ISO 13485:2016 - Quality Objectives Regulatory Requirement Examples

[RA_QA_Lady]

Hi,

New to this forum

I am looking to some guidance on the updated requirements for ISO 13485:2016 section 5.4.1 - Quality Objectives.

"Quality Objectives must meet applicable regulatory requirements. "

Does any one have any examples they would like to share on of how they plan on addressing this in their Quality Objectives (product objectives aside)?

 

[Philip B]

Hi,
Post-market surveillance is a regulatory requirement; we have an objective to issue and execute an annual PMS plan.
We also have an objective to audit our system for regulatory compliance (as well as compliance to ISO 13485).
Hope this helps.
Philip