ISO Compliance & Standards Insights

ISO 14971 explained — medical device risk management

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…

Point-of-care testing governance under ISO 15189

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ISO 22870 is withdrawn and point-of-care testing now sits inside ISO 15189.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,…

Critical value reporting in a medical laboratory

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…

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…

ISO 15189 explained — medical laboratory accreditation

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…

Proficiency testing for laboratory accreditation

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.…

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…

Measurement uncertainty budget for testing and calibration laboratories

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…

ISO 17025 accreditation for testing and calibration laboratories

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…

ISO 27017 and ISO 27018 cloud security controls

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…

Aerospace quality management: the AS9100, AS9110 and AS9120 standards and the NQA-1 nuclear parallel

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

Supply chain security compared: ISO 28000 for goods and TISAX for automotive information security

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