Accreditation to ISO/IEC

The standard requires that where inspection, testing, and calibration services are conducted bp a commercial/independent laboratorp facilify, the laboratorp shall be accredited to ISO/IEC 17025 or national equivalent. 

Currently laboratories seek accreditation to ISO/IEC Guide 25 but this is being replaced by ISO/IEC 17025 in 2000. 

Check that your external laboratories are accredited to ISO/IEC Guide 25 as a minimum. 

As mentioned previously, it is possible to include opinions and interpretations within the scope of accreditation. It should be realized that the opinions and interpretations themselves are not accredited. This accreditation is only given if the work is already accredited to ISO/IEC 17025 [1]. What is required by the Standard is evidence of the procedure used by the laboratory to authorize an individual to give an opinion or interpretation. This means there has to be a procedure within the management system of the laboratory that sets out the criteria upon which the quality of the person giving the opinion is assessed. This may be split into two parts, namely the criteria for assessing competence and the criteria for assessing experience. 

Measurement uncertainty is one of the key issues in quality assurance. It became increasingly important for analytical chemistry laboratories with the accreditation to ISO/IEC 17025. 

Accreditation is a formal recognition that a laboratory is competent to carry out specific (types of) calibrations or tests [2]. After the use of validated and standardized methods, the introduction and use of appropriate IQC procedures and the participation in PT schemes, accreditation to ISO/IEC 17025 is the fourth basic principle related to laboratory QA in general [4]. Guidelines on the implementation of ISO/IEC 17025, including the estimation of MU (see also Section 8.2.2), are published in the literature and by official accreditation bodies such as Eurachem, CITAC, EA, Eurolab, and ILAC (see Table 1) [2,60, 80, 81,110]. It is worthwile to mention that accreditation, just like participance in PT schemes, does not necessarily indicate good performance of the laboratory [108]. 

ILAC (2001), Guidance for accreditation to ISO/IEC 17025 (Rhodes, Australia International Laboratory Accreditation Cooperation). 

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). 

Laboratories accredited to ISO/IEC 17025 must establish the traceability of their test results, preferably to SI units of measurement. Participation in appropriate proficiency studies enables laboratories to demonstrate the comparability of their measurements. If the materials used for the studies have traceable assigned values, then proficiency testing also provides information about measurement accuracy and confirms, or otherwise, that appropriate traceability has been established. 

In addition the RM itself can be assessed as a product by an accredited (to ISO/IEC Guide 65 [15]) product certification body. Product certification can be recommended when the RM producer is not a laboratory and therefore accreditation is not possible. 

The outcome of this work is a new guide that describes a simple, yet metrologically robust strategy and contains worked examples to illustrate the approach. The guide is at an advanced draft stage and is available on the Eurachem web site. Inter-alia, it will help implement the traceability requirements of accreditation to ISO/IEC 17025. This paper discusses the key issues, coloured by the personal views of the author. The paper was presented at the ILAC Berlin Conference in September 2002. 

It would be wise of the researcher to write down the points of strategy agreed with the analyst and to leave a copy in the laboratory as confirmation of the arrangements. Such records form part of a workfile in a laboratory accredited to ISO/IEC 17025 (see Chapter 4, Section 6.1). 

The second aspect of some definitions is that validation must be seen to be done through proper documentation, objective evidence as the last definition given above (taken from International Organization for Standardization (ISO)/International Electrotechnical Commission (lEC) 17025) says. If a laboratory is seeking accreditation to ISO/IEC 17025 (general requirements for the competence of... 

ISO/TS 16949 states that accreditation of supplier facilities to ISO/IEC 17025 or national equivalent is neither required nor does it satisfy all requirements in ISO/TS 16949. It can also be said that ISO/TS 16949 does not satisfy all the requirements of ISO/IEC 17025. Hence, ISO/IEC 17025 is the equivalent of ISO/TS 16949 for the calibration sector. 

This chapter gives the background on the accreditation of testing and calibration laboratories according to ISO/IEC 17025 and sets out the requirements of this international standard. ISO 15189 describes similar requirements especially tailored for medical laboratories. Because of these similarities ISO 15189 is not separately mentioned throughout this lecture. 

The accreditation according to ISO/IEC 17025 (or ISO 15189 for medical laboratories) has turned out to be the most important and worldwide valid standard for competent testing and calibration laboratories... 

Preparation for accreditation according to ISO/IEC 17025 is not an easy task, especially when done for the first time. But it assures at most customers confidence about quality and correct procedures. 

Measurement uncertainty is increasingly gaining attention, in particular in the framework of accreditation. The new accreditation standard ISO/IEC 17025 [17], which has been in force from December 2002 on, contains clear requirements on the estimation of MU and when and how it should be stated in test reports. ISO/IEC 17025 requires MU to be reported when required by the client and when relevant to the application and interpretation of the measurement results in the framework of certain specifications or decision limits. The MU should be readily available and reported together with the result as X U, where U is the expanded uncertainty [17, 47, 51, 54]. Also Eurachem and CCMAS within the Codex Alimentarius deal with MU as a separate issue [14,18-20]. Some even claim that MU will become the main unifying principle of analytical data quality [37]. 

The standard was first published in 1978 as ISO Guide 25 (ISO 1978), and later as the standard ISO/IEC 25 (ISO/IEC 1990). It was revised in 1994, and then underwent a major revision (van der Leemput 1997) and number change in 1999 when it became ISO/IEC 17025 (ISO/IEC 1999). Further tweaking to ensure alignment with ISO 9001 2000, and other technical amendments were made in 2005 (ISO/IEC 2005). ILAC has published a guide to accreditation under ISO/IEC 17025 (ILAC 2001), as have many national accreditation bodies. 

In terms of criteria for the approval of private certification bodies, the EU regulation requires compliance to Annex 3 of the regulation in addition to ISO/IEC Guide 65. Annex 3 contains requirements not included in ISO Guide 65 such as parallel production. This format is similar to the IFOAM system with specific accreditation criteria that are not covered in the ISO guide. The USA and Japan have each developed distinct requirements. Beyond this, some countries such as India and Australia (in draft requirements) have chosen to base their criteria on IFOAMs (Commins 2003). 

Fig. 1 Metrological traceability and hierarchy of procedures and materials (according to ISO/IEC 17511). uc(y) Uncertainty BIPM International Bureau of Weights and Measures NMI National Metrology Institute ACL Accredited Calibration Laboratory MCL Manufacturer s Calibration Laboratory ML Manufacturer s Laboratory Mf Manufacturer...

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... 

The recommended approach to the quality assessment of RMs is accreditation of producers to ISO/IEC 17025 in combination with ISO Guide 34 [14]. 

ISO/IEC 17025 1999 Accreditation is the formal recognition of the competence of a body or an organization for a well-defined purpose. In contrast with the ISO 9001 processes, accreditation of a laboratory to ISO/IEC 17025 involves assessment of the technical competence and capability of the laboratory and its personnel. In practice, it is the procedure by which a laboratory is assessed to perform a specific range of tests or calibration measurements. Specific areas examined include infrastructure and staff qualifications, in addition to checks that an adequate quality management scheme is in place. The accreditation covers the range of materials tested or analyzed, the tests carried out, the method and equipment used, and the accuracy or precision expected, and is specific to the facility and the test. 

Medical laboratories have some specific needs and these are incorporated in ISO 15189 2003, Medical Laboratories - Particular Requirements for Quality and Competence [8]. The requirements of both ISO 9001 and ISO/IEC 17025 are incorporated within this Standard. It is a customized version of ISO/IEC 17025 for medical laboratories. In the UK, UKAS have designated Clinical Pathology Accreditation (UK) Ltd as the authoritative body to accredit against this Standard. 

Some customers will require the results of the analysis to be interpreted or an opinion given, e.g. does the discharged water from the factory comply with the current legislation ) or how many cigarettes can be made from 2 kg of cannabis leaf There is now provision for this aspect of the work of an analyst to be included in the scope of accreditation of the laboratory to the Standard ISO/IEC 17025 2005 [1]. It is important to be clear about what is meant by Opinions and Interpretations. In the context of this book, it is the subjective expression given that is based on results, academic or scientific knowledge and experience gained over a period of time. 

Examples of Quality Audit report forms are shown in Tables 9.5 and 9.6 at the end of this chapter. Table 9.5 shows Report Form 1 which includes a record of what has been examined, so that subsequent audits can examine other aspects of the laboratory s operations. Note that when improvement actions are required, the form records not only what needs to be done, but also by when it must be completed, as shown in Table 9.6 (Report Form 2). The form is signed by the auditor and the responsible person from the area being audited. In the UK, the accreditation body UKAS refers to the corrective action as improvement action . This further emphasizes the continual improvement aspect of the ISO/IEC 17025 and ISO 9001 Standards. The examples shown in Tables 9.5 and 9.6 will probably have to be modified to meet a laboratory s particular requirements. It should also be remembered that both report forms should indicate (usually as a footer or header) the title of the document, its issue date, issue number, who authorized the document, page number and total number of pages. 

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