Treatment of an observed bias: New leaflet issued by EURACHEM

An information leaflet has been prepared by the Eurachem Measurement Uncertainty and Traceability Working Group concerning the treatment of an observed bias. The leaflet discusses whether or not an observed significant bias should be corrected and the impact this may have on the measurement uncertainty (MU). The leaflet does not describe how to apply a correction or how to increase the uncertainty to take account of an uncorrected bias, though it does provide relevant literature sources.  

View the leaflet in English (pdf, 354 kB)

Source: www.eurachem.org

Using repeated measurements to improve the standard uncertainty

Analysts often take multiple observations, and sometimes average the result of several observations to reduce the uncertainty associated with random variation. However, it is often unclear how the standard uncertainty associated with averaged results should be calculated from an observed standard deviation. Sometimes one should divide by the square root of the number of observations; sometimes the standard deviation is used unchanged, and sometimes some alternative formula is appropriate.

This information leaflet has been prepared by the Eurachem Measurement Uncertainty and Traceability Working Group to give further explanation of when the classical 'root n' formula can, and can not, be used. The leaflet amplifies principles described in the Eurachem Guide "Quantifying uncertainty in analytical measurement", which is available here.


Source: www.eurachem.org

ILAC MRA Report - Total Number of Accredited Bodies / Laboratories

Full ILAC Report available here

World Accreditation Day 2014

June 9th, 2014 will mark World Accreditation Day, a global initiative jointly established by the International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) to raise awareness of the importance of accreditation-related activities. The focus this year is on the role accreditation plays in providing confidence in the provision of energy. The day will be celebrated across the world.

Medical Laboratories: Transition to ISO/IEC 15189:2012 Third edition

On 1^st November 2012 the standard ISO 15189: 2012 Rev 3 Medical Laboratories –Requirements for quality and competence was published by ISO. Based on the resolutions of the International Laboratory Accreditation Co-Operation (ILAC) ISO 15189:2012 Rev 3 replaces the standard ISO 15189:2007 Rev 2- Particular requirements for quality and competence. 

According to the ILAC resolution, the transition period from ISO 15189:2007 to ISO 15189:2012 has to be completed by 29 February, 2016. 

 All accredited medical laboratories shall conclude their transition to the standard ISO 15189:2012 until 29.02.2016. After this date any accreditation against the standard ISO 15189:2007, will not be valid.

Clinical laboratories being already accredited according to the standard ISO 15189:2007 are required to make the relevant changes to their management system and the subsequent internal audit, in order to comply with the new requirements. The implementation of the changes will take place during the scheduled assessments or exceptional, if it is required. The assessment time is expected to increase.

Each accreditation body is expected to provide its accredited laboratories with more details concerning the transisiton plan.

Pre- and Post-analytical Proficiency Testing

EURACHEM through its Proficiency Testing Working Group has produced an information leaflet on Pre- and post-analytical proficiency testing aimed at PT participants and their customers. The Eurachem PT working group has released 11 new translations of this leaflet to accompany the English edition. The translations can be downloaded from http://www.eurachem.org/index.php/publications/leaflets/ptprepost. The leaflet focuses on cases where specific procedures,either before or after themeasurement, which are applied to the routine samples,but not to the PT test sample. Then, the PT result reflects only the quality of part of the measurement process.

Source: www.eurachem.org 

The role of measurement uncertainty in conformity assessment

The JCGM Working Group 1 (JCGM-WG1) produced and issued one more documnet to accompany the GUM.  The  Evaluation of measurement data – The role of measurement uncertainty in conformity assessment (JCGM 106:2012) has been approved and is available for download as PDF file in http://www.bipm.org/en/publications/guides/gum.html . This document provides guidance and procedures for assessing the conformity of an item (entity, object or system) with specified requirements. The procedures developed in this document can be used to realize an interval, called an acceptance interval, of permissible measured values of the property of interest. Acceptance limits can be chosen so as to balance the risks associated with accepting non-conforming items (consumer's risk) or rejecting conforming items (producer's risk).

International vocabulary of metrology (VIM) corrected 3rd edition - 2012

One of the most important events in the last decade for the future of measurement is the third edition of the International Vocabulary of Metrology, commonly called ‘‘VIM’’ (from the French title ‘‘Vocabulaire International de Metrologie’’). The corrected version (2012) of the third edition of the VIM has been approved by each and all of the eight JCGM Member organizations and is available at http://www.bipm.org/en/publications/guides/vim.html.

Terminology in Analytical Measurement: Introduction to VIM 3

A new guide has been produced by members of the Eurachem Education and Training Working Group and others co-opted to the Project group for this task.
This Eurachem Guide discusses a selection of the concepts in VIM 3 (International Vocabulary of Metrology), focusing on those most likely to be encountered in analytical laboratories. It aims to cover chemical, biological and clinical measurements and gives examples over and above those in the notes accompanying the definitions in VIM 3 .

The guide is intended for laboratory staff, accreditation bodies, for those commissioning measurements and for those using measurement results. Lecturers and trainers may also find this guide useful when teaching aspects of metrology.

Eurachem Guide is available at:
http://www.eurachem.org/guides/pdf/TAM_2011_Final_web.pdf

Accreditation and Quality Assurance Journal: The most downloaded article

The article of D. Theodorou under the title “Management review checklist for ISO/IEC 17025 and ISO 15189 for quality-management systems” that was published in Accreditation and Quality Assurance Journal is the most downloaded article from this publication. The work presents a management review checklist which helps laboratories carry out an effective management review going through all the important aspects of the quality management system.

See an older blog entry: http://iso4lab.blogspot.com/2010/04/isoiec-17025-iso-15189-management.html

Journal statistics:http://realtime.springer.com/journal/1432-0517

Medical Laboratories: ISO 9001 or ISO 15189?

ISO 9001:2008 certification involves Quality System Management whereas accreditation to the ISO 15189:2007 standard recognizes the technical competence of medical laboratories, thus providing a ready means for customers to find reliable testing services. Accreditation focuses on creating laboratory competency.

Laboratories can be checked and certified for their conformance to international management system standards such as ISO 9001:2008. This involves the assessment of an organization’s quality management system. Although this will provide confidence about the laboratory’s quality management system, it will not indicate anything about a laboratory’s technical competence or its ability to provide reliable and accurate test data that will be accepted by customers and trading partners.

Therefore laboratory accreditation to ISO 15189:2007, which is based on ISO/IEC 17025, is a measure of both technical competence and quality management and is the most appropriate process for laboratories use, rather than the quality ISO 9001:2000 certification.

Source: www.cap.org

Accreditation Scope: New ILAC Guide

ILAC has published the ILAC G18:04/2010 Guideline for the Formulation of Scopes of Accreditation for Laboratories.

The purpose of this publication is to provide information on how to define the scope of accreditation (fixed and flexible) and to identify criteria and ways of assessing the scope in order to allow an effective and harmonised application among Accreditation Bodies in relation to the relevant international Standards.

For more details on Flexible Scopes see also: http://iso4lab.blogspot.com/2010/04/workshop-accreditation-with-flexible.html

Workshop “Accreditation with Flexible Scope - Needs, Current Situation, Future Developments”

Over 50 participants representing 18 European countries, from numerous conformity assessment bodies, various industries and 8 accreditation bodies attended the workshop held at the Technical and Test Institute for Construction in Prague on November 4, 2009. It was organized by the Technical Committee for Quality Assurance and dedicated to the accreditation with flexible scope as the follow up of the workshop organized three years before in Borås. At that time the general conclusion of the presentations and discussions highlighted the need and the benefit of a flexible scope in accreditation but there was not a full consensus on how to interpret the term flexible scope and how to implement it in practice.

The rationale of the Prague workshop was to exchange experience as well as to benchmark and promote good practices. The aim was to give documented input to the relevant interested parties, specially the community of accreditation bodies.

Workshop presentation are available at:

http://www.eurolab.org/workshop_presentations/Prague_2009/Eurolab_Prague_2009.html

Joint IAF-ILAC-ISO Communiqué on the Management Systems Requirements of ISO 15189

Medical laboratories accredited to ISO 15189:2007 (a sector-specific technical competence and management system standard) are recognized as meeting the management system principles of ISO 9001:2008.

The move was announced in a joint communiqué by ISO (the International Organization for Standardization), ILAC (the International Laboratory Accreditation Cooperation) and the IAF (the International Accreditation Forum) in September 2009.

The ISO-IAF-ILAC communiqué was issued to address the misconception in the market that medical laboratories accredited to ISO 15189:2007 do not operate a recognized management system.

This document follows another ISO-IAF-ILAC communiqué that was issued to address the misconception in the market that laboratories accredited to ISO/IEC 17025 do not operate a recognized management system.

Source: www.ilac.org

ISO/IEC 17025 - ISO 15189: Management Review Checklist

An article of D. Theodorou under the title “Management review checklist for ISO/IEC 17025 and ISO 15189 for quality-management systems” was published in Accreditation and Quality Assurance Journal. The work presents a management review checklist which helps laboratories carry out an effective management review going through all the important aspects of the quality management system.

Abstract: Management reviews are key processes in many quality-management systems, including laboratory-management systems, in accordance with ISO/IEC 17025 and ISO 15189. These reviews are fine opportunities to understand and manage all the inputs and outputs of a quality-management system. Laboratories often meet some difficulties fully exploiting the management-review process because either they do not realize the importance of this process or they do not have the experience to run this process in a way producing the intended results. This work presents a management review checklist which helps laboratories carry out an effective management review going through all the important aspects of the quality-management system.

Full paper available at:

http://springerlink.com/content/3215745772370380/?p=d84692b64e814af4ac65e316e232b0cd&pi=6