The Gap Analysis is one of the most important steps in your project. It outlines what areas of your current Laboratory System needs to migrate from ISO 17025:2005 to ISO 17025:2017. This gap analysis checklist is prepared for use in evaluating your Laboratory Management System (LMS) against the requirements of ISO 17025:2017 as you transition from ISO 17025:2005 to ISO 17025:2017. Each requirement is expressed as a question that the user (auditor / assessor) can ask to evaluate your LMS capabilities. You will need to have copies of the ISO 17025:2017 and ISO 17025:2005 standards to use along with this checklist so that you can refer to the requirements if necessary. While the two versions of the standard do not line up when comparing the requirements:
- New requirements and / or new terminology are highlighted in yellow.
- The intent of the main clauses of the new standard is shown in bold blue font.
- The right hand column in green shade is intended to provide reference / comparison / similarities to the ISO 17025:2005 requirements, and to identify and locate where in the new clauses, the former requirements are relevant.
- Comments highlighted in bold red font indicate removed / missing requirements.
- Includes Technical Support
- 62 page Gap Analysis Checklist
Which version is right for me?
ISO 17025:2017 Gap Checklist is for those just creating their first ISO Management System.
If you are transitioning from ISO 17025:2005 to ISO 17025:2017, the Gap Transition Checklist provides you a map of where to copy some text from your existing LMS, and place it in a new LMS structure.
If you are adding ISO 17025:2017 to ISO 9001:2015 structure, the ISO 9001:2015 to ISO 17025:2017 Gap Checklist highlights the differences with ISO 9001:2015 requirements and ISO 17025:2017.