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Cook Books

EUROLAB Cook Books are short documents on quality issues to help laboratories comply with ISO/IEC 17025. To open a cook book, click on its title in the graphic.

Tool for Transition from ISO 17025 2005 to 2017

This document has been created by EUROLAB as a tool to help the laboratories when creating their own Transition Plan to the new Standard ISO/IEC 17025:2017.

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Selection, Verification and Validation of methods

Standard methods need verification to ensure that the laboratory is capable of performing the stated activities. Verification is the demonstration that the laboratory is capable of replicating, with an acceptable level of performance, a standard method.

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Criteria for the Selection of a Proficiency Testing Scheme

With the increasing availability of PT schemes in many technical fields, the criteria for selecting an appropriate one are becoming more important. The purpose of this document is to establish the relationship between accreditation and the criteria for selecting a scheme.

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Handling of Untestable / Deviating Samples

Untestable/deviating samples are items which have been received by a laboratory but do not adequately reflect the original sample. This document provides recommendations on how to deal with such samples in respect of the requirements of ISO/IEC 17025.

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Use of Interlaboratory Comparison Data by Laboratories

Interlaboratory comparisons are used to validate test methods, certify reference materials, assess the performance of laboratories, or more general, to investigate the degree of equivalence among laboratories

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Conflict Handling within the Accreditation Process

This paper is intended to give some advice on which measures are available for a Conformity Assessment Body to resolve problems or conflicts during the accreditation assessment in a constructive way without endangering its accreditation.

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How to Assess the Competence of Staff

his document provides guidance on the specification of job requirements, the evaluation, qualification and training of the staff, to comply with the requirements of the management system and ISO/IEC 17025.

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Management Reviews for Laboratories

By means of management reviews, an organisation may develop its quality system and its entire organisation. Management reviews will help an organisation to develop and improve its quality system and are an additional tool for the sound management of its organisation.

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Determination of Conformance with Specifications or Limit Values

Decisive for a suitable definition of a decision rule is the question of what should be proved with the conformity assessment: compliance or non-compliance with a specification or a limit value. Based on the answer, either the supplier's risk (α) or the consumer's risk (ß) has to be specified.

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Internal Audits

This document provides guidelines on what are internal audits are good for, audit programme and auditors, planning of internal audits, implementation of on-site audit activities, and follow-up corrective action and close-out.

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Internal Audits, the Auditor

This document discusses the role of the internal auditor. Subjects covered: mandate of the auditor, the independence, confidence in, competence, training and qualification, personal skills, and attitude of the auditor.

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Induction of New Staff Members

This document covers: the purpose, objective, content and duration of induction training, documentation and records, and effectiveness. A well organised induction training targeted to the needs of the new jobholder is a pro-active effort that is worth spending.

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Use of Excel Data Handling in Laboratories

This Cook Book is not intended to provide comprehensive guidance on every thinkable use of Excel in laboratories, but to uncover some key sources of errors and provide good advice on how to avoid them.

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Technical Records

Many laboratories do not know exactly how to handle electronic records. This document covers procedures for electronic and hand written technical records: their storage, retention time, raw data, identification, amendments, with regard to ISO/IEC 17025:2017.

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Internal Audits, Audit Report

The audit report is the document resulting from the audit activity. Any laboratory in compliance with Standard ISO/IEC 17025:2017 requirements should describe and implement an internal audit process as part of its internal control system.

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Assessment of the Trueness Measurement of a Procedure by use of a Reference Material (RM)

While it is rather straightforward for a laboratory to evaluate the precision of a measurement procedure, the trueness of the procedure is more difficult to assess. The use of a suitable RM is one method which is described in this document.

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Corrective Actions

A corrective action is an activity that shall be used to stop the re-occurrence of these non-conformities or the occurrence of similiar non-conformities. This document addresses identification and classification of non-conformities, cause and root analysis, and monitoring of corrective actions.

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Interlaboratory Comparison: the Views of Laboratories

The purpose of this document is to provide audited elements on the purpose of interlaboratory comparisons, i.e. one of the tools that help to monitor the validity of results. You can, when questions are too focused on comparisons, put these questions in a broader context.

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Risk Based Approach

The aim of this cookbook is to provide basic concepts and simple tools and possibilities of applying the 'considering of risks and opportunities' in the framework of the ISO/IEC 17025:2017.

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Impartiality and Confidentiality

It is important for the laboratory to be sure that there is no commercial, financial or other pressure that could compromise impartiality and if there is a risk it shall be eliminated or minimized. This document examines the identification of risks, their elimination, and confidentiality.

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Planning of Activities to Ensure the Validity of Test Results

A laboratory shall have a procedure for monitoring the validity of the results it produces. In ISO/IEC 17025:2017 different ways of carrying out this monitoring are mentioned, such as the use of CRM, intralaboratory comparisons and retesting of retained test items.

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GPDR - General Data Protection Regulation

Starting May 2018, the new EU Regulation 2016/679 (GDPR - General Data Protection Regulation) on the protection of personal data has imposed new rules and requirements for management of data relating to individuals. These new requirements are also applicable to testing laboratories.

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Position Papers

EUROLAB Position Papers set out the EUROLAB opinion in various matters related to laboratories as well as European legislation.

CEOC International, IFIA and EUROLAB Position Paper European Parliament seeks to enhance product safety in Europe

Position Paper of EUROLAB, CEOC International and IFIA regarding further improvements to the European Commission proposals from 13th February 2013 on the Product Safety and Market Surveillance Package

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EUROLAB Position Paper on Selection of PT-providers and RM producers by accredited laboratories

year: 2015

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EUROLAB position on possible revision of ISO/IEC 17043 Conformity assessment – General requirements for Proficiency Testing

year: 2015

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Position Paper on the Revision of the GUM

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EUROLAB Position Paper on First-, Second- and Third-Party Testing – How and When?

year: 2017

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EUROLAB Position Paper on Risk Based Approach

Advocating a mandatory system to check comparability of results when applying different risk-based assessment approaches

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Opinions and Interpretations in Test Reports

Based on an inquiry among members, EUROLAB wants to contribute to a more harmonised approach in Europe

On the selection and surveillance of notified bodies and on the coordination and cooperation between them, as well as with the EU Commission and the member states (document CERTIF 94/6)

1/1996

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EUROLAB comments on the designation procedure of conformity assessment bodies (CABs) under mutual recognition agreements (MRAs) (document CERTIF 94/8)

2/1996

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EUROLAB Position paper on document CERTIF 96/4: Elements to be considered for a clarification of the meaning of the CE marking

1/1998

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Technical Reports

Technical Reports are meant to identify and exemplify issues of interest for laboratory technicians as well as provide guidance and recommendations on specific topics.

Measurement uncertainty revisited : Alternative approaches to uncertainty evaluation

Alternative approaches to uncertainty evaluation

Guide to the Evaluation of Measurement Uncertainty for Quantitative Tests Results

Alternative approaches to the “bottom-up” approach, based on a comprehensive mathematical model.

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Measurement uncertainty in testing

A short introduction on how to characterise accuracy and reliability of results including a list of useful references

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Reference laboratories in the field of testing

1/2007

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Quality assurance according to EN 45001 and OECD GLP. A guide to simultaneous implementation (in cooperation with EURACHEM Netherlands)

3/1996

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Validation of test methods. General principles and concepts (in cooperation with EAL, European cooperation for accreditation of laboratories

4/1996

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The scope of accreditation and consideration of methods and criteria for the assessment of the scope

5/1996

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Independence and impartiality in testing laboratory operations

1/1997

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Improving cost effectiveness in the assessment of laboratories. Copenhagen, September 10, 1997. Joint EAL/EUROLAB workshop in cooperation with Eurachem

2/1997

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One-stop for the customer

2/1998

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Comms

Package

The EUROLAB Communications Package includes a set of documents and videos explaining EUROLAB, including its representation, members, activities and cooperation with other organisations.

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In case you would like to use these materials in your communications activities, provided that you will mention the source for IP rights purposes, please contact us at info@eurolab.org.

 

MoUs

In order to strengthen co-operation and to join forces on issues of mutual interest, EUROLAB has signed several MoUs (memoranda of understanding) with various organisations.

MoU with Eurachem

1999, renewed 2002

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MoU with CEOC

1999, renewed 2010

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MoU with Nordtest

2002/2003

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MoU between EA, Eurachem, Eurolab, Euromet and CEOC

Renewed 2005?, Original missing

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MoU with EC JRC

2007, Original missing

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Draft MoU with NCSLI

Original missing

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MoU with Euramet

Year: 2007

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MoU with CEOC International and EFNDT

year: 2010

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MoU EUROLAB - UILI

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MoU with NCSL International

Renewed during the General Assembly, 10th April 2015, Odense, Denmark

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