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.
1
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.
2
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.
7
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.
8
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.
15
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.
16
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.
17
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.
19
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.
20
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.
21
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.
22
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.
23
Complaints
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.
24
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.