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Guidelines for the Requirementsfor the Competence of Providersof Proficiency Testing Schemes

ILAC-G13:2000

ILAC-G13:2000

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Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes

PREAMBLE

Proficiency testing schemes are used by laboratoryaccreditation bodies as part of the assessment process toassess the ability of laboratories to perform competentlytests for which accreditation is held. Proficiency tests com-plement the traditional technique of on-site laboratory re-view by technical specialists.

Some laboratory accreditation bodies develop and operatetheir own proficiency testing schemes. Their assessors mayalso, where appropriate, utilise the data generated by otherinterlaboratory test comparisons in which accreditedlaboratories participate.

It is recognised that schemes conducted by otherorganisations may have other primary aims, such asestablishing the effectiveness and precision of test methods,checking the individual testing performance of laboratorystaff, or determining the characteristics of a material to aparticular degree of accuracy (such as in preparation ofreference materials).

Assessors and laboratory accreditation bodies will be betterplaced to use the results of external proficiency testingschemes as an aid in the accreditation process if they areconfident that such schemes are operated competently andin harmony with appropriate requirements. Other usersof proficiency testing schemes may also have additionalconfidence if the schemes have been independentlyaccredited.

This document is directed to providers of proficiency testingschemes who wish, on a voluntary basis, to demonstratetheir competence, for the purposes of accreditation or otherrecognition, by formal compliance with a set ofinternationally-acceptable requirements for the planningand implementation of proficiency testing schemes.

For the selection of proficiency testing schemes bylaboratories, and their acceptance during laboratoryassessment, the requirements of ISO/IEC Guide 43 Parts 1and 2 also form a sound basis.

The following sections of this document provideappropriate requirements for competence of providers ofproficiency testing schemes.

These Guidelines have been developed with the followingmajor features:

a) They are a basis for recognising the competenceof providers of proficiency testing schemes. Theorganisation which is responsible for coordinatingand providing a proficiency testing schemeshould ensure that all tasks involved in theprovision of such a scheme have been performedcompetently, whether they are carried out bythe coordinating organisation itself or incombination with collaborators.[Note: Definition 1.3.2 refers]

Accordingly, it is the provider (and any sub-contractual arrangements used by the provider)which should be evaluated for compliance withthese Guidelines.

b) The Guidelines are based on ISO Guide43-1:1997 and on the relevant elements of ISO/IEC 17025:2000 applicable to thecharacterisation, homogeneity and stabilitytesting of proficiency testing test materials.Additionally, relevant elements of ISO9000:1994 are included to eliminate the needfor separate recognition of a provider ofproficiency testing schemes for compliance withISO 9000:1994. Accordingly, the Guidelines havebeen prepared in two sections covering,respectively:

(i) Management System Requirements;

(ii) Technical Requirements.

c) In ISO Guide 43-1:1997, the Introduction onpage (v) identifies various uses of interlaboratorycomparisons. As with ISO Guide 43, these ILACGuidelines apply only to the use of interlaboratorycomparisons for the purpose of proficiency testing(i.e. to determine the performance of individuallaboratories for specific tests or measurements andto monitor laboratories’ continuing performance).

Note: Proficiency testing schemes are sometimes known bydifferent names (e.g. external quality assessment (EQA)schemes or laboratory performance studies).

PURPOSE

This document is directed to providers of proficiency testingschemes who wish, on a voluntary basis, to demonstratetheir competence, for the purposes of accreditation or otherrecognition, by formal compliance with a set ofinternationally-acceptable requirements for the planningand implementation of proficiency testing schemes.

Note: Fulfilment of these Guidelines is not the only tool forestablishing confidence in proficiency testing schemes.

The criteria are not applicable to proficiency testing bet-ween only two laboratories.

AUTHORSHIP

This publication was prepared by the ILAC TechnicalAccreditation Issues Committee and endorsed forpublication by a decision of the ILAC General Assemblyin 1999.

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Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes ILAC-G13:2000Table of Contents

PREAMBLE ............................................................................................................................................... 4

PURPOSE .................................................................................................................................................. 4

AUTHORSHIP .......................................................................................................................................... 4

SECTION 1: GENERAL

1.1 Scope ............................................................................................................................................. 61.2 References ..................................................................................................................................... 61.3 Definitions .................................................................................................................................... 6

SECTION 2: MANAGEMENT SYSTEM REQUIREMENTS

2.1 Quality Management System ......................................................................................................... 72.2 Organisation and Management ...................................................................................................... 72.3 Document and Information Control .............................................................................................. 82.4 Request, Tender or Contract Review............................................................................................. 82.5 Use of Collaborators (Subcontractors) ........................................................................................... 92.6 Procurement of Services and Supplies ........................................................................................... 92.7 Client Feedback ............................................................................................................................. 92.8 Control of Non-conforming Materials ........................................................................................... 92.9 Corrective Action ........................................................................................................................ 102.10 Preventive Action ........................................................................................................................ 102.11 Records ....................................................................................................................................... 102.12 Internal Audits ............................................................................................................................ 112.13 Management Reviews .................................................................................................................. 11

SECTION 3: TECHNICAL REQUIREMENTS

3.0 General ........................................................................................................................................ 123.1 Management, Staffing and Training ............................................................................................. 123.2 Collaborators (Subcontractors) .................................................................................................... 123.3 Organisation and Scheme Design Logistics ................................................................................. 133.4 Choice of Method or Procedure .................................................................................................. 163.5 Conduct of Proficiency Testing Scheme ...................................................................................... 163.6 Data Analysis and Interpretation of Scheme Results .................................................................... 173.7 Communication with Participants ............................................................................................... 183.8 Confidentiality ............................................................................................................................ 193.9 Collusion and Falsification of Results ......................................................................................... 19

APPENDIX A STATISTICAL METHODS FOR TREATMENT OF PROFICIENCY TEST DATA .......... 20

APPENDIX B CROSS-REFERENCES TO ISO 9000, ISO/IEC GUIDE 43-1 AND ISO/IEC 17025 ............ 21

APPENDIX C BIBLIOGRAPHY ......................................................................................................... 23

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1 : GENERAL

1.1 Scope

These Guidelines set out the criteria which aprovider of proficiency testing schemes (andassociated collaborators) shall meet in order to berecognised as competent to provide specific typesof proficiency testing schemes.

1.1.1 It is the responsibility of the provider toensure that the requirements (i.e. both technicaland management systems) are met by the providerand any associated collaborators.

1.1.2 It is recognised that there may be a numberof alternative methods used by providers tocomply with these Guidelines and throughout thedocument Notes provide information on possiblesources of guidance. Such Notes do not form anintegral part of the Guidelines.

1.1.3 Where clauses of these Guidelines areconsidered to meet the existing requirements ofISO/IEC Guide 43-1:1997 andISO/IEC 17025:2000 or ISO 9000:1994, theseare cross-referenced in Annex 2.

1.1.4 Providers complying with these Guidelinesare considered to comply also with the relevantrequirements of ISO 9000 Series:1994 as appliedto the design and provision of specific types ofproficiency testing schemes.

1.2 References

ISO/IEC 17025:2000 General requirements for thecompetence of calibration and testing laboratories.

ISO Guide 35:1989 (under revision), Certificationof reference materials - General and statisticalprinciples.

ISO/IEC Guide 43-1 (1997), Proficiency testing byinterlaboratory comparisons - Part 1: Developmentand operation of proficiency testing schemes.

ISO 9000 Series:1994, (under revision) Qualitymanagement and quality assurance standards.

European Commission Guidelines for the Productionand Certification of Reference Materials: 1997,Document BCR/01/97 Part A.

The International Harmonised Protocol for theProficiency Testing of (Chemical) AnalyticalLaboratories. Journal of AOAC International, 76,No. 4, 1993, pp. 926-940.

Evaluation of Matrix Effects: Proposed Guideline,NCCLS Document EP-14P. National Committeefor Clinical Laboratory Standards, Villanova, PA,1994.

Eurachem document 1995 (under revision byEurachem and CITAC): Quantifying Uncertaintyin Analytical Measurement.

1.3 Definitions

For the purpose of these Guidelines, the followingdefinitions apply in addition to those described inISO/IEC Guide 43-1:1997 andISO/IEC 17025:2000.

1.3.1 Provider

A body (organisation or firm, public or private)that undertakes the design and conduct of aproficiency testing scheme.

1.3.2 Collaborator (Subcontractor)

A body, (organisation or firm (public or private))that undertakes subcontracted activities for aproficiency testing scheme provider.

1.3.3 Coordinator

The person with responsibility for coordinating allof the activities involved in the operation of aproficiency testing scheme.

1.3.4 Proficiency testing scheme

Interlaboratory comparisons designed andoperated to assure laboratory performance inspecified areas of testing, measurement orcalibration.

Note: A scheme might cover a particular type of testor a number of tests on particular products, items ormaterials.

1.3.5 Proficiency testing round

A single operation of a proficiency testing scheme.

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2 : MANAGEMENT SYSTEMREQUIREMENTS

2.1 Quality Management System

2.1.1 The provider of a proficiency testingscheme shall establish, implement and maintain aquality management system appropriate to itsscope of activities including the type, range andvolume of proficiency testing that it provides.

2.1.2 The provider shall define and document itspolicy, objectives and commitment to ensuringand maintaining the quality of all aspects ofproficiency testing, including test material quality(e.g. homogeneity and stability), characterisation(e.g. equipment calibration and measurementmethod validation), assignment of property values(e.g. use of appropriate statistical procedures),evaluation of participating laboratories’performance, distribution of artefacts and testmaterial, storage and transport procedures,statistical treatment of test results, and reporting.

The quality policy shall include a commitment toconduct proficiency testing schemes which con-form to the technical requirements contained inSection 3 of these Guidelines.

2.1.3 The provider shall establish and maintain adocumented quality management systemappropriate to the type, range and volume ofproficiency testing that it provides to ensure thatthe schemes conform to specified requirements.

The provider shall have a quality system that, inparticular, covers the following:

a) aims, scope, statistical design and formatof proficiency testing schemes;

b) operational procedures;

c) preparation and issuing of reports;

d) policies on confidential and ethicalprocedures;

e) computing and information systems;

f ) collaboration and sub-contracting, whererelevant;

g) fees for participation;

h) scope of availability of proficiency testingschemes;

i) general policies on participation;

j) use of scheme results;

k) procedures for handling complaints.

2.1.4 The documented quality managementsystem shall specify which activities areundertaken by the provider and, where relevant,which activities are undertaken by collaborators,and shall include policies and procedures used bythe provider to ensure that all activities conductedby collaborators comply with the relevant clausesof these Guidelines.

2.1.5 The documented quality managementsystem shall define the roles and responsibilities ofthe technical manager and the quality manager(however named) and the coordinator, includingtheir responsibilities for ensuring compliance withthese Guidelines.

2.2 Organisation and Management

2.2.1 The provider, or the organisation of whichit is part, shall be legally identifiable.

2.2.2 The provider:

a) shall have managerial personnel supportedby technical personnel with the authorityand resources needed to discharge theirduties and to identify the occurrence ofdepartures from the quality managementsystem or the procedures for providingproficiency testing schemes and to initiateactions to prevent or minimise suchdepartures;

b) shall have arrangements to ensure that itsmanagement and personnel are free fromany commercial, financial and otherinternal and external pressures that mayadversely affect the quality of their work;

c) shall have policies and procedures toensure the protection of confidentialinformation and proprietary rights ofparticipants in proficiency testingschemes;

d) shall have policies and procedures toavoid involvement in any activities thatmight diminish confidence in itscompetence, impartiality, judgement oroperational integrity;

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e) shall define, with the aid of organisationalcharts, the organisation and managementstructure of the provider, its place in anyparent organisation, and the relationsbetween management, technicaloperations, support services, collaboratorsand the quality management system;

f) shall specify the responsibility, authorityand interrelationships of all personnel whomanage, perform or verify work affectingthe quality of the provision of proficiencytesting schemes;

g) shall have technical management, whichhas overall responsibility for the technicaloperations and the provision of theresources needed to ensure the requiredquality of proficiency testing procedures;

h) should appoint a member of staff asquality manager (however named) who,irrespective of other duties andresponsibilities, shall have definedresponsibility and authority for ensuringthat these Guidelines are implemented andfollowed at all times. The quality managershall have direct access to the highest levelof management at which decisions aretaken on the proficiency testing policy orresources;

i) should, where possible, appoint deputiesfor key managerial personnel such as thecoordinator, technical manager andquality manager.

Note: Where providers have a small number ofpersonnel, individuals may have more than onefunction and it may be impractical to appointdeputies for all major functions.

2.3 Document Control

2.3.1 General

The provider shall establish and maintain procedu-res to control all documents (both internallygenerated and from external sources) and otherinformation that forms part of its qualitydocumentation.

2.3.2 Document approval and issue

2.3.2.1 All documents (including documentedprocedures) issued to personnel as part of thequality management system shall be reviewed and

approved for use by authorised personnel prior toissue. A master list or equivalent identifying thecurrent revision status of documents in the qualitymanagement system shall be established and bereadily available to preclude the use of invalid and/or obsolete documents.

2.3.2.2 The procedures adopted shall also ensurethat:

a) all documents are uniquely identified;

b) authorised editions of appropriatedocuments are available at all locationswhere operations essential to the effectiveprovision of proficiency testing schemesare performed;

c) documents are periodically reviewed andwhere necessary revised to ensurecontinuing suitability and compliancewith applicable requirements;

d) invalid or obsolete documents arepromptly removed from all points of issueor use, or otherwise assured againstunintended use;

e) obsolete documents retained for eitherlegal or information preservation purposesare suitably marked.

2.3.3 Document changes

2.3.3.1 Changes to documents (includingdocumented procedures) shall be reviewed andapproved by the same personnel who conductedthe original review and approval, unless specificallydesignated otherwise. The designated personnelshall have access to pertinent backgroundinformation upon which to base their review andapproval.

Where practicable, the nature of the change shallbe identified in the document or the appropriateattachments.

2.4 Request, Tender or Contract Review

2.4.1 Each request, tender or contract forprovision of a proficiency testing scheme shall bereviewed by the provider to ensure that:

a) the requirements are adequately defined,documented and understood;

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b) the provider has the capability andresources to meet the requirements;

c) any differences between the contract ororder requirements and those in a tenderare resolved.

2.4.2 Records of such reviews, including anychanges, shall be maintained. Records shall also bemaintained of pertinent discussions with a clientrelating to the client’s requirements, and/or theresults of the work during the period of executionof the contract or request.

2.4.3 The review shall include any work that iscarried out by collaborators.

2.5 Use of Collaborators (Subcontractors)

2.5.1 The provider shall have procedures forevaluating and selecting collaborators on the basisof their ability to meet subcontracted requirementsin terms of both their technical competence andany specific quality assurance requirementsrelevant to their tasks. The technical requirementsto be satisfied by collaborators shall be equivalentto the technical requirements defined in Section 3of these Guidelines.

2.5.2 The provider shall maintain a register of allcollaborators used in the provision of proficiencytesting schemes and include a record of anyassessments made of their abilities to conductsubcontracted tasks.

2.6 Procurement of Services and Supplies

2.6.1 The provider shall have procedures for theselection of services and supplies that affect thequality of its proficiency testing schemes.

2.6.2 The provider shall use only those servicesand supplies that are of adequate quality to sustainconfidence in its proficiency testing schemes.

2.6.3 When no formal approval of the quality ofservices and supplies is available, the provider shallhave procedures to ensure that purchasedmaterials and services comply with specifiedrequirements and records of actions taken shall bemaintained.

2.6.4 The provider shall ensure that purchasedequipment and consumable materials are not useduntil they have been inspected, calibrated orotherwise verified as complying with standardspecifications or requirements.

2.6.5 The provider shall maintain records ofapproved suppliers of services and supplies.

2.7 Client Feedback

The provider shall have procedures for theeffective handling of complaints or other feedbackreceived from participants. Records shall bemaintained of all complaints and of theinvestigations and corrective actions taken by theprovider.

2.8 Control of Non-conforming Activities

2.8.1 The provider shall have a procedure to beimplemented when it establishes that any aspect ofits proficiency testing activities does not conformwith its own procedures or the agreedrequirements of a client.

The procedure shall ensure that:

a) responsibilities and authorities for themanagement of nonconforming work aredesignated;

b) the actions to be taken when anonconformance is identified are defined;

c) an evaluation of the significance of thenonconforming work is made;

d) work is halted if necessary;

e) remedial actions are taken promptly;

f ) where necessary, the results ofnonconforming test materials or statisticalevaluations already issued to participantsare recalled;

g) the responsibility for authorisation of theresumption of work is defined;

h) complete records are maintained, wherepracticable, of all nonconformingactivities.

Note: Requirement (f ) extends to notifying clientswhen it is discovered that a proficiency testing samplewas inhomogeneous, or that an error has occurred inthe statistical report of the scheme.

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2.8.2 Where the evaluation indicates that thesupply of nonconforming test materials could recuror that there is doubt about the provider’s orcollaborator’s compliance with their own policiesand procedures, the corrective action proceduresin 2.9 shall be promptly followed to identify rootcauses of the problem and to eliminate thesecauses.

2.9 Corrective Action

2.9.1 General

The provider shall establish a policy and procedu-res and shall designate appropriate personnel forimplementing corrective actions whennonconforming test materials or departures fromthe policies and procedures in the quality manage-ment system or with proficiency testing activitieshave been identified.

Any corrective action taken to eliminate the causesof nonconformances or other departures shall beappropriate to the problems and commensuratewith the risks encountered.

The provider shall document and implement anyrequired changes to the operational proceduresresulting from corrective action investigations.

Note: The identification of problems with the qualitymanagement system or with proficiency testingactivities can occur at various places within thequality management system such as: client complaints,quality control, checking of test materials andstatistical evaluations, staff observations orsupervision, management reviews and internal orexternal audits.

2.9.2 Cause analysis

Corrective action procedures shall include aninvestigation process to determine the root causesof the problem.

2.9.3 Corrective actions

The provider shall identify possible causes andpotential corrective actions. It shall select theactions most likely to eliminate the problem and toprevent it recurring.

2.9.4 Monitoring of corrective actions

After having implemented the corrective action,the provider shall monitor the results to ensurethat the actions taken have been effective inovercoming the problems originally identified.

2.10 Preventive Action

2.10.1 All operational procedures shall besystematically reviewed at regular intervals toidentify any potential sources of nonconformancesand any opportunities for improvement, eithertechnical or within the quality managementsystem. Action plans shall be developed,implemented and monitored, to reduce thelikelihood of such nonconformances and to takeadvantage of the improvement opportunities.

2.10.2 After the implementation of preventiveactions, the provider shall monitor the results toestablish any reduction in nonconformances in thisoperational area, thereby establishing theeffectiveness of the preventive action.

2.11 Records [See also Clause 3.6.1]

2.11.1 General

2.11.1.1 The provider shall establish and maintainprocedures for identification, collection, indexing,access, storage, maintenance and disposal ofquality and technical records. [See also Clause3.6.1]

2.11.1.2 All records shall be legible and shall bestored and retained in such a way that they arereadily retrievable, and in facilities that provide asuitable environment to prevent damage,deterioration or loss. Retention times of recordsshall be established and recorded. [See also Clause3.6.1.4]

Note: Records may be in the form of any type ofmedia, such as hard copy or electronic storage media.

2.11.1.3 All records shall be held secure.

2.11.1.4 The provider shall have procedures toprotect electronically-held data at all times and toprevent unauthorised access to, or amendment of,such data.

2.11.2 Technical records

The provider shall establish and maintain arecords system to suit its particular circumstancesand to comply with any applicable regulations.The provider shall arrange for all individualmeasurement observations, appropriatecalculations and derived data (e.g. statisticaltreatments and uncertainty budgets), results fromparticipants and scheme reports to be retained

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until it is no longer probable that they will need tobe referred to.

The results of each calibration, measurement (orseries of either), or homogeneity or stability testscarried out by the provider and its collaborators,where appropriate, shall be reported accurately,legibly, indelibly, unambiguously and objectively,in accordance with any instructions in calibration,measurement or test methods. The results shallnormally be reported in a calibration ormeasurement report and shall include allinformation necessary for interpretation of thecalibration or measurement results and a summaryof the method employed.

2.12 Internal Audits

2.12.1 The provider shall, periodically and inaccordance with a predetermined schedule andprocedure, conduct internal audits of its activitiesto verify that its operations continue to complywith the requirements of the quality managementsystem and these Guidelines. The internal auditprogram shall address all elements of the qualitymanagement system, including the technical andtest item preparation activities leading to theprovision of a proficiency testing scheme. It is theresponsibility of the quality manager to plan andorganise audits as required by the schedule andrequested by management. Such audits shall,wherever resources permit, be carried out bytrained and qualified personnel who areindependent of the activity to be audited.

Note 1: Personnel should not normally audit theirown activities except where it is necessary and it canbe demonstrated that an effective audit has beencarried out.

Note 2: Audit personnel should also be independentof any parent organisation when those beingproficiency tested are commercial competitors of theparent organisation.

2.12.2 When audit findings cast doubt upon theeffectiveness of the operations or on thecorrectness or validity of test materials, procedu-res, proficiency testing results, or a scheme’simplementation, the provider shall take timelycorrective action and shall notify, in writing, itsclients and/or participants in proficiency testingschemes whose activities may have been affected.

2.12.3 All audit findings and corrective actionsthat arise from them shall be recorded. The

management shall ensure that these actions aredischarged within an appropriate and agreedtimescale.

2.13 Management Reviews

2.13.1 Senior management, unless they are from aparent organisation which has commercialcompetitors being proficiency tested by theproficiency testing scheme, shall periodicallyconduct a review of the provider’s quality manage-ment system and proficiency testing procedures toensure their continuing suitability andeffectiveness and to introduce any necessarychanges or improvements. The review should takeaccount of reports from management andsupervisory personnel, the outcome of recentinternal audits, assessments by external bodies,feedback from clients or participants and otherrelevant factors.

2.13.2 Findings from management reviews and theactions that arise from item shall be recorded.The management shall ensure that those actionsare discharged within an appropriate and agreedtimescale.

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3 : TECHNICAL REQUIREMENTS

3.0 General

This Section specifies the requirements that aprovider and any of its associated collaborators,must meet to demonstrate that they are technicallycompetent to provide specific types of proficiencytesting schemes.

3.1 Management, Staffing and Training

3.1.1 The coordination and conduct ofproficiency testing schemes shall only beundertaken by providers and associatedcollaborators having experience withinterlaboratory test comparisons and with theparticular type of test items and/or materials.Providers or associated collaborators shall alsohave competence in the measurement of theproperties being determined, e.g. for assignmentof values, and homogeneity and stability testing.

Note 1: In new areas of proficiency testing, it ispossible that no one would have direct experiencewith proficiency testing within that area.

Note 2: In evaluating the competence of a provider’slaboratory, prior possession of laboratoryaccreditation to ISO/IEC 17025:2000 forappropriate tests and/or measurements will satisfy therequirement for demonstration of competence. Incircumstances where the provider’s laboratory doesnot hold accreditation, other factors which should beconsidered when evaluating the provider’s compliancewith these Guidelines will include satisfactoryperformance in appropriate proficiency testingschemes.

[Refer also to Section 3.2 on Collaborators].

3.1.2 The provider and associated collaboratorsshall have managerial personnel with the necessaryauthority, resources and technical competencerequired to discharge their duties.

3.1.3 Measurement of the properties of interest(e.g. in determining the homogeneity and stabilityof test materials) and statistical treatment ofparticipants’ results shall be completed by, orunder the supervision of, a technically-competentmanager qualified preferably both in terms ofsuitable academic qualifications and relevant workexperience.

3.1.4 The provider’s management shall define theminimum levels of qualification and experiencenecessary for the key posts within its organisation.

3.1.5 The provider shall have sufficient personnelhaving the necessary education, training, technicalknowledge and experience for their assignedfunctions.

3.1.6 The provider shall ensure that staff receiveadditional training, when necessary, to ensurecompetent performance of measurements,operation of equipment and any other activitieswhich affect quality. Where possible, objectivemeasures should be used to assess the attainmentof competence through training.

Note: The need to periodically retrain staff should beconsidered. Staff training and retraining policiesshould take account of technological change and aimat continuous skills upgrading.

3.1.7 The provider shall maintain an up-to-daterecord of the training that each staff member hasreceived. These records shall provide evidence thatindividual staff members have been adequatelytrained and that their competence to perform theirassigned tasks has been assessed.

3.2 Collaborators (Subcontractors)

3.2.1 The provider shall be required todemonstrate that the collaborators’ experience andtechnical competence are sufficient for theirassigned tasks and comply with the relevant clausesof these Guidelines. [See also Clause 2.5.1]

3.2.2 Where the provider subcontracts any partof testing of a test material or test item (e.g. forassessment of homogeneity or stability), this workshall be placed with a competent laboratory. [Referto Note under 3.1.1.]

3.2.3 In assessing the competence of acollaborator, the provider shall require informationon the collaborator’s knowledge of the subject anddetails of past experience in the field, for example,by providing acceptable results for comparablemeasurements.

3.2.4 The provider shall ensure that all details ofthe methodology, results and all the outcomes ofmonitoring of any collaborators are available andthat a register or database of all collaborators andtheir accreditation or other form of competencedetermination is maintained.

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3.3 Organisation and Design Logistics

3.3.1 Planning

3.3.1.1 The provider shall identify and plan thoseprocesses which directly affect the quality of thescheme and shall ensure that they are carried outin accordance with prescribed procedures.

A plan should be agreed upon and shall bedocumented before commencement of thescheme, and typically would include the followinginformation:

a) the name and address of the provider ofthe proficiency testing scheme;

b) the name and address of the coordinatorand other personnel involved in the designand operation of the scheme;

c) the nature and purpose of the scheme;

d) where appropriate, a procedure forselection of scheme participants, orcriteria to be met before participation isallowed;

e) the names and addresses of collaboratorsinvolved in the provision of the scheme(e.g. sampling, sample processing,homogeneity testing and assigning values);

f ) the number and identity of expectedparticipants in the scheme;

g) a description of the manner in which testitems are to be obtained, processed,checked and distributed, which takesaccount, in its design, of the majorsources of analytical errors involved in thearea of proficiency testing offered;

h) a description of the information which isto be supplied to participants (pre-notification) and the time schedule for thevarious phases of the scheme;

i) the expected initial and target dates ordeadlines of the scheme, including, whereappropriate, the dates on which testing isto be carried out by participants;

j) for on-going schemes, the frequency ordates upon which test items are to bedistributed to participants;

k) information on methods or procedureswhich participants may need to use toperform the tests or measurements(commonly their routine procedures);

l) an outline of the statistical analysis to beused, including the determination ofassigned values and any outlier detectiontechniques;

m) a description of the data or informationto be returned to participants;

n) the basis of performance evaluationtechniques, where appropriate;

o) a description of the extent to which testresults, and the conclusions that will bebased on the outcome of the scheme areto be made public.

3.3.1.2 The organisational and technical input ofthe different collaborators involved shall beidentified, documented and regularly reviewed. Amechanism (e.g. a management/technical advisorygroup) shall be established to makerecommendations on how to plan the activitiesinvolved in the provision of each proficiencytesting scheme.

Note: These could include recommendations for theobjectives of the scheme, the production and testing oftest materials or test items prior to their distribution toparticipants, the determinations to be carried out byparticipants, distribution of test items, and thestatistical treatment of test results and expected outcomesand targets.

3.3.1.3 The provider should establish an advisorygroup which shall include technical specialists withdetailed experience in the relevant field of testingand include, or have access to, a statistician todesign and implement each proficiency testingscheme and analyse the test results submitted byparticipants.

3.3.1.4 The responsibilities of an advisory groupunder the direction of a coordinator shouldinclude, but are not necessarily be limited to,consideration of the following:

a) nomination of the most significant testsrequired to be undertaken on the testitems;

b) design of the scheme (e.g. number ofsamples, whether uniform or split leveldesign);

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c) the nature of the test item(s) and test(s)selected, as well as a short description ofthe considerations underlying thesechoices, where appropriate;

d) range of values to be expected for the testitems;

e) where appropriate, the test methods to beused;

f ) any difficulties expected in thepreparation and maintenance ofhomogeneous test items or in providing astable reference value for a measurementartefact;

g) preparation of detailed instructions forparticipants;

h) preparation of any standardised reportingformats to be used by participants;

i) number of significant figures to whichresults are to be reported;

j) comments on any technical difficultiesraised by participants;

k) provision of advice in assessing thetechnical competence of participatinglaboratories;

l) appropriate measures for judging thecompetence of participants;

m) comments on the performance both ofindividual participants and onparticipation as a whole;

n) technical commentary on the summaryreport;

o) evaluation of the responses of participantsperforming poorly (if feedback isrequired).

3.3.2 Preparation of test items

3.3.2.1 In planning the overall process forpreparation, testing and distribution of testmaterials and test items, the provider shall providefor, where appropriate, procedures and resourcesfor:

a) material selection;

b) maintaining suitable environments forpreparation and testing of test material;

c) material preparation;

d) measuring and testing;

e) calibration/validation of equipment andmeasurement methods;

f ) assessing test material homogeneity;

g) assessing test material stability;

h) organising interlaboratory testcomparisons with collaborators, wherenecessary; (see Note 1 below)

i) ensuring adequate storage facilities andconditions;

j) ensuring adequate packaging andlabelling;

k) ensuring appropriate transport anddistribution arrangements;

l) statistical analysis of test results andassigning values of measurands andassociated uncertainties;

m) ensuring adequate reporting service toparticipants.

Note 1: Item (h) may apply where the schemeprovider seeks to establish the capability of a potentialcollaborator to comply with these Guidelines byrequesting that it participate in related proficiencytesting schemes before using its services as acollaborator.

Note 2: The provider will need to give dueconsideration to preparation of additional test items,for potential use as reference materials, training aidsfor participants after results have been evaluated andto replace any test items lost or damaged duringdistribution.

3.3.2.2 The provider shall be able to demonstratethat the test material is sufficiently homogeneousfor the particular proficiency testing scheme.

Note: A relatively inhomogeneous material may be thebest available, and may therefore still be useful as aproficiency test material provided the uncertainty ofthe assigned property values takes due account of this.

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3.3.2.3 When producing matrix test materials,these should, where practicable, have the same ornearly the same matrix as routine test material inorder to simulate the measurement process asnearly as possible.

Note: An example of a protocol for establishing suchsimilarity is given in document NCCLS EP-14P,published by the National Committee for ClinicalLaboratory Standards, Villanova, PA, 1994.

3.3.3 Homogeneity and stability testing

3.3.3.1 The provider or its collaborators, whereappropriate, shall use a statistically randomselection of a representative number of samplesfrom a batch of test material to assess thehomogeneity of the material.

This assessment procedure shall be documentedand be conducted in accordance with acceptablestatistical designs, for example, analysis of varianceon replicate results under repeatability conditions.In the case of measurement artefacts, preliminarystability checks shall be made and periodic checksof assigned property values should be carried outthroughout the course of the scheme.

Note: It is recognised that different experimentaldesigns may be used for evaluation of homogeneity.Some guidance on possible techniques is given in ISOGuide 35 (under revision) and in BCR/01/97 andthe International Harmonised Protocol for theProficiency Testing of (Chemical) AnalyticalLaboratories. (See Clause 1.2 References.)

3.3.3.2 The assessment of homogeneity should beperformed after the test material has beenpackaged in its final form and before distributionto participants unless, for example, stability studiesindicate that it should be stored in bulk form. Insome cases, an intermediate homogeneity checkmay be necessary, for example, before sealing intoampoules.

Note: Homogeneity testing may on some occasions notbe done prior to distribution for practical, technical,or logistical reasons, but great caution must beexercised if it is not done or if it is done after testresults have been collated. In all cases, the provider isrequired to document the procedure by which it isensured that homogeneity is adequate.

3.3.3.3 Where appropriate, the property values tobe determined in the proficiency testing schemeshall be measured periodically, preferably over a

range of conditions under which the material is tobe stored prior to distribution.

3.3.3.4 Test items shall be demonstrated to besufficiently stable to ensure that they will notundergo any significant change throughout theconduct of the proficiency test.

Note: If the material is to be used for proficiencytesting schemes extending over a lengthy period oftime, then, depending on the nature of the samplematerial, it may also be necessary to carry outhomogeneity checks during the period of its use.

3.3.4 Statistical design

3.3.4.1 The provider shall document the statisticalmodel and data analysis techniques to be used,together with a description of the reasons for theirselection, and shall ensure that they are carried outin accordance with prescribed procedures.

Note: Details of commonly used statistical proceduresfor the treatment of proficiency testing data are givenin Annex A of ISO/IEC Guide 43-1 (1997).

3.3.4.2 Appropriate statistical design of aproficiency testing scheme is essential. Indesigning a scheme the provider shall give carefulconsideration to the following:

a) the trueness or precision required orexpected of the tests;

b) the smallest differences to be detectedbetween participating laboratories at adesired confidence level;

c) the number of participants in the scheme;

d) the number of samples to be tested andthe number of repeat tests ormeasurements to be conducted on eachsample or for each determination;

e) the procedures to be used to estimate theassigned value of each measurand;

f ) procedures to be used to identifystatistical outliers;

g) and, where appropriate, the homogeneityand stability of test materials.

Note: In the absence of reliable informationconcerning (a), it may be necessary to conduct apreliminary interlaboratory test comparison to obtainit.

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3.4 Choice of Method or Procedure

3.4.1 General

Scheme participants shall normally be permitted touse the test method or measurement procedure oftheir choice, which is consistent with routineprocedures used in their laboratories. In certaincircumstances the scheme coordinator mayinstruct participants to use a specified method.

3.4.2 Where participants are permitted to use amethod of their choice, the provider shall, whereappropriate, request details of the method used topermit comparison and comment on the resultsobtained by different test methods.

3.5 Conduct of Proficiency TestingSchemes

3.5.1 Instructions to participants[See also Clause 3.7.1]

3.5.1.1 The provider shall give participants earlywarning of the intention to conduct a scheme toensure that they are aware of the aims of thescheme and that their staff are available at therequired time.

3.5.1.2 The provider shall give detaileddocumented instructions to all participants. Suchinstructions may, for example, be included as anintegral part of the scheme protocol.

3.5.1.3 Instructions to participants shall includedetails of factors which could influence the testingof the test materials, for example, conditions ofstorage, the nature of the materials or test items,the test procedure employed, and the timing of thetesting.

3.5.1.4 Specific instructions on the manner ofrecording and reporting test results shall include,but are not necessarily limited to, the units ofmeasurement, the number of significant figures,reporting basis (e.g. on dry weight, or ‘asreceived’), and the latest date for receipt of testresults.

Note: For consistency in the presentation of testresults, and for ease of statistical treatment,standardised report sheets are often prepared anddistributed to participants. They are sometimessupplemented by asking participants to also submit atest report in their usual format .

3.5.1.5 Scheme participants shall be required totreat proficiency test samples in the same manner

as routine samples (unless there are particularrequirements of the proficiency testing schemewhich require departure from this principle).

3.5.1.6 The assigned value(s) shall not bedisclosed to participants until after the results havebeen collated.

Note: In some cases it may be appropriate to advisetarget ranges prior to testing.

3.5.2 Materials handling and storage

3.5.2.1 In order to avoid contamination of the testmaterial, the provider and any associatedcollaborators shall identify, preserve and segregateall test materials and test items, for example, fromall chemicals and other materials from the time ofpreparation through to their distribution toscheme participants.

3.5.2.2 The provider and any associatedcollaborators shall ensure adequate packaging of alltest materials and shall provide secure storageareas and/or stock rooms which prevent damageor deterioration of any item or material betweenpreparation and distribution. Appropriate methodsfor authorising despatch to, and receipt from, suchareas shall be defined.

Note: It is possible for a homogeneous sample tocontain an unstable analyte (for example, vitamins infeed), or for a stable analyte (for example, dioxins orPCBs) to be present in a sample subject todecomposition during storage.

3.5.2.3 When appropriate, the condition of allstored or stocked items and materials shall beassessed at specified intervals during their storagelife in order to detect possible deterioration.

3.5.3 Packaging, labelling and distribution

3.5.3.1 The provider shall control packaging andmarking processes to the extent necessary toensure conformity with relevant regional, nationaland/or international safety and transportrequirements.

Note 1: Adequate steps should be taken to make surethat samples are presented in such a manner to ensurethat the integrity of the samples is maintained; forexample, those which require uninterrupted storagein cold conditions or which should not be exposed toX-rays, shock or vibration. Most types of chemicalmaterials would benefit from air-tight packaging to

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avoid contamination by atmospheric contaminants,for example, fuel vapours or engine exhaust gaseswhich may be encountered during transport.

Note 2: In some schemes, such as measurementcomparisons, participating laboratories are requiredto transport the test items to other participants. Insuch cases the laboratories should be supplied withdocumented instructions for transport of test items.

3.5.3.2 The provider shall ensure that materiallabels are securely attached to the productpackaging of individual units and are designed toremain legible and intact within the period of usein a proficiency test.

3.6 Data Analysis and Interpretation ofScheme Results

3.6.1 Data analysis and records(see also Clause 2.11)

3.6.1.1 Data processing equipment shall beadequate for all data entry and statistical analysisrequirements and shall be capable of providingtimely and valid results. The provider shall alsoestablish and maintain a description of all dataprocessing equipment.

3.6.1.2 The provider shall define the role andresponsibility and designate a person to beresponsible for the effective operation of the dataprocessing system.

3.6.1.3 All data processing equipment and systemsoftware shall be properly maintained andvalidated in accordance with documented procedu-res before being brought into use. The results ofsuch maintenance and operational checks shall berecorded. Software maintenance shall include aback-up regime and system recovery plan.

3.6.1.4 Results received from participants shall bepromptly recorded and analysed by appropriatedocumented statistical procedures. Documentedprocedures shall be established and implementedto check the validity of data entry, data transferand statistical analysis. Data sheets, computerback-up files, printouts and graphs shall beretained for a specified period.

3.6.1.5 Data analysis shall generate summarymeasurement and performance statistics andassociated information consistent with theproficiency testing scheme statistical model andobjectives.

3.6.1.6 The influence of extreme results onsummary statistics shall be minimised by the useof appropriate tests to detect statistical outliers, orby the use of robust statistics.

The provider shall have documented criteria andprocedures for dealing with test results that may beinappropriate for statistical evaluation, forexample, gross errors, blunders, miscalculationsand transpositions.

Note: Annex A of ISO/IEC Guide 43-1 (1997)contains examples of statistical methods for treatment.Extreme results can provide important informationand should not be disregarded in treatment of resultsof proficiency tests without due consideration.

3.6.1.7 The provider shall have documentedcriteria for determining whether test items are notsuitable for evaluation, for example, because ofundetected inhomogeneity, instability orcontamination. (Refer also to Section 3.3.2.2)

3.6.2 Evaluation of performance

3.6.2.1 Where an evaluation of performance isrequired, the proficiency testing scheme providershall be responsible for ensuring that the methodof evaluation is appropriate for maintenance of thecredibility of the scheme. Such a method shall bedocumented and shall include a description of thebasis upon which the evaluation is made.

3.6.2.2 The provider shall, where appropriate,enlist the assistance of technical advisers, whichmay include a statistician, to provide expertcommentary on the performance of participantswith regard to the following:

a) overall performance against priorexpectations, taking measurementuncertainties into account;

b) variation within (intra) and between(inter) laboratories, and comparisons withany similar previous schemes or publishedprecision data;

c) variation between methods or procedures,if applicable;

d) possible sources of error (with referenceto extreme results) and suggestions forimproving performance;

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e) any other suggestions, recommendationsor general comments;

f ) conclusions.

Note 1: It may be useful to provide individualsummary sheets for participants periodically during orafter completion of a particular scheme. These mayinclude updated summaries of performance forindividual laboratories over successive rounds of anon-going scheme. Such summaries can be furtheranalysed and trends highlighted if required.

Note 2: There are a number of alternative proceduresfor assessing the performance of participants. (SeeReference in Annex A of ISO/IEC Guide 43-1(1997).

3.6.3 Proficiency testing scheme reports

3.6.3.1 General

The content of proficiency testing scheme reportswill vary depending on the purpose of a particularscheme, but each report shall be clear andcomprehensive and include data on thedistribution of results from all participants,together with an indication of the performance ofindividual participants.

3.6.3.2 The following information shall normallybe included in reports of proficiency testingschemes:

a) name and address of the provider;

b) names and affiliations of persons involvedin the design and conduct of the scheme;

c) date of issue of the report;

d) report number and clear identification ofthe scheme;

e) clear description of the items or materialsused, including, where appropriate,details of sample preparation andhomogeneity testing;

f ) laboratory participation codes and testresults;

g) statistical data and summaries, includingassigned values and range of acceptableresults and graphical displays;

h) procedures used to establish any assignedvalue;

i) details of the traceability and uncertaintyof any assigned values, where applicable;

j) assigned values and summary statistics fortest methods/procedures used by otherparticipants (if different methods are usedby different participants);

k) comments on participants’ performanceby the provider and technical advisers;

l) procedures used to design and implementthe scheme (which may include referenceto a scheme protocol);

m) procedures used to statistically analyse thedata, where applicable. (see Annex 1 forguidance);

n) advice, where appropriate, on theinterpretation of the statistical analysis.

Note: For schemes operated on a regular basis, it maybe sufficient to have simpler reports such that manyof the recommended elements in 3.6.3.2 could beexcluded from routine reports, but included inscheme protocols or in periodic summary reports andprovided upon request to participants.

3.6.3.3 Reports shall be made available toparticipants within specified timetables. Inschemes such as long term measurementcomparison schemes, interim reports shall beissued to individual participants.

Note: Although, ideally, all original data suppliedshould be reported to all participants, it may not bepossible to achieve this in some very extensiveschemes. Participants should receive at least the resultsfrom all participants in summary (e.g. graphical)form.

3.7 Communication with Participants

3.7.1 The provider shall provide prospectiveparticipants with detailed information, forexample, in the form of a scheme protocol, onhow to apply to participate in the program. Thisshould include details of the scope of the scheme,any fees for participation, and policies aboutwhich laboratories may participate.

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Note: Subsequent communication with participantsmay be by means of a letter, newsletter and/or reports,together with periodic open meetings.

3.7.2 Participants shall be advised promptly inwriting by the provider of any changes in schemedesign or operation.

3.7.3 There shall be documented procedures forenabling participants to refer to the provider ifthey disagree with the assessment of theirperformance in a proficiency testing scheme.

3.7.4 Feedback from participants should beencouraged so they may actively contribute to thedevelopment of a scheme.

3.8 Confidentiality

3.8.1 The identity of participants in a proficiencytesting scheme shall usually (see Note) beconfidential and known only to the minimumnumber of persons involved in the provision andevaluation of the scheme.

3.8.2 All information supplied by a participant tothe provider shall be treated as confidential.

Note: Participants may elect to waive confidentialitywithin the group for the purposes of discussion andmutual assistance, for example, to improveperformance. Confidentiality may also be waived forregulatory or accreditation purposes. In mostinstances, the proficiency results should be providedto the relevant authority by the participantsthemselves. In some cases, following consultationwith the authority, the authority may require theresults to be directly provided to the authority by thescheme coordinator. In the latter case, theparticipants must be made aware of and agree to thearrangements.

3.9 Collusion and Falsification of Results

Proficiency testing schemes shall, wherepracticable, be designed to ensure that there is aslittle opportunity as possible for collusion andfalsification of results.

Note: Although all reasonable measures should betaken by the provider to prevent collusion, it shouldbe appreciated that it is the responsibility of theparticipants to avoid it.

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APPENDIX A: COMMONLY-USED STATISTICAL METHODS FOR TREATMENT OFPROFICIENCY TEST DATA(Information for Guidance only)

To assist providers of proficiency testing schemes, guidance on the selection and use of statistical proceduresfor the treatment of proficiency test data is given in Annex A of ISO/IEC Guide 43:1.

The subjects covered in this Annex include:

• Determination of the assigned value and its uncertainty.

A description of the various procedures which can be used to establish assigned values. Thedetermination of uncertainty of assigned values. The use of a nominal or ordinal scale when dealingwith qualitative values. The use of a mean, median, mode or other robust measure when dealingwith quantitative values. Methods of treating extreme results.

• Calculation of performance statistics

Including consideration of performance on single test items, and combined performance scores.Examples of variability measures for calculation of performance statistics. Use of z scores and E

n

numbers.

• Evaluation of performance

Including consideration of initial performance and monitoring of performance over time. Fitnessfor purpose. Graphical techniques (error bars, histograms, Shewhart charts, Youden plots).

• Preliminary determination of test item homogeneity

In addition, Annex C of ISO/IEC Guide 43:1 contains an extensive bibliography of publications covering:

• Terms and definitions

• Criteria in proficiency testing for accreditation

• Interlaboratory comparisons

• Statistical techniques for collaborative tests

• Robust statistics

• Proficiency testing and pathology laboratories

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2.1.1 Quality management system2.1.2 QM policy objectives2.1.3 Documented quality system2.1.4 Activities specified2.1.5 Roles/responsibility2.2.1 Legal identity2.2.2 Coordinator requirements2.3.1 Document control procedures2.3.2 Document approval and issue2.3.3 Document changes2.4.1 Contract review2.4.2 Records of contract reviews2.4.3 Record includes subcontractors2.5.1 Selection of subcontractors2.5.2 Register of collaborators2.6.1 Supply selection policies2.6.2 Use of adequate services/supplies2.6.3 Compliance with requirements2.6.4 Inspection & approval2.6.5 Records of approved suppliers2.7 Client feedback2.8.1 Nonconformance with procedures2.8.2 Corrective actions2.9.1 Policy for CAs2.9.2 Cause analysis2.9.3 Selection of CAs2.9.4 Monitoring of CAs2.10.1 Preventive action review2.10.2 Monitoring results of PAs2.11.1.1 Identification etc of records2.11.1.2 Storage of records2.11.1.3 Security of records2.11.1.4 Security of data2.11.2 Technical records2.12.1 Internal audits2.12.2 Corrective action for NCRs2.12.3 Management review of audit records2.13.1 Periodic management reviews2.13.2 Record of findings of mgt reviews3.1.1 Staff experience etc requirements3.1.2 Managerial staff and resources3.1.3 Measurement staff and resources3.1.4 Min. levels of qualifications & experience3.1.5 Adequate personnel3.1.6 Additional training needs

APPENDIX B: CROSS-REFERENCES TO ISO 9000, ISO GUIDE 43-1 AND ISO/IEC 17025

Cross-references between elements of the ILAC Requirements for the Competence of Providers of ProficiencyTesting Schemes and, where relevant, ISO 9001:1994, ISO Guide 43-1:1997 and ISO/IEC 17025:2000

ILAC Requirements ISO 9001:1994 ISO Guide ISO/IEC 17025:43-1:1997 2000

4.2.14.1.1

4.2.1 & 4.2.24.1.2.1 & 4.6.2

4.1.2-

4.1.24.5.14.5.24.5.34.3.24.3.34.6.24.6.24.6.2

4.6.1 & 4.74.6.1, 4.6.2 & 4.7

4.6.4 & 4.74.6.4 & 4.74.6.4 & 4.7

4.14.24.13

4.14.2 & 4.14.34.14.14.14.24.14.24.14.24.14.34.14.34.164.164.164.164.164.174.174.174.1.34.4.3

4.1.2.2 & 4.184.1.2.2

4.1.2.2 & 4.184.1.2.2 & 4.18

4.1.2.24.18

--------------------

6.7-------------------

5.2.15.2.2

---

4.2.14.2.24.2.1

4.1.44.1.1

-4.3

4.3.24.3.34.4.14.4.24.4.34.5.14.5.44.6.14.6.24.6.34.6.44.6.4

4.7 & 4.84.9.14.9.2

4.9.2 & 4.104.10.24.10.34.10.44.11.14.11.2

4.12.1.14.12.1.24.12.1.34.12.1.3

4.12.2.1-34.13.14.13.24.14.14.14.14.14.25.2.15.2.55.2.5

5.2.2 & 5.2.45.2.1

5.2.1 & 5.2.2

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3.1.7 Records of training3.2.1 Appropriate collab. experience3.2.2 Compliance with ISO/IEC Guide 253.2.3 Technical competence3.2.4 Details of collaborators’ methodology3.3.1.1 Program planning3.3.1.2 Identificn/ review of collaborators’ input3.3.1.3 Establishment of specialist working grp3.3.1.4 Responsibilities of working group3.3.2.1 Preparation of test items3.3.2.2 Homogeneity test3.3.2.3 Matrix matching3.3.3.1 Selection of items for homogeneity test3.3.3.2 Testing after packaging3.3.3.3 Periodic checking of properties3.3.3.4 Stability checking of properties3.3.4.1 Statistical model and data analysis3.3.4.2 Appropriate stat design of program3.4.1 Participants’ choice of method3.4.2 Requested details of methods3.5.1.1 Early advice to participants3.5.1.2 Detailed instruction with samples3.5.1.3 Details of factors affecting testing3.5.1.4 Recording and reporting results3.5.1.5 Treat samples as normal samples3.5.1.6 Disclosure of assigned values3.5.2.1 Identification/preservation of test items3.5.2.2 Adequate packaging and storing3.5.2.3 Reassessment of sample condition3.5.3 Packaging, labelling and distribution3.6.1.1 Adequacy and documentation of data

processing equipment3.6.1.2 Role/responsibility of data system mgr3.6.1.3 Maint and validn of equipt and software3.6.1.4 Recording & processing of data3.6.1.5 Summary stats3.6.1.6 Tests for outliers3.6.1.7 Criteria for non-conforming data3.6.2.1 Evaluation of lab performance3.6.2.2 Tech comments on lab performance3.6.3.1 Program reports3.6.3.2 Information in program reports3.6.3.3 Promptness of reporting3.7.1 Information on participation3.7.2 Changes in program design3.7.3 Procedures for participant feedback3.7.4 Encouragement of participant feedback3.8.1 Confidentiality of participant identity3.8.2 Confidentiality of test data, etc3.9 Falsification of data

4.184.6.2

--

4.6.24.4 & 4.9

4.6.2 & 4.9--

4.9 & 4.104.9,4.10,4.12 & 4.4

4.9, 4.10 & 4.124.9 & 4.10

4.9, 4.10 & 4.124.9 & 4.104.9 & 4.10

4.20.14.20.2

--------

4.8 & 4.154.154.15

4.8 & 4.15

4.11.14.1.2

4.11.14.1.64.204.204.20

--

4.16---

4.44.14.2

----

-----

5.1.2-

5.1.15.2.3

5.5.1 & 5.6.25.5.2 & 5.6.2

5.5.35.6.25.6.25.6.35.6.35.4.15.4.2

5.7.1, 5.7.25.7.3

6.2.1 & 6.7.16.2.16.2.26.2.36.2.45.5.55.6.1

-5.6.3 & 5.6.4

6.3

5.3, 6.4--

6.4.16.4.26.4.26.4.3

6.6.1&6.6.46.6.2 & 6.6.56.5.1 & 6.5.36.5.2 & 6.6.3

6.5.46.7.16.7.16.7.26.7.37.17.17.2

5.2.14.5 & 5.2

4.5.1 & 4.5.24.5.1 & 4.5.2

-4.4 & 4.5.3

---------------------

5.8.2 & 5.8.35.8.1

-

5.5.11--

4.12.25.10

---

5.10.55.105.10

--------

ILAC Requirements ISO 9001:1994 ISO Guide ISO/IEC 17025:43-1:1997 2000

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APPENDIX C: BIBLIOGRAPHY

(1) ISO/IEC Guide 2:1996, Standardisation and related activities - General vocabulary.

(2) ISO/IEC Guide 43-2:1997, Proficiency testing by interlaboratory comparisons - Part 2: Selection and useof proficiency testing schemes by laboratory accreditation bodies.

(3) ASTM E1301-95 Standard Guide for Proficiency Testing by Interlaboratory Comparisons.

(4) ISO 3534-1:1993, Statistics - Vocabulary and symbols - Part 1: Probability and general statistical terms.

(5) ISO 5725-1:1994, Accuracy (trueness and precision) of measurement methods andresults - Part 1: General principles and definitions.

(6) ISO 5725-2:1994, Accuracy (trueness and precision) of measurement methods andresults - Part 2: Basic method for the determination of repeatability and reproducibility of a standardmeasurement method.

(7) ISO 5725-4:1994, Accuracy (trueness and precision) of measurement methods andresults - Part 4: Basic methods for the determination of the trueness of a standard measurement method.

(8) ISO 8402:1994, Quality management and quality assurance - Vocabulary.

(9) ISO Guide to the expression of uncertainty of measurement (1995).

(10) VIM:1993, International vocabulary of basic and general terms in metrology (under revision).

(11) ISO 13528 (Draft 1998) Statistical methods for use in proficiency testing by interlaboratorycomparison.

The International Laboratory Accreditation Cooperation (ILAC) is the principal international forum for the exchange of ideas and information on laboratory accreditation.

Established in the late 1970s, ILAC membership has grown rapidly and includes representatives from the world’s major laboratory accreditation systems in Europe, Asia, North America, Australia and the Pacifi c. Countries that are developing their own laboratory accreditation systems are also welcome to participate and contribute.

ILAC operates a series of committees which investigate issues such as the harmonisation of international laboratory accreditation practices, the effectiveness of mutual recognition agreements in facilitat-ing trade and the promotion of the aims and awareness of laboratory accreditation around the world.

There are regular meetings of individual ILAC committees as well as a major plenary meeting of all ILAC members.

The activities of ILAC affect a diverse range of areas including standardisation, accreditation, certifi cation, testing, calibration, and regulation in both the public and private sectors.

ILAC Publications Currently AvailableInformation Documents (I Series)

ILAC-I1:1994 Legal Liability in Testing

ILAC-I2:1994 Testing, Quality Assurance, Certifi cation and Accreditation

ILAC-I3:1996 The Role of Testing and Laboratory Accreditation in International Trade

ILAC-I4:1996 Guidance Documents for the Preparation of Laboratory Quality Manuals

Guidance Documents (G Series)

ILAC-G2:1994 Traceability of MeasurementILAC-G3:1994 Guidelines for Training Courses for AssessorsILAC-G4:1994 Guidelines on Scopes of AccreditationILAC-G7:1996 Accreditation Requirements and Operating Criteria for Horseracing LaboratoriesILAC-G8:1996 Guidelines on Assessment and Reporting of Compliance with Specifi cationILAC-G9:1996 Guidelines for the Selection and Use of Certifi ed Reference MaterialsILAC-G10:1996 Harmonised Procedures for Surveillance & Reassessment of Accredited LaboratoriesILAC-G11:1998 Guidelines on Assessor Qualifi cation and CompetenceILAC-G12:2000 Guidelines for the Requirements for the Competence of Reference Material ProducersILAC-G13:2000 Guidelines for the Requirements for the Competence of Providers of Profi ciency Testing SchemesILAC-G14:2000 Guidelines for the Use of Accreditation Body Logos and for Claims of Accreditation StatusILAC-G15:2001 Guidance for Accreditation to ISO/IEC 17025

Secretariat Documents (S Series)

ILAC-S1:2000 Guidelines for the Preparation, Layout and Numbering of ILAC Publications

ILAC-S2:1998 Rules

Procedural Documents (P Series)

ILAC-P1:2000 ILAC Mutual Recognition Arrangement (Arrangement): Requirements for Evaluation

of Accreditation Bodies

ILAC-P2: 2000 ILAC Mutual Recognition Arrangement (Arrangement): Procedures for the Evaluation of

Regional Cooperation Bodies for the Purpose of Recognition

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