iso-standards-readiness
Skill1 starsChanged 52 days agoNo licenceView on GitHub
Prepares and structurally reviews readiness evidence for ISO management-system and laboratory-competence standards - ISO 13485 medical device QMS, ISO 14971 device risk management, ISO/IEC 17025 testing and calibration laboratories, and ISO 15189 medical laboratories. Use when organizing declared scope, controlled documents, risk-management files, scope of accreditation, traceability, CAPA, external-provider controls, or bounded local evidence manifests, and when separating ISO certification from laboratory accreditation, FDA QMSR inspection, CLIA certification, MDSAP, and EU MDR/IVDR evidence boundaries. Not for legal applicability, compliance, certification, or accreditation decisions; contains no clause text.
1 other project uses a version of this, 1 of them edited.
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Most recently taken up by
- patoangolano/bio-stackedited, first seen Oct 15, 2026
Other versions1 project uses a version of this.
Word for word · 0
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Edited · 1
- patoangolano/bio-stack★ 090% same
Wrote their own version · 0
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How matches are found. Word for word: the exact same text. Edited: shares passages with this file (“99% same” means 99% of its five-word phrases also appear here; 10% or more counts). Their own version: similar meaning, or, weakest, the same name. We can’t tell which project had it first. Projects are counted among the 200 most-starred candidates, and mentions are links to the repository we found, up to 50 per site, so both counts are a floor.
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19 rules. About 0 are common, 13 are distinctive, and 6 are very specific to this project.
≈0
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≈13
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6
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