![]() Once the audit is complete, the auditor should hold a closing meeting with the process owner to communicate any findings right away, such as any weaknesses in the process, any particularly positive observations, or any areas that are functioning as expected, but that could be improved. During the process, it is valuable if the auditor can point out any areas that do not have sufficient evidence that they are functioning as expected, or any areas they notice that could be improved.Ĥ) Report on the audit. This information can be gathered through analyzing key process data, reviewing records, talking with employees, or observing the process itself. Then, the auditor can go to work gathering the evidence they need to determine whether the process is functioning as it should, according to the Quality Management System, and if it is producing the desired results. To begin, the auditor and process owner should meet to discuss the audit plan, and make sure it is complete and ready to go. Taking the time to plan the audit well is the best way to make sure that both the company and the process owner will benefit from the audit process.ģ) Conduct the audit. This is also a good time to go over previous audit reports to determine what follow-up might be needed, and to talk about any areas that either party would like to pay extra attention to. This allows both auditor and auditee to find a time that works for each, and a timeline that is comfortable. Now that everyone has an idea of when to expect an audit, you’ll need to plan and schedule (with more precision) the audits of each individual process. So, without further ado, here are the five key steps in the internal audit process, plus tips for how to best use this process to the advantage of your company.Ģ) Plan the individual process audits. The goal is not to criticize, but rather to find ways to streamline processes so that they work more efficiently. As a process owner, it can be very helpful to step away for a moment and allow a second set of eyes to look for opportunities you may have missed. The purpose of the internal audit is to examine your processes more closely and try to identify areas for improvement. In truth, the internal audit is neither of these things – at least, these are certainly not the intent. Some think of it as a waste of time, merely duplicating the work of the certification body others see it as a witch hunt, looking for mistakes (or trying to hide their own), or searching for someone to blame or discipline. Like many companies, you may view the internal audit process as one more necessary evil required for ISO 13485 certification and maintenance.
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