Training is one of the areas that result in many non-conformances being issued during quality system audits.
It is not enough for device manufacturers to simply clone a QMS or develop procedures employed for device manufacturing. Manufacturers must be able to gauge the effectiveness of their policies, procedures and processes, and provide objective evidence that their approach to quality and the manufacturing of devices is effective.
Internal audits, regardless of the regulatory environment, are a fundamental requirement for an effective QMS. ISO 13485:2012; 21 CFR, Part 820, and MO 169, each clearly specifies that device manufacturers must plan and perform internal quality audits in order to gauge the overall effectiveness of the QMS.