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LABORATORY ACCREDITATION
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 667–674, © 2004, Elsevier Ltd
Glossary Accreditation A process in which competency, authority, or credibility is certified. Accreditation body Organization auditing compliance with the requirements to fulfill. Codex Alimentarius Collection of internationally recognized standards, codes of practice, guidelines, and other recommendations relating to foods, food production, and food safety.
Introduction Food samples are generally analyzed in order to decide whether they are acceptable with respect to safety, quality, and regulatory requirements. For this decision to be made, the analytical results have to reflect the real condition of the sample. However, every analytical procedure is influenced by numerous external and internal factors, and confidence in analytical results is only justified if the laboratory performing the work (1) uses an appropriate analytical method and (2) controls all factors potentially influencing 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 official approval of their competence to perform specific tests or types of 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 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 ‘notification’
Encyclopedia of Meat Sciences, Volume 2
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. Fulfilling the Requirements assures the quality of analytical test results. Notification Process, in which laboratories are empowered to conduct official analyses of public responsibility.
procedure. 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 Notification 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 prescribed by legislation during the 1970s. However, it was recognized 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 result, from the 1980s there was a general move toward the
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Laboratory Accreditation
prescription of a general quality system within which the laboratory must operate. This is best illustrated by Article 12 of regulation (EU) 882/2004: laboratories involved in official controls must ‘‘... operate and are assessed and accredited in accordance with the following European standards: (a) EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’; y’’. Although these requirements apply only to laboratories involved in public food control, this also affects food laboratories in the private service sector. For the results to be accepted as equivalent, the latter are advised to voluntarily adopt the same standards.
Standards to be Met To guarantee the quality of test data, a system of quality standards has to be implemented in the laboratory. Such a system must comply with generally accepted and standardized norms. As early as 1978, the International Laboratory Accreditation Cooperation (ILAC) provided a statement of technical criteria for accreditation of laboratories to the International Organization for Standardization (ISO). Published as ISO Guide 25:1984, this standard formed the basis for laboratory accreditation worldwide, and also for the European Standard EN 45001, which was adopted by the joint European Standards Institution (CEN, Comité Européen de Normalisation/ European Committee for Standardization; CENELEC, Comité Européen de Normalisation Electrotechnique/European Committee for Electrotechnical Standardization) in 1989. The further sophistication of laboratory quality system
requirements necessitated several revisions of ISO Guide 25. The last extensive revision finally resulted in the ISO 17025 standard, which brought the terms and requirements of laboratory quality systems in line with the quality management and quality assurance standards of the ISO 9000 series. This standard also replaces EN 45001. Figure 1 shows the hierarchical structure of the private-law accreditation system as well as the relevant standards to consider. Since the term ‘accreditation’ is not limited to testing laboratories, calibration laboratories and inspection and certification services are also included in the figure. Some relevant norms for laboratory accreditation are further detailed in Table 1. Organizations auditing compliance with the accreditation demands are called ‘accreditation bodies.’ Most accreditation bodies have adopted ISO/IEC 17025 as the basis for the accreditation procedure, which is crucial for safeguarding a uniform approach for determining laboratory competence. By procedures of mutual evaluation and acceptance between accreditation bodies according to ISO/IEC Guide 68:2002 accreditation systems may be recognized as equivalent and a mutual recognition agreement (MRA) may be signed. This helps test data that accompany exported goods on overseas markets to be more readily accepted, although it does not guarantee it. Notification is a similar process, in which laboratories are empowered to conduct official analyses of public responsibility. Herein, competence assessment will be performed by public authorities, mostly requiring accreditation according to ISO/IEC 17025 as a prerequisit and demanding several additional requirements. Table 2 compares briefly accreditation
Accreditation
ISO/IEC 17011 ISO/IEC ISO/IECTR17011 17010
ISO/IEC 17011
Certification bodies Inspection bodies
Products ISO/IEC 17065
Quality systems ISO/IEC 17021
Testing laboratories
Calibration laboratories
ISO/IEC 17025
ISO/IEC 17025
Personnel ISO/IEC 17024 ISO/IEC 17020
Quality management systems ISO 9000 series
Environmental management systems ISO 14000 series
Figure 1 Accreditation system and relevant European and International standards in the privately organized sector. Adapted from Wessel, H., 1998. ...ierungen – Begriffe der Qualitätssicherungen. DACH-Zeitung 63 (10), 57, with permission from Reichenberger & Co. GmbH.
Laboratory Accreditation
Table 1
Standards referring to accreditation and certification of analytical laboratories
Standard
Description
Terms • EN 45020:2006 • ISO/IEC Guide 2:2004 • ISO/IEC 17000:2004
Standardization and related activities – general vocabulary Standardization and related activities – general vocabulary Conformity assessment – general vocabulary
Laboratory requirements • ISO/IEC 17025:2005 • ISO/IEC 17043:2010 • ISO 15189:2012 • ISO 10012:2003
General requirements for the competence of testing and calibration laboratories Conformity assessment – general requirements for proficiency testing Medical laboratories – requirements for quality and competence Measurement management systems – requirements for measurement processes and measuring equipment Quality management systems – fundamentals and vocabulary Quality management systems – requirements Guidelines for quality management system documentation
• ISO 9000:2005 • ISO 9001:2008 • ISO/TR 10013:2001 Accreditation body requirements • ISO/IEC 17011:2004
• ISO/IEC 17040:2005 • ISO 19011:2011 • ISO/IEC Guide 68:2002 Table 2
147
Conformity assessment – general requirements for accreditation bodies accrediting conformity assessment bodies Conformity assessment – general requirements for peer assessment of conformity assessment bodies and accreditation bodies Guidelines for auditing management systems Arrangements for the recognition and acceptance of conformity assessment results
Comparison between accreditation and notification systems
Aim Basis Extent Requirements
Accreditation
Notification
To document the competence to perform specific tests for private clients Private contract between laboratory and accreditation body Free choice of the applicant laboratory (a single method would be possible) Testing environment and accommodation Personnel Technical equipment Quality system and manual according to ISO 17025 Participation in proficiency testing schemes desirable but not imperative Subcontracting possible at any time
To carry out state control tasks
and notification requirements. The Codex Alimentarius Commission Guideline CAC/GL 27–1997 concerning the ‘assessment of the competence of testing laboratories involved in the import and export control of food’ additionally laid down the use of internal quality control procedures, such as duplicate analysis or inclusion of particular reference materials into the analytical procedure. Owing to the formal acceptance of Codex standards in the World Trade Organization’s SPS (sanitary and phytosanitary measures) and technical barriers to trade agreements, the significance of these Codex standards has dramatically increased over the past few years.
Procedure In the private laboratory sector, accreditation is a voluntary procedure that a laboratory may choose to undergo. Nevertheless, since the beginning of the 1990s a strong movement toward conformity assessment has developed, resulting in a
Specific legal regulation All methods fixed in the legal regulation concerned Testing environment and accommodation Personnel Technical equipment Quality system and manual Successful participation in proficiency testing schemes imperative Subcontracting only exceptionally
huge number of conformity assessment bodies for multiple purposes in nearly all economic areas (Figure 2). Some websites that are useful for finding information on laboratory accreditation are given in section Relevant websites. Testing laboratory accreditation is usually restricted to defined testing procedures, for example, determination of dioxin in meat. By contrast, a notification demands the application of all analytical methods regulated in the legal norm applied, for example, Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. Generally, the assessment of competence includes the following five steps: 1. 2. 3. 4. 5.
preparatory steps application for approval of competence auditing procedure accreditation/notification surveillance
148
Laboratory Accreditation Accreditation/notification 2910
2000 1623 1260
1083 465
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After elimination of deficiencies, the accreditation body or state authority decides – usually by a council vote – on the accreditation/notification. Where the accreditation/notification is granted, competence to perform the specific tests is testified by the issue of an official accreditation certificate and publication in the register of accredited organizations.
314
0
Te s
1000
In s
Number
3000
Figure 2 Fields of activity of 3535 conformity assessment bodies in 29 European countries organized in the European Organisation for Conformity Assessment (EOTC) in April 2002.
Preparatory steps As a first step, it is necessary to become thoroughly informed about the requirements, so that it is clear what the accreditation’s or notification’s subject matter (analytical methods, testing procedures, and legal norms) is, and what the demands of the accreditation body are. Furthermore, the current laboratory’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 its implementation or revision must be prepared. It is necessary to determine which organizational and technical structures must be introduced, modified, or eliminated, and which documents must be produced (responsibility, schedule). This is the main area where resources are required. Depending on the existence and state of any current quality system, as well as the level of support provided by the laboratory’s management, this preparatory phase may last from 6 months for well-organized laboratories to 3 years for institutions that have more changes to implement.
Surveillance Subsequently, the laboratories are supervised according to the rules of the accreditation body or the state authority. Document reviews and periodical re-audits are a standing part of the surveillance activities.
Costs The costs for accreditation and notification are considerable. The establishment and implementation of the quality system is responsible for about 90% of the total expenses, which is the focal point of each approval of competence. These costs result mainly from release of personnel in order to establish the documented quality system and to train the staff involved. Technical upgrading or reconstruction may be necessary. However, the latter is mostly the removal of shortcomings that already existed. The fees charged by the accreditation body for the document review and auditing procedure, as well as the accreditation certificate, vary widely. They are different from country to country and depend on the size of the laboratory and the number of tests accredited. Laboratories in Germany, for example, must expect costs of €10 000–25 000. Costs in other countries may be lower. Owing to mutual recognition, private laboratories may choose foreign accreditation bodies. However, it should be recognized that accreditations that involve border crossing may incur considerable travel, translation, and shipment costs.
Benefits Application for approval of competence For private laboratories, the application for accreditation must be directed toward the accreditation body chosen by the laboratory and a civil law contract is made. In the case of notification, the state authority responsible for the legal norm in question should be contacted.
Auditing procedure The accreditation body or state authority assigns appropriate assessors and reviews in a first step the application and quality documentation. An on-site assessment is performed including review of the quality documentation, records, and sample handling. In addition, interviews with technicians may be held, 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 written report. Any deficiencies must be remedied before the next step can be taken.
The primary benefit of accreditation is obvious: the laboratory is formally recognized as being competent to carry out specific tests or specific types of tests and receives a written proof of this. This may be an effective marketing tool when laboratories are invited to tender for analyses. From the point of view of a client who wants a product to be checked, the availability of a list of accredited laboratories makes it easier to select a service, which is able to deliver accurate and reliable results. Additionally, notification as well as accreditation in combination with the concept of mutual recognition will reduce costs in international trade. Once the principle ‘once tested, accepted everywhere’ is recognized all over the world, expensive resampling and retesting, as well as multiple second-party audits, will be avoided for the most part. Furthermore, the laboratory itself will enjoy some internal advantages. The unbiased evaluation of the laboratory’s work by a science-based and experienced third party counteracts the organization’s natural myopia. The required quality system will result in clearly stated procedures and responsibilities.
Laboratory Accreditation
This will make it easier for new personnel to become familiarized with their work, facilitate mutual substitution between staff members, and help to increase confidence when carrying out rarely applied analytical methods.
149
applicable to the performance of all objective measurements, whether routine, nonroutine, or as part of research and development.
Personnel
Laboratory Requirements The main objective of a laboratory quality system is to ensure the consistency of laboratory results day to day and their conformity with defined criteria. Therefore, sample handling and all methodical procedure steps have to be documented, and all data relevant for the test as well as the test results have to be recorded in order to guarantee traceability. There is no generally applicable plan for establishing a laboratory quality management system. Each organization will have its own idiosyncrasies and problems that require special consideration and treatment. However, the general principles and requirements are laid down in the International Standard ISO 17025. The requirements are grouped into two main categories, i.e., management and technical aspects.
Management Requirements To guarantee objective analysis and data reporting, the laboratory has to ensure its integrity and independence from any undue internal and external commercial, financial, and other pressures. Also, the staff’s duties and responsibilities must be specified and documented in order to avoid faults due to unclear organizational structures. In this respect, the role of the laboratory’s senior management is very important: it maintains the general accountability, establishes the marketing strategy and the quality policy, and commits the required resources. Therefore, a quality system cannot be established without the senior management’s support. Additionally, review and assessment of the quality activities and assurance of a continuous improvement are aspects of the management’s duties. Further management requirements are the establishment of a system for approval, issue, change, and access for documents and records, as well as rules for the review of requests, tenders, and contracts and for the service to clients including handling of complaints. Standards for subcontracting work and for purchasing services and supplies must be set, in order to guarantee the fulfillment of the laboratory’s own quality standards. Furthermore, rules for dealing with nonconforming work including 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 of performance. For laboratories carrying out microbiological testing of materials, products, and substances, the joint EA/ EURACHEM working group document EA-04/10 Accreditation for Microbiological Laboratories provides detailed and specific guidance on the interpretation of ISO 17025. The guidance is
Testing has to be either performed or supervised by an experienced person, qualified to degree level. Furthermore, staff should have relevant practical work experience before being allowed to perform work covered by the scope of accreditation. If the laboratory includes interpretation of test results in the report, this has to be done by authorized personnel with suitable experience and relevant knowledge of the specific application, including, for example, legislative and technological requirements. The laboratory management has to ensure that all personnel have received adequate training for the competent performance of tests and operation of equipment.
Environment A typical laboratory is comprised of the testing facilities and ancillary facilities. In general, there are specific environmental requirements for the testing facilities, for example, to construct the premises according to the ‘no way back’ layout principle, to designate areas for sample receipt and storage, to separate the areas of sample preparation, examination of samples, media and equipment preparation, and sterility assessment and decontamination. Reduction of contamination may be achieved by having smooth surfaces on walls and minimal opening of windows and doors while tests are being carried out. Laboratory clothing appropriate to the type of testing being performed should be worn and removed before leaving the area. This is particularly 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 introduce cross-contamination. Moreover, there should be a documented cleaning program for laboratory fixtures, equipment and surfaces. In addition, an appropriate environmental monitoring program should be devised, including all factors potentially influencing the test results. In microbiological laboratories, for example, the microbial counts of the air and the working surfaces should be monitored.
Equipment As part of the quality system, a laboratory is required to operate a documented program for maintenance, calibration, and performance verification of its equipment. The maintenance has to be carried out at specified intervals determined by factors such as the rate of use. A calibration and performance verification program of equipment directly influencing the test results (e.g., scales and pH meters) has to be established. Even for rather simple equipment items this may be a sophisticated affair. For microbiological incubators, for example, the time required to achieve temperature equilibrium conditions, temperature stability, and uniformity of temperature distribution have to be established and documented, in particular with respect to its typical use. Subsequent to the initial validation of the equipment, the constancy of the characteristics should be checked and recorded after each significant modification. Moreover, the laboratory has to monitor the operating parameters during each use and retain records of the results.
150
Laboratory Accreditation
Reagents, culture media, and reference material
Sampling and sample handling While testing laboratories are responsible for primary sampling to obtain test items, for example, sampling of drinking water in food establishments, the sampling procedure also has to be covered by the quality assurance program. Transport and storage conditions have to maintain the integrity of the sample. The conditions should be monitored and records should be maintained. The laboratory has to establish sample delivery and sample identification procedures. All relevant information such as date and time of receipt, and sample condition on receipt, have to be recorded. Samples have to be stored under suitable conditions in order to minimize changes, and storage conditions have to be defined and recorded.
Testing methods and quality of performance All methods used in a laboratory have to be validated. The validation process should reflect the matrices and test conditions used in the laboratory. The specificity, relative trueness, positive and negative deviation, detection limits, matrix effects, repeatability and reproducibility of the method should be determined. Additionally, the uncertainty of measurement has to be estimated and the laboratories should be aware of the incidence of false positive and false negative results associated with qualitative tests used. A program of periodic checks is necessary to demonstrate that variability (e.g., between analysts and between equipment or materials) is under control. The program may involve internal quality controls such as the use of reference materials, spiked samples, and replicate testing. The example in Figure 3 compares the variability of two microbiological methods during replicate testing. Furthermore, it is recommended (if not prescribed; see above) regularly to take part in external proficiency testing schemes, which are relevant to their scope of accreditation and matrices used.
Prospects As described above, laboratory accreditation and notification provide important benefits. Nevertheless, a further evolution of the whole system will support its effectiveness. Generally, the establishment, implementation, and maintenance of a quality system in a laboratory bind relevant personnel and monetary resources, and the necessities of surveillance and documentation will usually result in an increased workload. However, the laboratory should be careful not to bureaucratize the processes. Over-organization and pure
40 Number of replicates
The suitability of each batch of reagents, culture media, and diluents, critical for the test has to be verified initially as well as during its shelf life. Furthermore, all reagents, media, and diluents have to be labeled adequately to indicate identity, concentration, storage conditions, preparation date, validated expiry date, and recommended storage period. Reference materials, certified reference materials, and reference cultures have to be used, for example, to demonstrate the accuracy of results, to calibrate equipment, to monitor laboratory performance, or to validate methods.
Pour-plating Surface-plating
30 20 10 0 < 0.1
0.11_ 0.20
0.21_ 0.30
> 0.31
Standard deviation (SD) Figure 3 Variability during replicate microbiological testing for purposes of internal quality control. Standard deviations (SD) are shown for replicate testing using the pour-plating and surface-plating methods.
formalism only results in personnel demotivation and superfluous workload. The quality system should be a helpful tool to control factors influencing the analytical results, and not an obstacle to work! Owing to the universal character of the standards, there may be some lack of clarity when realizing the requirements. Several organizations provide documents in order to interpret the normative text. However, this should not result in ‘flooding’ of the laboratory with documents of limited importance. Accreditation bodies and other organizations should restrict information to helpful and practical advice. In the future, it is likely that the incorporation of specific analytical methods into legislation will be replaced by the specification of method performance characteristics, for example, proof of applicability, in-house method validation, specification of detection limits, determination of measurement uncertainty, etc. This will have the advantage that the analyst’s expertise is emphasized, thus allowing a certain degree of freedom with respect to the choice of the method. Furthermore, laboratory automation will be furthered and administrative difficulties involved with changing a method delivering unsatisfactory or inferior results in comparison with another will be eliminated. However, this increased degree of freedom must go hand in hand with a strengthening of the expertise of the accreditation bodies in order to ensure a uniform quality during competence assessments of laboratories. Furthermore, to overcome barriers to international trade, an international harmonization of the accreditation/notification requirements as well as the further development of mutual recognition of accreditations is mandatory. This should be a worldwide effort, otherwise accreditation itself will serve as a new barrier. Laboratories in many countries are still not in a suitable state to take part in this development since infrastructural problems such as unstable energy supply or a lack of local accreditation bodies render the establishment of an accredited quality system difficult.
See also: Chemical Analysis: Standard Methods. Microbiological Analysis: Standard Methods. Microbiological Safety of Meat: Listeria monocytogenes. Preslaughter Handling: Preslaughter Handling
Laboratory Accreditation
Further Reading AOAC Analytical Laboratory Accreditation Criteria Committee, 2001. Accreditation Criteria for Laboratories Performing Food Microbiological and Chemical Analyses in Foods, Feeds, and Pharmaceutical Testing. Gaithersburg, MD: AOAC International. Codex Alimentarius Commission, 1997. Guidelines for the Assessment of the Competence of Testing Laboratories Involved in the Import and Export Control of Food. 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 concerning the official control of foodstuffs. Official Journal L290, 14−17. Garfield, F.M., Klesta, E., Hirsch, J., 2000. Quality Assurance Principles for Analytical 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.org American Association for Laboratory Accreditation. http://www.aplac.org Asia Pacific Laboratory Accreditation Cooperation. http://www.aoac.org Association of Analytical Communities.
http://www.citac.cc Cooperation on International Traceability in Analytical Chemistry. http://www.eurachem.org Eurachem. http://www.cenorm.be European Committee for Standardization. http://www.european-accreditation.org European Cooperation for Accreditation. http://www.eurolab.org European Federation of National Associations of Measurement, Testing and Analytical Laboratories. http://www.eoq.org European Organisation for Quality. http://iaac-accreditation.org Interamerican Accreditation Cooperation. http://www.iaf.nu International Accreditation Forum. http://www.ianz.govt.nz International Accreditation New Zealand. http://www.iasonline.org International Accreditation Service. http://www.ilac.org International Laboratory Accreditation Cooperation. http://www.iso.ch International Organization for Standardization. http://www.nacla.net National Cooperation for Laboratory Accreditation. http://www.apec-pac.org Pacific Accreditation Cooperation. http://www.sadca.org Southern African Development Community Cooperation in Accreditation.
151
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 667–674, © 2004, Elsevier Ltd
Glossary Accreditation A process in which competency, authority, or credibility is certified. Accreditation body Organization auditing compliance with the requirements to fulfill. Codex Alimentarius Collection of internationally recognized standards, codes of practice, guidelines, and other recommendations relating to foods, food production, and food safety.
Introduction Food samples are generally analyzed in order to decide whether they are acceptable with respect to safety, quality, and regulatory requirements. For this decision to be made, the analytical results have to reflect the real condition of the sample. However, every analytical procedure is influenced by numerous external and internal factors, and confidence in analytical results is only justified if the laboratory performing the work (1) uses an appropriate analytical method and (2) controls all factors potentially influencing 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 official approval of their competence to perform specific tests or types of 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 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 ‘notification’
Encyclopedia of Meat Sciences, Volume 2
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. Fulfilling the Requirements assures the quality of analytical test results. Notification Process, in which laboratories are empowered to conduct official analyses of public responsibility.
procedure. 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 Notification 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 prescribed by legislation during the 1970s. However, it was recognized 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 result, from the 1980s there was a general move toward the
doi:10.1016/B978-0-12-384731-7.00228-2
145
146
Laboratory Accreditation
prescription of a general quality system within which the laboratory must operate. This is best illustrated by Article 12 of regulation (EU) 882/2004: laboratories involved in official controls must ‘‘... operate and are assessed and accredited in accordance with the following European standards: (a) EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’; y’’. Although these requirements apply only to laboratories involved in public food control, this also affects food laboratories in the private service sector. For the results to be accepted as equivalent, the latter are advised to voluntarily adopt the same standards.
Standards to be Met To guarantee the quality of test data, a system of quality standards has to be implemented in the laboratory. Such a system must comply with generally accepted and standardized norms. As early as 1978, the International Laboratory Accreditation Cooperation (ILAC) provided a statement of technical criteria for accreditation of laboratories to the International Organization for Standardization (ISO). Published as ISO Guide 25:1984, this standard formed the basis for laboratory accreditation worldwide, and also for the European Standard EN 45001, which was adopted by the joint European Standards Institution (CEN, Comité Européen de Normalisation/ European Committee for Standardization; CENELEC, Comité Européen de Normalisation Electrotechnique/European Committee for Electrotechnical Standardization) in 1989. The further sophistication of laboratory quality system
requirements necessitated several revisions of ISO Guide 25. The last extensive revision finally resulted in the ISO 17025 standard, which brought the terms and requirements of laboratory quality systems in line with the quality management and quality assurance standards of the ISO 9000 series. This standard also replaces EN 45001. Figure 1 shows the hierarchical structure of the private-law accreditation system as well as the relevant standards to consider. Since the term ‘accreditation’ is not limited to testing laboratories, calibration laboratories and inspection and certification services are also included in the figure. Some relevant norms for laboratory accreditation are further detailed in Table 1. Organizations auditing compliance with the accreditation demands are called ‘accreditation bodies.’ Most accreditation bodies have adopted ISO/IEC 17025 as the basis for the accreditation procedure, which is crucial for safeguarding a uniform approach for determining laboratory competence. By procedures of mutual evaluation and acceptance between accreditation bodies according to ISO/IEC Guide 68:2002 accreditation systems may be recognized as equivalent and a mutual recognition agreement (MRA) may be signed. This helps test data that accompany exported goods on overseas markets to be more readily accepted, although it does not guarantee it. Notification is a similar process, in which laboratories are empowered to conduct official analyses of public responsibility. Herein, competence assessment will be performed by public authorities, mostly requiring accreditation according to ISO/IEC 17025 as a prerequisit and demanding several additional requirements. Table 2 compares briefly accreditation
Accreditation
ISO/IEC 17011 ISO/IEC ISO/IECTR17011 17010
ISO/IEC 17011
Certification bodies Inspection bodies
Products ISO/IEC 17065
Quality systems ISO/IEC 17021
Testing laboratories
Calibration laboratories
ISO/IEC 17025
ISO/IEC 17025
Personnel ISO/IEC 17024 ISO/IEC 17020
Quality management systems ISO 9000 series
Environmental management systems ISO 14000 series
Figure 1 Accreditation system and relevant European and International standards in the privately organized sector. Adapted from Wessel, H., 1998. ...ierungen – Begriffe der Qualitätssicherungen. DACH-Zeitung 63 (10), 57, with permission from Reichenberger & Co. GmbH.
Laboratory Accreditation
Table 1
Standards referring to accreditation and certification of analytical laboratories
Standard
Description
Terms • EN 45020:2006 • ISO/IEC Guide 2:2004 • ISO/IEC 17000:2004
Standardization and related activities – general vocabulary Standardization and related activities – general vocabulary Conformity assessment – general vocabulary
Laboratory requirements • ISO/IEC 17025:2005 • ISO/IEC 17043:2010 • ISO 15189:2012 • ISO 10012:2003
General requirements for the competence of testing and calibration laboratories Conformity assessment – general requirements for proficiency testing Medical laboratories – requirements for quality and competence Measurement management systems – requirements for measurement processes and measuring equipment Quality management systems – fundamentals and vocabulary Quality management systems – requirements Guidelines for quality management system documentation
• ISO 9000:2005 • ISO 9001:2008 • ISO/TR 10013:2001 Accreditation body requirements • ISO/IEC 17011:2004
• ISO/IEC 17040:2005 • ISO 19011:2011 • ISO/IEC Guide 68:2002 Table 2
147
Conformity assessment – general requirements for accreditation bodies accrediting conformity assessment bodies Conformity assessment – general requirements for peer assessment of conformity assessment bodies and accreditation bodies Guidelines for auditing management systems Arrangements for the recognition and acceptance of conformity assessment results
Comparison between accreditation and notification systems
Aim Basis Extent Requirements
Accreditation
Notification
To document the competence to perform specific tests for private clients Private contract between laboratory and accreditation body Free choice of the applicant laboratory (a single method would be possible) Testing environment and accommodation Personnel Technical equipment Quality system and manual according to ISO 17025 Participation in proficiency testing schemes desirable but not imperative Subcontracting possible at any time
To carry out state control tasks
and notification requirements. The Codex Alimentarius Commission Guideline CAC/GL 27–1997 concerning the ‘assessment of the competence of testing laboratories involved in the import and export control of food’ additionally laid down the use of internal quality control procedures, such as duplicate analysis or inclusion of particular reference materials into the analytical procedure. Owing to the formal acceptance of Codex standards in the World Trade Organization’s SPS (sanitary and phytosanitary measures) and technical barriers to trade agreements, the significance of these Codex standards has dramatically increased over the past few years.
Procedure In the private laboratory sector, accreditation is a voluntary procedure that a laboratory may choose to undergo. Nevertheless, since the beginning of the 1990s a strong movement toward conformity assessment has developed, resulting in a
Specific legal regulation All methods fixed in the legal regulation concerned Testing environment and accommodation Personnel Technical equipment Quality system and manual Successful participation in proficiency testing schemes imperative Subcontracting only exceptionally
huge number of conformity assessment bodies for multiple purposes in nearly all economic areas (Figure 2). Some websites that are useful for finding information on laboratory accreditation are given in section Relevant websites. Testing laboratory accreditation is usually restricted to defined testing procedures, for example, determination of dioxin in meat. By contrast, a notification demands the application of all analytical methods regulated in the legal norm applied, for example, Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. Generally, the assessment of competence includes the following five steps: 1. 2. 3. 4. 5.
preparatory steps application for approval of competence auditing procedure accreditation/notification surveillance
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After elimination of deficiencies, the accreditation body or state authority decides – usually by a council vote – on the accreditation/notification. Where the accreditation/notification is granted, competence to perform the specific tests is testified by the issue of an official accreditation certificate and publication in the register of accredited organizations.
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Figure 2 Fields of activity of 3535 conformity assessment bodies in 29 European countries organized in the European Organisation for Conformity Assessment (EOTC) in April 2002.
Preparatory steps As a first step, it is necessary to become thoroughly informed about the requirements, so that it is clear what the accreditation’s or notification’s subject matter (analytical methods, testing procedures, and legal norms) is, and what the demands of the accreditation body are. Furthermore, the current laboratory’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 its implementation or revision must be prepared. It is necessary to determine which organizational and technical structures must be introduced, modified, or eliminated, and which documents must be produced (responsibility, schedule). This is the main area where resources are required. Depending on the existence and state of any current quality system, as well as the level of support provided by the laboratory’s management, this preparatory phase may last from 6 months for well-organized laboratories to 3 years for institutions that have more changes to implement.
Surveillance Subsequently, the laboratories are supervised according to the rules of the accreditation body or the state authority. Document reviews and periodical re-audits are a standing part of the surveillance activities.
Costs The costs for accreditation and notification are considerable. The establishment and implementation of the quality system is responsible for about 90% of the total expenses, which is the focal point of each approval of competence. These costs result mainly from release of personnel in order to establish the documented quality system and to train the staff involved. Technical upgrading or reconstruction may be necessary. However, the latter is mostly the removal of shortcomings that already existed. The fees charged by the accreditation body for the document review and auditing procedure, as well as the accreditation certificate, vary widely. They are different from country to country and depend on the size of the laboratory and the number of tests accredited. Laboratories in Germany, for example, must expect costs of €10 000–25 000. Costs in other countries may be lower. Owing to mutual recognition, private laboratories may choose foreign accreditation bodies. However, it should be recognized that accreditations that involve border crossing may incur considerable travel, translation, and shipment costs.
Benefits Application for approval of competence For private laboratories, the application for accreditation must be directed toward the accreditation body chosen by the laboratory and a civil law contract is made. In the case of notification, the state authority responsible for the legal norm in question should be contacted.
Auditing procedure The accreditation body or state authority assigns appropriate assessors and reviews in a first step the application and quality documentation. An on-site assessment is performed including review of the quality documentation, records, and sample handling. In addition, interviews with technicians may be held, 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 written report. Any deficiencies must be remedied before the next step can be taken.
The primary benefit of accreditation is obvious: the laboratory is formally recognized as being competent to carry out specific tests or specific types of tests and receives a written proof of this. This may be an effective marketing tool when laboratories are invited to tender for analyses. From the point of view of a client who wants a product to be checked, the availability of a list of accredited laboratories makes it easier to select a service, which is able to deliver accurate and reliable results. Additionally, notification as well as accreditation in combination with the concept of mutual recognition will reduce costs in international trade. Once the principle ‘once tested, accepted everywhere’ is recognized all over the world, expensive resampling and retesting, as well as multiple second-party audits, will be avoided for the most part. Furthermore, the laboratory itself will enjoy some internal advantages. The unbiased evaluation of the laboratory’s work by a science-based and experienced third party counteracts the organization’s natural myopia. The required quality system will result in clearly stated procedures and responsibilities.
Laboratory Accreditation
This will make it easier for new personnel to become familiarized with their work, facilitate mutual substitution between staff members, and help to increase confidence when carrying out rarely applied analytical methods.
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applicable to the performance of all objective measurements, whether routine, nonroutine, or as part of research and development.
Personnel
Laboratory Requirements The main objective of a laboratory quality system is to ensure the consistency of laboratory results day to day and their conformity with defined criteria. Therefore, sample handling and all methodical procedure steps have to be documented, and all data relevant for the test as well as the test results have to be recorded in order to guarantee traceability. There is no generally applicable plan for establishing a laboratory quality management system. Each organization will have its own idiosyncrasies and problems that require special consideration and treatment. However, the general principles and requirements are laid down in the International Standard ISO 17025. The requirements are grouped into two main categories, i.e., management and technical aspects.
Management Requirements To guarantee objective analysis and data reporting, the laboratory has to ensure its integrity and independence from any undue internal and external commercial, financial, and other pressures. Also, the staff’s duties and responsibilities must be specified and documented in order to avoid faults due to unclear organizational structures. In this respect, the role of the laboratory’s senior management is very important: it maintains the general accountability, establishes the marketing strategy and the quality policy, and commits the required resources. Therefore, a quality system cannot be established without the senior management’s support. Additionally, review and assessment of the quality activities and assurance of a continuous improvement are aspects of the management’s duties. Further management requirements are the establishment of a system for approval, issue, change, and access for documents and records, as well as rules for the review of requests, tenders, and contracts and for the service to clients including handling of complaints. Standards for subcontracting work and for purchasing services and supplies must be set, in order to guarantee the fulfillment of the laboratory’s own quality standards. Furthermore, rules for dealing with nonconforming work including 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 of performance. For laboratories carrying out microbiological testing of materials, products, and substances, the joint EA/ EURACHEM working group document EA-04/10 Accreditation for Microbiological Laboratories provides detailed and specific guidance on the interpretation of ISO 17025. The guidance is
Testing has to be either performed or supervised by an experienced person, qualified to degree level. Furthermore, staff should have relevant practical work experience before being allowed to perform work covered by the scope of accreditation. If the laboratory includes interpretation of test results in the report, this has to be done by authorized personnel with suitable experience and relevant knowledge of the specific application, including, for example, legislative and technological requirements. The laboratory management has to ensure that all personnel have received adequate training for the competent performance of tests and operation of equipment.
Environment A typical laboratory is comprised of the testing facilities and ancillary facilities. In general, there are specific environmental requirements for the testing facilities, for example, to construct the premises according to the ‘no way back’ layout principle, to designate areas for sample receipt and storage, to separate the areas of sample preparation, examination of samples, media and equipment preparation, and sterility assessment and decontamination. Reduction of contamination may be achieved by having smooth surfaces on walls and minimal opening of windows and doors while tests are being carried out. Laboratory clothing appropriate to the type of testing being performed should be worn and removed before leaving the area. This is particularly 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 introduce cross-contamination. Moreover, there should be a documented cleaning program for laboratory fixtures, equipment and surfaces. In addition, an appropriate environmental monitoring program should be devised, including all factors potentially influencing the test results. In microbiological laboratories, for example, the microbial counts of the air and the working surfaces should be monitored.
Equipment As part of the quality system, a laboratory is required to operate a documented program for maintenance, calibration, and performance verification of its equipment. The maintenance has to be carried out at specified intervals determined by factors such as the rate of use. A calibration and performance verification program of equipment directly influencing the test results (e.g., scales and pH meters) has to be established. Even for rather simple equipment items this may be a sophisticated affair. For microbiological incubators, for example, the time required to achieve temperature equilibrium conditions, temperature stability, and uniformity of temperature distribution have to be established and documented, in particular with respect to its typical use. Subsequent to the initial validation of the equipment, the constancy of the characteristics should be checked and recorded after each significant modification. Moreover, the laboratory has to monitor the operating parameters during each use and retain records of the results.
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Reagents, culture media, and reference material
Sampling and sample handling While testing laboratories are responsible for primary sampling to obtain test items, for example, sampling of drinking water in food establishments, the sampling procedure also has to be covered by the quality assurance program. Transport and storage conditions have to maintain the integrity of the sample. The conditions should be monitored and records should be maintained. The laboratory has to establish sample delivery and sample identification procedures. All relevant information such as date and time of receipt, and sample condition on receipt, have to be recorded. Samples have to be stored under suitable conditions in order to minimize changes, and storage conditions have to be defined and recorded.
Testing methods and quality of performance All methods used in a laboratory have to be validated. The validation process should reflect the matrices and test conditions used in the laboratory. The specificity, relative trueness, positive and negative deviation, detection limits, matrix effects, repeatability and reproducibility of the method should be determined. Additionally, the uncertainty of measurement has to be estimated and the laboratories should be aware of the incidence of false positive and false negative results associated with qualitative tests used. A program of periodic checks is necessary to demonstrate that variability (e.g., between analysts and between equipment or materials) is under control. The program may involve internal quality controls such as the use of reference materials, spiked samples, and replicate testing. The example in Figure 3 compares the variability of two microbiological methods during replicate testing. Furthermore, it is recommended (if not prescribed; see above) regularly to take part in external proficiency testing schemes, which are relevant to their scope of accreditation and matrices used.
Prospects As described above, laboratory accreditation and notification provide important benefits. Nevertheless, a further evolution of the whole system will support its effectiveness. Generally, the establishment, implementation, and maintenance of a quality system in a laboratory bind relevant personnel and monetary resources, and the necessities of surveillance and documentation will usually result in an increased workload. However, the laboratory should be careful not to bureaucratize the processes. Over-organization and pure
40 Number of replicates
The suitability of each batch of reagents, culture media, and diluents, critical for the test has to be verified initially as well as during its shelf life. Furthermore, all reagents, media, and diluents have to be labeled adequately to indicate identity, concentration, storage conditions, preparation date, validated expiry date, and recommended storage period. Reference materials, certified reference materials, and reference cultures have to be used, for example, to demonstrate the accuracy of results, to calibrate equipment, to monitor laboratory performance, or to validate methods.
Pour-plating Surface-plating
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Standard deviation (SD) Figure 3 Variability during replicate microbiological testing for purposes of internal quality control. Standard deviations (SD) are shown for replicate testing using the pour-plating and surface-plating methods.
formalism only results in personnel demotivation and superfluous workload. The quality system should be a helpful tool to control factors influencing the analytical results, and not an obstacle to work! Owing to the universal character of the standards, there may be some lack of clarity when realizing the requirements. Several organizations provide documents in order to interpret the normative text. However, this should not result in ‘flooding’ of the laboratory with documents of limited importance. Accreditation bodies and other organizations should restrict information to helpful and practical advice. In the future, it is likely that the incorporation of specific analytical methods into legislation will be replaced by the specification of method performance characteristics, for example, proof of applicability, in-house method validation, specification of detection limits, determination of measurement uncertainty, etc. This will have the advantage that the analyst’s expertise is emphasized, thus allowing a certain degree of freedom with respect to the choice of the method. Furthermore, laboratory automation will be furthered and administrative difficulties involved with changing a method delivering unsatisfactory or inferior results in comparison with another will be eliminated. However, this increased degree of freedom must go hand in hand with a strengthening of the expertise of the accreditation bodies in order to ensure a uniform quality during competence assessments of laboratories. Furthermore, to overcome barriers to international trade, an international harmonization of the accreditation/notification requirements as well as the further development of mutual recognition of accreditations is mandatory. This should be a worldwide effort, otherwise accreditation itself will serve as a new barrier. Laboratories in many countries are still not in a suitable state to take part in this development since infrastructural problems such as unstable energy supply or a lack of local accreditation bodies render the establishment of an accredited quality system difficult.
See also: Chemical Analysis: Standard Methods. Microbiological Analysis: Standard Methods. Microbiological Safety of Meat: Listeria monocytogenes. Preslaughter Handling: Preslaughter Handling
Laboratory Accreditation
Further Reading AOAC Analytical Laboratory Accreditation Criteria Committee, 2001. Accreditation Criteria for Laboratories Performing Food Microbiological and Chemical Analyses in Foods, Feeds, and Pharmaceutical Testing. Gaithersburg, MD: AOAC International. Codex Alimentarius Commission, 1997. Guidelines for the Assessment of the Competence of Testing Laboratories Involved in the Import and Export Control of Food. 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 concerning the official control of foodstuffs. Official Journal L290, 14−17. Garfield, F.M., Klesta, E., Hirsch, J., 2000. Quality Assurance Principles for Analytical 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.org American Association for Laboratory Accreditation. http://www.aplac.org Asia Pacific Laboratory Accreditation Cooperation. http://www.aoac.org Association of Analytical Communities.
http://www.citac.cc Cooperation on International Traceability in Analytical Chemistry. http://www.eurachem.org Eurachem. http://www.cenorm.be European Committee for Standardization. http://www.european-accreditation.org European Cooperation for Accreditation. http://www.eurolab.org European Federation of National Associations of Measurement, Testing and Analytical Laboratories. http://www.eoq.org European Organisation for Quality. http://iaac-accreditation.org Interamerican Accreditation Cooperation. http://www.iaf.nu International Accreditation Forum. http://www.ianz.govt.nz International Accreditation New Zealand. http://www.iasonline.org International Accreditation Service. http://www.ilac.org International Laboratory Accreditation Cooperation. http://www.iso.ch International Organization for Standardization. http://www.nacla.net National Cooperation for Laboratory Accreditation. http://www.apec-pac.org Pacific Accreditation Cooperation. http://www.sadca.org Southern African Development Community Cooperation in Accreditation.
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