Abstract
When routine laboratories merge or are taken over by larger entities, their quality management systems usually need to be integrated. In many laboratories, quality management systems according to ISO/IEC 17025 are in place. The integration of the quality management systems is often advantageous in terms of efficiency of operations, reduction in number of processes and consequently amount of quality documentation. However, a number of practical problems, some of them hard to overcome, may be encountered. Examples are: how to deal with multi-site activities showing technical and/or cultural differences, how to merge historically different ways of working and how to overcome psychological resistance to change from laboratory staff. This paper demonstrates a way of working used in our organisation to integrate successfully the quality management systems of several laboratories under one quality management system. The laboratories were located in two different countries (Belgium and Italy) and had activities under ISO/IEC 17025, ISO/IEC 17043 and ISO Guide 34 accreditation. Involvement of the laboratory staff was essential for obtaining a fast and efficient integration.
Highlights
Accreditation allows testing laboratories to demonstrate that they operate competently and generate valid results. These laboratories have a quality management system in line with this accreditation standard. It implies that the laboratory has developed documented procedures for its processes covered by the standard
Their quality management systems usually need to be merged as well for a number of reasons: 1. The merged laboratory may like to be accredited by only one accreditation body
Despite the listed advantages of integrating the quality management systems, a number of practical obstacles may be experienced that can hamper this integration process: 1. When the laboratory sites are located in different countries, different accreditation bodies were responsible for assessing the different quality management systems before the merge
Summary
Analytical laboratories, just like any other organisation, are subject to change. Small laboratories merge with other laboratories or are taken over by large entities. When the laboratory sites are located in different countries, different accreditation bodies were responsible for assessing the different quality management systems before the merge. These accreditation bodies assess against the same quality standard, different interpretations of the standard may occur. 3. The tools used to manage certain laboratory processes may be different, e.g. the document control software, sample registration and test reporting tools like Laboratory Information Management System (LIMS) or tools to monitor environmental conditions. The tools used to manage certain laboratory processes may be different, e.g. the document control software, sample registration and test reporting tools like Laboratory Information Management System (LIMS) or tools to monitor environmental conditions Harmonising these may result in serious information technology (IT) challenges. Quality management system (QMS) structure: Adaptation of the QMS structure to the new organisational structure of the merged laboratory
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
