7
L LABORATORY ACCREDITATION M Upmann, University of Applied Sciences, Lemgo, Germany R Stephan, University of Zürich, Zürich, Switzerland r 2014 Elsevier Ltd. All rights reserved. This article is a revision of the previous edition article by M Upmann and R Stephan, volume 2, pp 667674, © 2004, Elsevier Ltd Glossary Accreditation A process in which competency, authority, or credibility is certied. Accreditation body Organization auditing compliance with the requirements to fulll. Codex Alimentarius Collection of internationally recognized standards, codes of practice, guidelines, and other recommendations relating to foods, food production, and food safety. Equivalent By procedures of mutual evaluation and acceptance between accreditation bodies accreditation systems may be recognized as equivalent. ISO 17025 standard Standard on general requirements for the competence of testing and calibration laboratories. Fullling the Requirements assures the quality of analytical test results. Notication Process, in which laboratories are empowered to conduct ofcial analyses of public responsibility. Introduction Food samples are generally analyzed in order to decide whe- ther they are acceptable with respect to safety, quality, and regulatory requirements. For this decision to be made, the analytical results have to reect the real condition of the sample. However, every analytical procedure is inuenced by numerous external and internal factors, and condence in analytical results is only justied if the laboratory performing the work (1) uses an appropriate analytical method and (2) controls all factors potentially inuencing the accurate run of the analytical procedure. In other words, a quality assurance program for laboratory testing is essential. Having introduced a system to assure the quality of test results, laboratories may subsequently strive for an ofcial approval of their competence to perform specic tests or types of tests. This ofcial approval of competence is called accreditation.The term is derived from the Latin word accredo, which means to yield ones belief to another,i.e., to believe unconditionally, to trust, and to accept wholeheartedly. Hence, this term in connection with laboratory work indicates that the client may trust the analytical results delivered. Laboratories entrusted with tasks in the public food control sector are obliged to go through the trouble of a noticationprocedure. Derived from the Latin expression notum facere, meaning to make well known,this essentially means an administrative procedure resulting in the public listing of laboratories that have been state inspected and found to be competent to take over legally prescribed state control tasks. Accreditation and Notication System Development One of the earliest approaches to promoting laboratory quality systems dates from 1947 in Australia, when the Australian National Association of Testing Authorities (NATA) was founded. The intention was to organize a national testing service by identifying what was important for the reliability of test results and by developing standards to be met. In the 1960s, many countries developed their own laboratory standards, the application of which became increasingly pre- scribed by legislation during the 1970s. However, it was rec- ognized that the prescription of methods alone without the exclusion of interfering factors during testing did not result in a uniformly high level of laboratory performance. As a re- sult, from the 1980s there was a general move toward the Encyclopedia of Meat Sciences, Volume 2 doi:10.1016/B978-0-12-384731-7.00228-2 145

Laboratory acreditation

Embed Size (px)

DESCRIPTION

Laboratory acreditation

Citation preview

L

LABORATORY ACCREDITATION

M Upmann, University of Applied Sciences, Lemgo, Germany

En

R Stephan, University of Zürich, Zürich, Switzerland

r 2014 Elsevier Ltd. All rights reserved.

This article is a revision of the previous edition article by M Upmann andR Stephan, volume 2, pp 667–674, © 2004, Elsevier Ltd

GlossaryAccreditation A process in which competency, authority,or credibility is certified.Accreditation body Organization auditing compliancewith the requirements to fulfill.Codex Alimentarius Collection of internationallyrecognized standards, codes of practice, guidelines, andother recommendations relating to foods, food production,and food safety.

cyclopedia of Meat Sciences, Volume 2 doi:10.1016/B978-0-12-384731-7.0022

Equivalent By procedures of mutual evaluation andacceptance between accreditation bodies accreditationsystems may be recognized as equivalent.ISO 17025 standard Standard on general requirementsfor the competence of testing and calibration laboratories.Fulfilling the Requirements assures the quality of analyticaltest results.Notification Process, in which laboratories are empoweredto conduct official analyses of public responsibility.

Introduction

Food samples are generally analyzed in order to decide whe-ther they are acceptable with respect to safety, quality, andregulatory requirements. For this decision to be made, theanalytical results have to reflect the real condition of thesample. However, every analytical procedure is influenced bynumerous external and internal factors, and confidence inanalytical results is only justified if the laboratory performingthe work (1) uses an appropriate analytical method and (2)controls all factors potentially influencing the accurate run ofthe analytical procedure. In other words, a quality assuranceprogram for laboratory testing is essential.

Having introduced a system to assure the quality of testresults, laboratories may subsequently strive for an officialapproval of their competence to perform specific tests or typesof tests. This official approval of competence is called‘accreditation.’ The term is derived from the Latin word accredo,which means ‘to yield one’s belief to another,’ i.e., to believeunconditionally, to trust, and to accept wholeheartedly.Hence, this term in connection with laboratory work indicatesthat the client may trust the analytical results delivered.

Laboratories entrusted with tasks in the public food controlsector are obliged to go through the trouble of a ‘notification’

procedure. Derived from the Latin expression notum facere,meaning ‘to make well known,’ this essentially means anadministrative procedure resulting in the public listing oflaboratories that have been state inspected and found to becompetent to take over legally prescribed state control tasks.

Accreditation and Notification System

Development

One of the earliest approaches to promoting laboratory qualitysystems dates from 1947 in Australia, when the AustralianNational Association of Testing Authorities (NATA) wasfounded. The intention was to organize a national testingservice by identifying what was important for the reliability oftest results and by developing standards to be met. In the1960s, many countries developed their own laboratorystandards, the application of which became increasingly pre-scribed by legislation during the 1970s. However, it was rec-ognized that the prescription of methods alone – without theexclusion of interfering factors during testing – did not resultin a uniformly high level of laboratory performance. As a re-sult, from the 1980s there was a general move toward the

8-2 145

146 Laboratory Accreditation

prescription of a general quality system within which the la-boratory must operate. This is best illustrated by Article 12 ofregulation (EU) 882/2004: laboratories involved in officialcontrols must ‘‘... operate and are assessed and accredited inaccordance with the following European standards: (a) ENISO/IEC 17025 on ‘General requirements for the competenceof testing and calibration laboratories’; y’’. Although theserequirements apply only to laboratories involved in publicfood control, this also affects food laboratories in the privateservice sector. For the results to be accepted as equivalent, thelatter are advised to voluntarily adopt the same standards.

Standards to be Met

To guarantee the quality of test data, a system of qualitystandards has to be implemented in the laboratory. Such asystem must comply with generally accepted and standardizednorms.

As early as 1978, the International Laboratory AccreditationCooperation (ILAC) provided a statement of technical criteriafor accreditation of laboratories to the International Organ-ization for Standardization (ISO). Published as ISO Guide25:1984, this standard formed the basis for laboratoryaccreditation worldwide, and also for the European StandardEN 45001, which was adopted by the joint European Stand-ards Institution (CEN, Comité Européen de Normalisation/European Committee for Standardization; CENELEC, ComitéEuropéen de Normalisation Electrotechnique/EuropeanCommittee for Electrotechnical Standardization) in 1989.The further sophistication of laboratory quality system

Accredita

Certification bodies

Inspectbodie

ProductsISO/IEC 17065 Quality systems

ISO/IEC 17021

Qualitymanagement

systemsISO 9000 series

Environmentalmanagement

systemsISO 14000 series

PersonnelISO/IEC 17024

ISO/IEC 17

ISO/IEC 17011ISO/IEC ISO/IEC TR TR ISO/IEC 17

Figure 1 Accreditation system and relevant European and International stan1998. ...ierungen – Begriffe der Qualitätssicherungen. DACH-Zeitung 63 (10)

requirements necessitated several revisions of ISO Guide 25.The last extensive revision finally resulted in the ISO 17025standard, which brought the terms and requirements of la-boratory quality systems in line with the quality managementand quality assurance standards of the ISO 9000 series. Thisstandard also replaces EN 45001.

Figure 1 shows the hierarchical structure of the private-lawaccreditation system as well as the relevant standards to con-sider. Since the term ‘accreditation’ is not limited to testinglaboratories, calibration laboratories and inspection and cer-tification services are also included in the figure. Some relevantnorms for laboratory accreditation are further detailed inTable 1.

Organizations auditing compliance with the accreditationdemands are called ‘accreditation bodies.’ Most accreditationbodies have adopted ISO/IEC 17025 as the basis for theaccreditation procedure, which is crucial for safeguarding auniform approach for determining laboratory competence.By procedures of mutual evaluation and acceptance betweenaccreditation bodies according to ISO/IEC Guide 68:2002accreditation systems may be recognized as equivalent and amutual recognition agreement (MRA) may be signed. Thishelps test data that accompany exported goods on overseasmarkets to be more readily accepted, although it does notguarantee it.

Notification is a similar process, in which laboratories areempowered to conduct official analyses of public responsi-bility. Herein, competence assessment will be performed bypublic authorities, mostly requiring accreditation according toISO/IEC 17025 as a prerequisit and demanding several add-itional requirements. Table 2 compares briefly accreditation

tion

ions Testing

laboratoriesCalibrationlaboratories

020

ISO/IEC 17025 ISO/IEC 17025

1701017010011 ISO/IEC 17011

dards in the privately organized sector. Adapted from Wessel, H.,, 57, with permission from Reichenberger & Co. GmbH.

Table 1 Standards referring to accreditation and certification of analytical laboratories

Standard Description

Terms• EN 45020:2006 Standardization and related activities – general vocabulary• ISO/IEC Guide 2:2004 Standardization and related activities – general vocabulary• ISO/IEC 17000:2004 Conformity assessment – general vocabulary

Laboratory requirements• ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories• ISO/IEC 17043:2010 Conformity assessment – general requirements for proficiency testing• ISO 15189:2012 Medical laboratories – requirements for quality and competence• ISO 10012:2003 Measurement management systems – requirements for measurement processes and

measuring equipment• ISO 9000:2005 Quality management systems – fundamentals and vocabulary• ISO 9001:2008 Quality management systems – requirements• ISO/TR 10013:2001 Guidelines for quality management system documentation

Accreditation body requirements• ISO/IEC 17011:2004 Conformity assessment – general requirements for accreditation bodies accrediting

conformity assessment bodies• ISO/IEC 17040:2005 Conformity assessment – general requirements for peer assessment of conformity

assessment bodies and accreditation bodies• ISO 19011:2011 Guidelines for auditing management systems• ISO/IEC Guide 68:2002 Arrangements for the recognition and acceptance of conformity assessment results

Table 2 Comparison between accreditation and notification systems

Accreditation Notification

Aim To document the competence to perform specific tests forprivate clients

To carry out state control tasks

Basis Private contract between laboratory and accreditation body Specific legal regulationExtent Free choice of the applicant laboratory (a single method

would be possible)All methods fixed in the legal regulation concerned

Requirements Testing environment and accommodation Testing environment and accommodationPersonnel PersonnelTechnical equipment Technical equipmentQuality system and manual according to ISO 17025 Quality system and manualParticipation in proficiency testing schemes desirable butnot imperative

Successful participation in proficiency testingschemes imperative

Subcontracting possible at any time Subcontracting only exceptionally

Laboratory Accreditation 147

and notification requirements. The Codex AlimentariusCommission Guideline CAC/GL 27–1997 concerning the ‘as-sessment of the competence of testing laboratories involved inthe import and export control of food’ additionally laid downthe use of internal quality control procedures, such as dupli-cate analysis or inclusion of particular reference materials intothe analytical procedure. Owing to the formal acceptance ofCodex standards in the World Trade Organization’s SPS(sanitary and phytosanitary measures) and technical barriersto trade agreements, the significance of these Codex standardshas dramatically increased over the past few years.

Procedure

In the private laboratory sector, accreditation is a voluntaryprocedure that a laboratory may choose to undergo. Never-theless, since the beginning of the 1990s a strong movementtoward conformity assessment has developed, resulting in a

huge number of conformity assessment bodies for multiplepurposes in nearly all economic areas (Figure 2). Some web-sites that are useful for finding information on laboratory ac-creditation are given in section Relevant websites.

Testing laboratory accreditation is usually restricted to de-fined testing procedures, for example, determination of dioxinin meat. By contrast, a notification demands the application ofall analytical methods regulated in the legal norm applied, forexample, Council Directive 98/83/EC of 3 November 1998 onthe quality of water intended for human consumption.

Generally, the assessment of competence includes the fol-lowing five steps:

1. preparatory steps2. application for approval of competence3. auditing procedure4. accreditation/notification5. surveillance

1083

465314

1260

2910

1623

0

Produ

ct ce

rtific

ation

Num

ber

QS certi

ficat

ion

Perso

nnel

certi

ficat

ion

Insp

ectio

n

Testi

ng

Calibr

ation

1000

2000

3000

Figure 2 Fields of activity of 3535 conformity assessment bodies in29 European countries organized in the European Organisation forConformity Assessment (EOTC) in April 2002.

148 Laboratory Accreditation

Preparatory stepsAs a first step, it is necessary to become thoroughly informedabout the requirements, so that it is clear what the accredit-ation’s or notification’s subject matter (analytical methods,testing procedures, and legal norms) is, and what the demandsof the accreditation body are. Furthermore, the currentlaboratory’s status quo must be established.

Since a quality system according to an appropriate norm(in general ISO/IEC 17025) is demanded, a concept for itsimplementation or revision must be prepared. It is necessaryto determine which organizational and technical structuresmust be introduced, modified, or eliminated, and whichdocuments must be produced (responsibility, schedule). Thisis the main area where resources are required. Depending onthe existence and state of any current quality system, as well asthe level of support provided by the laboratory’s management,this preparatory phase may last from 6 months for well-or-ganized laboratories to 3 years for institutions that have morechanges to implement.

Application for approval of competenceFor private laboratories, the application for accreditation mustbe directed toward the accreditation body chosen by the la-boratory and a civil law contract is made. In the case of noti-fication, the state authority responsible for the legal norm inquestion should be contacted.

Auditing procedureThe accreditation body or state authority assigns appropriateassessors and reviews in a first step the application and qualitydocumentation. An on-site assessment is performed includingreview of the quality documentation, records, and samplehandling. In addition, interviews with technicians may beheld, demonstrations of tests or calibrations may be requested,and equipment and calibration records may be examined.

The assessor’s findings will be summarized in a writtenreport. Any deficiencies must be remedied before the next stepcan be taken.

Accreditation/notificationAfter elimination of deficiencies, the accreditation body orstate authority decides – usually by a council vote – on theaccreditation/notification. Where the accreditation/notifi-cation is granted, competence to perform the specific tests istestified by the issue of an official accreditation certificate andpublication in the register of accredited organizations.

SurveillanceSubsequently, the laboratories are supervised according to therules of the accreditation body or the state authority. Docu-ment reviews and periodical re-audits are a standing part of thesurveillance activities.

Costs

The costs for accreditation and notification are considerable.The establishment and implementation of the quality systemis responsible for about 90% of the total expenses, which is thefocal point of each approval of competence. These costs resultmainly from release of personnel in order to establish thedocumented quality system and to train the staff involved.Technical upgrading or reconstruction may be necessary.However, the latter is mostly the removal of shortcomings thatalready existed.

The fees charged by the accreditation body for the docu-ment review and auditing procedure, as well as the accredit-ation certificate, vary widely. They are different from country tocountry and depend on the size of the laboratory and thenumber of tests accredited. Laboratories in Germany, for ex-ample, must expect costs of €10 000–25 000. Costs in othercountries may be lower. Owing to mutual recognition, privatelaboratories may choose foreign accreditation bodies. How-ever, it should be recognized that accreditations that involveborder crossing may incur considerable travel, translation, andshipment costs.

Benefits

The primary benefit of accreditation is obvious: the labora-tory is formally recognized as being competent to carry outspecific tests or specific types of tests and receives a writtenproof of this. This may be an effective marketing tool whenlaboratories are invited to tender for analyses. From the pointof view of a client who wants a product to be checked, theavailability of a list of accredited laboratories makes it easierto select a service, which is able to deliver accurate andreliable results.

Additionally, notification as well as accreditation in com-bination with the concept of mutual recognition will reducecosts in international trade. Once the principle ‘once tested,accepted everywhere’ is recognized all over the world, expen-sive resampling and retesting, as well as multiple second-partyaudits, will be avoided for the most part.

Furthermore, the laboratory itself will enjoy some internaladvantages. The unbiased evaluation of the laboratory’s workby a science-based and experienced third party counteracts theorganization’s natural myopia. The required quality systemwill result in clearly stated procedures and responsibilities.

Laboratory Accreditation 149

This will make it easier for new personnel to become famil-iarized with their work, facilitate mutual substitution betweenstaff members, and help to increase confidence when carryingout rarely applied analytical methods.

Laboratory Requirements

The main objective of a laboratory quality system is to ensurethe consistency of laboratory results day to day and theirconformity with defined criteria. Therefore, sample handlingand all methodical procedure steps have to be documented,and all data relevant for the test as well as the test results haveto be recorded in order to guarantee traceability.

There is no generally applicable plan for establishing a la-boratory quality management system. Each organization willhave its own idiosyncrasies and problems that require specialconsideration and treatment. However, the general principlesand requirements are laid down in the International StandardISO 17025. The requirements are grouped into two maincategories, i.e., management and technical aspects.

Management Requirements

To guarantee objective analysis and data reporting, the la-boratory has to ensure its integrity and independence from anyundue internal and external commercial, financial, and otherpressures. Also, the staff’s duties and responsibilities must bespecified and documented in order to avoid faults due tounclear organizational structures. In this respect, the role of thelaboratory’s senior management is very important: it main-tains the general accountability, establishes the marketingstrategy and the quality policy, and commits the required re-sources. Therefore, a quality system cannot be establishedwithout the senior management’s support. Additionally, re-view and assessment of the quality activities and assurance of acontinuous improvement are aspects of the management’sduties.

Further management requirements are the establishment ofa system for approval, issue, change, and access for documentsand records, as well as rules for the review of requests, tenders,and contracts and for the service to clients including handlingof complaints.

Standards for subcontracting work and for purchasingservices and supplies must be set, in order to guarantee thefulfillment of the laboratory’s own quality standards.Furthermore, rules for dealing with nonconforming workincluding corrective and preventive actions are required.

Technical Requirements

Technical requirements concern personnel, environment,equipment, reagents, culture media and reference materials,sampling and sample handling, test methods, and quality ofperformance. For laboratories carrying out microbiologicaltesting of materials, products, and substances, the joint EA/EURACHEM working group document EA-04/10 Accreditationfor Microbiological Laboratories provides detailed and specificguidance on the interpretation of ISO 17025. The guidance is

applicable to the performance of all objective measurements,whether routine, nonroutine, or as part of research anddevelopment.

PersonnelTesting has to be either performed or supervised by an ex-perienced person, qualified to degree level. Furthermore, staffshould have relevant practical work experience before beingallowed to perform work covered by the scope of accredit-ation. If the laboratory includes interpretation of test results inthe report, this has to be done by authorized personnel withsuitable experience and relevant knowledge of the specificapplication, including, for example, legislative and technolo-gical requirements. The laboratory management has to ensurethat all personnel have received adequate training for thecompetent performance of tests and operation of equipment.

EnvironmentA typical laboratory is comprised of the testing facilities andancillary facilities. In general, there are specific environmentalrequirements for the testing facilities, for example, to constructthe premises according to the ‘no way back’ layout principle, todesignate areas for sample receipt and storage, to separate theareas of sample preparation, examination of samples, mediaand equipment preparation, and sterility assessment and de-contamination. Reduction of contamination may be achievedby having smooth surfaces on walls and minimal opening ofwindows and doors while tests are being carried out. Laboratoryclothing appropriate to the type of testing being performedshould be worn and removed before leaving the area. This isparticularly important in the molecular biology laboratory,where movement from an area of high deoxyribonucleic acid(DNA) load to one of low DNA load may unwittingly introducecross-contamination. Moreover, there should be a documentedcleaning program for laboratory fixtures, equipment and sur-faces. In addition, an appropriate environmental monitoringprogram should be devised, including all factors potentiallyinfluencing the test results. In microbiological laboratories, forexample, the microbial counts of the air and the working sur-faces should be monitored.

EquipmentAs part of the quality system, a laboratory is required to op-erate a documented program for maintenance, calibration, andperformance verification of its equipment. The maintenancehas to be carried out at specified intervals determined by fac-tors such as the rate of use. A calibration and performanceverification program of equipment directly influencing the testresults (e.g., scales and pH meters) has to be established. Evenfor rather simple equipment items this may be a sophisticatedaffair. For microbiological incubators, for example, the timerequired to achieve temperature equilibrium conditions,temperature stability, and uniformity of temperature distri-bution have to be established and documented, in particularwith respect to its typical use. Subsequent to the initial valid-ation of the equipment, the constancy of the characteristicsshould be checked and recorded after each significant modi-fication. Moreover, the laboratory has to monitor the oper-ating parameters during each use and retain records of theresults.

_ _0

< 0.1 0.11 0.20 0.21 0.30 > 0.31

10

20

30

40 Pour-plating

Surface-plating

Standard deviation (SD)

Num

ber

of r

eplic

ates

Figure 3 Variability during replicate microbiological testing forpurposes of internal quality control. Standard deviations (SD) areshown for replicate testing using the pour-plating and surface-platingmethods.

150 Laboratory Accreditation

Reagents, culture media, and reference materialThe suitability of each batch of reagents, culture media, anddiluents, critical for the test has to be verified initially as well asduring its shelf life. Furthermore, all reagents, media, and di-luents have to be labeled adequately to indicate identity,concentration, storage conditions, preparation date, validatedexpiry date, and recommended storage period. Reference ma-terials, certified reference materials, and reference cultureshave to be used, for example, to demonstrate the accuracyof results, to calibrate equipment, to monitor laboratory per-formance, or to validate methods.

Sampling and sample handlingWhile testing laboratories are responsible for primary sam-pling to obtain test items, for example, sampling of drinkingwater in food establishments, the sampling procedure also hasto be covered by the quality assurance program. Transport andstorage conditions have to maintain the integrity of the sam-ple. The conditions should be monitored and records shouldbe maintained.

The laboratory has to establish sample delivery and sampleidentification procedures. All relevant information such asdate and time of receipt, and sample condition on receipt,have to be recorded. Samples have to be stored undersuitable conditions in order to minimize changes, and storageconditions have to be defined and recorded.

Testing methods and quality of performanceAll methods used in a laboratory have to be validated. Thevalidation process should reflect the matrices and test con-ditions used in the laboratory. The specificity, relative trueness,positive and negative deviation, detection limits, matrix ef-fects, repeatability and reproducibility of the method shouldbe determined. Additionally, the uncertainty of measurementhas to be estimated and the laboratories should be aware ofthe incidence of false positive and false negative results asso-ciated with qualitative tests used.

A program of periodic checks is necessary to demonstratethat variability (e.g., between analysts and between equipmentor materials) is under control. The program may involve in-ternal quality controls such as the use of reference materials,spiked samples, and replicate testing. The example in Figure 3compares the variability of two microbiological methodsduring replicate testing. Furthermore, it is recommended (ifnot prescribed; see above) regularly to take part in externalproficiency testing schemes, which are relevant to their scopeof accreditation and matrices used.

Prospects

As described above, laboratory accreditation and notificationprovide important benefits. Nevertheless, a further evolutionof the whole system will support its effectiveness.

Generally, the establishment, implementation, and main-tenance of a quality system in a laboratory bind relevantpersonnel and monetary resources, and the necessities of sur-veillance and documentation will usually result in an in-creased workload. However, the laboratory should be carefulnot to bureaucratize the processes. Over-organization and pure

formalism only results in personnel demotivation and su-perfluous workload. The quality system should be a helpfultool to control factors influencing the analytical results, andnot an obstacle to work!

Owing to the universal character of the standards, theremay be some lack of clarity when realizing the requirements.Several organizations provide documents in order to interpretthe normative text. However, this should not result in ‘flood-ing’ of the laboratory with documents of limited importance.Accreditation bodies and other organizations should restrictinformation to helpful and practical advice.

In the future, it is likely that the incorporation of specificanalytical methods into legislation will be replaced by thespecification of method performance characteristics, for ex-ample, proof of applicability, in-house method validation,specification of detection limits, determination of measure-ment uncertainty, etc. This will have the advantage that theanalyst’s expertise is emphasized, thus allowing a certain de-gree of freedom with respect to the choice of the method.Furthermore, laboratory automation will be furthered andadministrative difficulties involved with changing a methoddelivering unsatisfactory or inferior results in comparison withanother will be eliminated.

However, this increased degree of freedom must go hand inhand with a strengthening of the expertise of the accreditationbodies in order to ensure a uniform quality during competenceassessments of laboratories. Furthermore, to overcome barriersto international trade, an international harmonization of theaccreditation/notification requirements as well as the furtherdevelopment of mutual recognition of accreditations is man-datory. This should be a worldwide effort, otherwise accredit-ation itself will serve as a new barrier. Laboratories in manycountries are still not in a suitable state to take part in thisdevelopment since infrastructural problems such as unstableenergy supply or a lack of local accreditation bodies render theestablishment of an accredited quality system difficult.

See also: Chemical Analysis: Standard Methods.Microbiological Analysis: Standard Methods. MicrobiologicalSafety of Meat: Listeria monocytogenes. Preslaughter Handling:Preslaughter Handling

Laboratory Accreditation 151

Further Reading

AOAC Analytical Laboratory Accreditation Criteria Committee, 2001. AccreditationCriteria for Laboratories Performing Food Microbiological and Chemical Analysesin Foods, Feeds, and Pharmaceutical Testing. Gaithersburg, MD: AOACInternational.

Codex Alimentarius Commission, 1997. Guidelines for the Assessment of theCompetence of Testing Laboratories Involved in the Import and Export Control ofFood. CAC/GL 27−1997. Available at: http://www.codexalimentarius.org/standards/list-of-standards/ (accessed 15.01.14).

Council Directive 93/99/EEC, 1993 on the subject of additional measures concerningthe official control of foodstuffs. Official Journal L290, 14−17.

Garfield, F.M., Klesta, E., Hirsch, J., 2000. Quality Assurance Principles forAnalytical Laboratories. Gaithersburg, MD: AOAC International.

Kohl, H., 1996. Qualitätsmanagement im Labor. Berlin: Springer-Verlag.Prichard, F.E., 2002. Quality in the Analytical Chemistry Laboratory. Hoboken, NJ:

John Wiley & Sons.Ratliff, T.A., 2003. The Laboratory Quality Assurance System: A Manual of Quality

Procedures and Forms. Hoboken, NJ: John Wiley & Sons.Seiler, J.P., 2000. Good Laboratory Practice: The Why and the How. Berlin:

Springer-Verlag.Wessel, H., 1998. ...ierungen − Begriffe der Qualitätssicherungen. DACH-Zeitung 63

(10), 57.Wood, R., 2001. Laboratories and analytical methods. In: Dillon, M., Griffith, C.

(Eds.), Auditing in the Food Industry. Cambridge: Woodhead Publishing Limited,pp. 111–144.

Relevant Websites

http://www.a2la.orgAmerican Association for Laboratory Accreditation.

http://www.aplac.orgAsia Pacific Laboratory Accreditation Cooperation.

http://www.aoac.orgAssociation of Analytical Communities.

http://www.citac.ccCooperation on International Traceability in Analytical Chemistry.

http://www.eurachem.orgEurachem.

http://www.cenorm.beEuropean Committee for Standardization.

http://www.european-accreditation.orgEuropean Cooperation for Accreditation.

http://www.eurolab.orgEuropean Federation of National Associations of Measurement, Testing andAnalytical Laboratories.

http://www.eoq.orgEuropean Organisation for Quality.

http://iaac-accreditation.orgInteramerican Accreditation Cooperation.

http://www.iaf.nuInternational Accreditation Forum.

http://www.ianz.govt.nzInternational Accreditation New Zealand.

http://www.iasonline.orgInternational Accreditation Service.

http://www.ilac.orgInternational Laboratory Accreditation Cooperation.

http://www.iso.chInternational Organization for Standardization.

http://www.nacla.netNational Cooperation for Laboratory Accreditation.

http://www.apec-pac.orgPacific Accreditation Cooperation.

http://www.sadca.orgSouthern African Development Community Cooperation in Accreditation.