- Keep the impartiality risk register live, reviewed on its own cycle
- Maintain traceability chains and uncertainty budgets per method
- Hold method verification and validation records against a stated specification
- Run the proficiency testing plan and close out every unsatisfactory score
- Keep authorisation records current per analyst and per method
ISO/IEC 17025:2017
The accreditation standard for laboratories. Everything in it reduces to three questions: is the laboratory impartial, is the measurement traceable, and does the number come with an honest uncertainty.
- 4General requirements2
- 5Structural requirements2
- 6Resource requirements7
- 7Process requirements14
- 8Management system requirements4
ISO 17025, in practice.
General requirements for the competence of testing and calibration laboratories.
Testing, calibration and sampling laboratories whose results are relied on by regulators, certification bodies or customers who need the accreditation mark.
The clause numbers and titles above are the standard's own public structure. The standard itself is copyright of its issuing body and you buy it from them. What we add is the interpretation underneath, and that lives in your workspace.
Every month, on a schedule you can check.
This is the running work for this standard specifically. The general shape is the same across all of them.
- Impartiality risk register with safeguards applied
- Traceability chain per measurement with certificates at each link
- Uncertainty budgets identifying the largest contributions
- Proficiency testing results with z-scores and investigations
- Documented decision rule for statements of conformity
Each one is filed against the requirement it satisfies as the work happens, so the pack for the next visit already exists.
Standards that share the structure.
ISO 9001:2015
The quality management standard most certified organisations start with, and the one most other management system standards borrow their structure from.
ISO 22301:2019
The continuity standard, built around one question: when the thing you deliver stops, how quickly does it come back, and who decided that was fast enough.
SOC 2 (TSC 2017, rev. 2022)
Not a certification but an attestation. An independent auditor reports on whether your controls were designed properly, and for Type II, whether they operated over a period.
Name a clause in ISO 17025 and we will open it.
The requirement, the control attached to it, the evidence that satisfies it, and the audit checklist it generates. Nothing prepared in advance, because there is nothing to prepare.
