Guidelines for Forensic Science Laboratories

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Guidelines for Forensic Science Laboratories ILAC-G19:2002

Transcript of Guidelines for Forensic Science Laboratories

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Guidelines for Forensic Science

Laboratories

ILAC-G19:2002

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© Copyright ILAC 2002

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Guidelines forForensicScienceLaboratories

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PREAMBLE

The general requirements for the competence oftesting and calibration laboratories are described inISO/IEC 17025. These requirements are de-signed to apply to all types of calibration andobjective testing and therefore need to be inter-preted with respect to the type of calibration andtesting concerned and the techniques involved.

This document does not re-state all the provisionsof ISO/IEC 17025 and laboratories are remindedof the need to comply with all of the relevantcriteria detailed in ISO/IEC 17025. The clausenumbers in this document follow those of ISO/IEC 17025 but since not all clauses require inter-pretation, the numbering may not be continuous.

This document may also be used by accreditationbodies to provide appropriate criteria for theassessment and accreditation of laboratoriesproviding forensic services.

Laboratories are also reminded of the need tocomply with any relevant statutory or legislativerequirements.

PURPOSE

This document is intended to provide guidance forlaboratories involved in forensic analysis andexamination by providing application of ISO/IEC17025.

AUTHORSHIP

This document has been produced in consultationwith Working Group 4 of the ILAC TechnicalAccreditation Issues Committee, and approved forpublication by the ILAC General Assembly in2001.

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Guidelines for Forensic Science Laboratories ILAC-G19:2002Table of Contents

Preamble ................................................................................................................................................ 4

Purpose ................................................................................................................................................... 4

Authorship .............................................................................................................................................. 4

1 SCOPE.......................................................................................................................................... 6

2 REFERENCES ........................................................................................................................... 8

3 TERMS AND DEFINITIONS ................................................................................................... 8

4 MANAGEMENT REQUIREMENTS ....................................................................................... 8

5 TECHNICAL REQUIREMENTS ............................................................................................. 9

ANNEX: BIBLIOGRAPHY ................................................................................................................. 13

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1. SCOPE

Forensic science refers to the examination of scenes of crime, recovery of evidence, laboratoryexaminations, interpretation of findings and presentation of the conclusions reached for intelligencepurposes or for use in court. The activities range from instrumental analysis with unequivocal results,such as blood alcohol determination and glass refractive index measurement, to the investigation ofsuspicious fires and vehicle accidents, to comparison work such as handwriting and toolmark examina-tion, which is largely subjective in nature but which, with training, can produce consistent outcomesbetween different forensic scientists.

1.1 Forensic science work involves the examination of a wide range of items and substances. The follow-ing list describes the activities that may be encountered in a forensic laboratory. This does not,however, preclude other activities being undertaken in a forensic laboratory.

Controlled Substances! Controlled pharmaceutical and illicit drugs ! Botanical material! Related chemicals and paraphernalia

Toxicology! Pharmaceutical products ! Alcohol! Poisons

Hairs, Blood, Body Fluids and Tissues! Serology ! DNA profiling

Trace Evidence! Fire debris ! Hydrocarbon fuels! Pyrotechnic devices ! Explosives and explosion debris! Glass ! Light filaments! Paint ! Vehicle components! Metals and alloys ! Firearm discharge residues! Fibres and hairs ! Clothing/garments! Adhesives ! Dyes and pigments! Oils and greases ! Cosmetics! Lachrymatory chemicals ! Soils! Fertilisers ! Corrosives! Acids ! Alkalis! Food ! Lubricants and spermicidal agents! Feedingstuffs and ancillary items ! Electrical devices and components! Components of technical or household appliances ! Manufacturers marks (incl serial number! Botanical material restoration)

(excluding controlled substances)

Firearms and ballistics! Firearms ! Bullets and cartridges

Handwriting and Document Examination! Handwriting ! Inks and printing materials! Paper ! Copiers and copied material! Rubber stamps ! Indentations! Security marks ! Typewriters and typewritten material! Printers and other printed objects ! Embossing and embossed materials

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Fingerprints! Fingerprints ! Palmprints! Footprints

Marks and Impressions! Toolmarks ! Tyre prints! Shoe prints ! Fabric prints! Glove marks ! Non-friction ridge body prints! Toolmarks and impressions

Audio, Video and Computer Analysis! Audiotape recordings ! Speech samples! Language samples ! Computers (hardware and software)! Image enhancement ! Videogrammetry! Facial mapping ! Recovery of information

Accident Investigation! Tachograph charts ! Trace evidence! Component failures ! Unsafe loads! Speed calculations ! Electrical failures! Car immobiliser systems

Scene Investigation! Crime scene investigation ! Evidence recovery! Computer simulations ! Photography! Fire investigation ! Blood splash pattern interpretation

Forensic pathology, Entomology, Odontology

1.2 The techniques adopted in the analysis and examination of forensic material cover a broad rangefrom visual examination to sophisticated instrumental procedures. Techniques which are employedinclude but are not limited to:

! Chemical colour tests ! Autoradiography! Chemiluminescence ! DNA analysis! Chromatography ! Mass spectrometry! Atomic absorption and emission ! Nuclear magnetic resonance

spectrometry spectroscopy! Ultraviolet, infrared and visible ! Physical measurements eg weight,

spectrophotometry volume, length, density, refractive index! Optical and electron microscopy ! X-ray analysis! Serology ! Immunoassay! Electrophoresis ! Visual inspections! Metallurgy ! Computer simulations

It is anticipated that the majority of the work carried out in forensic science laboratories will becapable of satisfying the definition of an objective test, although in some instances a different empha-sis may be placed on the particular aspect of ‘control’ required. The level of training and experiencefor staff involved in the work will be dependent on the nature of the examination or test.

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2. REFERENCES

ISO/IEC 17025:1999, General requirements forthe competence of testing and calibration laborato-ries.

ISO/IEC Guide 2, General terms and theirdefinitions concerning standardisation and relatedactivities.

ISO Guide 30:1992, Terms and definitions usedin connection with reference materials.

ILAC-P10: 2002, ILAC Policy on Traceabilityof Measurement Results

ILAC-G2: 1994, Traceability of measurements

3. TERMS AND DEFINITIONS

For the purposes of the Guide, the relevantterms and definitions given in ISO/IECGuide 2 apply.

Objective Test

A test which having been documented andvalidated is under control so that it can bedemonstrated that all appropriately trainedstaff will obtain the same results withindefined limits. These defined limits relate toexpressions of degrees of probability as wellas numerical values.

Objective tests will be controlled by:! documentation of the test! validation of the test! training and authorisation of staff! maintenance of equipment

and where appropriate by;! calibration of equipment! use of appropriate reference materi-

als! provision of guidance for interpreta-

tion! checking of results! testing of staff proficiency! recording of equipment/test perfor-

mance

Visual inspection, qualitative examinationsand computer simulations are included inthe definition of objective test.

Reference Collection

A collection of stable materials, substances,objects or artefacts of known properties ororigin that may be used in the determinationof the properties or origins of unknownitems.

Court Statement

A written report of the results and interpre-tations of forensic tests/examinationssubmitted to court. Such reports may be ina format prescribed in legislation.

4. MANAGEMENT REQUIREMENTS

4.12 Control of Records

4.12.2.1a) The forensic science laboratory shouldhave documented procedures to ensurethat it maintains a coordinated recordrelating to each case under investigation.The information that is to be included incase records should be documented andmay include records of telephoneconversations, evidence receipts, descrip-tions of evidence packaging and seals,subpoenas, records of observations andtest/examination results, reference toprocedures used, diagrams, print-outs,autoradiographs, photographs, etc. Ingeneral, the records required to supportconclusions should be such that in theabsence of the analyst/examiner,another competent analyst/examinercould evaluate what had been per-formed and interpret the data.

b) Where instrumental analyses are con-ducted, operating parameters should berecorded.

c) Where appropriate, observations or testresults should be preserved by photogra-phy or electronic scanning (eg electro-phoretic runs, physical matches). Photo-copies, tracings or hand-drawn facsimilesmay also be suitable (eg thin-layerchromatography results, questioneddocuments).

d) When a test result or observation isrejected, the reason(s) should be re-corded.

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e) Calculations and data transfers which donot form part of a validated electronicprocess should be checked, preferablyby a second person. The case recordshould include an indication that suchchecks have been carried out and bywhom.

f) Each page of every document in thecase record should be traceable to theanalyst/examiner and where appropriate,to a uniquely identified case or exhibit.It should be clear from the case recordwho has performed all stages of theanalysis/examination and when eachstage of the analysis/examination wasperformed (eg relevant date(s)).

g) Laboratory generated examinationrecords should be paginated using a pagenumbering system which indicates thetotal number of pages.

h) The laboratory should have documentedpolicies and procedures for the reviewof case records, including test reports.

Where independent checks on criticalfindings are carried out by otherauthorised personnel, the records shouldindicate that each critical finding hasbeen checked and agreed and by whomthe checks were performed. This maybe indicated in a number of waysincluding entries against each finding,entry on a summary of findings or astatement to this effect in the records.

5. TECHNICAL REQUIREMENTS

5.2 Personnel

5.2.1 The laboratory should have a defined policythat ensures that all staff working in thelaboratory are competent to perform thework required. The term ‘competent’implies possessing the requisite knowledge,skills and abilities to perform the job. Thelaboratory’s policy should also includeprocedures for retraining and maintenanceof skills and expertise.

Where test or technique specific training isgiven, acceptance criteria should be assignedeg observation of the relevant tests oranalyses by an experienced officer, satisfac-

tory performance in the analysis of qualitycontrol/quality assurance samples, correla-tion of results with those obtained by othertrained staff. Where necessary, trainingprograms should also include training in thepresentation of evidence in court.

5.2.5 A laboratory should have clear statementsof the competencies required for all jobsand records should be maintained todemonstrate that all staff are competent forthe jobs they are asked to carry out.

Each laboratory or section should maintainan up-to-date record of the training thateach member of staff has received. Theserecords should include academic andprofessional qualifications, external orinternal courses attended and relevanttraining (and retraining, where necessary)received whilst working in the laboratory.

Records should be sufficiently detailed toprovide evidence that staff performingparticular tasks have been properly trainedand that their subsequent ability to performthese tests has been formally assessed.

5.3 Accommodation and EnvironmentalConditions

5.3.3 Special care is needed in forensic testinglaboratories involved in the analysis ordetermination of trace levels of materials,including DNA. Physical separation ofhigh-level and low-level work is required.Where special areas are set aside for thistype of work, access to these areas shouldbe restricted and the work undertakencarefully controlled. Appropriate recordsshould be kept to demonstrate this control.It may also be necessary to carry out‘environmental monitoring’ of equipment,work areas, clothing and consumables.

5.3.4 a) Access to the operational area of thelaboratory should be controllable andlimited. Visitors should not have unre-stricted access to the operational areasof the laboratory. A record should beretained of all visitors to the operationalareas of the laboratory.

b) Evidence storage areas should be secureto prevent theft or interference andthere should be limited, controlled

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access. The storage conditions should besuch as to prevent loss, deterioration andcontamination and to maintain theintegrity and identity of the evidence.This applies both before and afterexaminations have been performed.

5.4 Test and calibration methods and methodvalidation

5.4.1 All methods should be fully documentedincluding procedures for quality control,and, where appropriate, the use of refer-ence materials.

5.4.2 a) All technical procedures used by aforensic science laboratory should befully validated before being used oncasework.

b) Where a laboratory introduces a new(validated) method, it should firstdemonstrate the reliability of the proce-dure in-house against any documentedperformance characteristics of thatprocedure.

Records of performance verificationshould be maintained for future refer-ence.

c) Laboratories should institute a procedureto identify infrequently performed testsor analyses. For these tests or analyses,there are two methods of demonstratingcompetence, either of which would beequally valid. These are:

i. regular analysis of control samplesand use of control charts even whencasework samples are not beinganalysed; or

ii. reverification before the test oranalysis in question is performed ona casework sample involving at leastthe use of an appropriate referencematerial, followed by replicate testingor analysis of the real sample.

d) The quality of standard materials andreagents should be adequate for theprocedure used. Lot/batch numbers ofstandard materials and critical reagentsshould be recorded. All critical reagentsshould be tested for their reliability.

Standard materials and reagents shouldbe labelled with:! name;! concentration, where appropriate,! preparation date and or expiry date;! identity of preparer;! storage conditions, if relevant;! hazard warning, where necessary.

5.4.5.1 All technical procedures used by aforensic science laboratory must be fullyvalidated before being used on case-work.

Methods may be validated by compari-son with other established methods usingcertified reference materials (whereavailable) or materials of known charac-teristics. In validating test methods, thefollowing issues (among others) mayneed to be determined, as appropriate:! matrix effects! interferences! sample homogeneity! concentration ranges! specificity! stability of measured compounds! linearity range! population distribution! precision! measurement uncertainty

Validation studies can be conducted bythe scientific community (as in the caseof standard or published methods) or bythe forensic science laboratory itself (asin the case of methods developed in-house or where significant modificationsare made to previously validated meth-ods).

5.5 Equipment

5.5.2 As part of a quality system, all laboratoriesare required to operate a program for themaintenance and calibration of equipmentused in the laboratory. The equipment usedin a forensic science laboratory is diverseand will range across a number of differentscientific and technical disciplines.

a) General service equipment not directlyused for making measurements (e.g. hotplates, stirrers, non-volumetric glassware,cameras, refrigerators, thermal cyclers).

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Such equipment will typically be main-tained by visual examination, safetychecks and cleaning as necessary.Calibrations or performance checks willonly be necessary where the equipmentsetting can significantly affect the test oranalytical result (eg temperature of amuffle furnace or constant temperaturebath).

b) Microscopes including attachments

Microscopes should be cleaned andserviced periodically. Steps should betaken to ensure that microscopes areproperly set up for use and are usedonly by competent staff. Where micro-scopes are used for measurement theguidance given in paragraph d) applies.

c) Volumetric equipment

Volumetric equipment will typically bemaintained by visual examination andcleaning but calibration and perfor-mance checks will need to be carried outbefore initial use and at intervals de-pending on the type and frequency ofuse.

d) Measuring instruments - thermometers,balances, densitometers, chromato-graphs, spectrometers and spectropho-tometers, refractometers, autoanalysers,DNA sequencers

Correct use combined with periodicservicing, cleaning and calibration willnot necessarily ensure that a measuringinstrument or detection system isperforming adequately. Therefore,where appropriate, periodic perfor-mance checks shall be carried out andpredetermined limits of acceptabilityshall be assigned. The frequency ofsuch performance checks should bedetermined by need, type and previousperformance of the equipment.

It is often possible to build performancechecks or system suitability checks intotest methods (eg chromatographicsystems, measurement of glass refrac-tive index). These checks should bedocumented and should be satisfactorilycompleted before the equipment is used

or before results are accepted.

e) Computers and data processors

5.6 Measurement traceability

5.6.1 Individual calibration programs should beestablished depending on the specificrequirements of the testing or analyticalwork being carried out. It will normally benecessary to check instrument calibrationafter any shut down, whether deliberate orotherwise, and following service or othersubstantial maintenance. In general, calibra-tion intervals should not be less stringentthan manufacturers’ recommendations.

5.6.2.2.2 For many types of analysis, ‘calibration’may be carried out using syntheticstandards containing the analytes undertest, prepared within the laboratory fromchemicals of known purity and composi-tion, or matrix matched standards.Alternatively, ‘standard’ solutions may bepurchased. Many chemicals can bepurchased with manufacturer’s state-ments or certificates. Wherever possible,laboratories should obtain supplies ofchemical standards from competentsuppliers.

5.6.3.2 Reference collections of data or items/materials encountered in casework whichare maintained for identification, com-parison or interpretation purposes (egmass spectra, motor vehicle paints orheadlamp lenses, drug samples, type-writer printstyles, wood fragments,bullets, cartridges, DNA profiles, fre-quency databases) should be fullydocumented, uniquely identified andproperly controlled.

5.7 Sampling

5.7.1 Selection, recovery, prioritisation andsampling of materials from submitted testitems and from scenes of crime are impor-tant parts of the forensic process. In thearea of forensic science emphasis is placedon the competence of the scientist and thetraining of staff in these activities is there-fore of prime importance. Laboratoriesshould ensure that there are documentedprocedures and training programs to coverthis aspect of their work and that detailed

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competency/training records are kept for allstaff involved.

5.8 Handling of test and calibration items

5.8.1 For legal purposes, forensic science labora-tories should be able to demonstrate thatthe items/samples examined and reportedon were those submitted to the laboratory.A ‘chain of custody’ record should bemaintained from the receipt of items/samples which details each person whotakes possession of an item or alternativelythe location of that item (eg if in storage).

5.8.4 There should be documented procedureswhich describe the measures taken to secureexhibits in the process of being examinedwhich must be left unattended.

5.9 Assuring the quality of test and calibra-tion results

5.9.1 a) Analytical performance should bemonitored by operating quality controlschemes which are appropriate to thetype and frequency of testing under-taken by a laboratory. The range ofquality control activities available tolaboratories includes the use of :! reference collections;! certified reference materials and

internally generated referencematerials;

! statistical tables;! positive and negative controls;! control charts;! replicate testing;! alternative methods;! repeat testing;! spiked samples, standard additions

and internal standards;! independent checks (verification) by

other authorised personnel.

Depending on the particular test beingperformed, the laboratory may makeuse of one or several of these examplesto demonstrate that the test or examina-tion is ‘under control’.

The quality control procedures necessaryin any particular area of work should bedetermined by the laboratory responsiblefor the work, based on best professionalpractice. The procedures should be

documented and records should beretained to show that all appropriate QCmeasures have been taken, that all QCresults are acceptable or, if not, thatremedial action has been taken.

b) An effective means for a forensicscience laboratory to monitor its perfor-mance, both against its own require-ments and against the performance ofpeer laboratories, is to take part inproficiency testing programs. Whenparticipating in proficiency testingprograms, the laboratory’s own docu-mented test procedures should be used.Performance in the programs should bereviewed regularly and where necessary,corrective action should be taken.

Proficiency testing records shouldinclude:! full details of the analyses/examina-

tions undertaken and the results andconclusions obtained;

! an indication that performance hasbeen reviewed;

! details of the corrective actionundertaken, where necessary.

c) The laboratory should have and follow adocumented procedure whereby thetestimony of each examiner is moni-tored on a regular basis. The evaluationshould include appearance, performanceand effectiveness of presentation. Themonitoring procedure should alsoprescribe the remedial action that is tobe taken should the evaluation be lessthan satisfactory.

5.10 Reporting the results

5.10.2 It is accepted that forensic science laborato-ries may not be able to include all of theitems in ‘Court Statements’ that are detailedin sub-clause 5.10 of ISO/IEC 17025 asthe format of these documents is pre-scribed in legislation. Forensic sciencelaboratories may therefore elect to adoptone or more of the following means ofmeeting these requirements.! the preparation of a test report which

includes all of the information requiredby ISO/IEC 17025;

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! the preparation of an annex to theCourt Statement which includes anyadditional information required by ISO/IEC 17025;

! ensuring that the case record relating toa specific investigation contains all therelevant information required by ISO/IEC 17025.

ANNEX: BIBLIOGRAPHY

ISO/IEC Application Document, SupplementaryRequirements for Accreditation in the Field of ForensicScience: 2000 version 1, National Association ofTesting Authorities, Australia (NATA).

Accreditation for Forensic Analysis and Examination,NIS 46, Edition 2, December 1994, UnitedKingdom Accreditation Service (UKAS).

American Society of Crime Laboratory Directors– Laboratory Accreditation Board Manual, 1999

NIS 96, Accreditation for Suppliers to the UK NationalDNA Database, March 1997, United KingdomAccreditation Service (UKAS).

CAN-P-1578, Guidelines for the Accreditation ofForensic Testing Laboratories, 2nd Edition, November1998, Standards Council of Canada (SCC).

Specific Criteria for Forensic Analysis, Raad voorAccreditatie (RVA), October 1993.

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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 accredi-tation practices, the effectiveness of mutual recognition agreements in facilitating 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 has a comprehensive website at www.ilac.org which contains a wealth of information regarding accreditation, testing, trade related publications and other information of interest to industry, regulators, government, trade bodies, laboratories,

accreditation bodies, and users of testing and calibration services.

The following ILAC publications are available free of charge on the ILAC website at www.ilac.org:

BrochuresILAC Information BrochureWhy Use An Accredited Laboratory?Why Become An Accredited Laboratory?How Does Using an Accredited Laboratory Benefi t Government & Regulators?The Advantages of Being An Accredited Laboratory Information Documents (I Series)ILAC-I1:1994 Legal Liability in TestingILAC-I2:1994 Testing, Quality Assurance, Certifi cation and AccreditationILAC-I3:1996 The Role of Testing and Laboratory Accreditation in International TradeILAC-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 17025ILAC-G17:2002 Introducing the Concept of Uncertainty of Measurement in Testing in Association with the

Application of the Standard ISO/IEC 17025ILAC-G18:2002 The Scope of Accreditation and Consideration of Methods and Criteria for the Assessment of the

Scope in TestingILAC-G19:2002 Guidelines for Forensic Science Laboratories

Secretariat Documents (S Series)ILAC-S1:2000 Guidelines for the Proposal, Drafting, Approval and Publication of ILAC DocumentsILAC-S2:1998 Rules

Procedural Documents (P Series)ILAC-P1:2000 ILAC Mutual Recognition Arrangement (Arrangement): Requirements for Evaluation of Accreditation

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

Cooperation Bodies for the Purpose of RecognitionILAC-P3: 2002 ILAC Mutual Recognition Arrangement (Arrangement): Procedures for the Unaffi liated Bodies for the

Purpose of Recognition ILAC Mutual Recognition Arrangement (Arrangement): Terms of Reference and Composition of the

Arrangement Management Committee ILAC Mutual Recognition Arrangement (Arrangement) ILAC Mutual Recognition Arrangement (Arrangement): Policy Statement