NB Audit Finding for Supplier Calibration Failure


In an ISO 13485 audit, we were asked for our contract manufacturer's performance validation reports for a sterile packaging process. We require that our contract manufacturers submit these reports (through quality agreements) for us to review. I was confident that the reports were complete and accurate. While reviewing the reports, the auditor requested calibration records for the equipment used in the process. We discovered that one of the key parameters had not been calibrated. This was an immediate finding. We were so surprised by the contract manufacturer's obvious oversight that we didn't even think to contest it in the audit. After the audit, we began to reflect. Our quality agreement with the contract manufacturer states that they are responsible for calibration. My question for the Cove is "To what extent are we responsible for contract manufacturer calibration?" As I begin to wonder, are we also accountable if a contract manufacturer fails to calibrate their equipment in a timely manner or if the calibration is not performed correctly? I don't see this as a reasonable expectation. This is why we have established the quality agreement. Should we have received a finding from our notified body? We routinely audit this CM and have sampled their calibration records with no issues.

By the way, the equipment was later calibrated and found to be within tolerance.


Unfortunately yes, you are responsible for the performance of the supplier and you need to prove through your desktop or site audit that they conform; although if they are a sterile provider they will be classed as critical in your system i presume. I assume given their place in the product lifecycle that now this would fall into their NC process and be also picked up (potentially) by their respective NB audit. Key thing in your QMS is now to have some CAPA that leans on them to prove their future compliance and, annoyingly for you, for them to assist on any previous or current risk. And as SV has stated, in words that I wouldn't use, you should judge them against your SQA and update it if required...based on their investigation and your acceptance.


Quite Involved in Discussions
As a contract manufacturer of medical devices, I can say that many of the quality agreements we have signed with customers require that equipment be calibrated and to maintain records of calibration. Some also indicate to report any out of tolerance calibration events that may impact customer's product. It should not be unusual to your suppliers to see some requirements regarding calibration in the quality agreement.

Ed Panek

QA RA Small Med Dev Company
Super Moderator
ISO 13485:2016(E)
7.4 Purchasing
7.4.1 Purchasing process
The organization shall document procedures (see 4.2.4) to ensure that purchased product conforms to
specified purchasing information.
The organization shall establish criteria for the evaluation and selection of suppliers. The criteria shall be:
a) based on the supplier’s ability to provide product that meets the organization’s requirements;
b) based on the performance of the supplier;
c) based on the effect of the purchased product on the quality of the medical device;
d) proportionate to the risk associated with the medical device.

Unfortunately sterilization seems higher risk so there is no escape ship waiting,
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