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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.

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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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Classification and Handling of Information in a Laboratory

A laboratory handles several different kinds of information, all of them with specific requirements on their handling. This paper provides guidance on laboratories' information management systems and provides a classification model in order to make information handling much more effective.

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GDPR - 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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A laboratory will sooner or later have to deal with customers that are complaining on the laboratory and its activities. According to ISO 17025 a complaint is an expression of dissatisfaction by any person or organization to a laboratory, relating to the activities or results of that laboratory, where a response is expected. The document provides the process to be followed in these cases.

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Method and Procedure Validation in Calibration Laboratories

In many cases, Calibration Laboratories do not work to a published standard or method but are required to generate laboratory specific methods or procedures for customer equipment where there are no calibration procedures published or supplied by the equipment manufacturer. In other cases, a calibration procedure is required for a prototype product or a specialised measurement system. This means that the approach to Method and Procedure Validation is different. This document focuses on the requirements for Calibration Laboratories.

Cook Books
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