ISO 13485 7.5.4 Manufacturer, service documents from distributors

[Osho030]

Does the manufacturer need to collect and analyse all service records from all distributors for all services even if the service was performed on a devices sold by the manufacturer and the service contract is between the distributor and the user. We sell our systems without installation and service contracts. But annual service is required and specified by us in proper instructions. Collecting all records is a mission impossible for us but seems to be required according to our iso auditor.

 

[Osho030]

Does the clause require the manufacturer to collect and review all records from all distributors that perform service based on the distributors service contract with the end user? Or does it only require to do it for services performed by own personell or personal paid by the manufacturer?

 

[yodon]

How would you know if changes are warranted without getting that data? I'm leaning towards agreeing with the auditor. Maybe you don't need individual records but I think the data (summarized) would be a key point of discussion in Management Review.

 

[William55401]

Think of service records as similar to complaints from a performance monitoring standpoint. The records should be analyzed for identification of issues and potential improvements. Sometimes, service reports can have complaints hiding in them.