Scope of Certification for a Design Organization with Outsourced Mfg. - ISO 13485

DannyK

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#11
There is no requirement in ISO 13485:2016 that states that your suppliers must have ISO 13485:2016.
Controls that could be implemented are to do an audit of the supplier for how they would handle servicing.
If there are any problems, issue them a nonconformity and follow-up.
Perform a 100% review of all service reports and service activities.
If you are still worried ask the supplier to get an extension of scope to add servicing.
 
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