ISO 15189:2012 implementation : an applied guide for medical laboratories

ISO 15189:2012 provides an update in both management system and technical competence requirements for the pathology services industry. While most of the requirements remain similar, there are new requirements that require further investment of resources to achieve compliance. These include measurement of uncertainty estimation and additional requirements in induction and training. Furthermore, several new requirements, such as contingency planning and evaluation, are likely to require specialised support. The intent of this guide is to assist with the implementation process by highlighting the main differences between ISO 15189:2007 and ISO 15189:2012 through a gap analysis using a total of 22 administrative requirement headings. Resources for implementation preparation are recommended, including relevant guidance documents, practical tools, such as checklists, internal audits and key performance indicators. Additional change management notes are also provided for further implementation guidance. The implementation process is likely to be successful if relevant knowledge is obtained and relevant guidance documents are consulted during the planning phase.40 page(s