Scribd Logo
Upload

Welcome to Scribd!

  • March2018 Iso Standards PDF

    Uploaded by

    adfasfdafssaf
    27 views24 pages

    Original Title

    march2018-iso-standards.pdf

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    27 views24 pages

    March2018 Iso Standards PDF

    Uploaded by

    adfasfdafssaf

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 24
    INL GRUINALIUINAL IDU/ LEU STANDARD 17025 ‘hid edition arracuaent A, 201781 General requirements for the competence of testing and calibration laboratories Exigences générales concernant la compétence des laboratoires Aétalonnages et dessais Reference number Isobe 700S200708) o1soptsc 2017 A... {© 180/18 2017, ube Swtaeand ‘Migs ere: nether spin pa hpi my be ea a ln ther ym ‘rbylany mesos tron or meant cluding phtcoping or psig on tenet oan an, thas Pot ‘rien peso fermion a requested meter ate ares blow 150s member Doyo Oy of "SO coppice Geseandonne 4 Gita termer Genes Setaerand fen anon opener, eae u ‘80/2017 - A hs reer Contents age Foreword. v Introduction . a 1 Scope. co = 1 2 Normative references. ss a 3 Termsand definitions 1 4 General requirements. 3 4a impartiality = 3 42° Confidentiality : a ey 5 Structural requirements. 4 6 Resource requirements ee 5 61 General oo eee 62° Personnel = 5 63 Faclites and environmental conditions 6 64 Equipment 6 65 Metrologia traceability i 8 66 Externally provided products and services. = 8 7 Process requirements 9 TAL Review of requests, tenders and contracts 9 72. Selection, verification and validation of methods 10 721 Seletion and verification of methods et 12.2 Validation of methods. os ss 1 13 = 1 % 2 3 13 7.6 valuation of measurement uncertainty 13 77 Bnsuring the validity of results. foo S 3B 78 Reporting of esults = ir 74a. Genera 4 782 Common requiements for reports (test, calibration o sampling) 15 783. Specificrequirements for testreports 15 784 Specific requirements for calibration certicates 16 785 Reporting sampling - specific requirements. 16 788 Reporting statements of conformity ~ 7 787 Reporting opinions and interpretations v 788 Amendments to reports. ———— 7 29. Complaints. 7 7.10 Nonconforming work : 7 18 711 Control of data and information management o 8 Management system requirements - a a9 ‘Options = 19 Bt General a ag 812 Option S 20 813 Option B 2 82 Management system documentation (Option A). 20 83 Control of management system documents (Option A). 20 84 Control of recards (Option A). = RS Actions to address risks and opportunities (Option A). = 85 Improvement (Option A). aes 87 Correcte actions (Option A) 88 Internal audits (Option A) 89 Management reviews (Option A). ‘rsoneczo17 AN ihe eerie 7 ‘Annex A (informative) Metrological traceability 25 ‘Annex‘B (informative) Management system options. 27 Bibliography... - 29 w (150/160 2017-Anighsreved Foreword 150 (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally Carried out through ISO technical committees. Each member body interested in a subject for which 4 technical committee has been established has the right to be represented on that committee Taternational organizations, governmental nd non-governmental, liaison with ISO, aso take parts ‘the work. Inthe field of conformity assessment, ISO and the International Electrotechnical Commission (UEC) develop joint ISO/IEC documents under the management ofthe ISO Committee on Conformity assessment (S0/CASCO}, ‘The procedures used to develop this document and those intended for its further maintenance are ‘described in the ISO/IEC Directives, Part 1 In particular the different approval eritria needed forthe ‘ifferent types of I$ documents should be noted, This document was drafted In accordance with the ‘editorial rules ofthe ISO/IEC Directives, Pare 2 (See wissso.aryliestves), ‘Attention is drawa tothe possibility that some ofthe elements of this document may be the subject of patent rights, 90 shall ot be held responsible fr identifying any oral such patent eights. Details of ‘ny patent rights identified during the development ofthe document will be in the Introduction and/or ‘onthe ISO list of patent declarations received (ee isa. or8/palea). ‘Any trade name used in tis documents information given fr the convenience af users and does not ‘onstitte an endorsement For an explanation on the voluntary nature of standards, the meaning of 1SO specific terms and ‘expressions related to conformity assessment, as well as information about ISO's adherence to the ‘World Trade Organization (WTO) principles in the Techoical Barriers to Trade (TBT) see the fllowing URL: swinisnorg/iso/foreword. html. ‘This document was prepared by the ISO Committe on Conformity Assessment (CASCO) and circulated {in voting tothe national bodies ofboth 180 and IEG, and was approved by both organizations “This third edition cancels and replaces the second edition (ISO/IEC 17025:2005), which has been technically revised. ‘The main changes compared to the previous eition area follows = the riskcbased thinking applied in this edition has enabled some reduction in prescriptive requirements and their replacement by prformance-based requirements; = thereis greater flexbilty thanin the previousealtion inthe requirements fr processes procedures, documented information and organizational responsibilities; definition of "laboratory" has been added (see 3), (6150/1 2017 A ighseserved v Introduction ‘This document has been developed with the objective of promoting confidence in the operation of laboratories. This docurment contain requirement for laboratories tenable them to demonstrate they ‘operate competently, and are able to generate valid results Laboratories that conform to this document ‘willalso operate generally in accordance with the principles of $0 9001. ‘This document requires the laboratory toplan and implement actions to address risks and opportunities. ‘Addressing both risks and opportunities establishes a basis for Increasing the effectiveness of the management system, achieving improved results and preventing negative elects. The laboratory Is responsible for deciding which risks and opportunities need tobe addressed ‘The use ofthis document will facilitate cooperation between laboratories and other bodies, and assist Inthe exchange of information and experience, and in the harmoaization of standards and procedures, ‘The acceptance of results between countries is facilitated iflaboratories conform to this document In this documeng, the following verbal forms are used: = “shall” indicates a requirement: “should” indicates a recommendation; = “may” indicates a permission = “can indicates. possibilty ora capability. Further detail canbe found inthe ISO/IEC Directives, Part 2. For the purposes af research, users are encouraged to share thelr views on this document and their priorities for changes to future editions. Click onthe link below to take part inthe online survey 202A usecaureey “ (© 80/18 2017 aris esr INTERNATIONAL STANDARD General requirements for the competence of testing and calibration laboratories 1 Scope This document specifies the goneral requirements for the competence, impartiality and consistent ‘operation of laboratories. ‘This document is applicable to all organizations performing laboratory activities, regardless of the ‘number of personnel Laboratory customers, regulatory authortles, organizations and schemes using peerassessment, accreditation bodies, and others use this document in confirming oF recognizing the competence of lnboratores. 2 Normative references ‘The following documents are referred to in the text in such a way that some or all oftheir content constitutes requirements ofthis document. For dated references, only the edition cited applies. For Undated references the latest edition ofthe referenced document (including any amendments) applies. 1S0/1EC Guide 98, International vocabulary of metrology — Basic and general concepts ond associated terms (VIM! 180/1EC 17000, Conformity assessment — Vocabulary and general principles 3. Terms and definitions For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99 and ISO/IEC 17000 and the fllowing appl. 180 and 12¢ maintain terminological databases for use in standardization atthe following addresses — 180 Online browsing platform: avalable at hitnsdfwwiviseorg/obo = lec Electropedia available a https /wnewelectropedia. ares aa impartiality presence of abjectvity Note 1 to entry: Objectivity means that conflicts of meres do nt exist, are resolved so as not to adversely Influence subsequent activities of the ebortory (5). Note 2 to entry: Other terms that are useful in conveying the element of Impartiality incude “freedom fom ‘confi of meres freedom from bia, "lackoY prejudice’, "neutrality, lraess open-mindedness "een fandednese’ “detachment balance” [SOURCE:180/1EC 170214:2015, 3.2, modified — The words “the certification body" have been replaced by "the laboratory” in Note 1 to entry, andthe word “independence” has been deleted from the list n Noe 2to entry] 1) Also known a8 [GM 200 (© 80/2017 - Albee 2 32 ‘complaint ‘expression of dissatisfaction by any person or organization toa laboratory (3.6), relating totheactivites ‘results ofthat laboratory, where a responses expected [SOURCE:150/18C 17000:2004, 6.5, modified — The words “other than appeal” have been deleted, and ‘the words "a conformity assessment body or accreditation body, relating othe activites ofthat body” have been replaced by “a laboratory, relating the activities or results ofthat laboratory") 33 interlaboratory comparison ‘organization, performance and evaluation of measurements or tests onthe same or similar tems by ‘two oF more laboratories in accordance with predetermined conditions [OURCE:Iso/1Ec 17043.2010, 34) 34 intralaboratory comparison organization, performance and evaluation of measurements or tests on the same or similar items ‘within the same laboratory (3.6) in accordance with predetermined conditions as proficiency testing valuation of partiipant performance against pre-established criteria by means of interlaboratory comparisons (3.3) [SOURCE:1s0/1EC 17043.2010,37, modified — Notes to entry have been deleted] 36 laboratory boy that performs one or more ofthe following activities: = testing: = calibration; — sampling, associated with subsequent testing or calibration Note 1 to entry tn the context ofthis document, “aboratory sctvte” refer tothe three above-mentioned 37 fecision rule ‘ale that describes how measurement uncertainty is accounted for when stating conformity with 2 specified requirement 38 verification provision of objective evidence that given tem flfls specified requirements EXAMPLE Confirmation that a given rofoence material as climed is homogeneous forthe quantity value snd measurement procedure concerned down ta measurement portion havings mass of 10 Ms EXAMPLE Confirmation that performance properties or legal requirements of a measuring system are sehioved EXAMPLE Confirmation that target measurement uncertainty ean be met. Note 1t entry: When applicable, measurement uncertainty shoul! be taken into consideration Note 2 to entry: The item may be, for example, «process, measurement procedure, material, compound, of measuring system. 2 (6 80/1-2017-arigus reed Note 3 to entzy The specified requirements maybe, Forexample, that a manufacturer's specications are met. Note 4 to entry: Verification in legal metrology, as defined in VIML, and In conformity as Dertainsta the examination and marking andor ssulng ofa verification cerufeate fo measur en in general este, "Note Sto entry: Verifiaton shoul ate confused with calibration, Not every verification isa vldtion (39). Note 6toenry:tn chemistry, veiflation ofthe Kenly othe entity involved or facivityrequirsadesription the srctare or properses ofthat ety o act. [SOURCE:1S0/1EC Guide 99:2007, 244) 39 validation Vverfiation (3.8), where the specified requirements are adequate foran intended use EXAMPLE A measurement procedure, ordinarily used for the measurement of mass concentration of ftragen in water, my be validated ais for measurement of mas concentration a atrogen a hua Sern, [SOURCE:1S0/18C Gulde 99:2007, 245) 4 General requirements 4.1 Impartiality 4.1.1 Laboratory activities shall be undertaken impartially and structured and managed so as to safeguard impartiality. 44.2. The laboratory management shal be committed to impartial 4.4.3 The laboratory shall be responsible ror the impartiality of ts laboratory activities and shall not allow commercial, financial oF other pressures t compromise impartiality. 4.14 The aboratory shall identify risks tits impartiality onan on-going bass. This shall include those "sks that arse from Its activites, or from its relationships, or from the relationships of its personnel However such relationships donot necessarily presenta laboratory with 2rsk to impartial NOTE A relationship that threatens the impartiality ofthe laboratory can be based on ownership, overnance, management personel, shared resources, finances, contracts, marketing (incuding branding), and puyienta sles commission or ther indictment forthe referral of new customers 445 _tfariskto impartiality sldentied, the laboratory shall be able to demonstrate how it eliminates ‘or minimizes such risk. 42. Confidentiality 42. The laboratory shall be responsible, ehrough legally enforceable commitments, for the ‘management ofall information obtained or created during the performance of laboratory activites. ‘The laboratory shal inform the customer in advance, ofthe information ic intends to place in che public domain Except for informatio that the customer makes publily available, or when agreed between the laboratory and the eustomer (ee forthe purpose of responding to complaints), all ather information is considered proprietary information and shall be regarded as confidential 42.2. When the laboratory is required by law or authorized by contractual arrangements to release Confidential information, the customer oF individual concerned shall, unless prohibited by law, be ratified ofthe information provided. (© 80/18¢2017- A eigeereserid 3 42.3 Information about the customer obtained from sources other than the customer (eg. complainant, ‘egulators) shall be confidential between the customer and the laboratory. The provider (source) ofthis Information shall be confidential to the laboratory and shall not be shared withthe custome, unless agreed bythe source. 424 Personnel, including any committee members, contractors, personnel of external bodies, or Individuals acting onthe laboratory's behal shall keep confidential ll information obtained or ereated during the performance of laboratory activites, except a required by aw. 5. Structural requirements 5. The laboratory shall bea legal entity, oF a defined part ofa legal entity, that legally responsible for ts laboratory activites. NOTE For the purposes of this document, governmental laboratory is deemed tobe alga entity onthe Buss ofits governmental status 52 The laboratory shall identify management that ha overall esponsibility forthe laboratory. 53. The laboratory shal define and document the range of laboratory activites for which t conforms ‘sith this document. The laboratory shall only claim conformity with this document for this range of Taboratory activities, which excludes externally provided laboratory activities onan ongoing bass. 54 Laboratory activities shall be cacied out in such a way as to meet the requirements of this document, the laboratory's customers, regulatory authorities and organizations providing recognition ‘This shall include laboratory activities performed in all ts permanent faites at sites away from its permanent facies in associated temporary or mobile faites or at customer's ality. 5S The laboratory shall: 8) define the organization and management structure of the laboratory, its place fn any parent brganization, and the relationships between management, technical operations and support services: 1) specify the responsibilty, authority and interrlationship ofall personae! who manage, perform or verify work affecting the results of laboratory activities; ©) document its procedures to the extent necessary to ensure the consistent application of its laboratory activities and the validity ofthe results, 56 The laboratory shall have personnel who, respective of other responsibilities, have the authority and resources needed to carry out their duties, including 8) implementation, maintenance and improvement ofthe management system; 1) identification of deviations from the management system or from the procedures for performing laboratory activites; )_ Initiation of actions to prevent or minimize such deviations 4) reporting to laboratory management on the performance ofthe management system and any need for improvement, ©) ensuring the effectiveness of laboratory activities 4 ‘© 80/18¢2017-Alighsceserved 5.7 Laboratory management shall ensure that: 3) communication takes place regarding the effectiveness of the management system and the Importance of meeting customers’ and other requltemens; 1) the integrity of the management system is maintained when changes to the management system are planned and implemented, 6 Resource requirements 6A General “The laboratory shall have available the personnel, facilites, equipment, systems and support services necessary to manage and perform its laboratory activities. 6.2 Personnel 62.1 All personnel of the laboratory either internal or external, that could influence the laboratory activities shall act impartially be competent and work in accordance with the laboratory's management system, 62.2. The laboratory shall document the competence requirements for each function infuencing the results of laboratory activities, including requirements for education, qualifiation, taining, technical knowledge, skills and experience. 62.3. The laboratory shall ensure thatthe personnel have the competence to perform laboratory _ctvties for which they ae responsible and to evaluate the significance of deviations. 624. The management ofthe laboratory shall communicate to personnel their duties, responsibililes and authorities 62.5 The laboratory shall have procedure(@) and retain ecords fr: 4) determining the competence requirements; 1) selection of personnel ©) training of personnel; 4) supervision of personnel; 12) authorization of personnel; 1) monitoring competence of personne! 62.6 The laboratory shall authorize personnel to perform specific laboratory activites, including but not limited, the following 4) development, modification, verification and validation of methods; 1b) analysis of results, including statements of conformity or opinions and interpretations; ©) report, review and authorization of results. (© 80/18¢2017 abe reserved 5 6.3. Facilities and environmental conditions 63:1. The facilites and environmental conditions shall be suitable forthe laboratory activities and Stall nt adversely affect the vallity of results. NOTE nfuences that can adversely affect the validity of results canned butare not inited ta, meobl Contamination due electromagnetic disturbances adition, humidity, electrical supply, temperature, ound tnd vibration, 63.2. The requirements for facilities and environmental conditions necessary forthe performance of the laboratory activites shall be documented, 63:3. The laboratory shall monitor, control and record environmental conditions in accordance with Felevant speciieations, methods or procedures ar where they influence the validity ofthe result. 6.3.4 Measures to control facilities shall be Implemented, monitored and periodically reviewed and Shall nude, but not belimited to: 4) access toand use of areas affecting laboratory activities; 1b) prevention of contamination interference or adverse influences on laboratory activities; 16) effective separation between areas with incompatible laboratory activities, 6.3.5 When the laboratory performs laboratory activites at sites or facilites ouside its permanent ‘ontral, it shall ensure thatthe requirements related to felis and environmental condition af this ‘locumentare met 64 Equipment 641 The laboratory shall have access to equipment (including. but not limited to, measuring Instruments, software, measurement standards, reference materials, reference data, reagents, consumables or auxllary apparatus) that is required for the correct performance of laboratory activities ‘and that can fluence the results NOTE1 _Amulituleofnamesexistforreferencematerialsandcertilied reference materlals.ncluding reference anards calloration standards standard relerene material nd quaity conta materials 10 17034 contains ‘uconal information on reference material producers (RMPa) RMP that meet the requirements af $0 17034 {reconsidered to be competent. Reference materials from RMPs meeting the requirements of (SD 17034 are Provided with product information sheecertieate hat specs, amongst other characters, Nomogenelty lind stability for specified properties and for ceried reference materials, specified properties With cariied ‘ales theirasrocted mearurement uncertainty and meteclogial acest. NOTE2 _ SO Guide 38 provides guidance onthe selection and ue of reference materials. ISO Guide 60 provides fuidance to produce in-house quality control materials 642 When the laboratory uses equipment outside its permanent control, It shall ensure thatthe Fequirements for equipment of this dacumeat are met. 643 ‘The laboratory shall have a procedure for handling. transport, storage, use and planned ipitenance of equipment inorder ensue proper Tunconing ead to prevent contamination or 644 The laboratory shall verify that equipment conforms to specified requirements before being placed or returned into service. 6 (9150/1 2017 = argh saved 645 The equipment used for measurement shall be capable of achieving the measurement accuracy and/or measurement uncertainty required to providea valid result 64.6 Measuring equipment shall be ealibrated when: — the measurement accuracy or measurement uncertainty affects the validity of the reported results, and/or — calibration of the equipment is required to establish the metrological traceability ofthe reported results NOTE ‘Typesofequipment having aneffecton the validity ofthe reported results en include: — those used forthe drectmeasurementofthe measurand eg use of abalancetoperforma massmeasurement, = those used tomake corrections to the measured value eg temperature measurements; = chose used to obtain a measurementresutcalulte fom mulple quanti. 6.4.7 The laboratory shall establish a calibration programme, which shall be reviewed and adjusted as necessary in order to maintain confidence inthe status of albration. 6.4.8 All equipment requiring calibration or which has 2 defined period of validity shall be labelled, coded or otherwise Kentiied to allow the user of the equipment to readily identify the status of Calibration or period of validity, 649. Equipment that has been subjected to overoading or mishandling gives questionable results, or has been shown tobe defective or outside specified requirements, shall be taken out of service. It shall be isolated to prevent its use or larly labelled or marked as being ou of service unt ithas been verified to perform correcly, The laboratory shall examine the effect of the defector deviation from specified equiremens and shall inate the management of nonconforming work procedure (see 0}. 6.4.10 When intermediate checks are necessary to maintain confidence in the performance of the ‘equipment, these checks shall be earsied aut according toa procedure 64.11. When calibration and reference material data include reference values or correction factors, the laboratory shall ensure the reference values and correction factors are updated and implemented, as sppropriate,to meet specified requirements 6.4.12 The laboratory shall tke practicable measures to prevent unincended adjustments of equipment fom invalidating results, 6.4.13 Records shall be retained for equipment which can influence laboratory activities. The records Shall indlude the following, where applicable: 8} the denity of equipment, including sofware ad firmware version; 1b) the manufacturers name, type Mentfeaton, and serial number or other unique identification; ©) evidence of verification that equipment conforms with specified requirements; 4) thecurrentlocation: ©) calibration dats, results of calibrations adjustments, acceptance criteria, and the due date ofthe ‘next callration or the calibration interval, 1) documentation of reference materials, results, acceptance criteria, relevant dates and the period of validity: 1150/1207 igh reserve 7 {the maintenance plan and maintenance caried out co date where relevant to the performance of ‘the equipment; 1) details of any damage, malfunction, modification to, oF repair of the equipment. 65 Metrological traceability 65:1 The aboratory shall establish and maintain metrological traceabiliy of its measurement results by means of a documented unbroken chain of callbratons, each contributing to the measurement "uncertainty linking them tan appropriate reference NOTE1 In ISO/IEC Guide 99, metrological traceability is defined asthe “property ofa measurement result (whereby the result can be relted toa reference through a documented unbroken chain of ealibratons, each Contributing othe measurement uncertain NOTE2 See Annes. for additions information on metrological traceability. 65.2. The laboratory shall ensure that measurement results are traceable tothe International Sytem of Units (S) through: 1) calibration provided by a competent laboratory; or NOTE — Laboratories fulling the requiements of his document are consid v4to be competent, 1) certified values of certitied reference materials provided by a competent producer with stated metrological traceability tothe Sivor NOTE2 Reference material producers fling the requirements of I$0 17034 are considered to be ‘competent ©) direct realization of the SI units ensured by comparison, directly or indirectly, with national or International standards. NOTE Details of practical ealiation ofthe definitions of some importanunts are given inthe! brochure. 65.3 When metrological aceabilty to the SI units isnot technically possible, the laboratory shall ‘demonstrate metrologial traceability to an appropriate reference, eg 4) certified values of certified reference materials provided bya competent producer 1) results of reference measurement procedures, specified methods or consensus standards that are ‘early described and accepted as providing measurement results fit for thelr intended use and ‘ensured by sultable comparison. 6.6. Externally provided products and services 6.6.1. The laboratory shall ensure that only suitable externally provided products and services that affect laboratory activities ae sed, when Such products and services: 83} areintended for incorporation into the laboratory’s own activities 1) are provided, in part or in fll, directly to the customer by the laboratory, as recived from the ‘external provider: ©) areused to support the operation of the laboratory. NOTE Products can inclu, for example, measurement standards and equipment, auxllary eglproeat ‘Consumable materials and eference materials Services ean sel, for exam, calibration services samping Services, testing services, facility and equipment maintenance services, poficency testing Services and ‘Scsmentand suiting services, 8 16150102017 rigs eevee 646.2 Thelaboratory shall havea procedure and retain records for: 2) detiningreviawing and approving the borat’ requirments for external provided products 1) defining the criteria for evaluation, selection, monitoring of performance and reevaluation of the external providers; ‘ensuring that externally provided products and services conform tothe laboratory’ established requirements, of when applicable, to the relevant requirements ofthis document, before they are used or directly provided tthe customer; 4) taking any actions arising from evaluations, monitoring of performance and re-ealuations ofthe external providers. 643 The laboratory shall communicate its requirements to external providers fr: 4) the products and services tobe provided; 1) the acceptance eer; competence, including any required qualifieation of personnel 4d) activities thatthe laboratory, or Its customer, intends to perform at the external provider's premises. 7 Process requirements 7A. Review of requests, tenders and contracts, ‘TAA The laboratory shall have a procedure forthe review of requests, tenders and contracts. The ‘procedure hall ensure that: 4) the requirements are adequately defined, documented and understood; 1b) the lboratory has the capability and resources to meet the requirements: 19) where external providers are used, the requirements of 6.6 are applied and the laboratory advises the customer of the specific laboratory activites to be performed by the external provider and tains the customer's approval, NOTE1 tis recognized that externally provided laboratory atvtes can occur when: =the laboratory has the resources and competence to perform the activites, oweves for unforeson ‘ease lsunable undertake these in par oral — shelaboratry does not have the resources or compsteneto perform the activities 48) the appropriate methods or procedures are selected and are capable of meeting the customers) requlrements. NOTE2 _ For internal or routine customers, reviews of requests, tenders and contracts can be performed ina Simplified way. 74.2. The laboratory shall inform the customer when the method requested by the customer Is considered tbe inappropriate or ou of date 7.3. When the customer requests & statement of conformity ta specification or standard for the {est or calibration (eg. pass/falin-tolerance/out-otolerance), the specification or standard and the (© 80/2017 argheareerved ° decision rule shal be clearly defined. Uniess nerent inthe requested specification or standard, the ‘decison rule selected shall be communicated to, and agreed with, the customer. NOTE Forfurther uidanceon statements of conformity, se ISO/IEC Guide 98-4 744 Any dlferences between the request or tender and the contract shall be resolved before laboratory activities commence. Each contract shall be acceptable both to the laboratory and the customer: Deviations requested by the customer shall not impact the integrity ofthe laboratory or the validity ofthe results, TAS. The customer shall be informed of any deviation from the contract. 74.6 ia contracts amended after work has commenced, the contract review shall be repeated and ‘ny amendments shall be communicated toll affected personnel 74.7 The laboratory shall cooperate with customers or their representatives in clariying the cstomer’s request and in monitoring the laboratory's performance in relation tothe work performed. NOTE Such cooperation ea include: 8) providing eeasonable acess to relevant aeas ofthe laboratory to witness custmerspecific laboratory ) preparation, packaging and dispatch fitems needed by the customer for verification purpses 7.8 Records of reviews, including any significant changes, shall be retained. Records shal also be ‘etaned of pertinent discussions wit 2 customer relating tothe customer's requirements or the results ofthe laboratory activites, 7.2. Selection, verification and validation of methods, 724 Selection and verification of methods 72.1.1 The laboratory shall use appropriate methods and procedures forall laboratory aetvtes ang “where appropriate, for evaluation ofthe measurement uncertainty as well as statistical techniques for analysis of data, NOTE “Method” as used in this document can be considered synonymous with the term "measurement procedure” as defined nS0/1EC Gude 93 722.2 All methods, procedures and supporting documentation, such as instructions, standards, ‘manials and reference data relevant to the laboratory activities, shall be kept upto date and shal be ‘made readily available to personnel (se 3). 7213 The laboratory shall ensure that it uses the latest valid version of a method unles tis not Appropriate or possible todo so, When necessary the application ofthe method stall be supplemented ‘with adlitional details to ensure consisent application NOTE International regional or national standards or other recognized specifications that contain suffident Sd concise tformation on how to perform laboratory activities donot need tobe Supplemented ar Feweten as {eternal procedures these standards are writen in away that they canbe wed By the operating personnel in laboratory. can be necessary to provide addtional documentation for optional step in the method 9° tional details 72.14 When the customer does not specify the method to be used the laboratory shall sleet an Appropriate method and inform the customer of the method chosen, Methods published either in International, reglonal ot national standards, or by reputable technical organizations, oF in relevant 10 ‘© 80/2017 Aig reered sclentifie eats or Journals, or as specified by the manufacturer ofthe equipment, are recommended, Laboratory-developed or modified methods can also be use. 72.45 The laboratory shall verify that ican properly perform methods before introducing them by ‘ensuring that can achieve the required performance. Records of the verification shal be retained. the ‘method i revised bythe isuing body verification shall be repeated tothe extent necessary 7.2.1.6 When method development is required, this shall be a planned activity and shall be assigned 1 competent personnel equipped with adequate resources, As method development proceeds, periodic review shall be carried out to confirm that the needs of the customer are still being flied. Any ‘modifications to the developmen plan shall be approved and authorized. 7.2.1.7 Deviations from methods for all laboratory activities shall occur only ifthe deviation has been documented technically justified, authorized, and accepted by the customer. NOTE Customer acceptance of deviations canbe agred in advance nthe contract. 72.2. Validation of methods 72.2.1 The laboratory shall validate non-standard methods, laboratory-developed methods and ‘Sandard methods used outside their intended scope or otherwise modified The validation shall be as fxtensive a is necessary to meet the needs ofthe given application or eld of application NOTE —Valiaton can include procedures for sampling handling and transportation oftest or calration ems NOTE2 Thetechniques used for method validation can be one of or combination of the allowing 4) callration or evaluation of bias and precision using reference standards or reference materia 1) cyetematicaeartmant ofthe factors influencing the rel 6) testing method robustness through vaition ofconralied parameters, such at incubator temperature, ‘Volume dispensed 4) comparison of results achieved with other validated methods: 6) lnterlaboratory comparisons 1, evahstion of measurement uncertalnty ofthe resuls based onan understanding ofthe theoretical principles ‘ofthe method and praca experince a the performance ofthe sampling or test method. 72.22 When changes are made to a validated method, the influence of such changes shall be

    You might also like