If your clinical testing organization is seeking accreditation for the first time, the standards and their requirements can often feel overwhelming. Although the road seems long from the start, A2LA’s friendly customer care representatives, knowledgeable accreditation officers, and expert assessors are here to help you every step of the way.
In this infographic, we’ve broken down the process of achieving ISO 15189:2022 accreditation into 9 steps. The timeline for each step will vary depending on your organization and where you are in the process implementing a quality management system.
The fourth edition and latest version of ISO 15189 was published by The International Organization for Standardization (ISO) on December 6, 2022, with a three-year transition period. The revisions to the standard were developed over the course of four years by a team of experts, including A2LA Director of Government Relations Randy Querry.
Clinical laboratories seeking training on ISO 15189:2022 in advance of the accreditation process can contact A2LA’s preferred training vendor, AWPT. Courses are taught by leaders in their fields who walk you through the requirements of the standard and more.
For laboratories ready to apply for accreditation to ISO 15189:2022, complete an estimate request form here: A2LA.org/estimate-request