Software Development
ISO Standards Readiness
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.
- Publisher / source
- KalarisLabs/research-agent-skills (found on the CSV list)
- Upstream record
- KalarisLabs/research-agent-skills
- Version
- Version 2
- Published
- Publication review
- Approved for publication
- Content fingerprint
8f33960c061b63250aae40a5ec3f6009c621722bfcf9cd3946707d725bba4c87