ISO 14971: The Risk Management File and Where Files Break
What ISO 14971:2019 requires, the four places risk management files reliably break, and one widely repeated error about…
Read More
Point-of-Care Testing Governance After ISO 22870
ISO 22870 is withdrawn and point-of-care testing now sits inside ISO 15189. Deployment, operator authorisation at ward scale,…
Read More
Critical Value Reporting: Getting the Result to Someone Who Can Act
Building a critical value list that works, the read-back, escalation when nobody answers, and the one measure that…
Read More
Pre-analytical Errors: Where Laboratory Mistakes Actually Happen
What goes wrong before the examination starts, why the laboratory's controls are weakest exactly where the risk is…
Read More
ISO 15189: Patients, Pre-examination and Where Medical Laboratories Lose Findings
What ISO 15189:2022 requires, what the fourth edition changed, and the four areas where medical laboratories most often…
Read More
Proficiency Testing: Coverage, Scores and What Follows a Bad Result
Internal controls tell a laboratory it is consistent. Only comparison with others tells it whether it is right.…
Read More
Decision Rules and Statements of Conformity Under ISO 17025
You measure 9.8 against a maximum of 10.0, with an uncertainty of 0.4. Does it pass? It depends…
Read More
Measurement Uncertainty: How to Build a Budget That Holds Up
A budget built from repeatability alone can understate uncertainty fourfold. How contributions are identified, converted and combined, with…
Read More
ISO 17025: Accreditation, Scope and Where Laboratories Lose Findings
Laboratories are accredited, not certified — and only for a defined scope. What ISO 17025 requires, how Option…
Read More
ISO 27017: Cloud Security Controls and What the 2026 Edition Changes
ISO 27017 is not a certification. Here is what the standard actually contains, how it differs from ISO…
Read More
Aerospace Quality Management: 3 Essential AS9100 Standards
In most industries a quality escape costs money. In aerospace and nuclear it can cost lives, and the quality regimes reflect that. Aerospace quality management under the AS9100 family, and
Read More
Supply Chain Security: 2 Essential Assurance Routes
Ask two companies how they prove supply chain security and you will get two unrelated answers. One will describe physical controls over goods in transit; the other will describe how
Read More