This video course provides in-depth training in the requirements of ISO/IEC 17025: 2017 ‘General requirements for the competence of testing and calibration laboratories’. It commences with an overview of the principles of Quality Management and improvement in the context of a laboratory, provides an overview of ISO/IEC 17025 followed by a detailed discussion on each requirement. The course also provides an overview of typical quality management system structures and on the steps required to implement the standard and to obtain accreditation.
The revision of ISO 15189 Medical laboratories – Requirements for quality and competence commenced in 2019 under the direction of the ISO technical committee TC 212 Clinical laboratory testing and in vitro diagnostic test systems. Feedback on the proposed new standard has now been gathered and it is likely that the document will be published as a Final Draft International Standard mid 2022 with full publication as an ISO standard shortly after that. The proposed changes include re-alignment of the clause structuring to bring it in line with the latest version of ISO/IEC 17025: 2017 and the incorporation of Point-Of-Care Testing (POCT) standard ISO 22870 which at present is a ‘stand-alone’ add-on standard used in conjunction with the current version of ISO 15189.
Qualimetric will be providing a full gap assessment of the changes as soon as the FDIS is produced and running transition awareness courses as soon as the full standard is published. Please contact us at [email protected] if you wish to register interest and we will update you as soon as the changes occur and notify you of any planned training/awareness sessions.
Qualimetric has published resources to aid implementation of ISO/IEC 17020:2012.
ISO/IEC 17020:2012 Video Training Course –
We are pleased to offer an ISO/IEC 17020 training video via UDEMY. Click here to be re-directed to UDEMY. This is in addition to our on-line ISO/IEC 17020 Introduction and Internal Auditor training courses for inspection bodies and crime scene investigation.
See our ISO/IEC 17020:2012 infographic which provides help to navigate the standard which sets out the Requirements for the operation of various types of bodies performing inspection.