Measurement uncertainty: requirements set in the accreditation standards

Accreditation and Quality Assurance - Measurement uncertainty is of high importance to all testing and calibration laboratories and those involved in sampling activities. Its evaluation requires...     

Correction to: Measurement uncertainty: requirements set in the accreditation standards

Accreditation and Quality Assurance - Unfortunately, the references 12 and 13 were incorrectly published in the original publication. The correct references are:     

Reference material requirements for laboratories and the role of accreditation bodies

It is now over two years since ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories was published. The standard places increased emphasis on the demonstration of traceability of measurements made by laboratories. In the areas of chemical and biological metrology, the introduction of this standard has brought new challenges for laboratories to grapple with. This paper will examine the requirements regarding traceability for chemical and biological measurements, with specific reference to the use of reference materials by laboratories. This will be explored from the perspective of both accreditation bodies and a laboratory which is both a user and producer of certified reference materials. Moreover, the paper will describe mechanisms that are being used to improve the use of reference materials by accredited laboratories and hence the traceability of measurements. Finally the role of accreditation programs for reference material producers in assisting with this aspect will be examined.Electronic Supplementary Material Supplementary material is available for this article if you access the article at . A link in the frame on the left on that page takes you directly to the supplementary material.Presented at BERM-9—Ninth International Symposium on Biological and Environmental Reference Materials, June 15–19, 2003 Berlin, Germany.     

Chemical and environmental sampling: quality through accreditation, certification and industrial standards

Executive summary In the CEN/STAR Trends Analysis workshop on Sampling, initiated by request of the Nordic Innovation Centre, specially invited experts provided presentations on demands about regulation concerning sampling quality, sampling standard developments, quality assurance systems and practical experience from different sampling situations and cases. The workshop arrived at recommendations on the importance of proper sampling for environmental and product control purposes, especially to support European regulations, trade agreements and monitoring of environment. Sampling is an integrated part of the whole measurement process and should therefore be especially considered from the viewpoint of the end-user of the results. There is a need for raising quality control issues in sampling and for the establishment of a more uniformly co-ordinated European quality system for sampling. With the standard methods available, there are in principle two different ways of achieving third party assessment of the sampling protocols and procedures: accreditation of sampling organisations based upon international, national, or in-house standards and methods, and certification of individual samplers’ competences for sampling. Several activities or efforts as well as research and standardisation needs for raising the quality issues in sampling were identified and presented in a paper by the workshop.All the presentations and Workshop Proceedings are electronically available on the Nordic Innovation Centre's web site at and more specifically at     

Hematological health-related intervals estimated using an indirect method in order to satisfy the accreditation standards

 The estimation of reference limits represents quite a taxing task for laboratories which frequently adopt the limits suggested by manufacturers or those reported in the literature. This practice does not meet the requirements of accreditation programs (i.e. Essential Criteria, Clinical Pathology Accreditation) that require laboratories to produce or check all their reference intervals. We collected 15 244 hematological results from females aged 0–99 years obtained by the Rovereto Hospital Laboratory and calculated the reference intervals, or to be more precise the health-related intervals, using an indirect method (based on all the inpatient and outpatient results). All the measurements were carried out using an automatic Coulter STK S analyzer, and the results were transferred to Verona by e-mail. The results for hemoglobin were: <1 year (n=154)=90–171 g/l; 2–8 years (n=619)=104–136 g/l; 9–14 years (n=322)=118–143 g/l; 15–44 years (n=6329)=106–144 g/l; 45–75 years (n=4893)=107–148 g/l; 75–99 years (n=2927)=90–153 g/l. The results appear different from the results currently used by Rovereto Hospital (120–160 g/l) but comparable to those reported in the literature with the exception of the subjects under 1 year and over 75 years, probably due to the excess of "diseased" subjects in these classes. The indirect method allows even small laboratories to produce or check their reference intervals for all age groups, increasing the clinical effectiveness of laboratory results and satisfying the accreditation standards. Received: 15 April 2000 · Accepted: 20 April 2000     

Review of European Union requirements: quality standards for food analysis laboratories

 The European Union has prescribed strict quality standards for official food laboratories and the methods of analysis to be used in laboratories when carrying out official food control work. These requirements, which are based on accreditation, participation in proficiency testing schemes and using validated methods of analysis, are described in detail. The similar approach being taken within the Codex Alimentarius Commission is also outlined. The procedures prescribed will ensure that official food control laboratories have in place the measures to ensure that consistently reliable data can be produced. Received: 29 November 1995 Accepted: 8 January 1996     

The role of an independent laboratory association in the standards,metrology, quality assurance and accreditation environment

Whilst there can be no doubt as to the benefit that an independent 3rd party conformity assessment accreditation body plays in ensuring the competency of results, personnel and processes, it is often at the expense of an adversarial relationship with the laboratory community it serves. A significant improvement in this relationship can be obtained by the formation and active participation by an independent laboratory association. This paper describes such an organisation, how it was formed, what role and the functions it currently performs and, most importantly, how it interacts with the national accreditation body and the stakeholders who are its members.     

Pathology laboratory accreditation: the Australian experience

 The National Associating of Testing Authorities, Australia (NATA) is a laboratory accreditation company that has been involved in the accreditation of pathology laboratories since 1982. This role is carried out in conjunction with the Royal College of Pathologists of Australasia (RCPA). The accreditation process is known as the NATA/RCPA scheme. The NATA/RCPA accreditation scheme originated from the desire to raise professionalstandards in pathology. The scheme aimed to achieve this through a peer review process in which education and voluntary participation were stressed. In 1986, the Australian Federal Government adopted the scheme as its measure of the competence of testing by pathology laboratories seeking payment from the Commonwealth Department of Human Services and Health reimbursement scheme, Medicare. This meant that NATA/RCPA accreditation became mandatory for such laboratories. The benefits of peer review as a means for establishing professional competence and the challenges a mandatory accreditation program poses to such a scheme will be discussed. Received: 6 May 1996 Accepted: 29 May 1996     

NATA: 50 years experience with accreditation

 Laboratory accreditation is becoming increasingly accepted around the world as a means of identifying technically competent laboratories. It is also being used as a mechanism for the acceptance of test data both nationally and internationally. The concept and mechanisms of accreditation have been developed over the past 50 years. The first national laboratory accreditation system appeared in Australia in 1947. This organisation, known as the National Association of Testing Authorities (NATA), has since taken a leading role in developing accreditation practices that are now used world-wide in evaluating testing, measurement and calibration laboratories. This paper examines the development of the world's first and largest laboratory accreditation system, and looks at the difficulties and triumphs in gaining acceptance and recognition by government and industry of the benefits of laboratory accreditation. Received: 24 June 1996 Accepted: 25 June 1996     

Laboratory accreditation in New Zealand

A voluntary system for the registration of testing laboratories was established in New Zealand in 1972. It requires laboratories to meet specific standards, maintain adequate methods manuals and records and exhibit competence in the test methods for which registration is granted. The system also authorizes the endorsement of test documents.     

On the way to formal accreditation

The Radiochemical Laboratory participated in the Technical Co-operation (TC) Project on Quality Control and Quality Assurance for Nuclear Analytical Techniques RER/2/004 organized by the International Atomic Energy Agency (IAEA) during the period June 1999 and September 2001. Motivations, major goals of participation in the project, milestones of implementation of the project, establishing the quality system, improvements fulfilling both technical and management requirements as well as major achievements for future activities of the laboratory with respect to technical and financial conditions are discussed in detail.     

Development of laboratory accreditation in the United States

 Laboratory accreditation in the United States is an old profession. Users and regulators have, it seems, been concerned about the quality of test data they obtain from laboratories for well over half a century. These users have developed many different systems to meet their needs. As a result, there is much duplication of effort and overlapping in accreditation requirements and many laboratories have to maintain current accreditation from a number of organizations. A number of attempts have been made over the years to reduce this duplication, but it still remains. In the meantime, rapid progress has been made internationally to recognize laboratory accreditation systems in different countries. This paper describes this situation and speculates on the future, considering the international thrust to simplify and consolidate conformity assessment procedures. Received: 26 May 1998 · Accepted: 6 June 1998     

Joint Commission International accreditation: a laboratory perspective

Joint Commission International accreditation (JCIA) offers the international community a standards-based, objective process for evaluating healthcare organizations. The eleven JCIA standards are functionally organized. The standards are grouped by functions related to the provision of patient care and functions covering the provision of a safe, effective, and well-managed organization. The focus of the JCIA survey process is on the whole organization rather than on individual departments/services. The survey is carried out by trained and experienced healthcare peers. Healthcare organizations worldwide should be encouraged to seek accreditation such as that offered by JCIA. Where affordable, laboratories that are part of larger healthcare organizations should strive to achieve independent laboratory accreditation. The perspective of a laboratory undergoing a JCIA survey is briefly presented. Presented at the conference Quality in the Spotlight, March 2007, Antwerp, Belgium.     

Setting a precedent in international accreditation

 The accreditation procedure that the Department of Laboratory Sciences, CHPPM-Europe underwent is described. The laboratory obtained ISO/IEC 25 accreditation through the American Association for Laboratory Accreditation (A2LA) and the Deutsches Akkreditierungssystem Prüfwesen (DAP) as well as EN 45001 from DAP following the A2LA and DAP joint inspection. The accreditation process and the importance of obtaining national and international accreditation are discussed. Received: 30 May 1997 · Accepted: 16 June 1997     

Secondary standards : Acetylacetonates

The preparation of several acetylacetonates is described, the novel feature being that the organic reagent is added in substoichiometric amount. Several of the compounds are obtainable 99.9% pure or better, and are proposed as secondary standards for the metals they contain or for elementary analysis. These are the copper(II), chromium (III), zinc, cadmium, magnesium, thorium, cobalt(III), iron(II) and calcium compounds. Cobalt (II) and nickel dipyridine acetylacetonates are also proposed. Aluminium and beryllium acetylacetonates are suitable as routine test materials.     

Laboratory accreditation: The operation of an established scheme

NAMAS, the National Measurement Accreditation Service, was formed in 1985 and has currently accredited some 1050 testing and calibration laboratories in the United Kingdom. NAMAS is managed by an Executive of 60 staff which is based at the National Physical Laboratory, one the UK's largest Government Research Establishments. Laboratories seeking accreditation are assessed by fully trained technical experts contracted by NAMAS, against the criteria set out in the NAMAS Accreditation Standard M10; the criteria contained in this document are fully consistent with the international standards for laboratory accreditation EN 45001 and ISO Guide 25. NAMAS has recently published a document which provides guidance on the interpretation of the NAMAS Accreditation Standard for analytical laboratories. Assessment involves a consultative preassessment visit which is followed by a thorough on-site assessment of a laboratory's quality system and testing activities by a team of expert assessors. Following the correction of any noncompliances found at the assessment, the laboratory receives a certificate of accreditation and a schedule which defines those tests and analyses for which the laboratory is accredited. NAMAS has negotiated a number of mutual recognition agreements with similar accreditation bodies in other countries and negotiations with other schemes are underway. The imminent approach of the European Single Market has highlighted the need for independent third party assurance of testing and calibration and this should ensure the continued growth of NAMAS and similar schemes elsewhere in Europe.