Clause 7.1.3: Infrastructure Maintenance
ISO 9001 does not dictate how you maintain your equipment, only that you must "determine, provide, and maintain the infrastructure necessary for the operation of its processes." However, auditors look for a systematic approach rather than ad-hoc repairs.
A compliant system must demonstrate:
- A documented schedule of preventative maintenance (PM).
- Records proving that the PM was performed on schedule.
- A process for handling equipment that falls out of tolerance.
The Calibration Trap (Clause 7.1.5)
A CNC machine itself is not typically treated as a "measuring resource" requiring traceable calibration (like a micrometer). The machine produces the part; the CMM measures the part. However, if you are using on-machine probing to verify final part dimensions and bypassing external inspection, the machine's probe system falls under Clause 7.1.5 and must be calibrated to national standards.
Documenting Machine Geometry
To prove infrastructure capability, implement an annual geometry check (e.g., laser ballbar testing) for critical machining centers. This data proves to auditors (and aerospace/medical customers) that the asset is physically capable of holding the required tolerances, shifting quality control from reactive inspection to proactive process capability.