompetentpersonnelequippedwithadequateresources.
Asmethoddevelopmentproceeds,periodicreviewshallbecarriedouttoconfirmthattheneedsofcustomerarestillbeingfulfilled.
Anymodificationstothedevelopmentplanshallbeapprovedandauthorized.
当需要制定方法时,应予策划,并指定具有足够资源并有能力的人员进行.
在方法制定的过程中,应进行定期评审,以确认持续满足客户需求.
开发计划的任何变更应得到批准和授权.
7.
2.
1.
7Deviationsfrommethodsforalllaboratoryactivitiesshalloccuronlyifthedeviationhasbeendocumented,technicallyjustified,authorized,andacceptedbythecustomer.
7.
2.
1.
7实验室活动与方法的偏离,应事先将该偏离形成文件、做技术判断、获得授权并被客户接受.
NOTECustomeracceptanceofdeviationscanbeagreedinadvanceinthecontract.
注:客户接受偏离可以事先在合同中约定.
7.
2.
2Validationofmethods7.
2.
2方法确认ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page14/357.
2.
2.
1Thelaboratoryshallvalidatenon-standardmethods,laboratory-developedmethodsandstandardmethodsusedoutsidetheirintendedscopeorotherwisemodified.
Thevalidationshallbeasextensiveasisnecessarytomeettheneedsofthegivenapplicationorfieldofapplication.
7.
2.
2.
1实验室应对非标准方法、实验室制定的方法、超出预定范围使用的标准方法、或其他修改的标准方法进行确认.
确认应尽可能全面,以满足预期用途或应用领域的需要.
NOTE1Validationcanincludeproceduresforsampling,handlingandtransportationoftestorcalibrationitems.
NOTE2Thetechniquesusedformethodvalidationcanbeoneof,oracombinationof,thefollowing:a)calibrationorevaluationofbiasandprecisionusingreferencestandardsorreferencematerials;b)systematicassessmentofthefactorsinfluencingtheresult;c)testingmethodrobustnessthroughvariationofcontrolledparameters,suchasincubatortemperature,volumedispensed;d)comparisonofresultsachievedwithothervalidatedmethods;e)interlaboratorycomparisons;f)evaluationofmeasurementuncertaintyoftheresultsbasedonanunderstandingofthetheoreticalprinciplesofthemethodandpracticalexperienceoftheperformanceofthesamplingortestmethod.
注1:确认可包括对抽样、检测或校准物品的处置和运输程序的确认.
注2:可用以下一种或多种技术进行方法确认:a)使用参考标准或标准物质进行校准或评估偏倚和精密度;b)对影响结果的因素做系统性评审;c)通过改变控制参数检验方法的稳健性,如恒温箱温度、加样体积等;d)与其他已确认的方法进行结果比对;e)实验室间比对;f)根据对方法原理的理解和抽样或检测方法的实践经验评定结果的测量不确定度.
7.
2.
2.
2Whenchangesaremadetoavalidatedmethod,theinfluenceofsuchshallbedeterminedandwheretheyarefoundtoaffecttheoriginalvalidation,anewmethodvalidationshallbeperformed.
7.
2.
2.
2当修改已确认过的方法时,应确定这些修改的影响.
当发现影响原有的确认时,应重新进行方法确认.
7.
2.
2.
3Theperformancecharacteristicsofvalidatedmethodsasassessedfortheintendeduse,shallberelevanttothecustomers'needsandconsistentwithspecifiedrequirements.
7.
2.
2.
3当按使用目的对方法的性能特性进行确认时,应满足客户的需求,并符合规定要求.
NOTEPerformancecharacteristicscaninclude,butarenotlimitedto,themeasurementrange,accuracy,themeasurementuncertaintyoftheresults,limitofdetection,limitofquantification,selectivityofthemethod,linearity,repeatabilityorreproducibility,robustnessagainstexternalinfluencesorcross-sensitivityagainstinterferencefromthematrixofthesampleortestobject,andbias.
注:方法性能特性包括但不限于:测量范围、准确度、结果的测量不确定度、检出限、定量限、方法的选择性、线性、重复性或复现性、抵御外部影响的稳健度或抵御来自样品或测试物基体干扰的交互灵敏度以及偏倚.
7.
2.
2.
4Thelaboratoryshallretainthefollowingrecordsofvalidation:a)thevalidationprocedureused;b)specificationoftherequirements;c)determinationoftheperformancecharacteristicsmethod;d)resultsobtained;e)astatementonthevalidityofthemethod,detailingitsfitnessfortheintendeduse.
7.
2.
2.
4实验室应保存以下确认记录:a)使用的确认程序;b)规定的要求;c)确定的方法性能特性;d)获得的结果;e)方法有效性声明,并详述与预期用途的适宜性.
7.
3Sampling7.
3抽样ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page15/357.
3.
1Thelaboratoryshallhaveasamplingplanandmethodwhenitcarriesoutsamplingofsubstances,materialsorproductsforsubsequenttestingorcalibration.
Thesamplingmethodshalladdressthefactorstobecontrolledtoensurethevalidityofsubsequenttestingorcalibrationresults.
Thesamplingplanandmethodshallbeavailableatthesitewheresamplingisundertaken.
Samplingplansshall,wheneverreasonable,bebasedonappropriatestatisticalmethods.
7.
3.
1当实验室为后续检测或校准而对物质、材料或产品进行抽样时,应有抽样计划和方法.
抽样方法应明确需要控制的因素,以确保随后检测或校准结果有效性.
在抽样的地点应能够得到抽样计划和方法.
只要合理,应根据适当的统计方法制定抽样计划.
7.
3.
2Thesamplingmethodshalldescribe:a)theselectionofsamplesorsites;b)thesamplingplan;c)preparationandtreatmentofsample(s)fromasubstance,materialorproducttoyieldtherequireditemforsubsequenttestingorcalibration.
NOTEWhenreceivedintothelaboratory,furtherhandlingcanberequiredasspecifiedin7.
4.
7.
3.
2抽样方法应描述:a)样品或位置的选择;b)抽样计划;c)从物质、材料或产品中取得样品的制备和处理,以作为随后检测或校准的物品.
注:实验室接收样品后,进一步处理要求见7.
4的规定.
7.
3.
3Thelaboratoryshallretainrecordsofsamplingdatathatformspartofthetestingorcalibrationthatisundertaken.
Theserecordsshallinclude,whererelevant:a)referencetothesamplingmethodused;b)dateandtimeofsampling;c)datatoidentifyanddescribethesample(e.
g.
number,amount,name);d)identificationofthepersonnelperformingsampling;e)identificationoftheequipmentused;f)environmentalortransportconditions;g)diagramsorotherequivalentmeanstoidentifythesamplinglocationwhenappropriate;h)deviations,additionstoorexclusionsfromthesamplingmethodandsamplingplan.
7.
3.
37.
3.
3实验室应将抽样数据作为检测或校准工作的一部分保留记录.
这些记录应包括以下相关信息:a)所用的抽样方法;b)抽样日期及时间;c)识别和描述样品的数据(如编号、数量和名称);d)抽样人识别信息;e)所用设备的识别;f)环境或运输条件;g)适当时,识别抽样位置的图示或其他等效方式;h)与抽样方法和抽样计划的偏离或增减.
7.
4Handlingoftestorcalibrationitems7.
4检测和校准物品的处置7.
4.
1Thelaboratoryshallhaveaprocedureforthetransportation,receipt,handling,protection,storage,retention,anddisposalorreturnoftestorcalibrationitems,includingallprovisionsnecessarytoprotecttheintegrityofthetestorcalibrationitem,andtoprotecttheinterestsofthelaboratoryandthecustomer.
Precautionsshallbetakentoavoiddeterioration,contamination,lossordamagetotheitemduringhandling,transporting,storing/waiting,andpreparationfor,testingorcalibration.
Handlinginstructionsprovidedwiththeitemshallbefollowed.
7.
4.
1实验室应有检测或校准物品的运输、接收、处置、保护、存储、保留、清理或返还的程序,包括为保护检测或校准物品的完整性以及实验室与客户利益所需的所有规定.
在处置、运输、保存/等候、制备、检测或校准过程中,应注意避免物品变质、污染、丢失或损坏.
应遵守随物品提供的操作说明.
7.
4.
2Thelaboratoryshallhaveasystemfortheunambiguousidentificationoftestorcalibrationitems.
Theidentificationshallberetainedwhiletheitemisundertheresponsibilityofthelaboratory.
Thesystemshallensurethatitemswillnotbeconfusedphysicallyorwhenreferredtoin7.
4.
2实验室应有清晰标识检测或校准物品的系统.
实验室应在物品的保管期间保留该标识.
标识系统应确保物品不会在实物上、记录或其他文件中混淆.
适当时,标识系统应包含一个物品或一ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page16/35recordsorotherdocuments.
Thesystemshall,ifappropriate,accommodateasub-divisionofanitemorgroupsofitemsandthetransferofitems.
组物品的细分和物品的传递.
7.
4.
3Uponreceiptofthetestorcalibrationitem,deviationsfromspecifiedconditionsshallberecorded.
Whenthereisdoubtaboutthesuitabilityofanitemfortestorcalibration,orwhenanitemdoesnotconformtothedescriptionprovided,thelaboratoryshallconsultthecustomerforfurtherinstructionsbeforeproceedingandshallrecordtheresultsofthisconsultation.
Whenthecustomerrequirestheitemtobetestedorcalibratedacknowledgingadeviationfromspecifiedconditions,thelaboratoryshallincludeadisclaimerinthereportindicatingwhichresultsmaybeaffectedbythedeviation.
7.
4.
3接收检测或校准物品时,应记录与规定条件的偏离.
当对物品是否适于检测或校准有疑问,或当物品不符合所提供的描述时,实验室应在开始工作之前询问客户,以得到进一步的说明,并记录询问的结果.
当客户知道偏离了规定条件仍要求进行检测或校准时,实验室应在报告中做出免责声明,说明偏离可能影响结果.
7.
4.
4Whenitemsneedtobestoredorconditionedunderspecifiedenvironmentalconditions,theseconditionsshallbemaintained,monitoredandrecorded.
7.
4.
4如物品需要在规定环境条件下储存或调置,应保持、监控和记录这些环境条件.
7.
5Technicalrecords7.
5技术记录7.
5.
1Thelaboratoryshallensurethattechnicalrecordsforeachlaboratoryactivitycontaintheresults,reportandsufficientinformationtofacilitate,ifpossible,identificationoffactorsaffectingthemeasurementresultanditsassociatedmeasurementuncertaintyandenabletherepetitionofthelaboratoryactivityunderconditionsascloseaspossibletotheoriginal.
Thetechnicalrecordsshallincludethedateandtheidentityofpersonnelresponsibleforeachlaboratoryactivityandforcheckingdataandresults.
Originalobservations,dataandcalculationsshallberecordedatthetimetheyaremadeandshallbeidentifiablewiththespecifictask.
7.
5.
1实验室应确保每一项实验室活动的技术记录包含结果、报告和以便在可能时识别影响测量结果及其测量不确定度的因素的充足信息,并确保在尽可能接近原条件的情况下复现该实验室活动.
技术记录应包括每项实验室活动和审查数据结果的日期和负责人.
原始的观察结果、数据和计算应在观察到或获得时予以记录,并应按特定任务予以识别.
7.
5.
2Thelaboratoryshallensurethatamendmentstotechnicalrecordscanbetrackedtopreviousversionsortooriginalobservations.
Boththeoriginalandamendeddataandfilesshallbekept,includingthedateofalteration,anindicationofthealteredaspectsandthepersonnelresponsibleforthealterations.
7.
5.
2实验室应确保技术记录的修改可以追溯到前一个版本或原始观察结果.
应保存原始的以及修改后的数据和文件,包括更改的日期、标识更改的内容和负责更改的人员.
7.
6Evaluationofmeasurementuncertainty7.
6测量不确定度的评定7.
6.
1Laboratoriesshallidentifythecontributionstomeasurementuncertainty.
Whenevaluatingmeasurementuncertainty,allcontributionswhichareofsignificance,includingthosearisingfromsampling,shallbetakenintoaccountusingappropriatemethodsofanalysis.
7.
6.
1实验室应识别测量不确定度的贡献.
评定测量不确定度时,应采用适当的分析方法考虑所有显著贡献,包括来自抽样的贡献.
7.
6.
2Alaboratoryperformingcalibrations,includingofitsownequipment,shallevaluatethemeasurementuncertaintyforallcalibrations.
7.
6.
2开展校准的实验室,包括校准自己的设备,应评定所有校准的测量不确定度.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page17/357.
6.
3Alaboratoryperformingtestingshallevaluatemeasurementuncertainty.
Wherethetestmethodprecludesrigorousevaluationofmeasurementuncertainty,anestimationshallbemadebasedonanunderstandingofthetheoreticalprinciplesorpracticalexperienceoftheperformanceofthemethod.
7.
6.
3开展检测的实验室应评定测量不确定度.
当由于检测方法的原因难以严格评定测量不确定度时,实验室应基于对理论原理的了解或使用该方法的实践经验来进行评估.
NOTE1Inthosecaseswhereawell-recognizedtestmethodspecifieslimitstothevaluesofthemajorsourcesofmeasurementuncertaintyandspecifiestheformofpresentationofthecalculatedresults,thelaboratoryisconsideredtohavesatisfied7.
6.
3byfollowingthetestmethodandreportinginstructions.
NOTE2Foraparticularmethodwherethemeasurementuncertaintyoftheresultshasbeenestablishedandverified,thereisnoneedtoevaluatemeasurementuncertaintyforeachresultifthelaboratorycandemonstratethattheidentifiedcriticalinfluencingfactorsareundercontrol.
NOTE3Forfurtherinformation,seeISO/IECGuide98-3,ISO5725andISO21748.
注1:某些情况下,公认的检测方法对测量不确定度主要来源的值规定了限值,并规定了计算结果的表示方式,实验室只要遵守检测方法和报告说明,即满足7.
6.
3的要求.
注2:对一特定方法,如果已确定并验证了结果的测量不确定度,实验室只要证明已识别的关键影响因素受控,则不需要对每个结果评定测量不确定度.
注3更多信息参见ISO/IEC指南98-3、ISO5725和ISO21748.
7.
7Ensuringthevalidityofresults7.
7确保结果的有效性7.
7.
1Thelaboratoryshallhaveaprocedureformonitoringthevalidityofresults.
Theresultingdatashallberecordedinsuchawaythattrendsaredetectableand,wherepracticable,statisticaltechniquesshallbeappliedtoreviewtheresults.
Thismonitoringshallbeplannedandreviewedandshallinclude,whereappropriate,butnotbelimitedto:a)useofreferencematerialsorqualitycontrolmaterials;b)useofalternativeinstrumentationthathasbeencalibratedtoprovidetraceableresults;c)functionalcheck(s)ofmeasuringandtestingequipment;d)useofcheckorworkingstandardswithcontrolcharts,whereapplicable;e)intermediatechecksonmeasuringequipment;f)replicatetestsorcalibrationsusingthesameordifferentmethods;g)retestingorrecalibrationofretaineditems;h)correlationofresultsfordifferentcharacteristicsofanitem;i)reviewofreportedresults;j)intralaboratorycomparisons;k)testingofblindsample(s).
7.
7.
1实验室应有监控结果有效性的程序.
记录结果数据的方式应便于发现其发展趋势,如可行,应采用统计技术审查结果.
实验室应对监控进行策划和评审,监控应包括但不限于以下适当的方式:a)使用标准物质或质量控制物质;b)使用其他已校准能够提供可溯源结果的仪器;c)测量和检测设备的功能核查;d)适用时,使用核查或工作标准,并制作控制图;e)测量设备的期间核查;f)使用相同或不同方法进行重复检测或校准;g)保存样品的重复检测或重复校准;h)物品不同特性结果之间的相关性;i)审查报告的结果;j)实验室内比对;k)盲样测试.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page18/357.
7.
2Thelaboratoryshallmonitoritsperformancebycomparisonwithresultsofotherlaboratories,whereavailableandappropriate.
Thismonitoringshallbeplannedandreviewedandshallinclude,butnotbelimitedto,eitherorbothofthefollowing:a)participationinproficiencytesting;NOTEISO/IEC17043containsadditionalinformationonproficiencytestsandproficiencytestingproviders.
ProficiencytestingprovidersthatmeettherequirementsofISO/IEC17043areconsideredtobecompetent.
b)participationininterlaboratorycomparisonsotherthanproficiencytesting.
7.
7.
2可行和适当时,实验室应通过与其他实验室的结果比对来监控其表现.
这种监控应进行策划和审查,包括但不限于以下措施:a)参加能力验证;注:ISO/IEC17043包含关于能力验证和能力验证提供者的附加信息.
满足ISO/IEC17043要求的能力测试提供者被认为是有能力的.
b)参加除能力验证之外的实验室间比对.
7.
7.
3Datafrommonitoringactivitiesshallbeanalysed,usedtocontroland,ifapplicable,improvethelaboratory'sactivities.
Iftheresultsoftheanalysisofdatafrommonitoringactivitiesarefoundtobeoutsidepre-definedcriteria,appropriateactionshallbetakentopreventincorrectresultsfrombeingreported.
7.
7.
3应分析监控活动的数据,并用于控制和(如适用)改进实验室活动.
如果发现监控活动数据分析结果超出预定的准则时,应采取适当措施防止报告不正确的结果.
7.
8Reportingofresults7.
8报告结果7.
8.
1General7.
8.
1总则7.
8.
1.
1Theresultsshallbereviewedandauthorizedpriortorelease.
7.
8.
1.
1结果在发出前应经过审查和批准.
Theresultsshallbeprovidedaccurately,clearly,unambiguouslyandobjectively,usuallyinareport(e.
g.
atestreportoracalibrationcertificateorreportofsampling)andshallincludealltheinformationagreedwiththecustomerandnecessaryfortheinterpretationoftheresultsandallinformationrequiredbythemethodused.
Allissuedreportsshallberetainedastechnicalrecords.
实验室通常以报告的形式提供结果(例如检测报告、校准证书或抽样报告),应准确、清晰、明确和客观地出具结果,并且应包括客户同意的、解释结果所必需的以及所用方法要求的全部信息.
所有发出的报告应作为技术记录予以保存.
NOTE1Forthepurposesofthisdocument,testreportsandcalibrationcertificatesaresometimesreferredtoastestcertificatesandcalibrationreports,respectively.
NOTE2Reportscanbeissuedashardcopiesorbyelectronicmeans,providedthattherequirementsofthisdocumentaremet.
注1:在本文中,检测报告和校准证书有时称为检测证书和校准报告.
注2:只要满足本标准的要求,报告可以硬拷贝或电子方式发布.
7.
8.
1.
2Whenagreedwiththecustomer,theresultsmaybereportedinasimplifiedway.
Anyinformationlistedin7.
8.
2to7.
8.
7thatisnotreportedtothecustomershallbereadilyavailable.
7.
8.
1.
2经客户同意,可用简化的方式报告结果.
如果未向客户报告7.
8.
2至7.
8.
6中所列的信息,客户应能方便地获得.
7.
8.
2Commonrequirementsforreports(test,calibrationorsampling)7.
8.
2报告(检测、校准或抽样)的通用要求ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page19/357.
8.
2.
1Eachreportshallincludeatleastthefollowinginformation,unlessthelaboratoryhasvalidreasonsfornotdoingso,therebyminimizinganypossibilityofmisunderstandingormisuse:a)atitle(e.
g.
"TestReport","CalibrationCertificate"or"ReportofSampling");b)thenameandaddressofthelaboratory;c)thelocationofperformanceofthelaboratoryactivities,includingwhenperformedatacustomerfacilityoratsitesawayfromthelaboratory'spermanentfacilities,orinassociatedtemporaryormobilefacilities;d)uniqueidentificationthatallitscomponentsarerecognizedasaportionofacompletereportandaclearidentificationoftheend;e)thenameandcontactinformationofthecustomer;f)identificationofthemethodused;g)adescription,unambiguousidentification,and,whennecessary,theconditionoftheitem;h)thedateofreceiptofthetestorcalibrationitem(s),andthedateofsampling,wherethisiscriticaltothevalidityandapplicationoftheresults;i)thedate(s)ofperformanceofthelaboratoryactivity;j)thedateofissueofthereport;k)referencetothesamplingplanandsamplingmethodusedbythelaboratoryorotherbodieswherethesearerelevanttothevalidityorapplicationoftheresults;l)astatementtotheeffectthattheresultsrelateonlytotheitemstested,calibratedorsampled;m)theresultswith,whereappropriate,theunitsofmeasurement;n)additionsto,deviations,orexclusionsfromthemethod;o)identificationoftheperson(s)authorizingthereport;p)clearidentificationwhenresultsarefromexternalproviders.
7.
8.
2.
1除非实验室有有效的理由,否则每份报告应至少包括下列信息,最大限度地减少误解或误用的可能性:a)标题(例如"检测报告"、"校准证书"或"抽样报告");b)实验室的名称和地址;c)开展实验室活动的地点,包括在客户设施、实验室固定设施以外的地点,或在相关的临时或移动设施内;d)将报告中所有部分标记为整体报告一部分的唯一性标识,以及表明报告结束的清晰标识;e)客户的名称和联络信息;f)所用方法的识别;g)物品的描述、明确的标识以及必要时物品的状态;h)检测或校准的接收日期,以及对结果的有效性和应用至关重要的抽样日期;i)实验室活动的开展日期;j)报告的发布日期;k)如与结果的有效性或应用相关时,实验室或其他机构所用的抽样计划和抽样方法;l)结果仅与被检测、被校准或被抽物品有关的声明;m)结果,适当时,带有测量单位;n)对方法补充、偏离或删减;o)报告批准人的识别;p)当结果来自于外部提供者时,清晰标识Thelaboratoryshouldincludeastatementspecifyingthatthereportshallnotbereproducedexceptinfull,withoutapprovalofthelaboratory.
实验室应当做出未经实验室批准,不得复制报告的声明(全文复制除外).
7.
8.
2.
2Thelaboratoryshallberesponsibleforalltheinformationprovidedinthereport,exceptwheninformationisprovidedbythecustomer.
Dataprovidedbyacustomershallbeclearlyidentified.
Inaddition,adisclaimershallbeputonthereportwhentheinformationissuppliedbythecustomerandcanaffectthevalidityofresults.
Wherethelaboratoryhasnotbeenresponsibleforthesamplingstage(e.
g.
thesamplehasbeenprovidedbythecustomer),itshallstateinthereportthattheresultsapplytothesampleasreceived.
7.
8.
2.
2实验室对报告中的所有信息负责,由客户提供的信息除外.
客户提供的数据应予明确标识.
此外,当客户提供的信息可能影响结果的有效性时,报告中应有免责声明.
当实验室不负责抽样阶段(如样品由客户提供),应在报告中声明结果适用于收到的样品.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page20/357.
8.
3Specificrequirementsfortestreports7.
8.
3检测报告的特定要求7.
8.
3.
1Inadditiontotherequirementslistedin7.
8.
2,testreportsshall,wherenecessaryfortheinterpretationofthetestresults,includethefollowing:a)informationonspecifictestconditions,suchasenvironmentalconditions;b)whererelevant,astatementofconformitywithrequirementsorspecifications(see7.
8.
6);c)whereapplicable,themeasurementuncertaintypresentedinthesameunitasthatofthemeasurandorinatermrelativetothemeasurand(e.
g.
percent)when:—itisrelevanttothevalidityorapplicationofthetestresults;—acustomer'sinstructionsorequires,or—themeasurementuncertaintyaffectsconformitytoaspecificationlimit;d)whereappropriate,opinionsandinterpretations(see7.
8.
7);e)additionalinformationwhichmayberequiredbyspecificmethods,authorities,customersorgroupsofcustomers.
7.
8.
3.
17.
8.
3.
1除7.
8.
2所列要求之外,检测报告还应包含以下解释检测结果所必需的信息:a)特定的检测条件信息,如环境条件;b)相关时,与要求或规范的符合性声明(7.
8.
6);c)适用时,在下列情况下,带有被测量相同单位的测量不确定度或被测量的相对测量不确定度(如百分比):—测量不确定度与检测结果的有效性或应用有关时;—客户有要求时;—测量不确定度影响到与规范限量的符合性时.
d)适当时,意见和解释(见7.
8.
7);e)特定方法、法定管理机构或客户要求的其他信息.
7.
8.
3.
2Wherethelaboratoryisresponsibleforthesamplingactivity,testreportsshallmeettherequirementslistedin7.
8.
5wherenecessaryfortheinterpretationoftestresults.
7.
8.
3.
2当实验室负责抽样活动时,如果解释检测结果需要,检测报告应满足7.
8.
5条款的要求.
7.
8.
4Specificrequirementsforcalibrationcertificates7.
8.
4校准证书的特定要求7.
8.
4.
1Inadditiontotherequirementslistedin7.
8.
2,calibrationcertificatesshallincludethefollowing:a)themeasurementuncertaintyofthemeasurementresultpresentedinthesameunitasthatofthemeasurandorinatermrelativetothemeasurand(e.
g.
percent);NOTEAccordingtoJCGM200:2012,ameasurementresultisgenerallyexpressedasasinglemeasuredquantityvalueincludingunitofmeasurementandameasurementuncertainty.
b)theconditions(e.
g.
environmental)underwhichthecalibrationsweremadethathaveaninfluenceonthemeasurementresults;c)astatementidentifyinghowthemeasurementsaremetrologicallytraceable(seeAnnexA);d)theresultsbeforeandafteranyadjustmentorrepair,ifavailable;e)whererelevant,astatementofconformitywithrequirementsorspecifications(see7.
8.
6);f)whereappropriate,opinionsandinterpretations(see7.
8.
7).
7.
8.
4.
1除7.
8.
2的要求外,校准证书应包含以下信息:a)与被测量相同单位的测量不确定度或被测量的相对形式(如百分比);注:根据JCGM200:2012,测量结果通常表示为一个被测量值,包括测量单位和测量不确定度.
b)校准活动中对测量结果有影响的条件(如环境条件);c)测量如何计量溯源的声明(见附录A);d)如可获得,调整或修理前后的结果;e)相关时,与要求或规范的符合性声明(7.
8.
6);f)适当时,意见和解释(见7.
8.
7).
7.
8.
4.
2Wherethelaboratoryisresponsibleforthesamplingactivity,calibrationcertificatesshallmeettherequirementslistedin7.
8.
5wherenecessaryfortheinterpretationoftestresults.
7.
8.
4.
2当实验室负责抽样活动时,如果解释检测结果需要,校准证书应满足7.
8.
5条款的要求.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page21/357.
8.
4.
3Acalibrationcertificateorcalibrationlabelshallnotcontainanyrecommendationonthecalibrationintervalexceptwherethishasbeenagreedwiththecustomer.
7.
8.
4.
3校准证书或校准标签不应包含对校准周期的建议,除非已与客户达成协议.
7.
8.
5Reportingsampling–specificrequirements7.
8.
5报告抽样——特殊要求Wherethelaboratoryisresponsibleforthesamplingactivity,inadditiontotherequirementslistedin7.
8.
2,reportsshallincludethefollowing,wherenecessaryfortheinterpretationofresults:a)thedateofsampling;b)uniqueidentificationoftheitemormaterialsampled(includingthenameofthemanufacturer,themodelortypeofdesignationandserialnumbersasappropriate);c)thelocationofsampling,includinganydiagrams,sketchesorphotographs;d)areferencetothesamplingplanandsamplingmethod;e)detailsofanyenvironmentalconditionsduringsamplingthataffecttheinterpretationofthetestresults;f)informationrequiredtoevaluatemeasurementuncertaintyforsubsequenttestingorcalibration.
如果实验室负责抽样,除7.
8.
2中的要求外,报告应包括以下解释结果所必需的信息:a)抽样日期;b)抽取的物品或物质的唯一性标识(适当时,包括制造商的名称、标示的型号或类型以及序列号);c)抽样位置,包括图示、草图或照片;d)抽样计划和抽样方法;e)抽样过程中影响测试结果解释的详细环境条件信息;f)评定后续检测或校准的测量不确定度所需的信息.
7.
8.
6Reportingstatementsofconformity7.
8.
6报告符合性声明7.
8.
6.
1Whenastatementofconformitytoaspecificationorstandardisprovided,thelaboratoryshalldocumentthedecisionruleemployed,takingintoaccountthelevelofrisk(suchasfalseacceptandfalserejectandstatisticalassumptions)associatedwiththedecisionruleemployedandapplythedecisionrule.
7.
8.
6.
1当做出与规范或标准符合性声明时,实验室应考虑与所用判定规则相关的风险水平(如错误接受、错误拒绝以及统计假设),将所使用的判定规则制定成文件,并应用判定规则.
NOTEWherethedecisionruleisprescribedbythecustomer,regulationsornormativedocuments,afurtherconsiderationofthelevelofriskisnotnecessary.
注:如果客户、法规或规范性文件规定了判定规则,无需进一步考虑风险等级了.
7.
8.
6.
2Thelaboratoryshallreportonthestatementofconformity,suchthatthestatementclearlyidentifies:a)towhichresultsthestatementofconformityapplies;b)whichspecifications,standardsorpartsthereofaremetornotmet;c)thedecisionruleapplied(unlessitisinherentintherequestedspecificationorstandard).
7.
8.
6.
2实验室在报告符合性声明时应清晰标识:a)符合性声明适用于哪些结果;b)满足或不满足哪个规范、标准或其中的部分;c)使用的判定规则(除非规范或标准中已包含).
NOTEForfurtherinformation,seeISO/IECGuide98-4.
注:进一步信息见ISO/IEC指南98-4.
7.
8.
7Reportingopinionsandinterpretations7.
8.
7报告意见和解释7.
8.
7.
1Whenopinionsandinterpretationsareexpressed,thelaboratoryshallensurethatonlypersonnelauthorizedfortheexpressionofopinionsandinterpretationsreleasestherespectivestatement.
Thelaboratoryshalldocumentthebasisuponwhichtheopinionsandinterpretationshavebeenmade.
7.
8.
7.
1当表述意见和解释时,实验室应确保只有授权人员才能发布意见和解释.
实验室应将意见和解释的依据制定成文件.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page22/35NOTEItisimportanttodistinguishopinionsandinterpretationsfromstatementsofinspectionsandproductcertificationsasintendedinISO/IEC17020andISO/IEC17065,andfromstatementsofconformityasreferredtoin7.
8.
6.
注:应注意区分意见和解释与ISO/IEC17020中的检查声明、ISO/IEC17065中的产品认证声明以及7.
8.
6中符合性声明的差异.
7.
8.
7.
2Theopinionsandinterpretationsexpressedinreportsshallbebasedontheresultsobtainedfromthetestedorcalibrateditemandshallbeclearlyidentifiedassuch.
7.
8.
7.
2报告中的意见和解释应基于被检测或校准物品的结果,并清晰地予以标识.
7.
8.
7.
3Whenopinionsandinterpretationsaredirectlycommunicatedbydialoguewiththecustomer,arecordofthedialogueshallberetained.
7.
8.
7.
3当以对话方式直接与客户沟通意见和解释时,应保留对话记录.
7.
8.
8Amendmentstoreports7.
8.
8修改报告7.
8.
8.
1Whenanissuedreportneedstobechanged,amendedorre-issued,anychangeofinformationshallbeclearlyidentifiedand,whereappropriate,thereasonforthechangeincludedinthereport.
7.
8.
8.
1当更改、修订或重新发布已发布的报告,应在报告中清晰标识修改的信息,适当时标注修改的原因.
7.
8.
8.
2Amendmentstoareportafterissueshallbemadeonlyintheformofafurtherdocument,ordatatransfer,whichincludesthestatement"AmendmenttoReport,serialnumber.
.
.
[orasotherwiseidentified]",oranequivalentformofwording.
Suchamendmentsshallmeetalltherequirementsofthisdocument.
7.
8.
8.
2修改已发布的报告时,应仅以追加文件或数据传输的形式,并包含以下声明:"对序列号为(或其他标识)报告的修改",或其他等效的文字.
修改应满足本标准的所有要求7.
8.
8.
3Whenitisnecessarytoissueacompletenewreport,thisshallbeuniquelyidentifiedandshallcontainareferencetotheoriginalthatitreplaces.
7.
8.
8.
3当有必要发布全新的报告时,应给予唯一性标识,并注明所替代的原报告.
7.
9Complaints7.
9投诉7.
9.
1Thelaboratoryshallhaveadocumentedprocesstoreceive,evaluateandmakedecisionsoncomplaints.
7.
9.
1实验室应有制订成文件的过程来接收和评价投诉,并对投诉做出决定.
7.
9.
2Adescriptionofthehandlingprocessforcomplaintsshallbeavailabletoanyinterestedpartyonrequest.
Uponreceiptofacomplaint,thelaboratoryshallconfirmwhetherthecomplaintrelatestolaboratoryactivitiesthatitisresponsibleforand,ifso,shalldealwithit.
Thelaboratoryshallberesponsibleforalldecisionsatalllevelsofthehandlingprocessforcomplaints.
7.
9.
2利益相关方有要求时,应可获得对投诉处理过程的说明文件.
在接到投诉后,实验室应确认投诉是否与其负责的实验室活动相关,如相关,则应处理.
实验室应对投诉处理过程中的所有决定负责.
7.
9.
3Theprocessforhandlingcomplaintsshallincludeatleastthefollowingelementsandmethods:a)descriptionoftheprocessforreceiving,validating,investigatingthecomplaint,anddecidingwhatactionsaretobetakeninresponsetoit;b)trackingandrecordingcomplaints,includingactionsundertakentoresolvethem;c)ensuringthatanyappropriateactionistaken.
7.
9.
3处理投诉的过程应至少包括以下要素和方法:a)对投诉的接收、确认、调查以及决定采取处理措施过程的说明;b)跟踪并记录投诉,包括为解决投诉所采取的措施;c)确保采取适当的措施.
7.
9.
4Thelaboratoryreceivingthecomplaintshallberesponsibleforgatheringandverifyingallnecessaryinformationtovalidatethecomplaint.
7.
9.
4接到投诉的实验室应负责收集并验证所有必要的信息,以便确认投诉是否有效.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page23/357.
9.
5Wheneverpossible,thelaboratoryshallacknowledgereceiptofthecomplaint,andprovidethecomplainantwithprogressreportsandtheoutcome.
7.
9.
5只要可能,实验室应告知投诉人已收到投诉,并向其提供处理进程的报告和处理结果.
7.
9.
6Theoutcomestobecommunicatedtothecomplainantshallbemadeby,orreviewedandapprovedby,individual(s)notinvolvedintheoriginallaboratoryactivitiesinquestion.
NOTEThiscanbeperformedbyexternalpersonnel.
7.
9.
6与投诉人沟通的结果应由与所涉及的实验室活动问题无关的人员做出,或审查和批准.
注:可由外部人员实施.
7.
9.
7Wheneverpossible,thelaboratoryshallgiveformalnoticeoftheendofthecomplainthandlingtothecomplainant.
7.
9.
7只要可能,实验室在投诉处理完成后应正式通知给投诉人.
7.
10Nonconformingwork7.
10不符合工作7.
10.
1Thelaboratoryshallhaveaprocedurethatshallbeimplementedwhenanyaspectofitslaboratoryactivitiesorresultsofthisworkdonotconformtoitsownproceduresortheagreedrequirementsofthecustomer(e.
g.
equipmentorenvironmentalconditionsareoutofspecifiedlimits,resultsofmonitoringfailtomeetspecifiedcriteria).
Theprocedureshallensurethat:7.
10.
1当实验室活动或结果不符合自己的程序或与客户达成一致的要求时(例如,设备或环境条件超出规定限值,监测结果不能满足规定的准则),实验室应有程序予以实施.
该程序应确保:a)theresponsibilitiesandauthoritiesforthemanagementofnonconformingworkaredefined;b)actions(includinghaltingorrepeatingofworkandwithholdingofreports,asnecessary)arebasedupontherisklevelsestablishedbythelaboratory;c)anevaluationismadeofthesignificanceofthenonconformingwork,includinganimpactanalysisonpreviousresults;d)adecisionistakenontheacceptabilityofthenonconformingwork;e)wherenecessary,thecustomerisnotifiedandworkisrecalled;f)theresponsibilityforauthorizingtheresumptionofworkisdefined.
a)确定不符合工作管理的职责和权力;b)措施以实验室建立的风险等级为基础(包括必要时暂停或重复工作以及扣发报告);c)评价不符合工作的严重性,包括分析对先前结果的影响;d)对不符合工作的可接受性做出决定;e)必要时,通知客户并取消工作;f)规定批准恢复工作的职责.
7.
10.
2Thelaboratoryshallretainrecordsofnonconformingworkandactionsasspecifiedin7.
10.
1,bulletsb)tof).
7.
10.
2实验室应记录不符合工作和7.
10.
1条款中b)至f)规定的措施.
7.
10.
3Wheretheevaluationindicatesthatthenonconformingworkcouldrecur,orthatthereisdoubtabouttheconformityofthelaboratory'soperationswithitsownmanagementsystem,thelaboratoryshallimplementcorrectiveaction.
7.
10.
3当评价表明不符合工作可能再次发生时,或对实验室的运行与其管理体系的符合性产生怀疑时,实验室应采取纠正措施.
7.
11Controlofdataandinformationmanagement7.
11数据控制和信息管理7.
11.
1Thelaboratoryshallhaveaccesstothedataandinformationneededtoperformlaboratoryactivities.
7.
11.
1实验室应能获得开展实验室活动所需的数据和信息.
7.
11.
2Thelaboratoryinformationmanagementsystem(s)usedforthecollection,processing,recording,reporting,storageorretrievalofdatashallbevalidatedforfunctionality,includingtheproperfunctioningofinterfaceswithinthelaboratoryinformationmanagementsystem(s)bythe7.
11.
2用于收集、处理、记录、报告、存储或检索数据的实验室信息管理系统在投入使用前应进行功能确认,包括实验室信息管理系统中界面的适当运行.
当更改ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page24/35laboratorybeforeintroduction.
Wheneverthereareanychanges,includinglaboratorysoftwareconfigurationormodificationstocommercialoff-the-shelfsoftware,theyshallbeauthorized,documentedandvalidatedbeforeimplementation.
管理系统时,包括实验室软件配置或对商用现成软件的修改,在使用前应被授权、形成文件并确认;NOTE1Inthisdocument"laboratoryinformationmanagementsystem(s)"includesthemanagementofdataandinformationcontainedinbothcomputerizedandnon-computerizedsystems.
Someoftherequirementscanbemoreapplicabletocomputerizedsystemsthantonon-computerizedsystems.
NOTE2Commercialoff-the-shelfsoftwareingeneralusewithinitsdesignedapplicationrangecanbeconsideredtobesufficientlyvalidated.
注1:本文中"实验室信息管理系统"包括计算机化和非计算机化系统中的数据和信息管理.
相比非计算机化的系统,有些要求更适用于计算机化的系统.
注2:常用的商业软件在其设计的应用范围内使用可被视为已经过充分的确认.
7.
11.
3Thelaboratoryinformationmanagementsystem(s)shall:a)beprotectedfromunauthorizedaccess;b)besafeguardedagainsttamperingandloss;c)beoperatedinanenvironmentthatcomplieswithsupplierorlaboratoryspecificationsor,inthecaseofnon-computerizedsystems,providesconditionswhichsafeguardtheaccuracyofmanualrecordingandtranscription;d)bemaintainedinamannerthatensurestheintegrityofthedataandinformation;e)includerecordingsystemfailuresandtheappropriateimmediateandcorrectiveactions.
7.
11.
3实验室信息管理系统应:a)防止未经授权的访问;b)安全保护以防止篡改或丢失;c)在符合供应商或实验室规定的环境中运行,或对于非计算机系统,提供保护人工记录和转录准确性的条件;d)以确保数据和信息完整性的方式进行维护;e)包括系统失效记录和适当的紧急措施及纠正措施.
7.
11.
4Whenalaboratoryinformationmanagementsystemismanagedandmaintainedoff-siteorthroughanexternalprovider,thelaboratoryshallensurethattheprovideroroperatorofthesystemcomplieswithallapplicablerequirementsofthisdocument.
7.
11.
4当实验室信息管理系统在异地或外部供应商进行管理和维护,实验室应确保系统的供应商或运营商符合本标准的所有适用要求.
7.
11.
5Thelaboratoryshallensurethatinstructions,manualsandreferencedatarelevanttothelaboratoryinformationmanagementsystem(s)aremadereadilyavailabletopersonnel.
7.
11.
5实验室应确保员工易于获取与实验室信息管理系统有关的说明书、手册和参考资数据.
7.
11.
6Calculationsanddatatransfersshallbecheckedinanappropriateandsystematicmanner.
7.
11.
6应对计算和数据转换进行适当和系统的检查.
8Managementsystemrequirements8管理体系要求8.
1Options8.
1方式8.
1.
1General8.
1.
1总则Thelaboratoryshallestablish,document,implementandmaintainamanagementsystemthatiscapableofsupportinganddemonstratingtheconsistentachievementoftherequirementsofthisdocumentandassuringthequalityofthelaboratoryresults.
InadditiontomeetingtherequirementsofClauses4to7,thelaboratoryshallimplementamanagementsysteminaccordancewithOptionAorOptionB.
实验室应建立、编制、实施和保持管理体系,该管理体系应能够支持和证明实验室持续满足本标准要求并且保证实验室结果的质量.
除满足第4条款至第7条款的要求,实验室应按方式A或方式B实施管理体系.
NOTESeeAnnexBformoreinformation.
注:更多信息参见附录B.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page25/358.
1.
2OptionA8.
1.
2方式AAsaminimum,themanagementsystemofthelaboratoryshalladdressthefollowing:—managementsystemdocumentation(see8.
2);—controlofmanagementsystemdocuments(see8.
3);—controlofrecords(see8.
4);—actionstoaddressrisksandopportunities(see8.
5);—improvement(see8.
6);—correctiveaction(see8.
7);—internalaudits(see8.
8);—managementreviews(see8.
9).
实验室管理体系至少应包括下列内容:—管理体系文件(见8.
2)—管理体系文件的控制(见8.
3)—记录控制(见8.
4)—应对风险和机遇的措施(见8.
5)—改进(见8.
6)—纠正措施(见8.
7)—内部审核(见8.
8)—管理评审(见8.
9)8.
1.
3OptionB8.
1.
3方式BAlaboratorythathasestablishedandmaintainsamanagementsystem,inaccordancewiththerequirementsofISO9001,andthatiscapableofsupportinganddemonstratingtheconsistentfulfilmentoftherequirementsofClauses4to7,alsofulfilsatleasttheintentofthemanagementsystemrequirementsspecifiedin8.
2to8.
9.
实验室按照ISO9001的要求建立并保持管理体系,并且能够支持和证明持续符合第4条款至第7条款要求的实验室,也至少满足了第8.
2条款至第8.
9条款中规定的管理体系要求.
8.
2Managementsystemdocumentation(OptionA)8.
2管理体系文件(方式A)8.
2.
1Laboratorymanagementshallestablish,document,andmaintainpoliciesandobjectivesforthefulfilmentofthepurposesofthisdocumentandshallensurethatthepoliciesandobjectivesareacknowledgedandimplementedatalllevelsofthelaboratoryorganization.
8.
2.
1实验室管理者应建立、编制和保持符合本标准目的的政策和目标,且应确保该政策和目标在实验室组织的各级人员得到理解和执行.
8.
2.
2Thepoliciesandobjectivesshalladdressthecompetence,impartialityandconsistentoperationofthelaboratory.
8.
2.
2政策和目标应能体现实验室的能力、公正性和一致运行.
8.
2.
3Laboratorymanagementshallprovideevidenceofcommitmenttothedevelopmentandimplementationofthemanagementsystemandtocontinuallyimprovingitseffectiveness.
8.
2.
3实验室管理层应提供建立和实施管理体系以及持续改进其有效性承诺的证据.
8.
2.
4Alldocumentation,processes,systems,records,relatedtothefulfilmentoftherequirementsofthisdocumentshallbeincludedin,referencedfrom,orlinkedtothemanagementsystem.
8.
2.
4管理体系应包含、引用或链接与满足本标准要求相关的所有文件、过程、系统、记录等.
8.
2.
5Allpersonnelinvolvedinlaboratoryactivitiesshallhaveaccesstothepartsofthemanagementsystemdocumentationandrelatedinformationthatareapplicabletotheirresponsibilities.
8.
2.
5参与实验室活动的所有人员应可获得其职责适用的管理体系文件和相关信息.
8.
3Controlofmanagementsystemdocuments(OptionA)8.
3管理体系文件的控制(方式A)8.
3.
1Thelaboratoryshallcontrolthedocuments(internalandexternal)thatrelatetothefulfilmentofthisdocument.
8.
3.
1实验室应控制与满足本标准要求有关的内部和外部文件.
NOTEInthiscontext,"document"canbepolicystatements,procedures,specifications,manufacturer'sinstructions,calibrationtables,charts,textbooks,posters,notices,memoranda,drawings,plans,etc.
Thesecanbeonvariousmedia,suchashardcopyordigital.
注:本文中,"文件"可以是政策声明、程序、规范、制造商的说明书、校准表格、图表、教科书、张贴品、通知、备忘录、软件、图纸、计划等.
这些文件可能承载在各种载体上,例如硬拷ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page26/35贝或数字形式.
8.
3.
2Thelaboratoryshallensurethat:a)documentsareapprovedforadequacypriortoissuebyauthorizedpersonnel;b)documentsareperiodicallyreviewed,andupdatedasnecessary;c)changesandthecurrentrevisionstatusofdocumentsareidentified;d)relevantversionsofapplicabledocumentsareavailableatpointsofuseand,wherenecessary,theirdistributioniscontrolled;e)documentsareuniquelyidentified;f)theunintendeduseofobsoletedocumentsisprevented,andsuitableidentificationisappliedtothemiftheyareretainedforanypurpose.
8.
3.
2实验室应确保:a)文件发布前由授权人员批准其充分性;b)定期审查文件,必要时更新;c)识别文件更改和当前修订状态;d)在使用地点应可获得适用文件的相应版本,必要时,应受控其发放.
e)文件有唯一性标识;f)防止作废文件的非预期使用,无论出于任何目的而保留的作废文件,应有适当的标识.
8.
4Controlofrecords(OptionA)8.
4记录控制(方式A)8.
4.
1Thelaboratoryshallestablishandretainlegiblerecordstodemonstratefulfilmentoftherequirementsinthisdocument.
8.
4.
1实验室应建立和保存清晰的记录以证实满足本标准的要求.
8.
4.
2Thelaboratoryshallimplementthecontrolsneededfortheidentification,storage,protection,back-up,archive,retrieval,retentiontime,anddisposalofitsrecords.
Thelaboratoryshallretainrecordsforaperiodconsistentwithitscontractualobligations.
Accesstotheserecordsshallbeconsistentwiththeconfidentialitycommitmentsandrecordsshallbereadilyavailable.
8.
4.
2实验室应对记录的标识、存储、保护、备份、归档、检索、保存期和处置实施所需的控制.
实验室记录保存期限应符合合同义务.
记录的调阅应符合保密承诺,记录应易于获得.
NOTEAdditionalrequirementsregardingtechnicalrecordsaregivenin7.
5.
注:对技术记录的其他要求见7.
5.
8.
5Actionstoaddressrisksandopportunities(OptionA)8.
5应对风险和机遇的措施(方式A)8.
5.
1Thelaboratoryshallconsidertherisksandopportunitiesassociatedwiththelaboratoryactivitiesinorderto:a)giveassurancethatthemanagementsystemachievesitsintendedresults;b)enhanceopportunitiestoachievethepurposeandobjectivesofthelaboratory;c)prevent,orreduce,undesiredimpactsandpotentialfailuresinthelaboratoryactivities;d)achieveimprovement.
8.
5.
1实验室应考虑与实验室活动有关联的风险和机遇,以:a)确保管理体系能够实现其预期结果;b)增强实现实验室目的和目标的机遇;c)预防或减少实验室活动中的不利影响和可能的失败;d)实现改进.
8.
5.
2Thelaboratoryshallplan:a)actionstoaddresstheserisksandopportunities;b)howto:—integrateandimplementtheactionsintoitsmanagementsystem;—evaluatetheeffectivenessoftheseactions.
8.
5.
2实验室应策划:a)应对这些风险和机遇的措施;b)如何:—在管理体系中整合并实施这些措施;—评价这些措施的有效性.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page27/35NOTEAlthoughthisdocumentspecifiesthattheorganizationplansactionstoaddressrisks,thereisnorequirementforformalmethodsforriskmanagementoradocumentedriskmanagementprocess.
Laboratoriescandecidewhetherornottodevelopamoreextensiveriskmanagementmethodologythanisrequiredbythisdocument,e.
g.
throughtheapplicationofotherguidanceorstandards.
注:虽然本标准规定组织应策划应对风险的措施,但并未要求运用正式的风险管理方法或将风险管理过程形成文件.
实验室可决定是否采用超出本标准要求的更广泛的风险管理方法,如:通过应用其它指南或标准.
8.
5.
3Actionstakentoaddressrisksandopportunitiesshallbeproportionaltothepotentialimpactonthevalidityoflaboratoryresults.
8.
5.
3应对风险和机遇的措施应与其对实验室结果有效性的潜在影响相适应.
NOTE1Optionstoaddressriskscanincludeidentifyingandavoidingthreats,takingriskinordertopursueanopportunity,eliminatingtherisksource,changingthelikelihoodorconsequences,sharingtherisk,orretainingriskbyinformeddecision.
NOTE2Opportunitiescanleadtoexpandingthescopeofthelaboratoryactivities,addressingnewcustomers,usingnewtechnologyandotherpossibilitiestoaddresscustomerneeds.
注1:应对风险的方式包括识别和规避威胁,为寻求机遇承担风险,消除风险源,改变风险的可能性或后果,分担风险,或在了解相关信息的基础上决定承担风险.
注2:机遇可能促使实验室扩展活动范围,赢得新客户,使用新技术和其他方式应对客户需求.
8.
6Improvement(OptionA)8.
6改进(方式A)8.
6.
1Thelaboratoryshallidentifyandselectopportunitiesforimprovementandimplementanynecessaryactions.
8.
6.
1实验室应识别和选择改进机会,并采取必要的措施.
NOTEOpportunitiesforimprovementcanbeidentifiedthroughthereviewoftheoperationalprocedures,theuseofthepolicies,overallobjectives,auditresults,correctiveactions,managementreview,suggestionsfrompersonnel,riskassessment,analysisofdata,andproficiencytestingresults.
注:实验室可通过评审操作程序、实施政策、总体目标、审核结果、纠正措施、管理评审、人员建议、风险评估、数据分析和能力验证结果识别改进机会.
8.
6.
2Thelaboratoryshallseekfeedback,bothpositiveandnegative,fromitscustomers.
Thefeedbackshallbeanalysedandusedtoimprovethemanagementsystem,laboratoryactivitiesandcustomerservice.
NOTEExamplesofthetypesoffeedbackincludecustomersatisfactionsurveys,communicationrecordsandreviewofreportswithcustomers.
8.
6.
2实验室应向客户征求反馈,无论是正面的还是负面的.
应分析和利用这些反馈,以改进管理体系、实验室活动和客户服务.
注:反馈的类型示例包括:客户满意度调查、与客户的沟通记录和共同评价报告.
8.
7Correctiveaction(OptionA)8.
7纠正措施(方式A)【参考9001】ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page28/358.
7.
1Whenanonconformityoccurs,thelaboratoryshall:a)reacttothenonconformityand,asapplicable:—takeactiontocontrolandcorrectit;—addresstheconsequences;b)evaluatetheneedforactiontoeliminatethecause(s)ofthenonconformity,inorderthatitdoesnotrecuroroccurelsewhere,by:—reviewingandanalysingthenonconformity;—determiningthecausesofthenonconformity;—determiningifsimilarnonconformitiesexist,orcouldpotentiallyoccur;c)implementanyactionneeded;d)reviewtheeffectivenessofanycorrectiveactiontaken;e)updaterisksandopportunitiesdeterminedduringplanning,ifnecessary;f)makechangestothemanagementsystem,ifnecessary.
8.
7.
1当发生不符合时,实验室应:a)适用时,对不符合做出应对:—采取措施以控制和纠正不符合;—处置后果;b)通过下列活动,评价是否需要采取措施,以消除产生不符合的原因,避免其再次发生或者在其他场合发生:—评审和分析不符合;—确定不符合的原因;—确定是否存在或可能发生类似的不符合.
c)实施所需的措施;d)评审所采取的纠正措施的有效性;e)必要时,更新在策划期间确定的风险和机遇;f)必要时,变更管理体系.
8.
7.
2Correctiveactionsshallbeappropriatetotheeffectsofthenonconformitiesencountered.
8.
7.
2纠正措施应与不符合产生的影响相适应.
8.
7.
3Thelaboratoryshallretainrecordsasevidenceof:a)thenatureofthenonconformities,cause(s)andanysubsequentactionstaken;b)theresultsofanycorrectiveaction.
8.
7.
3实验室应保留记录,作为下列事项的证据:a)不符合的性质、产生原因和随后所采取的措施;b)纠正措施的结果8.
8Internalaudits(OptionA)8.
8内部审核(方式A)8.
8.
1Thelaboratoryshallconductinternalauditsatplannedintervalstoprovideinformationonwhetherthemanagementsystem:a)conformsto:—thelaboratory'sownrequirementsforitsmanagementsystem,includingthelaboratoryactivities;—therequirementsofthisdocument;b)iseffectivelyimplementedandmaintained.
8.
8.
1实验室应按照策划的时间间隔进行内部审核,以提供有关管理体系的下列信息:a)是否符合:—实验室自身的管理体系要求,包括实验室活动;—本标准的要求;b)是否得到有效的实施和保持.
8.
8.
2Thelaboratoryshall:a)plan,establish,implementandmaintainanauditprogrammeincludingthefrequency,methods,responsibilities,planningrequirementsandreporting,whichshalltakeintoconsiderationtheimportanceofthelaboratoryactivitiesconcerned,changesaffectingthelaboratory,andtheresultsofpreviousaudits;b)definetheauditcriteriaandscopeforeachaudit;c)ensurethattheresultsoftheauditsarereportedtorelevantmanagement;d)implementappropriatecorrectionandcorrectiveactionswithoutunduedelay;e)retainrecordsasevidenceofthe8.
8.
2实验室应:a)根据实验室活动的重要性、影响实验室的变化和以前审核的结果,策划、制定、实施和保持审核方案,审核方案包括频次、方法、职责、策划要求和报告.
b)规定每次审核的审核准则和范围;c)确保将审核结果报告给相关管理者;d)及时采取适当的纠正和纠正措施;ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page29/35implementationoftheauditprogrammeandtheauditresults.
NOTEISO19011providesguidanceforinternalaudits.
e)保留记录,作为实施审核方案以及审核结果的证据.
注:内部审核相关指南参见ISO190118.
9Managementreviews(OptionA)8.
9管理评审(方式A)8.
9.
1Thelaboratorymanagementshallreviewitsmanagementsystematplannedintervals,inordertoensureitscontinuingsuitability,adequacyandeffectiveness,includingthestatedpoliciesandobjectivesrelatedtothefulfilmentofthisdocument.
8.
9.
1实验室的管理层应按照策划的时间间隔对实验室的管理体系进行评审,以确保其持续的适宜性、充分性和有效性,包括执行本标准的相关方针和目标.
8.
9.
2Theinputstomanagementreviewshallberecordedandshallincludeinformationrelatedtothefollowing:a)changesininternalandexternalissuesthatarerelevanttothelaboratory;b)fulfilmentofobjectives;c)suitabilityofpoliciesandprocedures;d)statusofactionsfrompreviousmanagementreviews;e)outcomeofrecentinternalaudits;f)correctiveactions;g)assessmentsbyexternalbodies;h)changesinthevolumeandtypeoftheworkorintherangeoflaboratoryactivities;i)customerandpersonnelfeedback;j)complaints;k)effectivenessofanyimplementedimprovements;l)adequacyofresources;m)resultsofriskidentification;n)outcomesoftheassuranceofthevalidityofresults;ando)otherrelevantfactors,suchasmonitoringactivitiesandtraining.
8.
9.
2实验室应记录管理评审的输入,并包括以下相关信息:a)与实验室相关的内外部因素的变化;b)目标实现;c)政策和程序的适宜性;d)以往管理评审所采取措施的情况;e)近期内部审核的结果;f)纠正措施;g)由外部机构进行的评审;h)工作量和工作类型的变化或实验室活动范围的变化;i)客户和员工的反馈;j)投诉;k)实施改进的有效性;i)资源的充分性;m)风险识别的结果;n)保证结果有效性的输出;o)其他相关因素,如监测活动和培训.
8.
9.
3Theoutputsfromthemanagementreviewshallrecordalldecisionsandactionsrelatedtoatleast:a)theeffectivenessofthemanagementsystemanditsprocesses;b)improvementofthelaboratoryactivitiesrelatedtothefulfilmentoftherequirementsofthisdocument;c)provisionofrequiredresources;d)anyneedforchange.
8.
9.
3管理评审的输出至少应记录与下列事项相关的决定和措施:a)管理体系及其过程的有效性;b)履行本标准要求相关的实验室活动的改进;c)提供所需的资源;d)所需的变更.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page30/35AnnexA(informative)MetrologicaltraceabilityAnnexA(资料性)计量溯源性A.
1GeneralA.
1总则Thisannexprovidesadditionalinformationonmetrologicaltraceability,whichisanimportantconcepttoensurecomparabilityofmeasurementresultsbothnationallyandinternationally.
计量溯源性是为确保测量结果国内和国际可比较性的重要概念,本附录给出了计量溯源性的更详细的信息.
A.
2EstablishingmetrologicaltraceabilityA.
2建立计量溯源性A.
2.
1Metrologicaltraceabilityisestablishedbyconsidering,andthenensuring,thefollowing:a)thespecificationofthemeasurand(quantitytobemeasured);b)adocumentedunbrokenchainofcalibrationsgoingbacktostatedandappropriatereferences(appropriatereferencesincludenationalorinternationalstandards,andintrinsicstandards);c)measurementuncertaintyforeachstepinthetraceabilitychainmeasurementuncertaintyisevaluatedaccordingtoagreedmethods;d)eachstepofthechainisperformedinaccordancewithappropriatemethods,andthemeasurementresultsandassociated,recordedmeasurementuncertainties;e)thelaboratoriesperformingoneormorestepsinthechainsupplyevidencefortheirtechnicalcompetence.
A.
2.
1通过考虑并确保以下内容建立计量溯源性:a)规定被测量(被测量的量);b)一个形成文件的不间断的校准链,可以溯源到声明的适当的参考标准(适当的参考标准包括国家或国际标准以及自然基准);c)按照约定的方法评定溯源链中每步校准的测量不确定度;d)溯源链的每步校准按照适当的方法进行,具有测量结果及相关的已记录的测量不确定度;e)在溯源链中执行一步或多步校准的实验室应提供其技术能力的证据.
A.
2.
2Thesystematicmeasurementerror(sometimescalled"bias")ofthecalibratedequipmentistakenintoaccounttodisseminatemetrologicaltraceabilitytomeasurementresultsinthelaboratory.
Thereareseveralmechanismsavailabletotakeintoaccountthesystematicmeasurementerrorsinthedisseminationofmeasurementmetrologicaltraceability.
A.
2.
2当被校准的设备用来将计量溯源性传递到实验室的测量结果时,应考虑该设备的系统测量误差(有时称为偏倚).
有几种机制来考虑测量计量溯源传递中的系统测量误差.
A.
2.
3Measurementstandardsthathavereportedinformationfromacompetentlaboratorythatincludesonlyastatementofconformitytoaspecification(omittingthemeasurementresultsandassociateduncertainties)aresometimesusedtodisseminatemetrologicaltraceability.
Thisapproach,inwhichthespecificationlimitsareimportedasthesourceofuncertainty,isdependentupon:—theuseofanappropriatedecisionruletoestablishconformity;—thespecificationlimitssubsequentlybeingtreatedinatechnicallyappropriatewayintheuncertaintybudget.
A.
2.
3有能力的实验室报告测量标准的信息,如果只有与规范的符合性声明(省略了测量结果和相关不确定度),该测量标准有时也可用于传递计量溯源性,其规范限量是不确定度的来源,但此方法取于:—使用合适的判定规则确定符合性;—在随后不确定度评估中,以技术上合适的方式来处理规范限量.
Thetechnicalbasisforthisapproachisthatthedeclaredconformancetoaspecificationdefinesarangeofmeasurementvalues,withinwhichthetruevalueisexpectedtolie,ataspecifiedlevelofconfidence,whichconsidersbothanybiasfromthetruevalue,aswellasthemeasurementuncertainty.
此方式的技术基础在于与所声明的与规范符合性确定了测量值的范围,预计真值以规定的置信度在该范围内,该范围考虑了真值的偏倚以及测量不确定度.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page31/35EXAMPLETheuseofOIMLR111classweightstocalibrateabalance.
例.
法制计量委员会的国际建议111(OIMLR111:2004)中使用等级砝码来校准天平.
A.
3DemonstratingmetrologicaltraceabilityA.
3计量溯源性的证明A.
3.
1Laboratoriesareresponsibleforestablishingmetrologicaltraceabilityinaccordancewiththisdocument.
Calibrationresultsfromlaboratoriesconformingtothisdocumentprovidemetrologicaltraceability.
CertifiedvaluesofcertifiedreferencematerialsfromreferencematerialproducersconformingtoISO17034providemetrologicaltraceability.
Therearevariouswaystodemonstrateconformitywiththisdocument,i.
e.
thirdpartyrecognition(suchasanaccreditationbody),externalassessmentbycustomersorself-assessment.
Internationallyacceptedpathsinclude,butarenotlimitedtothefollowing.
A.
3.
1实验室负责按本标准建立计量溯源性.
符合本标准的实验室提供的校准结果具有计量溯源性.
符合ISO17034的标准物质生产者提供的有证标准物质的标准值具有计量溯源性.
有不同的方式来证明与本标准的符合性,即第三方承认(如认可机构)、客户进行的外部评审或自我评审.
国际上承认的途径包括,但不限于:a)Calibrationandmeasurementcapabilitiesprovidedbynationalmetrologyinstitutesanddesignatedinstituesthathavebeensubjecttosuitablepeer-reviewprocesses.
Suchpeer-reviewisconductedundereviewisconductedtheCIPMMRA(InternationalCommitteeforWeightsandMeasuresMutualRecognitionArrangement).
ServicescoveredbythebytheCIPMMRAcanbeviewedinAppendixCoftheBIPMKCDB(InternationalBureauWeightsandMeasuresKeyComparisonDatabase)whichdetailstherangeandmeasurementuncertaintyforeachlistedservice.
b)CalibrationandmeasurementcapabilitiesthathavebeenaccreditedbyanaccreditationbodysubjecttotheILAC(InternationalLaboratoryAccreditationCooperation)ArrangementortoRegionalArrangementsrecognizedbyILAChavedemonstratedmetrologicaltraceability.
Scopesofaccreditedlaboratoriesarepubliclyavailablefromtheirrespectiveaccreditationbodies.
a)已通过适当同行评审的国家计量院及其指定机构提供的国际计量委员会相互承认协议(CIPMMRA)下的校准和测量能力.
该同行评审是在国际计量委员会相互承认协议下实施的.
CIPMMRA所覆盖的服务可以在国际计量局的关键比对数据库(BIPMKCDB)附录C中浏览,其给出了每项服务的范围和测量不确定度.
b)签署国际实验室认可合作组织(ILAC)协议或ILAC承认的区域协议的认可机构认可的校准和测量能力能够证明具有计量溯源性.
获认可的校准实验室的范围可从各个认可机构公开获得.
A.
3.
2TheJointBIPM,OIML(InternationalOrganizationofLegalMetrology),ILACandISODeclarationonMetrologicalTraceabilityprovidesspecificguidancewhenthereisaneedtodemonstrateinternationalacceptabilityofthemetrologicaltraceabilitychain.
A.
3.
2当需要证明计量溯源链的国际承认时,BIPM、OIML(国际法制计量组织)、ILAC和ISO关于计量溯源性的联合声明提供了专门指南.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page32/35AnnexB(informative)ManagementsystemoptionsManagementsystemoptionsAnnexB(资料性附录)管理体系方式B.
1GrowthintheuseofmanagementsystemsgenerallyhasincreasedtheneedtoensurethatlaboratoriescanoperateamanagementsystemthatisseenasconformingtoISO9001,aswellastothisdocument.
Asaresult,thisdocumentprovidestwooptionsfortherequirementsrelatedtotheimplementationofamanagementsystem.
B.
1随着管理体系的广泛应用,对于实验室,要求其按照既符合ISO9001又符合本标准的管理体系运作的需求也在增长.
因此,本标准提供了实施管理体系相关要求的两种方式.
B.
2OptionA(see8.
1.
2)liststheminimumrequirementsforimplementationofamanagementsysteminalaboratory.
CarehasbeentakentoincorporateallthoserequirementsofISO9001thatarerelevanttothescopeoflaboratoryactivitiesthatarecoveredbythemanagementsystem.
LaboratoriesthatcomplywithClauses4to7andimplementOptionAofClause8willthereforealsooperategenerallyinaccordancewiththeprinciplesofISO9001.
B.
2方式A(见8.
1.
2)列出实验室管理体系实施的最低要求,其已纳入ISO9001中与实验室活动范围相关的管理体系所有要求.
因此,遵循了本标准第4条款至第7条款,并实施第8条款方式A的实验室,其运作也基本符合ISO9001的原则.
B.
3OptionB(see8.
1.
3)allowslaboratoriestoestablishandmaintainamanagementsysteminaccordancewiththerequirementsofISO9001,inamannerthatsupportsanddemonstratestheconsistentfulfilmentofClauses4to7.
LaboratoriesthatimplementOptionBofClause8willthereforealsooperateinaccordancewithISO9001.
ConformityofthemanagementsystemwithinwhichthelaboratoryoperatestotherequirementsofISO9001doesnot,initself,demonstratethecompetenceofthelaboratorytoproducetechnicallyvaliddataandresults.
ThisisaccomplishedthroughcompliancewithClauses4to7.
B.
3方式B(见8.
1.
3)允许实验室按照ISO9001的要求建立和维持管理体系,并能支持和证明持续符合第4条款至第7条款的要求.
因此实验室实施第8条款的方式B,也是按照ISO9001运作的.
实验室管理体系符合ISO9001的要求,并不证明实验室具有出具技术上有效的数据和结果的能力.
此时,实验室还应符合第4条款至第7条款.
B.
4BothoptionsareintendedtoachievethesameresultintheperformanceofthemanagementsystemandcompliancewithClauses4to7.
B.
4两种方式的目的都是为了达到相同的结果,既符合管理体系的要求又遵循第4条款至第7条款的要求.
NOTEDocuments,dataandrecordsarecomponentsofdocumentedinformationasusedinISO9001andothermanagementsystemstandards.
Controlofdocumentsiscoveredin8.
3.
Thecontrolofrecordsiscoveredin8.
4and7.
5.
Thecontrolofdatarelatedtothelaboratoryactivitiesiscoveredin7.
11.
注:如同ISO9001和其他管理体系标准,文件、数据和记录是制定成文件的信息的组成部分.
8.
3条款规定文件控制.
8.
4和7.
5条款规定了记录控制.
7.
11条款规定了有关实验室活动的数据控制.
B.
5FigureB.
1illustratesanexampleofapossibleschematicrepresentationoftheoperationalprocessesofalaboratory,asdescribedinClause7.
B.
5图B.
1给出了可能代表实验室运作过程中一个示意图,如第7条款的描述.
ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page33/35FigureB.
1—Possibleschematicrepresentationoftheoperationalprocessesofalaboratory图B.
1--可能代表实验室运作过程的示意图ISOIEC17025:2017检测和校准实验室能力的通用要求实验室认可交流,Tel.
:18657856588(微信同号)页码Page34/35Bibliography参考文献[1]ISO5725-1,Accuracy(truenessandprecision)ofmeasurementmethodsandresults—Part1:Generalprinciplesanddefinitions[2]ISO5725-2,Accuracy(truenessandprecision)ofmeasurementmethodsandresults—Part2:Basicmethodforthedeterminationofrepeatabilityandreproducibilityofastandardmeasurementmethod[3]ISO5725-3,Accuracy(truenessandprecision)ofmeasurementmethodsandresults—Part3:Intermediatemeasuresoftheprecisionofastandardmeasurementmethod[4]ISO5725-4,Accuracy(truenessandprecision)ofmeasurementmethodsandresults—Part4:Basicmethodsforthedeterminationofthetruenessofastandardmeasurementmethod[5]ISO5725-6,Accuracy(truenessandprecision)ofmeasurementmethodsandresults—Part6:Useinpracticeofaccuracyvalues[6]ISO9000,Qualitymanagementsystems—Fundamentalsandvocabulary[7]ISO9001,Qualitymanagementsystems—Requirements[8]ISO10012,Measurementmanagementsystems—Requirementsformeasurementprocessesandmeasuringequipment[9]ISO/IEC12207,Systemsandsoftwareengineering—Softwarelifecycleprocesses[10]ISO15189,Medicallaboratories—Requirementsforqualityandcompetence[11]ISO15194,Invitrodiagnosticmedicaldevices—Measurementofquantitiesinsamplesofbiologicalorigin—Requirementsforcertifiedreferencematerialsandthecontentofsupportingdocumentation[12]ISO/IEC17011,Conformityassessment—Generalrequirementsforaccreditationbodiesaccreditingconformityassessmentbodies[13]ISO/IEC17020,Conformityassessment—Requirementsfortheoperationofvarioustypesofbodiesperforminginspection[14]ISO/IEC17021-1,Conformityassessment—Requirementsforbodiesprovidingauditandcertificationofmanagementsystems—Part1:Requirements[15]ISO17034,Generalrequirementsforthecompetenceofreferencematerialproducers[16]ISO/IEC17043,Conformityassessment—Generalrequirementsforproficiencytesting[17]ISO/IEC17065,Conformityassessment—Requirementsforbodiescertifyingproducts,processesandservices[18]ISO17511,Invitrodiagnosticmedicaldevices—Measurementofquantitiesinbiologicalsamples—Metrologicaltraceabilityofvaluesassignedtocalibratorsandcontrolmaterials[19]ISO19011,Guidelinesforauditingmanagement[1]GB/T6379.
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2-2004,测量方法与结果的准确度(正确度与精密度)第2部分:确定标准测量方法重复性与再现性的基本方法[3]GB/T6379.
3-2012,测量方法与结果的准确度(正确度与精密度)第3部分:标准测量方法精密度的中间度量[4]GB/T6379.
4-2006,测量方法与结果的准确度(正确度与精密度)第4部分:确定标准测量方法正确度的基本方法[5]GB/T6379.
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:18657856588(微信同号)页码Page35/35systems[20]ISO21748,Guidancefortheuseofrepeatability,reproducibilityandtruenessestimatesinmeasurementuncertaintyevaluation[21]ISO31000,Riskmanagement—Principlesandguidelines[22]ISOGuide30,Referencematerials—Selectedtermsanddefinitions[23]ISOGuide31,Referencematerials—Contentsofcertificates,labelsandaccompanyingdocumentation[24]ISOGuide33,Referencematerials—Goodpracticeinusingreferencematerials[25]ISOGuide35,Referencematerials—Generalandstatisticalprinciplesforcertification[26]ISOGuide80,Guidanceforthein-housepreparationofqualitycontrolmaterials(QCMs)[27]ISO/IECGuide98-3,Uncertaintyofmeasurement—Part3:Guidetotheexpressionofuncertaintyinmeasurement(GUM)[28]ISO/IECGuide98-4,Uncertaintyofmeasurement—Part4:Roleofmeasurementuncertaintyinconformityassessment[29]IECGuide115,Applicationofuncertaintyofmeasurementtoconformityassessmentactivitiesintheelectrotechnicalsector[30]JointB.
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P.
M.
OIML,ILACandISOdeclarationonmetrologicaltraceability,20112)[31]InternationalLaboratoryAccreditationCooperation(ILAC)3)[32]Internationalvocabularyoftermsinlegalmetrology(VIML),OIMLV1:2013[33]JCGM106:2012,Evaluationofmeasurementdata—Theroleofmeasurementuncertaintyinconformityassessment[34]TheSelectionandUseofReferenceMaterials,EEE/RM/062rev3,Eurachem4)[35]SIBrochure:TheInternationalSystemofUnits(SI),BIPM5)[19]GB/T19011-2013,管理体系审核指南[20]ISO21748,Guidancefortheuseofrepeatability,reproducibilityandtruenessestimatesinmeasurementuncertaintyevaluation[21]ISO31000,Riskmanagement—Principlesandguideline[22]GB/T15000.
2-1994,标准样品工作导则(2)标准样品常用术语及定义[23]ISOGuide31,Referencematerials—Contentsofcertificates,labelsandaccompanyingdocumentationGB/T15000.
4-2003标准样品工作导则(4)标准样品证书和标签的内容[24]ISOGuide33,Referencematerials—GoodpracticeinusingreferencematerialsGB/T15000.
8-2003标准样品工作导则(8)有证标准样品的使用[25]ISOGuide35,Referencematerials—GeneralandstatisticalprinciplesforcertificationGB/T15000.
3-1994废止标准样品工作导则(3)标准样品定值的一般原则和统计方法[26]ISOGuide80,Guidanceforthein-housepreparationofqualitycontrolmaterials(QCMs)[27]ISO/IECGuide98-3,Uncertaintyofmeasurement—Part3:Guidetotheexpressionofuncertaintyinmeasurement(GUM)[28]ISO/IECGuide98-4,Uncertaintyofmeasurement—Part4:Roleofmeasurementuncertaintyinconformityassessment[29]IECGuide115,Applicationofuncertaintyofmeasurementtoconformityassessmentactivitiesintheelectrotechnicalsector[30]JointB.
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OIML,ILACandISOdeclarationonmetrologicaltraceability,20112)[31]InternationalLaboratoryAccreditationCooperation(ILAC)3)[32]Internationalvocabularyoftermsinlegalmetrology(VIML),OIMLV1:2013[33]JCGM106:2012,Evaluationofmeasurementdata—Theroleofmeasurementuncertaintyinconformityassessment[34]TheSelectionandUseofReferenceMaterials,EEE/RM/062rev3,Eurachem4)[35]SIBrochure:TheInternationalSystemofUnits(SI),BIPM5)