Lead Auditor qualifications:
Client will review Lead auditor qualification. Following requirements apply:
* The lead auditor shall have a Lead Auditor training requirement certificate provided by recognized and accredited/certified external training service provider.
* The lead auditor training shall be for the appropriate standard (see below standard requirements)
* Evidence of regular audits executions (at least 5 every 3 years)
* Lead Auditor area of expertise requirements:
Product: Lead auditor auditing per:
* ISO 13485
* ISO 9001
With expertise in the following area Products:
* PCBA
* Machining/ casting
* Injection molding
* Mechanical hardware
* Repair activity
Software—additional:
* ISO 27001 Services
* ISO 17025 for Calibration and Laboratory
* ISO 9001 / 13485 for installation / maintenance / warehouse / packaging