How exactly does one go about picking the right medical device equipment calibration vendor? While that itself is a loaded question and might require a sabbatical, a couple gallons of coffee and some pizza, I’m hoping that this blog can help you narrow your choices and approve the right vendor without stress.
When it comes to picking and approving vendors for calibration equipment used to verify and validate medical devices, the biggest question to ask is whether the vendor has an ISO Certification. Depending on the class of the medical device, if your vendor has ISO 13485, ISO 17025 or ISO 9001 you are one step closer to approving them. Once you confirm that they have an ISO Certification, make sure to ask for a copy of it. Then verify that they have an in-house Quality Management System (QMS). This should be a given since they have an ISO Certification, but better safe than sorry. After all, the vendor could be calibrating equipment that could potentially be used for verifying brain surgery devices. It doesn’t hurt to cover all your bases.
Once the vendor has confirmed that they have a QMS, ask if they would be willing to send you a copy of their written procedures as evidence. If not, request they provide you with a Document Number and Revision of their overarching quality management document and list of procedures.
The next thing you want to do is confirm with the vendor that the equipment they use to calibrate your equipment, is itself calibrated against international standards. Ask them to provide you with the ID# of the standard, and if possible, a calibration certificate.
This next check might seem like an obvious yes, but you should ask if the vendor trains their personnel. Calibrating equipment isn’t always an easy thing to do. Training personnel to do it the right way, not the easy way, is imperative. Request a copy of their training records for evidence.
One thing to note: just because a company manufactures a piece of equipment does not automatically approve them as a medical device equipment calibration vendor. Check the scope of their certificate and verify that they indeed can calibrate their equipment.
If you get a yes on all of the above requirements, then you’re in pretty good shape for approving the vendor for calibrating. Congratulations on approving your vendor!
Medical Device Equipment Calibration Vendor Checklist/Questionnaire
For those interested, I’ve created a checklist/questionnaire using the point covered in this blog. Use it as a guide the next time you’re looking to approve a calibration vendor.
- Which ISO Certification, if any, do they have? ISO 13485☐ ISO 17025☐ ISO 9001☐ None☐
- Can they provide you a copy of their ISO Certification? Yes☐ No☐
- Verify that the scope of the ISO Certification covers what you require for your equipment calibration Yes☐ No☐
- Can they send a calibration certificate? Yes ☐ No ☐
- Does the vendor have an in-house Quality Management System (QMS)? Yes☐ No☐
- Do they have written procedures and can they send them to you? Yes☐ No☐
- If no, can they provide you with a document number and revision of their overarching quality management document and list of procedures? DCN and Rev: ______________
- Is the equipment that the vendor uses calibrated against an international standard? Yes☐ No☐
- Do they train their personnel? Request a copy of their training records for evidence Yes ☐ No☐
SCORING: If any of the answers are “No” or “None”, you must work with the vendor to turn them into a “Yes” or find a new vendor.
Azra Rajwani is a StarFish Medical Jr. QA/RA Specialist. A graduate of the UVIC Biomedical Mechanical Engineering Program and former member of our biotechnology team, some of Azra’s work projects include water quality and neural networks.
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