17025 gap analysis

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 6/September 2005Document10 of 28

LABORATORY

ASSESSMENT

WORKSHEET

This assessment worksheet has been designed to assist both the laboratory staff andthe assessment team. Laboratory staff can use this checklist as part of theirpreparation for an assessment to ISO/IEC 17025. There is NO need to return thecompleted checklist to the Association. The assessment team, ie the NATA leadassessor and the technical assessor can use this worksheet to assist in the collectionof all relevant information during the assessment process.

References to the relevant clauses of the NATA Accreditation Requirements (NAR)have been provided. Both the Standard itself and the field application documentshould be checked for further details, as this worksheet provides only a brief summaryof the clauses of the Standard.

The text in bold indicates amended or new requirements included in the 2005version of ISO/IEC 17025.

Laboratory Assessment Worksheet No.

17025 Laboratory Assessment Worksheet (L12.5.2)/Issue 6/September 2005 of 28Document10

4 MANAGEMENT REQUIREMENTS

4.1 Organisation

CLAUSE REQUIREMENT COMMENTS

Scope ofmanagementsystem

4.1.3

ensure management system coversactivities in the laboratory’spermanent facility, sites away fromits permanent facilities, temporary ormobile facilities

Conflict ofinterest

4.1.4

when part of an organisation, ensurethe laboratory defines theresponsibilities of key personnel toidentify potential conflicts of interest

Managerial andtechnicalpersonnel

4.1.5a

ensure managerial and technicalpersonnel have the authority andresources needed to carry out dutiesand to identify and initiate actions toprevent or minimise departures fromthe management system ortesting/calibration procedures

Undue pressure

4.1.5b

ensure arrangements are in place sothat management and personnel arefree from internal and externalcommercial, financial and otherpressures that might adverselyaffect the quality of their work

Customerconfidentiality

4.1.5c

ensure there are policies andprocedures related to customerconfidentiality, including electronicstorage and transmission of results

Operationalintegrity

4.1.5d

ensure the laboratory has policiesand procedures to avoidinvolvement in activities thatcompromise the confidence in itscompetence, impartiality, judgementor operational integrity

Organisationchart

4.1.5e

the organisation and managementstructure needs to be defined,including relationships betweenquality management, technicaloperations, support services andparent organisation (if applicable)

Responsibilityand authority

4.1.5f

specify the responsibility andauthority of all personnel whomanage, perform or verify workaffecting the quality of the testsand/or calibrations




Laboratorysupervision

4.1.5g

ensure adequate supervision byappropriate personnel of all staffinvolved in calibration and testingactivities

Technicalmanagement

4.1.5h

identify technical management thathas overall responsibility fortechnical operations and resources

Qualitymanager

4.1.5i

appoint a member of staff, withdirect access to seniormanagement, as quality managerwho has defined responsibility andauthority for implementing andmaintaining the managementsystem

Managerialdeputies

4.1.5j

where practical, appoint deputies forkey managerial personnel

Importance ofroles

4.1.5k

ensure personnel aware ofrelevance and importance of theiractivities and how they contributeto the objectives of themanagement system

Appropriatecommuni-cation

4.1.6

appropriate communicationprocesses must be establishedand include the effectiveness ofthe management system

4.2 Management System

Policies andprocedures

4.2.1

document policies and proceduresas a management system to ensurequality of all work and that they arecommunicated, available,understood and implemented

Quality policystatement

4.2.2

ensure the quality policy statementis issued under the authority of topmanagement and includes:

� the laboratory management’scommitment to good professionalpractice and quality of its service

� a statement of the laboratory’sstandard of service

� the purpose of themanagement system




4.2.2 (cont) � a requirement for all personnel tobe familiar with and implementthe quality documentation

� the laboratory management’scommitment to compliance withthe Standard and to continuallyimprove the managementsystem

� these overall objectives are tobe reviewed as part ofmanagement review

Quality manual

4.2.2, 4.2.5,

4.2.6

maintain a quality manual that:

� defines management systempolicies and objectives

� includes or makes reference tosupporting procedures, includingtechnical procedures and outlinesstructure of the documentation inthe management system

� defines the roles andresponsibilities of technicalmanagement and the qualitymanager

Commitmenttomanagementsystem

4.2.3

evidence of commitment todevelopment, implementation andcontinual improvement of themanagement system must beavailable

Customerrequirements

4.2.4

importance of meeting customer,statutory and regulatoryrequirements must becommunicated

Changes tomanagementsystem

4.2.7

integrity of the managementsystem must be maintained whenchanges are made




4.3 Document Control

Procedures

4.3.1

ensure procedures to control alldocumentation included in themanagement system areestablished and maintained

Approval andissue

4.3.2.1

ensure documents are reviewed andapproved by authorised personnelprior to issue, and are included on amaster list which identifies therevision status and distribution

Availability

4.3.2.2

ensure all necessary qualitydocumentation is available whererequired, reviewed and revised tomaintain suitability

Obsoletedocuments

4.3.2.2

ensure documents are removedwhen obsolete and suitably markedif retained for either legal orknowledge preservation purposes

Identification

4.3.2.3

all management system documentsmust be uniquely identified andinclude date of issue and/or revisionidentification, page numbering, totalnumber of pages or a mark to signifythe end of the document, and theissuing authority(ies)

Documentchanges

4.3.3.1

ensure changes to documents arereviewed and approved by the samefunction that performed the originalreview, or a designate

Altered or newtext

4.3.3.2

ensure where practical, the alteredor new text is identified in thedocument or the appropriateattachments

Handwrittenamendments

4.3.3.3

ensure if hand written amendmentsare allowed, defined procedures areavailable, which include authorities,clear marking, initialling, dating, andformal re-issue

Electronicdocuments

4.3.3.4

establish procedures to describehow changes in documentsmaintained electronically are madeand controlled




4.4 Review of requests, tenders and contracts


4.4.1, 4.4.3

ensure policies and proceduresrelated to review of requests,tenders and contracts areestablished, maintained and include:

� defining, documenting andunderstanding customerrequirements before commencingwork

� laboratory’s capability andresources

� appropriate method selection

� work that is subcontracted by thelaboratory

Records ofreview

4.4.2

maintain records of reviews,including any significant discussionsand/or changes throughout thecontract

Notification ofcustomer

4.4.4

ensure customer is informed of anydeviation from the contract

Changes tocontracts

4.4.5

ensure same contract reviewprocess is repeated if a contract hasto be amended after work hascommenced and that all affectedstaff are advised of the amendment

4.5 Subcontracting of tests and calibrations

Competency

4.5.1, 4.5.4

ensure that subcontractors arecompetent (eg accreditedlaboratory) and records aremaintained of subcontractors usedand their competency (eg scope ofaccreditation)

Customerapproval

4.5.2

ensure customer is advised inwriting and approval gained whereappropriate

Responsibility

4.5.3

unless customer or regulatoryauthority specifies subcontractor,laboratory is responsible forsubcontractors’ work




4.6 Purchasing services and supplies


4.6.1

document policies and proceduresfor selection, purchasing, receptionand storage of relevant services andsupplies

Verification

4.6.2

ensure all purchased supplies thataffect the quality are not used untilverified as complying with definedspecifications, and records of theactions taken to demonstratecompliance are maintained

Purchasingdocuments

4.6.3

ensure purchasing documents foritems affecting the quality of workare reviewed and approved fortechnical content prior to release

Approvedsuppliers

4.6.4

maintain a list and records of theevaluations of all approved suppliers

4.7 Service to the customer

Cooperation

4.7.1

cooperate with customers toclarify requests and monitorlaboratory's performance whilstensuring confidentiality to othercustomers

Feedback

4.7.2

feedback must be sought andused to improve the laboratory’sactivities

4.8 Complaints

Policy,procedure andrecords

4.8

document policy and procedure forthe resolution of complaints fromcustomers or other parties andensure records of the complaints,investigations and corrective actions(4.11) are maintained




4.9 Control of nonconforming testing and/or calibration work


4.9.1

ensure policy and procedures areimplemented when work or resultsdo not conform to own proceduresor customer requirements andinclude:

� defined responsibilities,authorities and actions

� an evaluation of the significanceof the non conforming work

� corrective actions and decisionabout the acceptability of thenonconforming work to be takenimmediately

� notification of the customer andwork recall, if necessary

� defined responsibility forauthorising the resumption ofwork

Recurrence

4.9.2

corrective action procedures (4.11)must be implemented whenevaluation indicates recurrencecould occur or there is doubtregarding compliance of laboratory'soperations with own policies andprocedures

4.10 Improvement

Effectiveness

4.10

continually improve theeffectiveness of the managementsystem

4.11 Corrective action


4.11

establish policy and procedures, anddesignate appropriate authorities forimplementing corrective actionswhich include:

� cause analysis to determine theroot cause (4.11.2)

� selection, implementation anddocumentation of correctiveactions (4.11.3)

� monitoring results to ensure




4.11 (cont.) effectiveness of correctiveactions (4.11.4)

� areas affected are to be audited(4.14) if nonconformitiesindicate laboratory not complyingwith own management system(4.11.5)

4.12 Preventive action

Identificationand action

4.12

ensure needed improvements andpotential sources ofnonconformities are identified andaction plans developed,implemented and monitored, usingcontrols to ensure they are effective

4.13 Control of records

Procedures

4.13.1.1

establish and maintain procedurescovering aspects listed below forcontrol of quality and technicalrecords:

� identification

� collection

� indexing

� access

� filing

� storage

� maintenance

� disposal

� protect, back-up and preventunauthorised access to oramendment of records storedelectronically (4.13.1.4)




Record integrity

4.13.1.2

ensure all records are:

� legible

� readily retrievable

� maintained in a suitableenvironment

� retained for established time

� held secure and in confidence (4.13.1.3)

Technicalrecords

4.13.2.1

ensure laboratory retains technicalrecords of:

� original observations

� derived data

� sufficient information to establishan audit trail

� calibration records

� staff records

� copy of each test report orcalibration certificate issued

� identity of personnel responsiblefor the sampling

� identity of personnel responsiblefor test/calibration

� identity of personnel responsiblefor checking results

and that retained records of eachtest or calibration contain sufficientinformation to:

� identify factors affecting theuncertainty

� enable the test or calibration tobe repeated using originalconditions

Recording

4.13.2.2

ensure observations, data andcalculations are recorded at the timethey are made and are identifiable tothe specific task




Corrections torecords

4.13.2.3

ensure any changes to the originalrecords (including electronic) aremade so that:

� original record is not obscured

� correct value entered alongside

� alterations signed or initialled bythe person making the correction

� equivalent measures must betaken for records storedelectronically

4.14 Internal audits

Requirements

4.14.1

� internal audits shall be conductedperiodically and in accordancewith a predetermined scheduleand procedure to verifycontinuing compliance with therequirements of themanagement system and NAR

� quality manager is responsible forplanning and organising audits tobe carried out by trained andqualified personnel independentof activity being audited (whereresources permit)

Correctiveaction andnotification ofcustomers

4.14.2

where validity of results has beenquestioned, timely corrective actionmust be taken and customersnotified in writing if it is shown thatlaboratory results have beenaffected

Records

4.14.3

records of area audited, auditfindings and corrective actions mustbe retained

Follow-upaudits

4.14.4

follow-up audits shall verify andrecord implementation andeffectiveness of corrective action




4.15 Management reviews

Objectives

4.15.1

ensure the laboratory’smanagement conducts a reviewyearly of the management systemand testing/calibration activities,based on a predetermined scheduleand procedure to ensure continuingsuitability and effectiveness and tointroduce necessary changes orimprovements

Contents

4.15.1

ensure the review includes:

� suitability of policies andprocedures

� reports from managerial andsupervisory personnel

� outcome of recent internal audits

� corrective and preventive actions

� assessments by external bodies

� results of interlaboratorycomparisons or proficiency tests

� changes in the volume and typeof the work

� customer feedback

� complaints

� recommendations forimprovement

� other relevant factors (eg qualitycontrol activities, resources andstaff training)

Actions andrecords

4.15.2

ensure findings and actions arerecorded and carried out within anappropriate and agreed timescale



5 TECHNICAL REQUIREMENTS

5.2 Personnel


Competence

5.2.1

ensure personnel performingspecific tasks are qualified on thebasis of education, training,experience and/or demonstratedskills and that when staff are beingtrained appropriate supervision isprovided

Training policy

5.2.2

policy and procedures must beimplemented for identifying trainingneeds, providing training andevaluating its effectiveness

Employees

5.2.3

ensure personnel are employed orcontracted by the laboratory, andensure contracted personnel aresupervised, competent and work inaccordance with the managementsystem

Jobdescriptions

5.2.4

maintain current job descriptions formanagerial, technical and keysupport staff

Authorisedpersonnel

5.2.5

ensure management has authorisedspecific personnel to:

� perform specific sampling, testingand/or calibration activities

� issue test reports and/orcalibration certificates and thatNATA signatory approval hasbeen taken into consideration

� give opinions and interpretations(these are only permitted on testreports in the fields of Medical,Veterinary and Forensic testing)

� operate particular types ofequipment




5.2.5 (cont.) and that records for all technicalpersonnel (including contractedpersonnel) are maintained for:

� relevant authorisation(s) includingdate on which authorisationand/or competence is confirmed

� competence

� educational and professionalqualifications

� training, skills and experience

5.3 Accommodation and environmental conditions

Facility

5.3.1

ensure the laboratory or off-sitefacility(ies) and environmentalconditions do not compromise thequality of results and that thetechnical requirements for criticalaccommodation and environmentalconditions are documented

Monitoring

5.3.2

ensure the laboratory monitors,controls and records environmentalconditions, where applicable andthat tests and/or calibrations arestopped when results arejeopardised by the environmentalconditions

Incompatibleactivities

5.3.3

ensure there is effective separationbetween areas of incompatibleactivity

Access

5.3.4

ensure access to office andlaboratory areas is controlled

Housekeeping

5.3.5

ensure housekeeping measures areadequate

5.4 Test and calibration methods and method validation

Methods andprocedures

5.4.1

ensure laboratory uses appropriatemethods and procedures for allcalibration and test activitiescovered by scope of accreditationand that all instructions, standards,manuals, and reference data arecurrent and available to personnel




Methoddeviations

5.4.1

ensure that deviations from the testand calibration methods are:

� documented

� technically justified

� authorised

� accepted by customer

Methodselection

5.4.2

ensure laboratory selects and usestest and/or calibration methods that:

� meet the needs of the customer;and

� are appropriate for the test and/orcalibration

� the customer has been informedof the method chosen (if notspecified)

� where appropriate, are based onlatest international, regional ornational standards and wherenecessary the standard besupplemented with additionaldetails to ensure consistentapproach

� have been verified for use in thelaboratory, if a standard method

Inappropriatemethods

5.4.2

ensure laboratory informs thecustomer if the method proposedby the customer is inappropriate orout of date

Laboratory-developed andnon-standardmethods

5.4.3, 5.4.4

ensure introduction of thesemethods is planned, and assignedto qualified personnel with adequateresources and that plans areupdated as development proceedsand communicated as necessary

� when methods are used that arenot covered by standardmethods, then:- purpose of the test and/or

calibration must be identified- method developed must be

validated before use- customer agreement must

be obtained and includespecification of customerrequirements




Methodvalidation

5.4.5.2

� laboratory must validate:

- non-standard methods

- laboratory-designed/developed methods

- standard methods usedoutside their intended scope

- amplifications andmodifications of standardmethods

� records for method validationmust include

- results obtained

- procedure used

- statement as to whether themethod is fit for the intendeduse

Range andaccuracy

5.4.5.3

ensure the range and accuracy ofthe values obtainable from validatedmethods are relevant to thecustomers’ needs

Uncertainty ofmeasurement

5.4.6.1

calibration laboratories or testinglaboratories performing their owncalibrations must have andimplement procedures for estimatingthe uncertainty of measurement forall calibrations

5.4.6.2 testing laboratories must documentand implement procedures forestimating uncertainty ofmeasurement (refer to FAD forapplication of this clause)

5.4.6.3 all uncertainty components whichare of importance in the givensituation must be taken into accountusing appropriate methods ofanalysis when estimating theuncertainty of measurement

Calculationsand datatransfers

5.4.7.1

ensure calculations and datatransfers are checked in asystematic manner




Computers andautomatedequipment

5.4.7

ensure when computers orautomated equipment are used foracquisition, processing, recording,reporting, storage or retrieval oftest/calibration data that:

� laboratory developed software issufficiently documented andsuitably validated

� procedures are established andimplemented for protecting thedata and include

- integrity and confidentiality ofdata entry or collection

- data storage

- data transmission

- data processing

� computers and automatedequipment are maintained toensure proper functioning

� appropriate environmental andoperating conditions are provided

5.5 Equipment

Operation

5.5.1 to 5.5.4

ensure all equipment and itssoftware (including that outside thelaboratory’s permanent control)required for all testing and/orcalibration activities:

� is available and functioningproperly (5.5.1)

� is capable of achieving requiredaccuracy (5.5.2)

� complies with relevantspecifications (5.5.2)

� has calibration programsestablished for key quantities orvalues (5.5.2)

� is calibrated or checked beforebeing placed into service (5.5.2)

� is checked and/or calibratedbefore use (see 5.6 also) (5.5.2)

� is operated by authorisedpersonnel (5.5.3)

� has current instructions on useand maintenance available(5.5.3)

� is uniquely identified, wherepracticable (5.5.4)




Records

5.5.5

ensure records of equipment and itssoftware are maintained andinclude:

� identity of the equipment and itssoftware

� manufacturer’s name, model, andserial number or other uniqueidentification

� evidence that the equipmentcomplies with the accuracyrequirements and withspecifications relevant to thetests or calibrations

� current location, whereappropriate

� the manufacturer’s instructions, ifavailable, or reference to theirlocation

� calibration history and due dateof next calibration

� the maintenance plan, whereappropriate, and maintenancecarried out to date

� any damage, malfunction,modification or repair to theequipment

Procedures

5.5.6, 5.5.11

ensure procedures for measuringequipment are documented andinclude:

� safe handling

� transport

� storage

� use

� planned maintenance

� where applicable, that copies ofcorrection factors are correctlyupdated




Out-of-service

5.5.7

ensure equipment subjected tooverloading or mishandling, givingsuspect results, or shown to bedefective or outside specified limitsis taken out of service, and is:

� isolated or clearly labelled ormarked as being out of service

� examined for the effect of thedefect or departure from specifiedlimits on previous tests and/orcalibrations

� addressed under the “Control ofnonconforming work” procedure(4.9)

Calibrationstatus

5.5.8, 5.5.10

ensure equipment calibration statusis identified, where practicable andwhere intermediate checks areneeded to maintain confidence inthe calibration status that aprocedure is documented to carryout these checks

Return toservice

5.5.9

ensure when equipment goesoutside the direct control of thelaboratory, that the function andcalibration status are checkedbefore being returned to service

Adjustments

5.5.12

ensure equipment, both hardwareand software, is safeguarded fromadjustments which could invalidatethe test/calibration results

5.6 Measurement traceability

Calibrationprogram

5.6.1

ensure all equipment used in testingand/or calibration activities iscalibrated using a defined procedurebefore being put into service and isincluded in the equipment calibrationprogram




Calibrationlaboratories

5.6.2.1

must ensure the program forcalibration of equipment is designedand operated so that calibrationsand measurements are traceable toSI units, however, where traceabilitycannot be strictly made to SI units,traceability can be established byuse of:

� certified reference materials

� specified methods and/orconsensus standards that areclearly described and agreed byall parties concerned

Participation in suitableinterlaboratory comparisons isrequired where possible.

Testinglaboratories

5.6.2.2

the requirements given in 5.6.2.1apply for measuring and testequipment unless it can beestablished that the associatedcontribution from the calibrationcontributes little to the totaluncertainty of the test result

Referencestandards

5.6.3.1

� program and procedure forcalibration of reference standardsmust be implemented

� reference standards must includetraceability as described in5.6.2.1

� reference standards ofmeasurement must be used forcalibration only

� reference standards must becalibrated before and afteradjustment

Referencematerials

5.6.3.2

� where possible, referencematerials must be traceable to SIunits or certified referencematerials

� internal reference materials mustbe checked

Intermediatechecks

5.6.3.3

procedures and schedules must beavailable to carry out intermediatechecks on reference, primary,transfer or working standards andreference materials to maintainconfidence in the calibration status




Transport andstorage

5.6.3.4

procedures for safe handling,transport, storage and use ofreference standards and materialsmust be available

5.7 Sampling

Procedures andplan

5.7.1

ensure procedures for sampling areavailable at the sampling locationand include:

� a sampling plan (based onappropriate statistical methods,wherever reasonable)

� factors to be controlled to ensurevalidity of the test/calibrationresults

Deviations

5.7.2

ensure customer-requesteddeviations, additions or exclusionsfrom the documented samplingprocedures are recorded andcommunicated to the appropriatepersonnel

Records

5.7.3

ensure laboratory has proceduresfor recording sampling data andoperations and that the recordsinclude:

� sampling procedure used

� identification of the sampler

� environmental conditions(if relevant)

� diagrams (or equivalent) toidentify sampling location

� statistics that sampling procedureis based on, if appropriate




5.8 Handling of test and calibration items

Procedures

5.8.1

document procedures for test and/orcalibration item management whichensure protection of integrity of theitem and the interests of thelaboratory and customer and cover:

� transportation

� receipt

� handling

� protection

� storage

� retention and/or disposal

Identification

5.8.2

ensure laboratory has a system foridentifying test and/or calibrationitems both physically and in therecords and accommodatesubdivision of groups of items, ifapplicable

Deficiencies

5.8.3

� ensure any abnormalities ordeficiencies on item received arerecorded

� if there is doubt about suitabilityof item, or it does not conform todescription provided, or the testor calibration required is notspecified, ensure that thecustomer is contacted and thatthe instructions are recorded

Facilities

5.8.4

ensure laboratory has proceduresand appropriate facilities to maintainitem integrity, and the protection ofsecured items and when specifiedenvironmental conditions arerequired, that these are maintained,monitored and recorded

5.9 Assuring the quality of test and calibration results

Quality Control

5.9.1

� ensure laboratory has qualitycontrol procedures for monitoringvalidity of tests and calibrations; itmust be a planned activity that isreviewed and includes:




5.9.1 (cont.) - regular use of certifiedreference materials and/orsecondary referencematerials

- participation ininterlaboratory comparisonor proficiency-testingprograms

- replicates using the same ordifferent methods

- retesting or recalibration ofretained items

- correlation of results fordifferent characteristics ofan item

� resulting data must be recordedso as trends are detectable andstatistical techniques must beapplied to the reviewing of theresults where practicable

Action onquality controldata

5.9.2

analyse and take appropriateaction on quality control data thatfalls outside pre-defined criteria

5.10 Reporting the results

Test reportsand calibrationcertificates

5.10.1, 5.10.8

� results of tests and calibrationsmust be reported accurately,clearly, unambiguously,objectively and in accordancewith any specific instructions inthe methods

� test reports and calibrationcertificates must include allinformation requested by thecustomer, required by themethod and necessary for theinterpretation of the test orcalibration results

� results may be reported in asimplified way when performedfor internal customers or in thecase of a written agreement withcustomer, however, anyinformation not reported to thecustomer, but is normallyrequired to be, must be readily




5.10.1, 5.10.8(cont.)

available in the laboratory

� test reports and calibrationcertificates must be designed toaccommodate each type of testor calibration carried out and tominimise the possibility ofmisunderstanding or misuse

� for details on the use of theNATA endorsement refer to theField Application Document andthe NATA Rules

Test reports

5.10.2, 5.10.3

� test reports must include theinformation listed in the Standardunder 5.10.2 items (a) to (k) andthe FAD

- a title (a)

- name and address of thelaboratory, and the locationwhere the testing/calibrationswere carried out, if differentfrom the address of thelocation (b)

- unique identification of thetest/calibration document,including on each page anidentification to ensure thepage is recognised as part ofthe document and a clearidentification of the end of thedocument (c)

- name and address of thecustomer (d)

- identification of the methodused (e)

- description, condition andidentification of the itemtested or calibrated (f)

- date of receipt oftest/calibration item whereapplicable and the date thework was carried out (g)

- reference to the samplingplan and procedures used bythe laboratory or other bodieswhere applicable (h)




5.10.2, 5.10.3(cont.)

- results with, whereappropriate, the units ofmeasurement (i)

- name, function and signatureor equivalent identification ofperson authorising thetest/calibration document (j)

- statement to the effect thatthe results relate only to theitems tested or calibratedwhere applicable (k)

� where necessary for theinterpretation of the test resultsthe items included in 5.10.3.1 (a)to (e) must also be included inthe test report with the exceptionof (d) which is not allowableunder NATA’s regulationsexcept for Medical, Veterinaryand Forensic testing

- deviations, additions orexclusions from the testmethod, and specific testconditions, eg environmentalconditions (a)

- statement of compliance/non-compliance with requirementsand/or specifications (b)

- statement on the estimateduncertainty of measurementwhere applicable (informationon uncertainty is needed intest reports when it is relevantto the validity or application ofthe results, when acustomer’s instructionrequires or when theuncertainty affectscompliance to a specificationlimit) (c)

- opinions and interpretationswhere appropriate andneeded (d)

- additional informationrequired by specific methodsor customers (e)




5.10.2, 5.10.3(cont.)

� test reports containing the resultsof sampling must also include theadditional requirements listed in5.10.3.2 (a) to (f) as necessaryfor the interpretation of the testresults

- date of sampling (a)

- unambiguous identification ofthe material sampled (b)

- location of sampling includingany diagrams, sketches orphotographs (c)

- reference to the samplingplan and procedures used (d)

- details of environmentalconditions during sampling (e)

- any standard or specificationfor the sampling method orprocedure and deviations,additions or exclusions fromthe specification (f)

Calibrationcertificates

5.10.2, 5.10.4

� calibration certificates mustinclude the information listed inthe Standard under 5.10.2 items(a) to (k)

� where necessary for theinterpretation of the calibrationresults, the requirementsincluded in 5.10.4.1 (a) to (c)must also be included in thecalibration certificate

- conditions, eg environmentalduring calibration that have aninfluence on themeasurement results (a)

- uncertainty of measurementand/or statement ofcompliance with an identifiedmetrological specification(b)

- evidence that themeasurements are traceable(c)




5.10.2, 5.10.4(cont.)

� if a statement of compliance witha specification is made, theclauses of the specification whichare met or not met must beidentified (5.10.4.2)

� where a statement of complianceis made omitting themeasurement results andassociated uncertainties, thelaboratory must record and retainthose results (5.10.4.2)

� the uncertainty of measurementmust be taken into account whenstatements of compliance aremade (5.10.4.2)

� calibration results before andafter adjustment or repair, ifavailable, must be reported(5.10.4.3)

� calibration certificates or labelsmust not contain anyrecommendation on thecalibration interval except whenrequested by the customer(5.10.4.4)

Opinions andinterpretations

5.10.5

Are not permitted on test reportsunless written authority has beengranted by NATA’s Chief Executiveexcept for Medical, Veterinary andForensic testing

Testing andcalibrationresults obtainedfromsubcontractors

5.10.6

� results of tests performed bysubcontractors must be clearlyidentified

� where calibration work has beensubcontracted, the laboratoryperforming the work must issuethe calibration certificate to thecontracting laboratory

Electronictransmission ofresults

5.10.7

where results are transmittedelectronically or electromagneticallythe requirements set out in theStandard must be met




Amendments totest reports andcalibrationcertificates

5.10.9

� amendments to a test report orcalibration certificate after issuemust be in the form of a furtherdocument or data transfer andinclude reference to the originalas detailed in the Standard andmeet the requirements of NAR

� when a complete new test reportor calibration certificate isrequired, it must be uniquelyidentified and include a referenceto the original it replaces

17025 gap analysis

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