Guidance Documents Available from Accreditation Bodies

for the Preparation of Laboratory Quality Manuals

ILAC-I4:1996

© Copyright ILAC 1996ILAC publications may not be copied for sale by any individual or

body other than ILAC member organisations

Guidance DocumentsAvailable from AccreditationBodies for the Preparation ofLaboratory Quality Manuals

ILAC-I4:1996

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

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PREAMBLE

At ILAC ‘94, it was resolved that ILAC Committee 3 shouldinvestigate the subject of guidance documents for laborato-ries to enable them to develop their quality manuals tocomply with ISO/IEC Guide 25 (Resolution No 25/94). Asa result, Working Group 9 launched an enquiry seeking tocollect bibliographical references on published documentsproviding such guidance on laboratory quality manuals.Accreditation bodies were requested to forward copies ofthese documents to the working group. The results of thisenquiry were reported at ILAC ‘96, where it was recom-mended that the list of guidance documents be publishedas an ILAC document.

PURPOSE

To provide a reference list of guidance documents availablefrom accreditation bodies to assist laboratories in develop-ing their quality manual.

AUTHORSHIP

The following list was prepared by Working Group 9 ofILAC Committee 3 in 1996. The Convenor of the workinggroup was Ms L Neumann of the USA. The document wasendorsed for publication by ILAC Resolution No 17/96.

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

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American Association for LaboratoryAccreditation (A2LA)656 Quince Orchard Road, #704Gaithersburg,Maryland 20878-1409 USAContact: Peter Unger

Canadian Association for Environmental Analytical Laboratories(CAEAL)Suite 300-265 Carling Avenue,Ottawa, Ontario,Canada K15 Ze1Contact: Rick Wilson

CCIBLAC15 Fangcaodi Xijie, Beijing 100020People’s Republic of ChinaContact: Mr Huang Smouyun

Chinese National Laboratory AccreditationBldg 8, 321 Kuang Fu Road, Section 2,Hsinchu, Taiwan 30042, R.O.C.Contact: Mr Nighel N L Jou

COFRAC37 rue de Lyon,75012 FranceContact: Dr Nathalie Saveant

Duetscher Kalibrierdienst (DKD)PTBReferat 8.32,Bundesallee 100,D-38116 Braunschweig,GermanyContact: Mr Eberhard Fay

FINASPO Box 239,Fin-00181 Helsinke,FinlandContact: Tuulikki Hattula

HOKLAS36/F, Immigration Tower,7 Gloucester RoadWan Chai,Hong KongContact: Dr Lay Har Ng

INMETROAv N S das Gracas,50 XeremRio de Janeiro,Brasil CEP 25 250-020Contact: Ms Regina C Mendes

Title of Guidance DocumentAccreditation Body

Guide for Laboratory Quality System Documentation

Quality Manual Course

Guide for a Quality Manual (In Chinese only)

Quality Manual Writer’s Guide (In Chinese only)

Guide pour la Redaction d’un Manuel Qualite dans unLaboratoire D’essais ou D’analyses and Guide pour laRedaction d’un Manuel Qualite dans un LaboratoireD’analyses des Eaux (In French only)

Guidance for the Preparation of a Quality Manual forCalibration Laboratories of the DKD (DKD-6, Edition 1993)

Quality Manual: Instructions for Writing (In Finnish only)

Guidelines for Preparation of a Laboratory Quality Manual

Quality Manual for Laboratory Guidelines(Language not identified)

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

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Title of Guidance DocumentAccreditation Body

Malaysia Accreditation Council21st Floor, Wisma MPSA,Persiaran Perbandaran40675 Shah Alam, Selangor,MalaysiaContact: Chin Miew Lim

National Association of Testing Authorities, Australia (NATA)7 Leeds Street,Rhodes NSW 2138,AustraliaContact: Mr John Gilmour

PALCANStandards Council of Canada45 O’Connor StreetSuite 1200,Ottawa Ontario K1p 6N7,CanadaContact: Mr Peter Holden

Polish Centre for Testing and Certification (PCBC)Accreditation Office,ul. Klobucka 23A,02-699 WarszawaPoland

RELARstr General Berthelot,no 16, Sector 1,BucharestRomaniaContact: Executive Director: Vasile ONU

SINALVia Campania 3100187 Roma, ItalyContact: Mr R Bolla

SwedacBox 878,S-501 15 Boras, SwedenContact: Kent Gustavsson

Telarc New ZealandPrivate Bag 28901,Remuera,Auckland 1136,New ZealandContact: Dr Max Robertson

The National Accreditation BoardWilton Park House, Wilton Place,Dublin 4, IrelandContact: Tom Dempsey

Guidelines for Development of a Laboratory Quality Manual

Guide to the Development of a Quality System for aLaboratory

ISO 10013 Guidelines for Developing Quality Manuals andCAN-P-1511 Guidelines for Preparing a Quality Manual forTesting Organisations

Guideline to documenting of quality system in testinglaboratory (Polish only)

Guidelines for laboratory quality manual development(DG-003 Ed.(Romanian) 1-1994 / DG-003E Ed.(English)1/1994)

Guide to the Compilation of a Quality Manual for a TestingLaboratory

Quality Manuals for Accredited Laboratories, A Guide

Guidance for the Preparation of Laboratory QualityManuals (Technical Guide No 7)

Guidance Notes for the Compilation of a Quality Manual fora Testing Laboratory (P4)

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

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Title of Guidance DocumentAgency Responding

UKASQueens Road,Teddington, Middlesex TW11 ONA,United KingdomContact: Dr John Rogers

Vietnam Laboratory Accreditation Scheme (VILAS)Directorate for Standards and Quality70 - Tran Hung Dao Str.Hanoi VietnamContact: Nguyen Duy Tan

VILASQuatest 3,49 Pasteur - D1-Ho Chi Minh City,VietnamContact: Mr Huynh Van Xuan

The Quality Manual - Guidance for Preparation (M16)

Guidelines for Development of a Laboratory Quality Manual(In Vietnamese only)

Guidelines for Developing Quality Manuals(Vietnam Standard No. 5951-1995) (In Vietnamese only)

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