Creating a new manual when implementing ISO 17025

No, you do not need to create a totally new quality manual. The ISO 17025 Quality Manual serves to document the overall Lab Quality Management System, providing a way to reference and link all the requirements together in one place. Your laboratory can implement ISO 17025 according to Option B. You can use your already established ISO 9001:2015 quality management system (and manual) to demonstrate compliance with the requirements for ISO 17025 clauses 8.2 to 8.9. What is important is that processes must be implemented and maintained in a manner that supports and demonstrates the fulfilment of ISO 17025:2017 Clauses 4 to 7 for all your laboratory activities. This means that the way that the processes (8.2 to 8.9) were established, how they are performed, documented and controlled, must include the activities in Clauses 4 to 7. For example, your audit programme must be revised. You will start with a gap evaluation to determine what new processes you need to include, what mandatory documentation and records you need to “add-on” and include in your Quality Manual.

You can download a free Project Plan for ISO/IEC 17025 implementation from the ISO17025 Academy at  https://info.advisera.com/17025academy/free-download/project-plan-for-iso-17025-implementation to assist you; as well as preview the ISO 17025 Quality Manual at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

For more information on Option B, see the article Maintaining and improving quality management in laboratories according to ISO 17025:2017 at https://advisera.com/17025academy/blog/2019/08/30/iso-17025-maintenance-and-improvement-in-laboratories/For more information on the relationship between ISO 9001 and ISO 17025, see the article ISO 17025 vs. ISO 9001 – Main differences and similarities at https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities/