Transition between ISO 15189 2012 and ISO 15189 2022
An analysis of the additional requirements of ISO 15189:2022 over and above ISO 15189:2012
Ratings 4.73 / 5.00
What You Will Learn!
- Understand the structural changes between ISO 15189 2012 and the 2022 version
- Identify the detail of the additional changes made in the new standard
- Understand the actions that are required to be undertaken to comply with the new standard
- Create and action plan for implementation of the changes to your own management systems
Description
ISO 15189:2022 Medical laboratories — Requirements for quality and competence specifies requirements for quality and competence in medical laboratories. This course details the additional requirements of ISO 15189:2022 over and above those in the the previous 2012 edition. As well as providing a gap assessment of the changes to the standard it gives tools to record the implications of the changes as well as to plan implementation actions. This course is designed for those who already have a good understanding of the requirements of ISO 15189:2012 and who wish to plan out the implementation of changes to their existing systems to meet the requirements of the latest version.
The course is structured around the requirements of the previous edition so that changes to existing systems can be analysed and required actions identified and planned. At the each of each section covering the the previous standard requirements, there is a opportunity for participants to record their own actions and changes. At end of the course, there is an opportunity to compile the changes and capture them in a spreadsheet which allows actions to be planned and tracked through to completion.
Participants will require access to a copy of the new standard in order to make full benefit from the course. Unfortunately this can not be provided due to copyright reasons, but can be obtained from your country' standards agency or from ISO themselves.
Who Should Attend!
- Quality management management and staff who are responsible for conducting a gap assessment between the new and old versions of ISO 15189, identifying changes and implementing actions to comply with the new standard.
