Compliance Assessment Tool

Assignment Guidelines




As you now know, a first step towards transitioning from compliance with the ISO 15189:2012 to the ISO 15189:2022 is to identify the current gaps in your quality management system (QMS). You initiated this exercise in the action tracker assignment that was given following the Session February 20, 2024.

The next step in this process is to ensure compliance with the ISO 15189:2022 by beginning to develop the missing documents or to modify the incomplete documents that you have identified in your action tracker. The compliance matrix that has been provided in the assignment given following the Session March 26, 2024, helps you to keep track of the documents (policies, processes, procedures), that you are developing to ensure compliance with the ISO 15189:2022 Standard.

As you develop the documents listed for each Clause in the Standard, use the Compliance Matrix to record the unique ID for each document as well as the relevant clause number. Remember to assign responsibility for the development of documents.