For medical device manufacturers
Calibration documentation for ISO 13485 clause 7.6
ISO 13485 governs quality management for medical devices, where the regulatory stakes for measurement records are high. Clause 7.6 sets out how monitoring and measuring equipment must be controlled. Axiospec gives device manufacturers documented, attributable calibration records and the reverse traceability regulators expect when a measurement is later called into question.
What ISO 13485 clause 7.6 requires
Calibration & verification
Calibrate or verify measuring equipment at specified intervals against standards traceable to international or national measurement standards, and record the basis used where no such standard exists.
Status & safeguarding
Identify equipment calibration status and protect equipment from adjustments and handling that would invalidate measurement results.
Action on out-of-calibration findings
When equipment is found out of calibration, assess and record the validity of previous measuring results and act on the equipment and any affected product. Maintain records of calibration and verification.
How Axiospec helps ISO 13485 teams
Documented procedures and records
Clause 7.6 requires documented procedures and retained records. Axiospec captures every calibration with attribution and timestamps so the records exist by default, not as an afterthought.
Traceability to recognized standards
Record the reference standard and certificate behind each calibration, evidencing traceability to international or national measurement standards.
Validity assessment of prior results
When a device or gage is found out of calibration, trace the measurements and product affected so you can assess and document validity, as 7.6 requires.
Attributable e-signatures
Calibrations are signed and attributed in a tamper-evident ledger, supporting the record integrity expectations that accompany medical-device quality systems.
See it on your own equipment
Import your asset registry in an afternoon, whether you are starting fresh or moving off another calibration system, and log every event to a tamper-evident audit trail. Prefer to hand it off? White-glove migration is free.
Axiospec is a documentation and workflow tool. It helps you produce clean, traceable records that support ISO 13485 compliance; certification depends on your own processes, scope, and assessor.