Laboratory, accreditation

Representative z-value distributions for proficiency tests with a series of laboratories. 

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The first approach - quality through NDT laboratory accreditation - is widely used both in Western and Eastern Europe and is realized on rules and procedures specified in the EN 45000 series and EAL -G15 Accreditation for Non-Destructive Testing Laboratories . 

The National system of testing and ealibration laboratories accreditation is established in Belarus from July 1, 1994. The System of accreditation is specified in the series of standards CTB 941.0-93 - CTB 941.3- 93, CTB 941.4-95, CTB 941.5-96. 

Professional society promotes the study and control of environmental factors affecting the health and well-being of factory workers, including procedures for monitoring the exposure to toxic materials in the work place. Offers laboratory accreditation and testing programs and informational pamphlets on various health and safety topics. 

As laboratory accreditation becomes more established, the requirements to demonstrate traceability and to determine uncertainty will inevitably feature as part of method validation (Christensen 1996). The fundamental role which reference materials play in these steps has already been alluded to in the Introduction. 

Over the past decade, a major trend has been the development of the use of proficiency testing (PT) or evaluation materials (Fox 2000). PT materials are a type of reference material, which aid in assessment of analytical laboratory measurement quality. There will be an increased use of such materials as part of laboratory accreditation programs and other new quality assurance efforts, including internal audits. At the same time, a number of providers have used PT schemes to produce a form of RM intended to meet the ever-growing need for RMs required for routine QC use (Jenks 1995,1997). 

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. 

The Scope of Accreditation and Consideration of Methods and Criteria for the Assessment of the Scope in Testing , ILAC G18 2002, International Laboratory Accreditation Cooperation (ILAC), Silverwater, Australia, 2002. 

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]. 

ISO has two important functions in analytical chemistry. The first is to publish descriptions of accepted methods. These are effectively industry standard methods for particular protocols. The second is in laboratory accreditation. For a laboratory to be ISO accredited, compliance with international QA standards must be confirmed by an initial assessment and subsequently from repeated audits by an independent assessor. Since ISO has no legal or regulatory powers, the standards are voluntary. It is unlikely, however, that a forensic analysis which did not conform to an ISO standard would be upheld in court, for example. Most commercial laboratories need to be accredited to remain competitive and to deal with regulatory authorities. Most university labs are not accredited, mainly due to the time and costs involved, and also to the nonroutine nature of much university research. However, university accreditation may become a requirement in the near future, especially for publicly funded research in the UK. The details of laboratory accreditation are discussed by Christie et al. (1999) and Dobb (2004). 

Christie, W. W., Dobson, G., and Shepherd, T. (1999). Laboratory accreditation in a lipid analysis context. Lipid Technology 11 118-119. 

Member States shall designate bodies responsible for the assessment of laboratories as referred to in Article 7 of Directive 89/397/EEC. These bodies shall comply with the general criteria for laboratory accreditation bodies laid down in European Standard EN 45003.6... 

In addition, the bodies assessing the laboratories should comply with the general criteria for laboratory accreditation, such as those laid down in the ISO/IEC Guide 58 1993 Calibration and testing laboratory accreditation systems -General requirements for operation and recognition .13... 

European committee for standardization, General Criteria for Laboratory Accreditation Bodies - European Standard EN45003, Brussels, CEN/CENELEC, 1989. 

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Calibration and Testing Laboratory Accreditation Systems — General Requirements for Operation and Recognition — ISO/IEC Guide 58, Geneva, ISO, 1993. 

To which scheme is your laboratory accredited or GLP compliant ... 

College of American Pathologists Laboratory Accreditation Program (1997) Standards for Laboratory Accreditation, Commission on Laboratory Accreditation Inspection Checklist, Sections 1 and 8. 

ILAC (International Laboratory Accreditation Cooperation) http //www.ilac.org AFLAC (Asia Pacific Laboratory Accreditation Cooperation) http //www.aplac.org/... 

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. 

Asia/Australia Asian Pacific Laboratory Accreditation Cooperation (APLAC)... 

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... 

Further to these, the laboratory community has established very useful links to exchange information and ideas, to snbmit suggestions and develop policies. Some of the most important fora on European and international level are EA (European cooperation for Accreditation), EURACHEM, EUROLAB, ILAC (International Laboratory Accreditation Cooperation). 

The drafting of an ISO standard on laboratory accreditation to be used instead of EN 45001 was a need for international trade. ISO/IEC Guide 25 could not be used for this purpose since it was just a guide. However other needs were also reflected in the new standard, namely the ones related to the question accreditation vs. certification for laboratories and how to face problems arising from the existing confusion. 

International Laboratory accreditation cooperation ILAC (2002) ILAC Policy on Traceability of Measurement Results, ILAC P-10, available from www.ilac.org... 

International laboratory accreditation cooperation (ILAC-G13 2007) Guidelines for the requirements for the competence of providers of proficiency testing schemes. 

Because laboratory testing often applies to articles in international trade, international accreditation is often sought. There are many international accrediting agencies in existence. Two examples are the National Institute for Standards and Technology (NIST) and the American Association for Laboratory Accreditation (AALA). NIST administers what is called the National Voluntary Laboratory Accreditation Program (NVLAP). 

The NVLAP is comprised of a series of laboratory accreditation programs (LAPs), depending on what is requested and what is needed. Each LAP includes specific calibration and/or test standards and related methods and protocols assembled to satisfy the unique needs for accreditation in a field of testing or calibration. NVLAP accredits public and private laboratories based on evaluation of their technical qualifications and competence to carry out specific calibrations or tests. All are based on the ISO/IEC Guide 25 discussed in Section 2. The process involves an application and the payment of fees. This is followed by an on-site assessment. If deficiencies are found, these must be resolved to the satisfaction of the assessment team. The laboratory then participates in proficiency testing (Section 5.7) and a technical evaluation. 

In the US, the NIST administers the National Voluntary Laboratory Accreditation Program (NVLAP), which complies with ISO 9002, and with details available at ... 

International Standards Organization. Guide 25, 30-8402. Constitiution, bylaws, and standards. National Environmental Laboratory Accreditation Conference, EPA 600/R-99/068. 

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