Requirements of ISO 17025:2005 in imperative form (To do list

!o # Title $ana%ement requirements Requirements "etails

Have te()ni(al mana%ement *)i() )as overall responsi+ilit, for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations. "emonstrate impartialit,- independen(e of judgement and inte%rit, in relation to its testing. "emonstrate that managerial and technical personnel have the authority and resour(es needed to carry out their duties in relation to the quality management system. to ensure the prote(tion of its (ustomers/ (onfidential information and proprietar, ri%)ts0 including procedures for protecting the electronic storage and transmission of results; to avoid involvement in any a(tivities that would diminis) (onfiden(e in competence, impartiality, judgement or operational integrity.

.ave poli(ies and pro(edures #&1 Or%ani'ation "efine t)e or%ani'ation and mana%ement stru(ture of the laboratory, its place in any parent organization, and the relationships between quality management, technical operations and support services. Spe(if, t)e responsi+ilit,- aut)orit, and interrelations)ips of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations. 1ppoint a qualit, mana%er with defined responsibility for the qquality management system and direct access to the highest level of management. 1ppoint deputies for key managerial personnel. 2rovide adequate supervision of testing and calibration staff. 3nsure mplement and maintain a mana%ement s,stem appropriate to the scope of activities #&2 $ana%ement s,stem "o(ument to the e!tent necessary to assure the quality of the test and/or calibration results" #he system$s documentation shall be %.

that appropriate (ommuni(ation processes are established; that personnel are a*are of the relevance and importance of their activities.

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$ana%ement s,stem ((ontinuation

poli(ies s,stems pro%rammes pro(edures instru(tions (ommuni(ated to understood +, availa+le to implemented +, include or make reference to the supportin% pro(edures in(ludin% te()ni(al pro(edures. outline t)e stru(ture of t)e do(umentation used in the

%.the appropriate personnel "efine the laboratory&s management system poli(ies related to quality in a qualit, manual

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Title

Requirements

"etails management system define roles and responsi+ilities of te()ni(al mana%ement and t)e qualit, mana%er, including their responsibility for ensuring compliance with this nternational 'tandard

3sta+lis) the overall objectives and revie* it during management review ensure t)e inte%rit, of t)e mana%ement s,stem *)en ()an%es are planned and implemented the laboratory management&s commitment to %ood professional pra(ti(e and to the qualit, of its testing and calibration; the management$s statement of the laboratory&s standard of servi(e0 the purpose of t)e mana%ement s,stem related to quality; a requirement t)at all personnel familiari'e themselves with the quality documentation and implement the policies and procedures in their work; the laboratory management&s (ommitment to (ompl, *it) t)is International Standard and to (ontinuall, improve the effectiveness of the management system; the requirement that tests and/or calibrations s)all al*a,s +e (arried out in a((ordan(e *it) stated met)ods and (ustomers4 requirements0 provide eviden(e of (ommitment to the development and implementation of the management system and to continually improving its effectiveness; (ommuni(ate to t)e or%ani'ation t)e importan(e of meeting customer requirements as well as statutory and regulatory requirements. regulations; standards; other normative documents; test and/or calibration methods; drawings; software; specifications; instructions; manuals; revie* and approve by authorized personnel and prior to issue all documents issued to personnel; use same procedure for ()an%es0 set rules for )and made changes and for changes on (omputerised do(uments; uniquel, identif, documents (date of issue and/or revision, page number and total number of pages, issuing authority(ies.;

Issue a (on(ise qualit, poli(, statement under t)e aut)orit, of top mana%ement. t shall at least contain"

Top mana%ement

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"o(ument (ontrol (for data control see ).*.+, for record control see *.,-.

3sta+lis) and maintain pro(edures to (ontrol all do(uments that form part of its management system (#hese may be on various media, whether hard copy or electronic, and they may be digital, analogue, photographic or written.

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Revie* of requests- tenders and (ontra(ts

3sta+lis) and maintain poli(ies and pro(edures for the revie* of requests- tenders and (ontra(ts ensuring that

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Title

Requirements /lace subcontracted work with a (ompetent su+(ontra(tor (ompl,in% *it) ISO 17025:2005 $aintain a re%ister 1dvise t)e (ustomer and gain hid approval of the arrangement in writing .ave a poli(, and pro(edure(s

esta+lis) and ma6e readil, availa+le a master list identifying revision status and distribution; ma6e aut)ori'ed editions of appropriate do(uments availa+le at all relevant locations; revie* documents periodi(all, and revisewhere necessary; remove invalid or o+solete do(uments promptly; mar6 obsolete documents retained suitably; requirements are adequately defined, documented and understood; laboratory has the capability and physical, personnel and information resources to meet the requirements; method selected and is capable of meeting the customers& requirements; differences between request or tender and contract are resolved before any work commences; records of reviews and pertinent discussions with customer are maintained; reviews cover subcontracts; same contract review process is used for amendments; customer is informed of any deviation from the contract; "etails

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Su+(ontra(tin% of tests and (ali+rations

of all subcontractors; of the evidence of compliance;

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2ur()asin% servi(es and supplies

for the sele(tion and pur()asin% of services and supplies; for pur()ase- re(eption and stora%e of reagents and laboratory consumable materials; ensuring that purchased supplies, reagents and consumables are not used until they have been verified as (ompl,in% with specifications or requirements; that re(ords of a(tions ta6en to check compliance are maintained; that do(uments describing the ordered services and supplies are revie*ed and approved for technical content prior to release;

that suppliers of critical consumables, supplies and services are evaluated and re(ords of t)ese evaluations and lists t)ose approved are maintained; 8ooperate *it) (ustomers and in relation to the work performed, provided that the laboratory 3nsure (onfidentialit, to other customers See6 feed+a(6 from customers 0nalyse feedback to improve in clarifying the customer&s request; in monitoring the laboratory$s performance; the mana%ement s,stem; testin% and (ali+ration a(tivities0 (ustomer servi(e0 for the resolution of (omplaints received from customers or other parties; for maintaining re(ords of all complaints and of the investigations and corrective actions taken; responsibilities and authorities for the management of nonconforming work are designated (including halting of work, withholding of test reports, as necessary, and resumption of work.; actions are defined and taken; an evaluation of the significance of the nonconforming work is made and the corrective action procedures given in *.,, are promptly followed if necessary; the customer is notified and work is recalled where necessary. "etails quality policy; quality objectives; audit results; analysis of data; corrective actions; preventive actions; management review;

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Servi(e to t)e (ustomer

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8omplaints

.ave a poli(, and pro(edure

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8ontrol of non(onformin% testin% and;or (ali+ration *or6

.ave a poli(, and pro(edures that shall be implemented *)en an, aspe(t or t)e results of its testing and/or calibration work do not (onform to its own procedures or agreed requirements of the customer. #he policy and procedures shall ensure that"

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Title

Requirements

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Improvement

Improve t)e effe(tiveness of the management system through the use of

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8orre(tive a(tion

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<eneral

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8ause anal,sis Sele(tion and implementation of (orre(tive a(tions

3sta+lis) a poli(, and a pro(edure and desi%nate appropriate aut)orities for implementing corrective action when nonconforming work or departures from the policies and procedures in the management system or technical operations have been identified. 1se the following sequence in the procedure. 'tart with an investigation to determine the root cause(s. of the problem. dentify potential corrective which

most likely eliminate the problem and prevent recurrence; are appropriate to the magnitude and the risk

of the problem. 2ocument and implement any required changes resulting from corrective action investigations. 3onitor the results to ensure that the corrective actions taken have been effective. 0udit the appropriate areas of activity in accordance with *.,* as soon as possible where a serious issue or ris6 to t)e +usiness has been identified due to nonconformities Identif, needed improvements 2evelop, implement and monitor a(tion plans& #&12 2reventive a(tion Identif, potential sour(es of non(onformities 2evelop, implement and monitor a(tion plans "raft 2ro(edures for preventive actions including initiation and the appli(ation of (ontrols to ensure that they are effective. 3sta+lis) and maintain pro(edures %.. Te()ni(al0 concerning the mana%ement s,stem0 7ase it on review of the operational procedures, anal,sis of data- trend and ris6 anal,ses and profi(ien(,=testin% results& identification; collection; inde!ing; access; filing; storage; maintenance; disposal. "etails reports from internal audits; management reviews; records of corrective actions; records of preventive actions; are legible; are stored and retained in facilities that provide a suitable environment to prevent loss, damage or deterioration; are held secure and in confidence; are readily retrievable; have established retention times. protect and back8up records stored electronically; prevent unauthorized access to or amendment of these records. 9orms; :ontracts; work sheets;

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$onitorin% of (orre(tive a(tions 1dditional audits

with its own policies and procedures; with compliance with this '4 ,+56)"655). Te()ni(al0 concerning the mana%ement s,stem&

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8ontrol of re(ords <eneral %..for quality records %..for technical records Requirements In(lude in t)e list of qualit, re(ords

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Title

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<eneral (continuation.

3nsure t)at all re(ords (in any media, such as hard copy or electronic media.

.ave pro(edures to #&15&2 Te()ni(al re(ords Retain for a defined period te()ni(al re(ords (data and information resulting from carrying out tests and/or calibrations and indicating whether

specified quality or process parameters are achieved., such as%

2rovide suffi(ient information in test and calibration records to enable

In(lude t)e identit, of personnel responsible for

8orre(t mista6es in records by 3nsure alterations to re(ords are si%ned or initialled by the person making the correction and equivalent measures are taken for electronically stored records. !o Title Requirements

check sheets; work notes; control graphs; work books; records of original observations; derived data; sufficient information to establish an audit trail; copy of each (internal and e!ternal. test report; calibration records; copy of each calibration certificate issued; staff records; customers& notes, papers and feedback; if possible, identification of factors affecting the un(ertaint,0 repetition of tests or calibrations; the sampling; performance of each test; performance of each calibration; checking of results; crossing out (not erasing, making illegible or deleting. and entering the correct value alongside.

2eriodi(all, (cycle of one year. (ondu(t internal audits of activities (to verify that operations continue to comply with the requirements of the management system and '4 ,+56)"655)

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Internal audits

Ta6e t)e follo*in% a(tions when audit findings cast doubt on the effectiveness of operations, correctness or validity of test or calibration results

"etails in accordance with a predetermined schedule and procedure; addressing all elements of the management system, including the testing and/or calibration activities; under the responsibility of the quality manager; by trained and qualified personnel who are wherever independent of the activity to be audited; ta6e timel, (orre(tive a(tion0 notify customers in writing if laboratory results may have been affected; record the area of activity audited, the audit findings and corrective actions that arise from them; verify and record the implementation and effectiveness of the corrective action taken through follow8up audits.

the suitability of policies and procedures reports from managerial and supervisory personnel; t)e out(ome of re(ent internal audits0 corrective and preventive actions; assessments by e!ternal bodies; the results of inter8laboratory comparisons or proficiency tests; changes in the volume and type of the work; customer feedback; :omplaints; recommendations for improvement; other relevant factors, such as quality control activities, resources and staff training. findings from management reviews are recorded; arising actions are recorded and carried out within an appropriate and agreed timescale; results (goals, objectives and action plans. are fed into the laboratory planning system for the coming year; management review i related subjects are considered at regular management meetings.

2eriodi(all, (every ,6 months. (ondu(t (by top management. a revie* of t)e la+orator,4s mana%ement s,stem and testin% and;or (ali+ration a(tivities in accordance with a predetermined schedule and pro(edure taking account of" #&15 $ana%ement revie*s

3nsure t)at

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Title

Requirements 8onsider and ta6e a((ount of all fa(tors influencing correctness and reliability of the tests and/or calibrations contributing to different e!tent to the total uncertainty of measurement when developing test and calibration methods and procedures, training and qualifying personnel, and selecting and calibrating equipment.

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Te()ni(al requirements <eneral

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2ersonnel 3nsure t)e (ompeten(e of all who

>ualif, personnel performing specific tasks on the basis of Supervise appropriatel, staff undergoing training.

"etails human factors (see ).6.; accommodation and environmental conditions (see ).-." test and calibration methods and method validation (see ).*.; equipment (see ).).; measurement traceability (see ).;.; sampling (see ).+.; handling of test and calibration items (see ).<.. operate specific equipment; perform tests and/or calibrations; evaluate results; sign test reports and calibration certificates; appropriate education; training; e!perience; demonstrated skills.

3nsure t)at personnel responsi+le for t)e opinions and interpretation in(luded in test reports )ave in addition

$ana%ement formulate t)e %oals with respect to the personnel$s

.ave a poli(, and pro(edures for @se personnel *)o are emplo,ed by, or under (ontra(t to the laboratory. 3nsure t)at contracted and additional technical and key support personnel are used, the laboratory shall ensure that su() personnel are supervised and competent and that they work in accordance with the laboratory&s management system.

relevant 6no*led%e of the manufacturing technology, the intended uses, the defects or degradations likely occurring during service for the items, materials, products, etc. tested; 6no*led%e of t)e %eneral requirements e?pressed in t)e le%islation and standards0 an understandin% of t)e si%nifi(an(e of deviations found with regard to the normal use of the items, materials, products, etc. concerned. =ducation; #raining; 'kills; identifying training needs relevant to the present and anticipated tasks of the laboratory providing such training to personnel evaluating the effectiveness of the training

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Title 2ersonnel (continuation.

Requirements $aintain (urrent Ao+ des(riptions, , , , , and with respect to performing., for "efine the following as part of job descriptions

"etails mana%erial personnel; te()ni(al personnel; key support personnel involved in tests and/or calibrations; responsi+ilities for" /lanning; tests and/or calibrations /erforming; =valuating; >eporting; nterpreting; method modification; method development; method validation.

1ut)ori'e spe(ifi( personnel to $aintain readily available re(ords of %

%for all technical personnel. "o(ument t)e te()ni(al requirements for a((ommodation and environmental (onditions that can affect the results of tests and calibrations and ensure t)at t)e environmental (onditions % %of any measurement correct performance of the tests and/or calibrations $onitor- (ontrol and re(ord environmental conditions as required by the relevant specifications, methods and procedures or where they influence the quality of the results (and stop tests and calibrations when the environmental conditions jeopardize the results of the tests and/or calibration., for e!ample% Separate nei%)+ourin% areas in *)i() t)ere are in(ompati+le a(tivities to prevent cross8 contamination. 8ontrol a((ess to and use of areas affecting the quality of the tests and/or calibrations. 3nsure %ood )ouse6eepin% in the laboratory. Requirements

perform particular types of sampling, test and/or calibration; issue test reports and calibration certificates give opinions and interpretations; operate particular types of equipment. the relevant authorization(s. and dates of its confirmation; competence and date of its confirmation; educational and professional qualifications; #raining; skills and e!perience%.

facilitate and do not invalidate the results; do not adversely affect the required quality%

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1((ommodation and environmental (onditions

biological sterility; 2ust; #emperature; etc.

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Title Test and (ali+ration met)ods and met)od validation <eneral

@se appropriate met)ods and pro(edures for all tests and;or (ali+rations including

.ave up to date and readil, availa+le instru(tions (deviation from test and calibration methods shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer..

"etails 'ampling; Handling; #ransport; 'torage; preparation of items to be tested and/or calibrated; statistical techniques for analysis of test and/or calibration data; estimation of the measurement uncertainty. on the use and operation of all relevant equipment; on the handling and preparation of items for testing and/or calibration.

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Sele(tion of met)ods

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Ba+orator,=developed met)ods

"o not supplement or re*rite international, regional or national standards or other recognized specifications that they can be used as published and contain sufficient and concise information on how to perform the tests and/or calibrations t may be necessary to provide additional documentation for optional steps in the method or additional details. @se onl, test and/or calibration methods, including methods for sampling, which meet the needs of the customer and which are appropriate for the tests and/or calibrations it undertakes. @se prefera+l, methods published in international, regional or national standards or by reputable technical organizations, or in relevant scientific te!ts or journals, or as specified by the manufacturer of the equipment. @se la+orator,=developed met)ods or methods adopted by the laboratory onl, if they are appropriate for the intended use and if they are validated. @se an, met)od onl, following confirmation that the laboratory can properly operate it and repeat this conformation if the standard/method changes. Inform t)e (ustomer as to the method chosen. 2lan t)e introdu(tion of test and calibration methods developed by the laboratory for its own use and assi%n this activity to qualified personnel equipped with adequate resources. @pdate plans as development proceeds and ensure effe(tive (ommuni(ation amongst all personnel involved.

use the latest valid edition of a standard unless it is not appropriate or possible to do so; only when necessary, supplement the standard with additional details ensuring consistent application.

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Title !on=standard met)ods

Requirements "evelop pro(edures for t)e introdu(tion of validated met)ods not (overed +, standards and ensure that the method description contains at least the following information

"etails appropriate identification; 'cope; description of the type of item to be tested or calibrated; parameters or quantities and ranges to be determined; apparatus and equipment, including technical performance requirements; reference standards and reference materials required; environmental conditions required and any stabilization period needed; description of the affi!ing of

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Calidation of met)ods

8onfirm +, e?amination and provision of o+Ae(tive eviden(e that the particular requirements for a specific intended use are fulfilled by non8standard methods, laboratory8 designed/developed methods, standard methods used outside their intended scope, and amplifications and modifications of standard methods"

identification marks, handling, transporting, storing and preparation of items; checks to be made before the work is started; checks that the equipment is working procedure, including properly and, where required, calibration and adjustment of the equipment before each use; the method of recording the observations and results; any safety measures to be observed; criteria and/or requirements for approval/rejection; data to be recorded and method of analysis and presentation; the uncertainty or the procedure for estimating uncertainty. validate as e?tensivel, as is necessary to meet the needs of the given application or field of application and include sampling, handling and transportation ? if relevant; re(ord the procedure used for the validation, the results obtained, and a statement as to whether the method is fit for the intended use.

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Title Calidation of met)ods (continuation.

Requirements @se one or a (om+ination of t)e follo*in% te()niques for t)e determination of t)e performan(e of a met)od

"etails calibration using reference standards or reference materials; comparison of results achieved with other methods; nter8laboratory comparisons systematic assessment of the factors influencing the result; assessment of the uncertainty of the results based on scientific understanding of the

theoretical principles of the method and practical e!perience. Investi%ate t)e influen(e on method performance of changes later introduced into the validated method or carry out a new validation, if appropriate Cerif, t)at t)e ran%e and a((ura(, of t)e values o+taina+le from validated met)ods, e.g.,

%are relevant to the customers& needs. 3sta+lis) and appl, a pro(edure to estimate the uncertainty of measurement for all calibrations and types of calibrations.

uncertainty of the results; limit of detection; limit of quantification; selectivity of the method; @inearity; limit of repeatability and/or reproducibility; robustness against e!ternal influences; cross8sensitivity against interference from the matri!%

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3stimation of un(ertaint, of measurement

3sta+lis) and appl, pro(edures for estimating uncertainty of measurement for test methods (unless a well8recognized test method specifies limits to the values of the major sources of uncertainty of measurement and the form of presentation of calculated results.. Ta6e a((ount of sour(es contributing to the uncertainty, such as the reference standards and reference materials used, methods and equipment used, environmental conditions, properties and condition of the item being tested or calibrated, and the operator"

where possi+le use ri%orous, metrologically and statistically valid, calculation of uncertainty of measurement (degree of rigor mainly depending on limits on which decisions on conformity to a specification are based; in all ot)er (ases attempt to identify all components of uncertainty and make a reasonable estimation, to avoid that the form of reporting of the result gives a wrong impression of the uncertainty; knowledge of the performance of the method; measurement scope; +ase estimation on use of, for e!ample, previous e!perience; validation data. "etails

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Title

Requirements 8)e(6 calculations and data transfers s,stemati(all, and in an appropriate manner.

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8ontrol of data

3nsure in all situations where computers or automated equipment are used for the acquisition, processing, recording, reporting, storage or retrieval of test or calibration data that"

(omputer soft*are developed by the user is do(umented in sufficient detail and is suitably validated as being adequate for use; pro(edures are esta+lis)ed and implemented for prote(tin% t)e inte%rit, and (onfidentialit, of data (e.g., during entry or collection, storage, transmission and processing.; (omputers and automated equipment are

3nsure t)at %

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3quipment

3nsure t)at %

maintained to ensure proper functioning and are provided with the environmental and operating conditions necessary to maintain the integrity of test and calibration data; la+orator, spe(ifi( (onfi%urations; modifi(ations of commercial off8the8shelf software (e.g. word8processing, database and statistical programmes. are validated . the la+orator, is furnis)ed *it) all items of samplin%- measurement and test equipment required for the correct performance of the tests and/or calibrations (including sampling, preparation of test and/or calibration items, processing and analysis of test and/or calibration data.; the requirements of '4 ,+56)"655) are met in those cases where the laboratory needs to use equipment outside its permanent control; (ali+ration pro%rammes are established for key quantities or values of the instruments where these properties have a significant effect on the results; equipment (including that used for sampling. is (ali+rated or ()e(6ed to establish that it meets the laboratory&s specification requirements +efore it is pla(ed into servi(e and +efore it is used0 only aut)ori'ed personnel operates the equipment; @p=to=date instru(tions on the use and maintenance of equipment (including any relevant manuals provided by the manufacturer of the equipment. are readily available; =ach item of equipment and its software is uniquel, identified 8 where practicable. "etails the identit, of the item of equipment and its software; the manufa(turer4s name- t,pe identifi(ation- and serial num+er or other unique identification; ()e(6s t)at equipment (omplies with the specification; the (urrent lo(ation, where appropriate the manufa(turer4s instru(tions, if available, or reference to their location; dates- results and (opies of reports and

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Title 3quipment (continuation.

Requirements $aintain re(ords of ea() item of equipment and its software significant to the tests and/or calibrations performed which contain at least"

certificates of all calibrations, adjustments, acceptance criteria, and the due date of ne!t calibration; the maintenan(e plan, where appropriate, and maintenance carried out to date; any dama%e- malfun(tion- modifi(ation or repair to the equipment; .ave pro(edures for safe handling, transport, storage, use and planned maintenance of measuring equipment to ensure proper functioning and in order to prevent contamination or deterioration. Ta6e out of servi(e- isolate or (learl, la+el as being out of service (until it has been repaired and evidently performs correctly. all equipment that has been subjected to overloading or mishandling, or has been shown to be defective or outside specified limits, or gives suspect results. Ba+el all equipment under the control of the laboratory and requirin% (ali+ration to indicate, including the and the Cerif, satisfa(tor, fun(tion and (ali+ration status when, for whatever reason, equipment goes temporarily outside the direct control of the laboratory, the laboratory. 8arr, out all necessary intermediate ()e(6s of the calibration status of the equipment a((ordin% to a defined pro(edure .ave pro(edures to ensure that copies (e.g. in computer software. are correctly updated where calibrations give rise to a set of correction factors. Safe%uard all test and calibration equipment including its software from adAustments which would invalidate the test and/or calibration results.

e?amine t)e effe(t of the defect or departure from specified limits on previous tests and/or calibrations; institute the A8ontrol of non(onformin% *or6B pro(edure& the status of (ali+ration0 date when last (ali+rated0 date or e!piration criteria *)en re(ali+ration is due&

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Title $easurement tra(ea+ilit, <eneral Spe(ifi( requirements

Requirements 8ali+rate all equipment having a significant effect on the accuracy or validity of the result of the test, calibration or sampling used for tests and/or calibrations +efore puttin% it into servi(e and )ave an esta+lis)ed pro%ramme and pro(edure for the calibration of this equipment. "esi%n and operate (ali+ration la+oratories and )ave a pro%ramme for (ali+ration of equipment so as to ensure that calibrations and measurements made by the laboratory are traceable

"etails .ave a s,stem for selecting, using, calibrating, checking, controlling and maintaining measurement standards, reference materials used as measurement standards, and measuring and test equipment used to perform tests and calibrations. esta+lis) tra(ea+ilit, of own measurement standards and measuring instruments to the ' +, means of an un+ro6en ()ain of calibrations or comparisons linking them to

to the nternational 'ystem of 1nits ('ystCme international d&unitDs, ' ..

3sta+lis)in% tra(ea+ilit, of (ali+ration la+oratories to appropriate measurement standards in case of calibrations that currently cannot be strictly made in ' units by . n these cases calibration shall provide confidence in measurements by such as"

1ppl, t)e a+ove requirements to measuring and test equipment with measuring functions of testin% la+oratories depending on the contribution to the total uncertainty of the test result of the calibration.

relevant primary standards of the ' units of measurement (may be achieved in several steps carried out by different laboratories that can demonstrate traceability.; a()ieve t)e lin6 to SI units +, referen(e to national measurement standards (primary or secondary. or use (ali+ration servi(es from laboratories issuing calibration certificates that can demonstrate competence, measurement capability and traceability. n this case ensure t)at (ertifi(ates contain the measurement results, including the measurement uncertainty and/or a statement of compliance with an identified metrological specification (see also ).,5.*.6.. use of (ertified referen(e materials provided by a competent supplier to give a reliable physical or chemical characterization of a material; use of spe(ified met)ods and/or (onsensus standards that are clearly described and agreed by all parties concerned; parti(ipation in a suita+le pro%ramme of interla+orator, (omparisons0 ensure that the equipment used can provide the uncertainty of measurement needed; if calibration is the dominant factor, the requirements of traceability should be strictly followed; use certified reference materials, agreed methods and/or consensus standards as required for calibration laboratories 8 where traceability of measurements to ' units is not possible or not relevant.

!o 5&7&5

Title Referen(e standards and referen(e materials

Requirements .ave a pro%ramme and pro(edure for the calibration of referen(e standards by a body that can provide traceability. >eference standards shall be calibrated before and after any adjustment. 1se referen(e materials tra(ea+le to SI units of measurement, where possible or to (ertified referen(e materials and check internal reference materials as far as is technically and economically practicable.

"etails 1se reference standards of measurement for calibration only.

.ave defined pro(edures and s()edules for intermediate checks needed to maintain confidence in the calibration status of"

9or reference standards and reference materials )ave pro(edures for

.ave a samplin% plan and pro(edures for sampling of substances, materials or products for subsequent testing or calibration.

reference standards; primary standards; transfer standards; working standards; reference materials; safe handling; transport; storage; use. $a6e the sampling plan as well as the sampling procedure availa+le at t)e lo(ation where sampling is undertaken. Dase sampling plansl, whenever reasonable, on appropriate statisti(al met)ods. #he samplin% pro(ess shall address the factors to be controlled to ensure the validity of the test and calibration results.

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Samplin%

Re(ord in detail with the appropriate sampling data and include in all documents containing test and/or calibration results if the customer requires deviations, additions or e!clusions from the documented sampling procedure. :ommunicated these to the appropriate personnel. .ave pro(edures for re(ordin% relevant data and operations relating to sampling that forms part of the testing or calibration that is undertaken. nclude in the records" the sampling procedure used; the identification of the sampler; environmental conditions (if relevant.; diagrams or other equivalent means to identify the sampling location as necessary; the statistics the sampling procedures are based upon; transportation; receipt; handling; /rotection; 'torage; retention and/or disposal; "etails the integrity of the test or calibration item; the interests of the laboratory; the interests of the customer.

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.andlin% of test and (ali+ration items

.ave pro(edures for samples of test and/or calibration items covering"

!o 5&9

Title .andlin% of test and (ali+ration items (continuation.

Requirements @ay down provisions necessary to protect .ave a s,stem for identifying test and/or calibration items throughout the life of the item in the laboratory or upon transfer from the laboratory which e!cludes confusion of items either physically or when referred to in records or other documents. Re(ord an, a+normalities of items or departures from normal or specified conditions, as described in

the test or calibration method upon receipt of the test or calibration item. 8onsult t)e (ustomer for furt)er instru(tions before proceeding and record the discussion when there is doubt as to the suitability of an item for test or calibration, or when an item does not conform to the description provided, or the test or calibration required is not specified in sufficient detail. follow handling instructions provided with the item; maintained, monitor and record specified storage and environmental conditions; )ave arran%ements for stora%e and se(urit, for test or calibration item or a portion of an item that is to be held secure; provide a copy of the sampling procedure and information on storage and transport of samples, including information on sampling factors influencing the test or calibration result, to those responsible for taking and transporting the samples; use re%ularl, certified reference materials and/or internal quality control using secondary reference materials; parti(ipate in inter8laboratory comparison or proficiency8testing programmes; perform repli(ate tests or calibrations using the same or different methods; retest or recalibrate retained items; (orrelate results for different characteristics of an item; re(ord t)e resultin% data in such a way that trends are detectable; appl, statisti(al te()niques to the reviewing of the results where practicable; ta6e planned (orre(tive a(tion where quality control data fall outside pre8defined criteria; "etails Report results in a test report or a calibration certificate issued as hard copy or by electronic data transfer and including all the information requested by the customer and necessary for the interpretation of the test or calibration results and all information required by the method used. In(lude normall, for this purpose the information is required by ).,5.6, and ).,5.-

.ave pro(edures and appropriate fa(ilities for avoiding deterioration, loss or damage to the test or calibration item during storage, handling and preparation.

5&:

1ssurin% t)e qualit, of test and (ali+ration results

.ave qualit, (ontrol pro(edures for a planned monitoring of the validity of tests and calibrations undertaken

!o 5&10 5&10&1

Title Reportin% t)e results <eneral

Requirements Report a((uratel,- (learl,- unam+i%uousl, and o+Ae(tivel, , and in accordance with any specific instructions in the test or calibration method the results of each test, calibration, or series of tests or calibrations carried out by the laboratory.

5&10&2

Test reports and (ali+ration (ertifi(ates

.ave a format for test reports or (ali+ration (ertifi(ates that contains at least the following information

or ).,5.* of '4 ,+56)"655) (internal reports may be simplified.. .ave readil, availa+le all information listed in ).,5.6 to ).,5.* including parts not reported to the customer in the laboratory which carried out the tests and/or calibrations. title (e.g. A#est >eportB or A:alibration :ertificateB.; name and address of t)e la+orator, , and the location where the tests and/or calibrations were carried out, if different from the address of the laboratory; unique identifi(ation of the test report or calibration certificate (such as the serial number.; an identifi(ation on ea() pa%e in order to ensure that the page is recognized as a part of the test report or calibration certificate; a (lear identifi(ation of t)e end of the test report or calibration certificate; name and address of t)e (ustomer; identification of the met)od used; unambiguous identifi(ation- des(riptionand t)e (ondition of t)e item (s. tested or calibrated; date of re(eipt of the test or calibration item(s.; reference to the samplin% plan and pro(edures used by the laboratory or other bodies; results with, where appropriate, the units of measurement of the test or calibration; name(s - fun(tion(s and si%nature(s of person(s. authorizing the test report or calibration certificate; where relevant, a statement to the effect that the results relate only to the items tested or calibrated. "etails deviations from- additions to- or e?(lusions from the test method, and information on specific test conditions; a statement of (omplian(e;non=(omplian(e with requirements and/or specifications; where applicable, a statement on the estimated

!o 5&10&5

Title Test reports

Requirements In(lude t)e follo*in% additional information on test met)ods in the format for test reports

In(lude t)e follo*in% additional information on samplin% E where applicable = in the format for test reports

5&10&#

8ali+ration (ertifi(ates

In(lude t)e follo*in% additional information in the format for (ali+ration (ertifi(ates

5&10&5

Opinions and interpretations

$ar6 (learl, opinions and interpretations as such in a test report and do(ument the basis upon which they have been made. /rovide the following information Identif, (learl, any results of tests performed by subcontractors and use the calibration certificate of the laboratory performing the work. =nsure compliance with '4 ,+56)"655) in case of electronic transmission of test or calibration results

un(ertaint, of measurement; where appropriate and needed, opinions and interpretations (see ).,5.).; additional information which may be required by specific methods, customers or groups of customers; date of sampling; unambiguous identifi(ation of t)e su+stan(e, material or product sampled; the lo(ation of samplin%, including any diagrams, sketches or photographs; a referen(e to t)e samplin% plan and pro(edures used; details of any environmental (onditions during sampling that may affect the interpretation of the test results; any standard or ot)er spe(ifi(ation for t)e samplin% met)od or pro(edure, and deviations, additions to or e!clusions from the specification concerned. the conditions (e.g. environmental. under which the calibrations were made that have an influence on the measurement results; the uncertainty of measurement and/or a statement of compliance with an identified metrological specification or clauses thereof; evidence that the measurements are traceable. an opinion on t)e statement of (omplian(e;non(omplian(e of the results with requirements; fulfilment of (ontra(tual requirements; re(ommendations on how to use the results; %uidan(e for improvements0

5&10&7 5&10&7 !o 5&10&9 5&10&:

Testin% and (ali+ration results o+tained from su+(ontra(tors 3le(troni( transmission of results Title Format of reports and (ertifi(ates 1mendments to test reports and (ali+ration (ertifi(ates

Requirements 2esign the format to a((ommodate ea() t,pe of test or calibration carried out but harmonise the layout and minimize the possibility of misunderstanding or misuse. $a6e material amendments to a test report or calibration certificate after issue onl, in t)e form of a furt)er do(umentor data transfer.

"etails

9ulfil all requirements of '4 ,+56)"655). >efer to the original document and uniquely identify the new one if a complete new report or certificate is to issued.

nclude the statement" A'upplement to #est >eport Eor :alibration :ertificateF, serial number... Eor as otherwise identifiedFB.