Laboratory quality systems accreditation

Accreditation to ISO/IEC 17025 or GLP is becoming a standard approach to creating a quality system (chapter 9). Note that accreditation, as such, is not part of the VAM principles, but it is one of alternative quality systems (see chapter 1). Like any quality system, accreditation only fulfills its purpose if implemented properly. Some laboratories have done the minimum to achieve accreditation, and then take the view that having paid for their accreditation payment of the annual fee will then suffice. This practice is evidenced when accredited laboratories perform no better in testing rounds than experienced laboratories without accreditation (see chapter 5). 

Before the designation, the laboratories developed their laboratory methods for testing, constructed and made operational their laboratory quality system and obtained its accreditation, and continued the participation and successful performance in the OPCW proficiency tests (PT). Analytical methods in particular and a certain level of quality assurance systems have existed in the laboratories, involved often in research, well before their designation. Participation in the international interlaboratory... 

The main similarities of GLP and other laboratory quality systems may be seen in their focus on apparatus and instrument suitability, maintenance and calibration, where the requirements of accreditation systems go beyond what GLP is regulating, since these issues are of the utmost importance for generating accurate, precise and reproducible results. Thus, it has to be possible in every case to trace back the calibrations to the respective national standards of measurement, and the quality control of the measurements has to ensure that trends to deviations form the precision required are detected already early on. 

Laboratory Accreditation and Quality Systems" Together these make laboratory managers look for added security in assuring data quality and thus invoke a desire in them to fall back on the best available standard. The result is that a CRM is often used instead of a working standard. This is a tendency that is supported and encouraged by some RM providers but discouraged by others. 

In large laboratories, where dozens or even hundreds of different types of analyses are carried out, an additional internal process to test the quality system is particularly important. An external assessment team can only hope to observe and assess in detail a relatively small number of the analyses during each visit, so there may be years between any one of a laboratory s externally assessed analyses being re-examined in detail. Laboratories may not have entered all of the analyses that they carry out in their scope of external accreditation. If they wish to ensure quality is maintained in these other areas of their work, an internal... 

Section 1 Formal quality system in the laboratory if third party assessed (i.e. if UKAS accredited or GLP compliant)... 

This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 170252005. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system , (refer joint ISO-ILAC-IAF Communique dated 18 June 2005)... 

The AALA accreditation is also based on the ISO/IEC Guide 25. This accreditation indicates that a laboratory has demonstrated that it is competent to perform specific tests or specific types of tests that its quality system addresses and conforms to all elements of the Guide 25 and is fully operational and that it conforms to any additional requirements of AALA or specific fields of testing or programs necessary to meet particular user needs. 

Laboratories accredited by the DOD branches usually have better quality systems than the laboratories that work for private industry clients only. 

Because the NELAC standards are general, they require interpretation or clarification in certain areas of application. That is why the US DOD undertook a task of specifying some of these broad areas in definite terms in a manual that unifies laboratory requirements of the Navy, Air Force, and United States Army Corps of Engineers (DOD, 2000). This manual, titled Department of Defense Quality Systems Manual for Environmental Laboratories, is offered to the DOD representatives and contractors who design, implement, and oversee contracts with environmental laboratories. Currently, the three DOD branches implement their own laboratory accreditation programs with some reciprocity between the three a task force has been created to combine these programs into a single DOD accreditation process. 

Traceability and uncertainty of measurement results are basic technical elements of quality systems in analytical laboratories whose competence is recognized by accreditation according to ISO/IEC 17025 [24]. However, GLP and GMP standards widely used since the 1960s for the... 

After the authentication, the Secretariat s Office of the Internal Oversight (OIO) then certifies this data. The OPCW Laboratory has a quality system, which has been accredited by the Dutch Accreditation Council (RvA). The accreditation covers the quality system as well as the specific activity of the OCAD process and other processes. The OPCW Laboratory has in place quality documents (standard operating procedures (SOPs) and work instruction) for the OCAD process. 

Operating accredited quality system is beneficial to the laboratory in the following ways ... 

Agency, 2006). The scheme provides a framework within which environmental measurements can be made in accordance with the Agency s quality requirements and this includes documentation of the sampling and analytical procedures. Internationally, laboratories use the ISO/IEC 17025 Standard (British Standards, 2005) to implement a quality system aimed at improving their ability to produce valid results consistently. As the Standard is about competence, accreditation is simply formal recognition of a demonstration of that competence. 

In early days IMEP became internationally known because it was one of the few ILCs that was not based on consensus values derived from participants results. Contrary to common belief, the results of the various IMEP comparisons showed an unexpected large spread of participants results even for simple measurements, far from the laboratories own quoted standards of accuracy. To learn more about the origin of this spread, participants in IMEP were also asked to bll in a questionnaire. The questions gather information on the methodological approach, the establishment of traceability via the use of CRMs and the evaluation of uncertainty, the experience of the analyst, the self-declared status of accreditation, and the quality system. Based on general information about the laboratory (e.g., country of origin) and the answers given in the questionnaire, the results obtained... 

An assessment is always an external examination carried out by a laboratory accreditation body such as UKAS (see Section 5.2). It includes all of the elements of an audit, i.e. an in depth check that the quality system as documented is implemented and in operation. In addition, it involves a technical assessment of the laboratory to confirm that staff are qualified and competent and that the procedures being used for testing are fit for the intended purpose and able to achieve the level of performance claimed by the laboratory. 

European Communities Confederation of Clinical Chemistry (ECCCC) (1996) Essential criteria for quality systems of clinical biochemistry laboratories. In the EU Working Group on Harmonization of Quality Systems and Accreditation, EC4... 

IS015189 Medical Laboratories—-Particular Requirements for Quality and Competence is a universal standard for quahty management in medical laboratories that specifies requirements in general terms applicable to all medical laboratory fields, The standard is intended to form the basis for accreditation of medical laboratories. In addition to general laboratory conditions in relation to quality control, the standard focuses on medical competence, interpretation of test results, selection of tests, reference intervals, ethical aspects, and safety. An annex concerns quality management of laboratory computer systems. 

While it may thus be possible that in certain areas, the different quality systems may be similar to one another, it has nevertheless to be recognised that neither the adherence to an ISO or accreditation standard may replace GLP compliance (for this aspect see the respective OECD Position Paper), nor can a GLP compliant test facility claim the same technical competence as a laboratory operating under an accreditation scheme. However, the existing redundancies in the different sets of rules can make it possible to implement two such quality systems in one laboratory utilising the common points of the two systems to facilitate the tasks of personnel and quality management. The same can be true for the official compliance monitoring inspections and audits, where audit or inspection results of aspects that are fully covered by one system may be accepted by the other without further investigation. 

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