Peter Drucker has said ‘You cannot manage what you cannot measure’. During product realization, product specifications are defined. And throughout product realization, it is crucial to measure against specifications, analyze if there are trends, and make improvements. The same methodology also applies to the QMS as a whole.


There should be a proper Customer feedback and complaint handling process. However, there is one important distinction, in my opinion — feedback is about being proactive, whereas a complaint is typically reactive in nature. Feedback is about soliciting information to confirm that customer requirements have been addressed. Define procedures for gathering this feedback. Realize that the feedback you get may be positive, negative, or neutral.

When you identify a complaint, there are certain minimum requirements that should be documented. You need to have a complaint handling procedure to define these requirements and process.

Complaint records need to capture:

  •  Product information, including product name, lot number, UDI, and any other   identification information.
  •  Details of the issue, including date of the event.
  •  Date complaint received.
  •  Date and results of investigation.
  •  Any corrections and/or corrective actions taken.
  •  Correspondence with the person making the complaint.


Internal audits of your QMS should be considered prime opportunities for you to monitor the effectiveness of your processes. Internal audits should be conducted at planned intervals and documented in some type of internal audit schedule. If internal audits are run just to complete the process, the organization does not benefit anything from it.


During manufacturing, if products do not meet these specifications, this is considered nonconforming product. When nonconforming product is identified, it must be assessed and investigated. Disposition of a non-conformance should be risk-based in nature. And if so, consider escalating a corrective or preventive action investigation to explore the ramifications of changing the specification.

Rework is also a tricky disposition of a non-conformance. And the reworked product must meet the defined product specifications. If you notice potential systemic nonconforming product issues, consider escalating a corrective or preventive action investigation.


There should be a distinctive difference between corrective action and preventive action. And that major distinction is whether you are being reactive or proactive. Corrective action and preventive action are different enough that these should be handled differently. Practically and procedurally speaking, the process for conducting a corrective action investigation and preventive action investigation are for all intents and purposes very, very similar.

Corrective Action: eliminate the cause of nonconformities in order to prevent recurrence.
Preventive Action: eliminate the causes of potential nonconformities in order to prevent their occurrence.

Corrective Action shall be taken without any delay. The major difference is that with corrective actions, the preceding systemic events have already occurred. With preventive actions, you have identified a potential systemic issue and gotten ahead of it beforehand with proactive measures.

As discussed throughout this guide, your QMS includes numerous processes and procedures. Procedures for customer feedback, complaints, internal audits, non-conformances, and supplier management are all means for you to measure, analyze, and improve these processes. And when the issue becomes a bigger, more systemic issue in nature, consider a corrective or preventive action.


Most in the medical device industry view QMS as a must-have to check boxes for compliance sake. Few understand and implement a QMS as a strategic business advantage.

Exsolutiongroup views a QMS as the pinnacle solution for helping you run a better, more efficient medical device company. A QMS allows you to focus on the true quality of your products. And most importantly, a QMS should help your business always do what is best for the patients who will be recipients of your medical devices.

Why Exsolutions?

The regulations are constantly changing in the medical device industry. Keeping up with the latest regulatory requirements can be challenging and a full-time job all by itself. This is why exsolutiongroup comes to your help. Exsolutiongroup focuses on keeping up on the latest updates with ISO 13485, FDA, ISO 14971, and so on, so that you can focus on improving the quality of your products.