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- Medical Devices QMS
- Who it's for
- Component supplier quality
Component supplier quality
A supplier quality team needs to compare the inspected component with the certificate offered for it. Incoming inspections hold the subject reference, assigned person and requirement checks. Supplier certificates hold the supplier, component code, certificate type, expiry date and attachment, with a link to the same operational inspection.
How Medical Devices QMS is set up for you
Incoming work
The Inspector records the component subject and the results of the requirements checked at receipt.
Supplier evidence
The certificate record identifies whose document applies to which component and when that document expires.
Reviewer decision
The linked inspection is submitted to the Quality Reviewer with the check results and certificate in context.
Supplier audit
An Auditor can plan a supplier quality audit and assign requirement findings to owners.
A supplier quality team needs to compare the inspected component with the certificate offered for it. Incoming inspections hold the subject reference, assigned person and requirement checks. Supplier certificates hold the supplier, component code, certificate type, expiry date and attachment, with a link to the same operational inspection.
Choose one supplier and one component code for the pilot. Record an incoming inspection and the checks that matter to the acceptance decision. Attach the supplier certificate to the same inspection. The reviewer should compare the subject reference, component code, expiry date and the content of the file before deciding the inspection.
Rehearse a mismatch. If the certificate belongs to another component, the team should correct the evidence before relying on it. If a check fails, the rejected scope should lead to a linked nonconformance. The corrective action owner can then investigate the issue with the original inspection and certificate available.
A supplier audit can be a later step. Begin with a scoped audit, named auditor and a finding tied to a requirement. Give that finding an owner and due date. Keeping its audit number visible lets the supplier quality team distinguish an audit finding from an inspection failure while reviewing related work.
Features to start with
Supplier certificates
Keep component certificate evidence, expiry and supplier identity with the related inspection.
Inspections
Follow incoming, in-process, final and service inspections from assignment through reviewer disposition.
Nonconformances and corrective actions
Keep failed inspection scope, containment, root cause and effectiveness review connected.
Roles on the team
- Inspector
- Performs assigned inspections and submits their evidence.
- Quality Reviewer
- Decides inspection disposition and checks corrective action effectiveness.
- Corrective Action Owner
- Investigates failed scope and carries out the assigned action.
Set up Medical Devices QMS your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.