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    this document is widly use in testing and calibration laboratories and by implementing of this document in your lab. you will be able to get the ISO17025 Certificate from accreditation bodies.

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    ISO 17025-2005

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    this document is widly use in testing and calibration laboratories and by implementing of this document in your lab. you will be able to get the ISO17025 Certificate from accreditation bodies.

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    49 views35 pages

    Iso 17025-2005

    Uploaded by

    AHMAD YAGHI
    this document is widly use in testing and calibration laboratories and by implementing of this document in your lab. you will be able to get the ISO17025 Certificate from accreditation bodies.

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    Approved aan American National Sundard by ASTM Interstinal, American Soci for Quality, nd NCSL Interaonal INTERNATIONAL ANS/ISO/IEC STANDARD 17025 General requirements for the competence of testing and calibration laboratories Exigences générales concemantla compstence des laboratoires éiolonnages et Fessais, ‘Anrove Anst Nl Say AST aman, Anan Sc fr Quy, NCSL ia ANSIISONES 17025:2005(E) {AST neat man tA “Theo mali ar sb copy clo AST raat Neto res wiht th pr wt person of ASTM ‘lh oft pin yes rym rang Garon oon ot tn © AST herein — Al ee ‘Arproveéasan Areca Nato Sudard by ASTM Iteration), Ameren Soi fr Quy, and NCS terns Contents Page Feenon a Inoducon, “ 1 Sexo 4 2 Neanatve references. 2 3 Teme and defnitons. 2 4 Management requrements 2 43 gence 7 2 agement ji 3 43 Document convo! 4 431 Genera, 4 $32 Donen pprval andi, 4 433 Decument changes. $ 44° Review of requests, tenders and conracs $ 4S Gibconvacti of tate nd colvavons § 48 Purchesng sercas and supple 6 a) Sete iste customer § 23 Compiants + 45. Convo enaonianming ising andr eaibraon wai 7 450 Improvement : oo ait Gorecive acs 3 4314, General 8 a2 Sete envi 3 EH3 Sci td loa fcc ine 3 444 Nontorng of comactve acto. 3 N13 Addtonl suas § 412° Preventveacion 8 443. Convol of records 3 4121 Genel, 8 ‘Uia2 Techeal ecods 8 44 Item aude “9 4415 Managoment revows “0 5, Tesi euronent 0 8 Geno 0 52 Beromel ot 33 Aetemodalon ad srdnrrial conics 2 54 Testand calbraton methods and mathod vordaioh 2 S49 Genet 2 Sea Seicbontiiads 8 543 Laboratory. developed method 8 344 Nomelandard metiogs ors 3 548 Veldaton of monoce @ 848 Euan coy dimes a 547 Cont of data cH 55 Equpment 8 58 Monwurement vaceaby 7 5, Goal a pec earn t 363. Rolormce Sancard and eoroice alos % a7? Sone 8 ANSIISOMIEC 17026:2005(E) “@ASTI anal - Al rere “ -Avprove san Amsrian Nata Star by ASTM Iteration Amen Soy fr Quit, and NCSL Ineo ANSISOMIEC 17026:2005(E) 58 Handing of test and callration tems 58, Assuring the quay of test and cabanas 510 Reporting the results. 5101 General. 5102 Test reports and cliration cariicaes 5103. Test reports 7 5104 Calibration certificates. 5105. Opinions and interpretations 8406 Testing and calibration results biained from subsonvacters 5107 Electronic transmission of results... 5108 Format of reports and certificates 109 Amondiment to lest reports and calbraion ceiicates ‘Annex A (informative) Nominal cross-references to $0 9001:2000, ‘Annex & (informative) Guidelines for establishing applications for specific elds. ibiography. NBR DBRUNRNEB BBS ™ ‘CASTM rameter — Ale ee -Arproved as an Ameicen Nasional Sand by ASTM Ineronl,Amsrom Socio fr Quy, 4 NCS. tana ANS/ISONEC 17025:2005(E) Foreword 'SO (the International Organization for Standardization) and IEC (the Intemational Electrotechnical ‘Commission form the speciaized system for worgwide standardization, National bodies that are members of 180 or 1EC participate in the development of Intemational Standards tough technical committees established by the respective organization to deal with parlcular folds of technical acviy. ISO and TEC {echnical committees colaberate in feds of mutual interest, Other Intemational organizatons, governmental ‘end non-governmental in Faison with ISO and IEC, also take part in the work In the fed of conformity assessment the ISO Commitee on confomly assassment (CASCO) le reaponsibe for he ceveloprent of Intemational Standards are crate in accordance with the rules gven nthe ISOIEC Dvectives, Pat 2. Draft Intemational Standards are culated to the national bodies for ving. Publeaion a¢ an Inferatinal Standard requires approval by a east 75% af the national Bacies castng a vote. ‘Altetion is drawn tothe possibilty that some ofthe elements ofthis document may be the subject of patent Fights. ISO shall not be ned responsible for entiying any oral such patent rights 'SONEC 17028 was prepared bythe ISO Committee on conformity asessment (CASCO), It was circulated for voting to the national bodies of both ISO and IEC, and was approved by both ‘This second edition cancels and replaces the frst exton (ISO/IEC 17025:1990), which has been techricaly reveod. (CAST haere -Asren ‘Approved as an Aneian Nsom Studd by ASTM lteatnal, American Society or Quali NCSL teats ANS/ISOJIEC 17025:2008(E) Introduction ‘The first editon 1989) ofthis International Standard wae produced as the resut of extansive experience in the implementaton of ISO/EC Gulde 25 and EN 45001, both of which t replaced. W contained al of the requirements that testing and calibration laboratories have to meat # thay wish to demonstrate that they ‘operate]a management system, ae tachricaly compstent, and are able to generate tectnicaly vali result “The frst edton refered o ISO 8001:1094 and ISO 9002:1904. These standards hava been superseded by 180 8001:2000 wich made an alignment of ISO/IEC 17025 necessary. In this second edition, clauses Nave ‘been amended or added nly when considered necessary in the ight of [SO 800:2000, ‘Accreditation bodies that recognize the competence of testing and calraton laberalries should use tis International Standard as the basis for thelr acredtaton, Clause 4 species the requirements for sound management. Clause 5 species the requirements for technical competence forthe type of tests andlor Calibrations the boratory undertakes. Growth inthe use of management systems generally has increased the need to ensure that laboratories wich form par of larger organizations or offer otner services can operate toa qualy management sytem that is ‘seen as comptent with ISO 9001 as well as with ths International Standard. Care has been take, therefore, to incorporate a those roquirements of [SO 9001 that are relevant to the scope of testing and calbration services that ae covered by the laboralay’s management system. “Testing and calbration laboratories that comply with ths Intraional Standard wilt ‘accordance with ISO 900%, refore also operate Conformity of the qualty management system within which the laboratory operates tothe requirements of '80 8001 does not of tselfdamenstrate the competence ofthe laboratory to produce tacnically valid data and results. Nor does demonstrated conformity to tis Intemational Standard ply conormity of the qually ‘management system win which the laboratory operates to all the requirements of ISO 001 ‘Tne acceptance of testing and calibration resus between counties should be fecitated i laboratories comply with this Interaonal Standard and If they obtain accrediation from bodies which have entered into mutual recogniton agreements with equivalent bocies in other counties sing his Intorational Sancerd ‘The use of this Intemational Standard wil facitate cooperation between laboratories and cther bodies, and assist in the exchange of iniormation and experience, and inte harmonization of standards and procedures. ‘ BART arated — Agta Approved aan Amercan Nato Suu by ASTM Interatna,Amerin Soi fr Quy a NCSL neato INTERNATIONAL STANDARD ANS/SOMEC 17025:2005(E) General requirements for the competence of testing and calibration laboratories 1 Scope 7 ‘4 This Intemational Standard species the goneral requirements forthe competence to cary out tests ‘andor caloatons including sampling covers testing and cabbraton performed wing standard mathod, ‘non-standard methods, end laboratory developed methods 12, This Intemational Standart is applicable to all organizations performing tests andlor calibrations. These Include, for example, frst, second- and third-party laboratories, and laboratories where testing andlor Calbraion forms part of inspection and product certfcaton, ‘This intematonsl Standard is applicable to al aboratories regaaless ofthe numberof personnel or the extant the scope of testing andor carat actives, When laboratory does not undertake one of more ofthe ‘activites covered by this Intemational Standard, such as sampling and the design/developmont of new methods, the roqumonts of those causes do nt spp 413. The notes given provide clarification ofthe text, examples and guidance. They do not contain requirements and donot form an integral pat ofthis International Standaré 14 This Intemational Standard is for use by laboratories In developing theit management system for quali, _minstratve and technical oporetons. Laboratory customer, reguslry autores and accrediation bodes ‘may also use iin confirming or recognizing the competence of laboratorie, This Intemational Standerd isnot Intended tobe used as the basis for corication of aboratores, NOTE 1 The term management sya nti lntematonal Standard means the qualiy,amiisratve and technical ‘systems that govem te operaons oars NOTE2 Cerileaon of a management system s sometimes so caled registration. 415. Compiance with regulatory and safely requirements on the operation of laboratories isnot covered by this Intemational Standare 118 i tesung and caitraton lborstones comply with the roquiramants ofthis Intemational Standard, they will operate 2 quality management system for ther testing and calibration activites that also mets the rings of ISO 900". Annex A provides nominal cross-references between ths International Standard and 'S0 8001. This Intemational Standard covers technical competence requirements that are not cxvered by 's0.9001 NOTE 1 ttmight be necessary to explain ointerpret carta In this ielomatonal Standard ensure that {he require areapoled na conan manor Gulsance for exabieing appease pect flea, eepsaly {Gr ection bods (600 ISONEC T7OTT) agen Ane. NOTE 2 f laboratory wishes accrediation fo part o al of is testing an calration acties, shoul select an ‘acediaion bodyfat partes accordance with ISONEC 17011 ‘2A — lr enn ‘ Areroved aan Amrcen Neon Stan by AST eters, Ameren Soe fr Qualys NCSL Interation ANSIISO/EC 17025:2005(E) 2 Normative references ‘The following referenced documents are indispensable forthe application of this document, For dated Teterencos, ely the exon cited applies. For undated referonces, the latest exon of the referenced ‘document (incuding any amendments) applies, ISONEC 17000, Conformity assesement-- Vocabulary and general principles its, International vocabulary of basic and general terms in metrology, issued by BIPM, IEC, IFCC, ISO, TUPAC, JUPAP and OM NOTE Further related standards, guides, ec. on subjects incaded inthis International Standard are given in the Bbiogaty. 3. Terms and definitions For the purposes of tis document, the relevant terms and definitions given in ISONEC 17000 and VIM apply NOTE Goer ens ltd uly aw aver 0 9, haa SOE 7000 Os es ‘pean Tested Wo earticabon and laboratory scareataton. Where diferent defnons are given {SO 9000, the ‘eto SONEC #7000 are VM oe prefored, 4 Management requirements. 44 Organization 414._The laboratory or the organization of which itis part shall be an entity that can be held legally ‘Reporsie, + erclgt oe ueateotamon + Tex XD | peeroetan Aapaeueots ome 442 tis the responsi of the laboratory to cary outs tasting and calraion acts in such a way as tomest the requirements cf this Intemational Standard and to satisfy the reads of he customer, the regulaory authorities or organizations providing recogriton. * S1=xce NERA THe uw Macnee ad ‘SxS Cau) Hite. 443. The management system shall cover work cared oun the laboraton’s perrenent facies, at sites ‘nay rom is pormanent facies, oF n associated temporary or mobile facies, 444 tthe laboratory is part of an organization performing actives other than testing andlor calbatio, ‘he responciilies of fey personnel inthe organization that have an involvement or nuance onthe testing ‘ndoscalbration activites ofthe laboratory shal be defined in order to entity potential conics of intrest NOTE 1 Where a atraoy spar of lange rgartzatn, te organizational aranganerts shout be uch het To at rnc Feros, eh ox poduion sonersal akan or fancng do ret saves ‘epost re aoe vee tere fe orion Sano NOTE 2 ihe: shes tobe reccorized a a thir party laboratory, shoud be abl o demonstrate that tis Noaril an thet and ts personnel are fre orn any undue commer, fnancal and her pressures which mht ‘Rkence er ncrica pdgomert The fespary tesa calbreton brash raza ary aes bit Iney ndorge te tus nfs raepensonce of agarent ar ntegty nelaton is singer vis 448 The laboratory shall ‘have managerial and technical perzonnel who, irespectve of other responsibites, have the authority ‘tnd resourees needed to cary out thelr duties, including the implementation, maintenance and nprovement of the management system, and to identity the occurrence of departures from the iransgement system or from the provadures for performing tests and/or calbrabons, and to iitiate ‘tcions to prevent or minimize such departures (see also 52), Sougenenron Chet 2 @ AST tates! — Ale send ‘Approved sax Amrcan Neon Star hy ASTM Intentions, Amerian Soci Quality, nd NCSL net ANSIISOIIEC 17025:2005(€) ) have srangements to ensure that ts management and prsonel fe rm any undue neal and {eral cormeral arcal an dr pesos mu rapas lay aye fete gay re, aol ots roe oes earch network * Bice Se ana eee i have potes and procedures to anaure the potecon of ts cstoners' confidential ifomaton and Prony righ cng process pring he acon srage an anamsin evs 4) have pois and procedures io agi incvernt in any acs hat woul miih conerce in ts Competence, mpsraity, bepener or operational gy. ©) cee te oxanzaon and management erate o he beat place any parent creation fd he eters between qolly management, chica puri and suport secon 1) spcty he responsi, lt and telaonaip of prone wo manage, parton or verily ‘ent efocing he qty athe oss andr ealtratons 4) prove adequate supenision of testing an caltaton sa, inclaing renee, by persons fair wih foots and procedure prpoesaeach ia andr calrcbon an win he season ol eter ‘Siorton rs hy have technical managernont which has overall responsi forthe technical operations and the rosin oft resources ued ensues te roqrod gay! kourtoy opertons 1) appoint a member of sla as qual manager (however named) woo, especie of ober dts and ‘eayostes, shal have Sted vapensohy end suboty fr eau tna ho aragarent oyster tied quale nponie and flowed a aes te aunty ae sal have God aces tatugea evel of management ich decison remade Onabesoy poly or esas spon eptins okay manage pars (0a Noll 1) ena that ts personel ae anare ofthe elevance and inpornce of thee actos ard how they Conte tote sesame tie denies fe hanageet ye NOTE _Indviuals mayhave mere than one uncon and imaybsimpractcalto appoint depts fr every furcson 41.6 Top management shal ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system. 4.2, Management system 421 The laboratory shall establish, implement and maintain a management system appropriate to the: ‘scope of iis actives. The laboratory shall document its policies, systems, programmes, procedures and instuetions tothe extent necessary to assure the quay ofthe test andlor calibration resus, The system's ocumentaton shall be communicated fo, understood by, avaliable fo, and implemented bythe appropriate personnal. 422 The aboratoy’s management systom policies related to quality, cluding a quality policy etatement shall be defined in a quay manual (nowever named). The overal objectives shall be estabiahed, and shall be reviewed during management review. The qually polcy statement shal be issued under the auorty of topmanagement shall luge at east the folowing 4) the laboratory management’ commitment to good professional practice and tothe quality of ts testing ‘and calbraton in servicing ts customers; 1) the managements statement of the laborator/s standard of serves the purpose of the management system related to quality, SAS mata — Ae sae 8 Approved as an Armen National Suda by ASTI Intemtna, Americas Soi fer Qual, nd NCSL Inet ANSMISONIEC 17025:2005(E) 4) aroquicoment tha ll personnel concerned with testing and caioration activities within the laboratory famiarize themselves withthe quality documentation and implement the polices and procedures thee work an ©) the laboratory managements commitment to comply with this intemational Standard and to continualy improve the efecveness ofthe management system, [NOTE The quay poy statement shoud be concise and may include the requirement that tsts andlor calbraons shall aways be cared out aocordance with sated methods and custome requrements. When tp fest anor ‘aration laboratory part ofa larger ergarizatn, some qual poly eloments ray be oer documents 423. Top management shal provide evidence of commitment tothe development and implementation of ‘he management sfstom and to Continually mproving its effectiveness, 424 Top management shall communicate tothe organization the importance of meeting customer requiemerts as wellas statuary and regulatory roqurements rence tothe supporting procedures including techrical documentation used inthe management system. 425 The quality manvalsilinclude or make procedures It shall outine the structure of 428 The roles and esponstltis of technical management andthe quality manager, including their responsibly for ensuring compliance wih this Intemational Standard, shal be defined inthe quality manual 427 Top management shal ensure that the integrity ofthe management system ie maintained when changes tothe management systom are planned and implemented. 43, Document control 431 General ‘Tho laboratory shall establish and maintain procedures to control all documents that form pat of ts ‘management systam (etemally generated or fom exlemal sources), sich as regulations, standards, other normative documents, test andlor calltraon methods, as well ae drawings, software, specication, Ineructione and man [NOTE 4 inthis cont "document could be poy statements, procedures, specications, calralon table, chart tex books, posts, rotees, memoranda, sofware, drawings, las, et. These ay be on varus media, whether hard ‘copy or elconc an ey ay be pt, analog, phteraphic or wien OTE 2 The contol deta ree tsi and cartons covered in 5.47. The conta of rec covered 432 Document approval and issue 4321 All documents issued to personnal inthe laboratory as part of the management system shal be Teviewed and approved for use by authorized personnel prior to Issue. A master list or an equivalent document contol rrocedure identving the current revision status and distribution gf documents Inthe ‘management systen shal be established and shall be readily available to precude the Use of iva andlor 4322 The precedure(s) adopted shall ensure that: 12) authorized ectons of approprate documents are avalable at allocations where operations essental to {he effocive furconing ofthe laboratory are performed 1) documents are periodical reviewed and, where necessary, revised to ensure continuing sutabity and ‘compliance wih appicble requrements; 4 (©ASTM rman — Agere ‘Aygroved tan Ameen Nata Stn by ASTM Inerason), American Solty fr Quilty, a NCSL tert ANSMSOMIEC 170252005(€) ©) Invalid or obsolete documents ae promptly removed rom al points of sve or use, or otherwise assured against unitonded use; 1) obsolete documents retained for ether legal or knowledge preservation purposes are suitably mare. 43.2.3 Management system documents generated by the laboratory shall be uniquely ieatied. Such 'demtfeation shal inde the dato of gsue andlor revision identiieaton, page numbering, the ttal number of pages or @ mark to signity th end of the document, and the isting authontyes). 43.3 Document changes 4331 Changes to documents shal be reviewed and approved by the same function tha performed the ‘tiginal review unless specifically designatod otherwise. The designatod personnel shall have access © Pertinent background infomation upon which to base thei review and approval. 4332 Where practicable, the altered or new txt shall be identiied inthe document orth appropiate sflachments. 43.3 the laboraton’s document contol system allows fo the amendment of documents by hand ending the reissue ofthe documents, the procedures and aubriis for such amendmen shal be dened ‘Amnenarmens shall be clearly marked, initaed and dated. A revised document sal be formal relesued soon as praceabe 434 Procedures shal be established to describe how changes in documents mainta ‘computerized systems are made and conoid. 4.4 Review of requests, tenders and contracts 444. The laboratory shall establish and maintain procedures forthe review of requests, tenders 20d Contracts. The policies and procedures for thse reviews leading Io contact for tasting andr ealioraion ‘shal ensure that ) tho requirements, including the methods to be used, are adequately defined, documented and understood (600 5.42) 1b) the laboratory has the capability and resources to meet the requirements; 9. the appropriate test andlor calibration method is selected and is capable of mesting the customers! requrements (00 54.2). ‘Any differences between the request of tender and the contract shall be resolved before any work ‘commences. Each contract shall be scceptabe both tothe laboratory andthe customer [NOTE 1 The request, onder and contrac review shouldbe conducted in @ praca and ecient manne, andthe (ect of franca lopl and ine schecue ecnects shoud be taken io account For Hema catamaran of ‘quests, tndare and crc can be paioomed na angled way NOTE 2 The revow of capably should estabish tht te laboratory possesses the necessary physic, pesca and Infomation resouces, an tat th abeatory’s personnal have the sls ad expats nosey forthe peomarce ot {he tots andor clbratons in qurston The review ay also enesmpass ruts of eae partrpason meebo amparsons or protcency tesing andor te running of al et or calbaton programmes using samples of ton Of ‘own vauein oreo deternia uncorainees of measurement, irate of erection, conaaencs kn ta NOTES contact maybe any wien or rl apreemento provide a customer wh testing sno aration services, 442 Records of eviews, ndusing any sgnfcant changes, shal be mantsined. Records shal ao be maintained of pecinent cussions wih a customer relating othe customer’ roquremonts or the resuts of the work during the period of execution ofthe contract. SASTu maton — Aten * ‘Approved at a Ameria Natal Sunde by ASTM intraionl Ameican Society for Quali, and NCSL stermaionl ANSIISOIEC 17025:2005(E) [NOTE For rovow of routine and other simple tasks, the dat andthe identcton (6.9 the nals ofthe person in the laboratory responsible or crying out re eared work af coniered sdequte. For rpetine roe fark, the Foviow noad bo mace ony ate ial enquly sage oon grating of he ear oro-geng rouina work parommed Under a genoa! apreemont win the customer, prevdd thatthe customer’ requremens remain unchanged, Fo naw, ‘complex or advanced tating andlor cllraton ask, 2 mote comprehenave ec shoul be maine. 443 ‘Therovow sal ao cover ny wok tat ubconracte by the abort, 444 The customer shallbeinférmed of any deviation from the contrac. ‘tall be repeated and ary amendments challbe communicated tall fected personnel. 45 Subcontracting of tests and calibrations ‘451 Whona laboratory subcontracts work, whether bocause of unforeseen reasons (0.9. workin, need for further experise or tmporaryincapaciy) ofan a continuing bass (29 though permanent subcontracting, agency or franchising arrangements), tis work sal e placed wit a competent subeonvacte. A competan Sbcontractris one tha, for example, comptes with this Intemational Standerd forthe work in question 1452 _Tholabortory shal advice me customer ofthe arrangement in wetng and, when appropri, ga ‘he approval ofthe customer, preferably in wring 453 The laboratory i responsible tothe customer forthe subcontracio’s work. except inthe case where the customer ora regulatory authority species which subcontractors to be used 454 The laboratory shall miniain a register of all subcontractor that uses for tests andlor calibrations and a record of the evidence af compliance wih tis Intemational Standard forthe work in question, ing services and supp! 48 Purehs 461 The laboratory shall have a policy and procedure() forthe salection and purchasing of services ard Supplies uses that affect he qually ofthe tests andor callratons, Procedures shal exist or he purchase, reception and storage of reagents and laboratory consumable materials relevent forthe tests and calrations, ‘482. Thelaboratory shall encure that purchased supplies and reagents and consumable ators th affect the quay of tesis andlor calbratons ae rat used unl they have been inspected or otherwise verfied as complying wth standard specifications or requirements defined in the methods for tho tests andlor Calibrations concerned, These services and suppl used shall comply wih spected requirements, Records ‘factions taken to check compllance shall be maintained 469 Purchasing documents for items affecting the quality of laboratory ouput shall contain data dosing the services and supplies ordered Thase purchasing documents shall bs reviewed and approved for tecnica content prior to release. [NOTE ‘The desciston may incde type, class, grace, precise identification, specications, drawings, inspection Insructns, other tecrical data ncudng ot teat resus, the ually requred and bw managemant sys _Sandard under when hey were mae. ‘464 The laboratory shall evaluate supplrs of criical consumables, supplies and services utich affect he {qualty of tasting end cabraton, and shall maintain records of these evaluations and Ist those approved, AT Service to the customer 47.4 Tha laboratory shall be wiling to cooperate with customers or thelr representatives in clarying the ‘customer's roquest and in montoring the laboratory's performance In relaon tothe work performed, proved ‘hat te laboratory ensures confdentatty to other customers. . (© ASTM ard — AD te rev ‘proved aan Anercan Natal Star hy ASTM Isreal, American Soi) fr Quali, nd NCS nets} ANSIISONIEC 17025:2005(€) NOTE1 Such operation may int 8) proving tre cstomar oh customer's represointve reasonable acces 1 relevant areas fhe labors forthe ‘winessing of tests andor eatbatons perormed fo bo cusiemar, 19 proparaton, packaging, and path of et anor calraton tems needed bythe custome for vsicatin purposes. NOTE 2 Customers value the maintenance f good conmunicaton, saves and guidance in tectnical mats, and 22k feedback, both postive and negative, from itso NOTE Exams ofthe types of feedback include customer satsfaction surveys and rovew of teste cabaon "por wi ators 48. Complaints ‘The laboratory shall have a policy and procedure fr the resolution of complaints receved from customers ot ‘other pares. Records shalbe maintained ofall complaints and ofthe Investigations and comtetve actions taken by the laboratory (sae aso 4.11) 49. Control of nonconforming testing andior calibration work 4341 The laboratory shall have a policy and procedures tat shall be implemented when any aspect of is {esting andor calibration work, or he results of this work, do not conform tos own procedures o the agreed requirements ofthe customer. The poicy and procedures shall ensure that: 2) the responsibilities and authorities for the management of nonconforming work are designated and actions (ncluding halng of work and witholing oftet reports and caibraion cerca, 2s necessary) ‘af defined and taken when nonconforming works dented; 1b) an evaluation o the sigifcance ofthe nonconforming works made; 9) correton is taken immediately, together with any decision about the acceptabity ofthe nonconforming work 9) where necessary, the customer is notified and works recalled: {the responsibilty for authorizing the resumption of works defined, 49.2 _ Wore Be ovation incicates thatthe nanconfeming work could ecu oF Dat ari duet about ‘he complianes of the laboratory's operations witn fs own policies and procedures, the corrective action procedures ven in 4.11 shall be prompty flowed, 440 Improvement _ ‘The laboratory shall continually improve the effectiveness of its management system through the use of the uality policy, qualty objectives, audit resuls, analysis of data, correcive and preventive actions and management review. {©ASTM atonal — Ages 7 ‘Approved as an Ameen Natal Sud by ASTM Imerationl, Amc oct fr Quality, ed NCSL Iterations ANS/ISONEC 17025:2005(E) 411 Corrective action 4s14. General ‘The laboratory shall establish a policy and a procedure and shall designate appropriate authoctes f implementing corrective acon when nonconforming work or departares om the poles and procedures the management systam or tactical opraions have been eid NOTE A problem wit he management syst or we helena eporatons of th laberatary maybe ent (Notation shen erie notcroming wok rion cea oe, range oa {eudbank tom aber an fom oat beanie 4112 Cause analjsi ‘The procedure for corectve action shall start with an investigation to determine the root causo(s) of th problem NOTE Cause analysis isthe key and somtines the most fc part in the corecve acton procedure. Ohen Fool causes nat cbvous and tus a cart analysis fal potent causes ofthe problem sre, Poteal caus ‘ould neice customer requrements, the samples, sample specticaions, metleds and procedures, sta Sls at ‘arg ancuraion ocogupmortondts carota 4413 Solection and implementation of corrective actions \Wnere corecive action is needed, the laboratory shal dentty potential corrective actions. It shal seoct an implement the action(s) mast sel to elminate the problem and a prevent recurence. Corrective actions shal be toa degree appropiate tothe magnitude and the risk ofthe problem. ‘The laboratory shall document and implement any required changes resulting from corectve acto Invostigaons. 4414 Monitoring of corrective actions. ‘The laboratory shall monitor the resuls to ensure thatthe camective actions taken have boen effective 4415 Additional audits Where the identification of nonconformites or departures casts doubs onthe laboraton’s compliance with ‘own policies and procedures, or on its compliance wih this Inteational Standard, the laboratory shal ensu ‘hat he appropriote areas of acviy are austed in aocordence with 414 aa soon aa pose, [NOTE Such adetonal aud often flow the implementation of the corscive actions to confi tor flecivenes ‘Avan ut shoud be necessary oly when sous issue fk b the bushes rtd 442 Preventive action 4121 Neoded improvements and potential sources of nonconfomitis, ether technical or concerning the ‘management system, shall be entifed, When improvement opportunites are ntti orf praventve action [5 required, action plans shall be devsloped, implemented and monitored to reduce the likeinood ofthe ‘ecurrence of such nanconforiles and io take advantage ofthe cpportuities for improvement 4122, Procedures for preventive actions shal include the intiaon of such actions and the application of conto to ensure that hey are eectve. [NOTE 1 Preventive acon i proactive process to ently opportunites for improvement aber than a reaction tt ‘enticaton of poiers or compares. : . (© AST eration — Al hte care Aproved as an Ameen National Standby ASTM ltzatoel, Arres Society fr Quy, and NCSL Into ANSNOMEC 17025:2005(E) [NOTE 2 Apar trom the rviw of the operational procedures, the frevenve acon might involve anal of dat, eluding vend and rskanalyes and potceney ety routs 413. Control of records 4931 General 4131.1 The laboratory shal estabish and maintain procedures for idenicaion, collection, indexing ‘access fling, storage, maintenance and disposal of quality and technical records. Quality recorss shall Inelude reports fom nlm audits and management reviews ae wall as records of corectve and preventive ‘atone. 41312 _Allrecords shall be lagble and shall be stored and retained in such a way that thay are realy retrievable in facities that provide a sultabie environment to prevent damage or deteroraion and to prevent Toss. Retention times of records shal be established. NOTE. Recarés may be in any mesa such as hard copy o electric media, 44813 Allrecords shal beheld secure and in confidence. 4.19.14 _ The laboratory shal have procedures to protect and back-up recor stored electronically and to prevent unauthorized access lo of amendment of hese records 4422 Technical records 41321 The laboratory shal retain cords of orginal observations, derived data and sucient information {o establish an audit tral, callration records, sta records and @ copy of each test report or calibration Certificate issued, for & defined period. The records for each test or calibration shall contain sufficient Information to facta, if possblo, identication of factors affecting the uncertainty an to en Calation tobe repeated under condtlore as dose as possible othe orginal, The records ‘Genityof personnel response fo the sampling, pefoomance of each tes andlor calbraton and checking of reauts, NOTE 1 Inoetan elds may be impossbio or impractial ore mar of al agi cbeerations. NOTE 2 Tactical coi auras ciao 4.7) ar formation ich ei fm can ots ‘oder caloatons an which dete whethor proses parameters are scioved Thay may nude fe, creat wo shod, wat bose, Clack Sees xk Yeh, cael gas esta and Pld tales ed Caraton cas, cusirers nts, papas and feocbock 41322 Observations, data and caleuatons shal be recorded atthe time they are made and shall be ‘dentable tothe spect task. 41823 When mistakes occurin record, each mistako shall te crossed out, not arased, made Wogbe or deleted, and the corect value entered alongside. Al such alteratians to records shal be signed or inal by the person making the correction. In the case of record stored electronically, equivalent measures shall be taken to avoid loss or change of original data, 414 Internal audits 4.14.1 The laboratory shat periodically, and In accordance wih a predetermined schedule and procedure, Conduct intemal audits of ts activites 1 vanty tat fs operations continue to comply withthe requirements of the management system and ths Intemational Standard. The intemal audt programme shall address all sion te manager nsec be xing andr calran actos Hh apoay of the quality manager to plan and organize audits as required by the schedule and requ management Such suits thal bo cred out by Waied ano Quad personel who are wherever resources perm, independent ofthe actviy to be audited. NOTE The qe ferirtemalausting should normaly be complet cone year ‘©ASTI rons A igh nent ° ‘Arproved at an American Natal Sunrdby ASTM lta), Ararcmn Soe fr Quali, od NCSL tration ANSISOMEC 17025:2005(E) 4442 When audit findings cast doubt onthe effectiveness ofthe operatons or onthe correctness of vality ‘ofthe laboratn/s tes o cabration resus, tho laboratory shal take timely comectve action ang shal nly ‘customers in wring investigations show that ho laboratory reels may have been alec 44143 The ares of activity audited, the aut ndings and corrective actions that arse from them shal be recorded 4144 Folowup aut actives dhal verity and record the implementation and efectveness ofthe comectve asin taken 4.15 Management reviews 4481 _In accordance wih a predetermined schedule and procedur, the aborator/s top management shal Deverell, wnduct a eviow of Une buraonys management syst ane feng andor canraton sctves | 1 ensue te coniningsuabiy and oleconess, endo rodvenecestay changes or mproeret © the sutabiy of plies and procedures; — reports om managerial and supervisory personne tre outcome of recent intemal aud: — cores and preventive actions: = sssessments by extemal bodes: = the results of interlaboratory comparisons or proficiency test — changes in he vlume and yp of he wor: — customer foetack = complains — recommendations fr improvement — ther evant factors, such as quality conte acts, resources and sta ann. NOTE1 Atypical petodterconducng a managerent evi ones ever 12 monte NOTE 2, Results should feed ito the lboratay penning system and shoul ince fh goals, objectives and acon Bana forthe comng you: NOTES Amanagemantreviow nus consderaton fread abject at requar management mesings 44152 Findings from management reviews and the actions that arise from them shall be recorded. The ‘management shall ensue thal those actons are cartid aut within an appropiate and agreed timescale, 5 Technical requirements 51 General 54.4. Many factors determine the corciness and reliably of the tests andlor calibrations performed by @ laboratory. These factors include conmbutons fom: ura factors (6.2; ® (© AST raed — Aegean ‘Approved at an Ameen Nason Sandard by ASTM Interac), Ameren Solty for Quit, and NCSL nteatnst ANSIISONEC 17025:2005(€) accommodation and environmental condone (6:3); —testand caltrtion metnods and method validation (6.4) = eatipment 6.5) — measurement raceabity (6.6), = sampling (57; the handling of test and calibration tems (68) 15.4.2 The extent to which the facors contribute to the total uncertainty of measuremert ders considerably between (types of tests and betwaen (iypes of) calorations. The laboratory shal tcke account of hese factors in developing test and calioration methods and procedures, in the taining and qualification of personnel, and inthe selection and callraton of the equipment kus 52 Personnel 821 _ The laboratory management shall ens ‘equipment, omonetrstod Sil, os required. NOTE 1 n some technical areas (eg. non-destructive testing) may be rors tat the parsornl paroring cin {sts hod personel cartcaton Tho larly respi fr fing specd pec! coicaon guerre The rogaremers personnal cercton mghtbe regan, nchaed nh andar he otic oc Ta, cortege by tne custome NOTE 2 Te personel response forte ois ae interpretation Ines nts repr tau oso fo the ‘sppropatequaicatos, vaning, experience and sesfaory knowledge fhe txing carod out aso have = elevantinowedge ofthe technology used forthe menuactsing of the toms, mata produc, ee. asiod or he ‘ay ey ar used or ntended be used and of ha defects o degradations which may our ding orn Sonic — snontedge of ne genera requirements expessedin the lgjislaton and standards and — understanding of the significance of deviations found wih regard to the noma ute of he tems, materi, ‘posi. ets concord 522. The management ofthe laboratory shall formulate the goals wth respect to the education, training ‘2nd sls ofthe laboratory personnel. The laboratory shal have a plc and procedures for ientlyng raining ‘needs and providing training of personnel. The raining programme shall be relevant tothe present and ‘ntcipated tasks of he laboratory. The effectiveness ofthe training actions taken shall be ovelted 523 _ The laboratory shall use personnel who are employed by, or under contract to, the hboratry. Where Contracted and adtonal technical and key support personnel ae used, the laboratory shal ensure that such personnel are supervised and compatent and tal they Workin accordance wih the aborts management tom. 524 The laboratory shall maintain current ob descriptions for managerial, techrical and key support personnel involved in ess andor cabratons, NOTE Job desrnions canbe defnedin mary ways As 8 minimum, the folowing should be dened = the responses with respect perering tess ander caratons — eresponsies wi respect othe pling of txts andor cafbrations and evalion of resus; — the responses fr epering opens andiniretatons; -— the responses wih respect to method modcaton and development and vakdeton of new methods (oAST rtm — Alege send * ‘Approved san Anercn Natal Sandu by ASTM lnteasond, Ameria Seay for Quality and NCSL eran ANSISONIEC 17025:2005(E) expen and experience rea, = quafcatons ae tring pogrammes — manage des 5.2.5 The maragement shall authorize specific personnel to perform particular typas of sampling, test andlor calibration, to issue tot reports and calbation certificates, to give opinions apd terpretabons and to ‘operate partcuar types of equipment. The laboratory shall maintain records of the felevant authorizations), Competence, educational and professional qualiicatons, taining, sklls and experience of al technical personnel, ncuding contracted personnel. This information shall Be Feacly avaliable and shall ncide the ‘ale on which uthorization andlor competence is confirmed, 53 Accommodation and environmental conditions 1531 Laboratory facts for testing andlor calibration, including but not mite to energy sources, lighting ‘and envonmeralcoritons, shall be such ast facia correct perfomance ofthe tess andor calibrations. ‘The laboratory shall ensue thatthe environmental cantons do not invalidate the esuts or adversely affect the required gaily of any measurement Parteuiar care shall be taken when samping and tests andor calratons are undertaken at sites other than a permanent laboratory faci. The techrical requirements for SSccommadation and environmental condlons that can affect the resuls of tests and calbralons shall be ‘Socumented 532, Thellaboratory shall montr, contol and record environmental conditions as requied by the relevant specications, methods and procedures or where they inluence tve qual of the resus. Due atenton shal be paid, for exanpie, o ological stenily, dust electromagnetic dsturbances, radiation, humily,eloctcal ‘Uppy, temperature, and sound and vibration levels, as appropriate tothe technical aces concemed “Teats and calbations shall be stopped wen the envcnmental concltons jeopardize the esuts of te teats andlor catbrations, 533 _ There shallbe effective separation between neighbouring areas in which there are incompatibe actives. Measures shall be taken fo prevent cross-contamination. 534 Accesso and use of areas atecting the quality ofthe tests andlor calibrations shal be contaled. ‘The laboratory shall determine the extont of control based on ts parouar circumstances 1535 Measures shal be taken fo ensure good housekeeping inthe laboratory. Special procedures shall be prepared where necessary. 54. Test andealibration methods and method validation 541. General ‘The laboratory shal use appropriate methods and procedures forall tests andor calibratons within its scope. ‘These include samping, handing, anspor, storage and preparation of tems fo be tested andlor calvated, ‘and, where apgroprata, an estimation ofthe moasurement unoertainly as wel as satstial techniques for ‘analysis of test andr eairation data, ‘The laboratory shal have jnsructions on the use and operation of all relevant equipment, and on the hancing and preparation of tems fr fesing andlor calbration, or both, where the absence of sush instructions coud Jeopardize the tosuls of tsts andor caltratons. Al instrucions, standards, manuals and refoence data ‘elovant fo the work of th laboratory shall be Kept upto dato and shal be mado really avalatle to personnel {220 43), Deviaion from tat and calibration mathode shall occu ony te deviation has been documented, {echnical justified auhorized, and accepted by the customer. NOTE Intemational, regional or naionl standards or cher recognized specications tht ontansufcient and ‘concise informaton on how fo perform the fests andor calbratons donot need o be supplerented ox rewiton as Irtral procedures these santas are writen away tat they can be wed as pubished byihe opera ctn a IBhorsory maybe nocaseary io prove adStonal cosumertaton fr apbnal tps i he meted or Sedona Sete 2 © AST rato — Al gt ard ‘Approved at an Area Nato Sunt ty ASTM nero, Americ Soc fr Quality, nl NCSL Intention ANS/ISOMIEG 17025:2005(E) 542. Selection of methods ‘Tho laboratory shal use test andor calibration methods, including methods for sampling, which meet the ‘needs ofthe customer and which are appropriate forthe taste andor calibrations l undertakes, Metoos Bublshed in itematonal, regional o nalonal standards shall preferably be used. The laboratory shall ereore {hat it uses the latest valio ediion ofa standard unless i ie not appropriate or possible {o'40 eo, When ‘necessary, the standard shall be supplerpented with adeitonal deals to ensure consent application, wen the customer does not specty the method to be used, the laboratory shal select appropriate methods {hat have been published either in intemational, regional or national standard, or by Tepuable tocical ‘2tgantzatons, on relevant sctentie texts or journals, or as spaced by the manufacturer ofthe eqopmmont Laboratorydeveloped methods or methods adopted by the laboratory may alsa be used it hoy ore

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