ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records?

James

Involved In Discussions
#1
Hello friends

I have effectively launched my 13485 system, but it's an 'easing in' rather than than an overnight change. This is in part so that documentation can be further refined during the initial weeks of system implementation.

I'm wondering how to best reflect this in initial audits, management review minutes and other records?

Thanks

James
 
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yodon

Staff member
Super Moderator
#2
In essence, you determine the time the QMS is in effect. You can roll out individual pieces along the way. Updating your processes along the way is good, it helps you exercise your doc control and change control systems! I don't know why you'd have an internal audit until your processes are in place and have been operating for some time (to enable collection of evidence of compliance).
 

James

Involved In Discussions
#3
In essence, you determine the time the QMS is in effect. You can roll out individual pieces along the way. Updating your processes along the way is good, it helps you exercise your doc control and change control systems! I don't know why you'd have an internal audit until your processes are in place and have been operating for some time (to enable collection of evidence of compliance).
Thanks. The purpose of running internal audits prematurely is due to us having deadlines for having our certification audit. Covid has scuppered things a little and our production has slowed right down. We are still making things (custom made, low risk class 1) and due to budgetary committments we cant deviate from the certification audit timescales.
 

Tidge

Quite Involved in Discussions
#4
My $0.02 (US-based, I offer my pecuniary apologies to other markets):

Since audits are supposed to follow a plan and management reviews are supposed to have an agenda with identified metrics, I think it would be appropriate to establish a Quality Plan (approved by Executive Management) with specific goals and timetables. The Management team would then be able to establish a meaningful set of metrics. Typically Management Reviews aren't frequent enough to do more than gross oversight, and Internal Audits are likely to identify necessary corrective actions... so I'm concerned that without an established Plan you could be setting yourself up for a cycle of remediation (or three-mediation!) that could easily confuse things.

Part of the Quality Plan can explain how 'legacy' areas of the Quality System are supposed to work with (and interface with 'newly-minted') other areas of the Quality system until they get updated. This way even if the Internal Audit is reviewing a 'legacy' area of the quality system, there are meaningful criteria to be used during the evaluation. Internal Audits really aren't supposed to be 'for cause' audits... and presumably before rolling out 13485-compliant processes the deficiencies in the system were already identified.

Executive Management should be able to review the progress of the Quality Plan, as well as metrics related to the enacted portions of the plan, including internal audit results.
 
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