Clause 8: Option
Clause 8 Option- ISO 17025 states that the laboratory must establish, document, implement and maintain a management system that is capable of supporting and demonstrating commitment to the requirements. In addition to the requirements of Clauses 4-7, laboratories must implement a management system in accordance with Option A or B.
Option A has many clauses that need to be followed. Overall, at the bare minimum, the management system needs to address the following:
- Management System Documentation
- Control of Management System Documents
- Control of Records
- Actions to address risks and opportunities
- Corrective Actions
- Internal Audits
- Management Reviews
Option B states that your laboratory is in compliance if
- The laboratory has established and maintained a management system in accordance with the requirements of ISO 9001:2015
- You are capable of supporting and demonstrating the consistent fulfillment of the requirements from clause 4-7 of ISO 17025:2017
- You have fulfilled management system documentation and management review requirements (clauses 8.2 and 8.9 of ISO17025:2017).
In short, if your laboratory is certified to ISO 9001:2015, you may choose Option B. This allows for more flexibility as you implement 17025:2017.
Please note that certain text from the ISO 17025 standard is only used for instructional purposes. Standard Stores recognizes and respects the International Organization for Standardization (ISO) copyright and intellectual property guidelines.