Audit finding for JPAL



A contract manfacuturer is working towards JPAL compliance for our products. The contract manufacturer is ISO 13485 certified and is working on gap analysis between ISO 13485 and JPAL regulations for medical devices. The biggest gap exists with the training requirements. If we had an audit, and the auditor found that the training procedure exists and is compliant with ISO 13485 but not JPAL, would this be a major or a minor finding? All suggestions and opionions appreciated!

Jen Kirley

Quality and Auditing Expert
If an organization is certified to ISO 13485 and its training conforms to that standard's requirements but not yet the requirements of a document it is working toward, I would not list this as a nonconformity at all.

I would welcome others' inputs as well.
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