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The Importance of Self Auditing

Written By: 
Michael Falco / Quality Manager

Every company that manufactures medical devices knows that sooner or later, a third party is going to want to perform inspections at the manufacturing site. This may be initiated by customers, by third party auditors (when audits for ISO certification are conducted for instance) or by government bodies such as the FDA.

So how does a company prepare for all of these inspections and audits? The answer is simple; check yourself first! At ADC we apply this concept, and incorporate it into the deepest level of our quality management system with our self-auditing process.

Self-auditing is a requirement of the Code of Federal Regulations. 21 CFR part 820.22 lays out the criteria for establishing quality audits that monitor the effectiveness of a firm’s quality management system. We take this a step further with the application of the ISO 13485:2012 quality management system standard, which has additional requirements for auditing in part 8.2.2. By applying both the regulatory requirements as well as a voluntary quality management system standard, we ensure that we are not only complying with the regulations, but continuously improving our internal systems to meet the demands of our customers.

ISO 9001 and ISO 13485 CertificationsWhat sort of impact does this have for our customers? It touches virtually every part of our business, from the speed and efficiency of our shipping, to the quality of our devices, to the level of service provided when a customer reaches out to contact us. With internal auditing, we are regularly reviewing each and every part of our quality management system, examining all of our processes to improve efficiency, improve output, and reduce errors.

The regulations require that these audits be conducted on a regular basis to ensure that the entirety of the quality management system is reviewed for effectiveness. We do this with a continuous cycle of internal auditing, year after year. Each department is visited at least once annually, and where deviations from established processes are discovered, corrective actions can be taken and re-audits are conducted to correct these problems and verify that they have been effectively handled. This creates consistency in everything we do, reduces errors, and ensures that the products we sell today will be of equal quality to the products we sell ten years from now.

We take the auditing process seriously! There is nothing more beneficial than recognizing where you are weakest and improving upon it. Through our internal auditing, we have made great strides in improving a number of key processes throughout our organization, and hope to continue this trend well into the future.