Competence accreditation

QA principles. The golden standard ISO/IEC 17025 [17], which is the revised version of ISO Guide 25 [70], describes the general requirements for the competence of calibration and testing laboratories. In Europe, the accreditation criteria have been formalized in European standard EN45001 [109]. Participation in PT schemes forms the basis for accreditation, because PT is a powerful tool for a laboratory to demonstrate its competency. Accreditation guides use the information obtained by PT schemes [6,17,60,64]. 

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. 

Quality in NDT depends upon a number of factors. Qualification of NDT personnel, technical state and correctness of choice of testing equipment, availability of approved working procedures of examination, calibration of NDT equipment have decisive importance among those factors of an NDT laboratory. Assessment of NDT laboratory competence is provided through accreditation in compliance with the EN 45000 series standards. 

Requirements stated in the System of accreditation to the competence of calibration and testing laboratories are formulated in CTB 941.3-93. 

CTB 941.3-93 System of Accreditation for Verification and Testing Laboratory of Belarus. General Requirements for Estimation of Technical Competence of Verification and Testing Laboratory... 

Due to their wide range of analytical challenges centralized analytical laboratories are required to adopt a series of QM systems simultaneously. For example, the Competence Center Analytics of BASF AG in Ludwigshafen is certified and accredited to operate under four different QM systems. Undoubtedly, QM systems play a vital role in a modern industrial analytical laboratory. The sale of many products of the chemical industry is not possible without a GLP-certified analytical laboratory. However, in practical tenus the different QM systems can potentially reduce the efficiency of the analytical process and lead to increased costs. 

To receive ISO 9000 accreditation, a certification body must meet the requirements of ISO Guide 62 and EN 45012, which invokes ISO 10011. There is normally a mark of accreditation (a Grown and Tick in the case of UKAS accreditation) that certification bodies use to signify their credibility. Once accredited, a certification body may perform audits on suppliers offering products and services within the scope of accreditation. In theory, accreditation is granted only if the certification body has expertise (i.e. competent auditors) for the particular industry sectors (EAG codes) requested. 

It is not necessary that participating laboratories be formally recognized, accredited or certified. Measurement of the property of interest should be completed by, or under the supervision of a technically competent manager qualified either in terms of suitable academic qualifications or relevant work experience. The participating laboratory should consider the analysis as a very special one, to be performed with special attention and all possible care, and not have it performed as part of its regular routine. 

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. 

Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes , ILAC G13 2000, International Laboratory Accreditation Cooperation (ILAC), Silverwater, Australia, 2000. 

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. 

The nonconforming work that will require evidence of implementation of corrective and preventive action within a given timescale will include matters, such as, no corrective action taken when the results from a round of a Proficiency Testing scheme indicated the laboratory s result was an outlier, or the competency records of staff do not indicate they are competent to do the accredited work. Listings of nonconformities can be found in a publication produced by the International Laboratory Accreditation Cooperation (ILAC) [9]. 

Accreditation Third-party statement based on a decision following review that competence to carry out a task has been demonstrated. 

This code or standard was developed under procedures accredited as meeting the criteria for American National Standards. The Standards Committee that approved the code or standard was balanced to assure that individuals from competent and concerned interests have had an opportunity to participate. The proposed code or standard was made available for public review and comment that provides an opportunity for additional public input from industry, academia,... 

By using the combination of specific method accreditation and generic accreditation it will be possible for laboratories to be accredited for all the analyses of which they are capable and competent to undertake. Method performance validation data demonstrating that the method was fit-for-purpose shall be demonstrated before the test result is released and method performance shall be monitored by on-going quality-control techniques where applicable. It will be necessary for laboratories to be able to demonstrate quality-control procedures to ensure compliance with the EN 45001 Standard,3 an example of which would be compliance with the ISO/AOAC/IUPAC Guidelines on Internal Quality Control in Analytical Chemistry Laboratories.12... 

The need for laboratories carrying out analytical determinations to demonstrate that they are doing so competently has become paramount. It may well be necessary for such laboratories not only to become accredited and to use fully validated methods but also to participate successfully in proficiency testing schemes. Thus, proficiency testing has assumed a far greater importance than previously. 

The conformity assessment body could be a laboratory, the third-party could be the accreditor coming to your laboratory to inspect, whether the required documentation, manuals, procedures, or personnel are appropriate to perform the specific conformity assessment task e.g. determine PAHs by HPLC. If the laboratory (the conformity assessment body) and the personnel can do the job then accreditation might be granted. Being accredited can be of competitive advantage for laboratories. Sometimes contractors require the (analytical) work to be carried out in an accredited laboratory. Accreditation gives confidence to the customer that the laboratory will fulfil the requirements that are necessary for the work to be done competently. You find more about accreditation in chapter 2 of this book. 

Accreditation is the confirmation of the competence of a testing or calibration laboratory by an independent third party, the accreditation body. 

ISO/IEC 17025 is the basic standard that is utilised by testing and calibration laboratories for implementing a quality management system and they are accredited for their implementation of this standard. This standard contains the general requirements for the competence of testing and calibration laboratories. It is one of the most important standards for the worldwide globalization of trade. 

The standard ISO/IEC 17025 focuses on the technical competence for specific tests and this is attested by the accreditation body. 

Addresses the technical competence of laboratories to carry out specific tests and Is used worldwide by laboratory accreditation bodies as the core requirement for the accreditation of laboratories... 

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... 

Accreditation is the third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks (ISO 17000). 

Accreditation refers to competence to carry out specific tasks... 

Why do the laboratories need to demonstrate their competence and the reliability of their results Because they need to have competitive advantage and, at the same time, comply with legislation, where, more and more, reference is made to the need for reliable results and compliance with specific requirements (Accreditation, Good Laboratory Practice etc.)... 

The first documents dealing with the competence of laboratories were ISO/IEC Guide 25 and EN 45001 standard. They were issued to provide the necessary basis to be used by laboratories and by the bodies that assess their technical performance. In parallel, accreditation bodies nnder-took additional tasks with regard to the assessment of other activities (certification of products and systems) as specified in other EN 45000 series standards. The ISO/IEC 17025 has replaced EN 45001 (see slide 40), while other standards within EN 45000 series have been replaced by the ones in ISO/IEC 17000 series. 

Technical competence is dealt with only in accreditation and refers both to the methodology nsed and the peisormel involved. In accreditation, validation of methods and expression of imcer-tainty are of major importance as well as the calibration of eqnipment and traceability of measnrements. 

In accreditation the assessment team should consist of assessors/technical experts able to assess all relevant issues including the competence of the staff of the laboratory. This competence needs to be documented by relevant academic/technical qualifications, experience and training as well as successful participation in proficiency testing. 

Only a small percentage (up to 10%) hold an ISO 9001 certification (or recogiution). Big laboratories made more use of their accreditation certificates to demonstrate compliance to ISO 9001, but not very successfully (up to 40%). Accreditation is considered as more effective than certification to consolidate market position and demonstrate technical competence. 

Accreditation was preferred to certification to demonstrate technical competence... 

The diagram illustrates the successive steps to be taken by a laboratory to establish reliability. The various steps refer to different levels of this procedure. First of all we need to ensure the organizational backgroimd to deal with all management issues. The second step includes issues related to the technical competence while the third step refers to the successful assessment that the target is met. The steps correspond to different levels, e.g. the first step to certification while the third step to accreditation. 

The main objective is to ensure that the needs are adequately described in each case and that all stakeholders (customers, regulators, competent authorities and other interested parties) have a clear understanding of their needs and how to meet them. The compliance with quality management issues can be met by certification as well as by accreditation (relevant provisions) the demonstration of... 

A development of the last years is expected to serve more efficiently the need for clarification. Following the joint ISO-ILAC-IAF Communique of June 2005, a statement could be included on accreditation certificates. According to this statement, the accredited laboratory has demonstrated both its technical competence for the defined scope and the operation of a quality management system. 

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)... 

Why should a laboratory participate in PT schemes First there is the possibility to uncover errors that couldn t be found with other quality control measures and second a successful participation can be used as a certificate of competence for clients, authorities and accreditation bodies. 

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