An internal audit is a significant part of the Quality Management System (QMS) in ISO 13485. An organized process assists organizations with recognizing regions for development and guarantees that their QMS conforms to the standard’s requirements. The internal audit gives a potential chance to organizations to assess the viability of their QMS, recognize regions for development, and make remedial moves as needed.

By following the critical stages of an internal audit, organizations can guarantee that their QMS is working really and recognize amazing open doors for development.

Steps in the Internal Audit

The inspiration behind the internal audit is to analyze your cycles all the more intently and attempt to distinguish regions for development. As a process proprietor, it tends to be extremely useful to step away briefly and permit second planning of eyes to search for open doors you might have missed. The objective isn’t to censure, but rather to track down ways of smoothing out processes, with the goal that they work all the more proficiently. 

Thus, moving along, here are the 5 vital steps in the ISO 13485 Internal Audit process, in addition to tips for how to best utilize this cycle to the benefit of your organization.

Step-1: Plan and Declare the Audit Schedule

Be aware that the audit isn’t surprising anyone, you can “catch them hidden” of accomplishing something wrong. At the point when that’s what you do, top management sends a reasonable message that they have zero faith in their workers, and thus, they might attempt to safeguard themselves by concealing information or giving bogus data. 

Thus, in light of this, it is vital to set up a reasonable audit timetable and ensure that everybody knows when each cycle will be assessed, regardless of whether it’s simply a harsh rule to begin. This shows a responsibility from management to support staff through ISO 13485 Internal Auditor Training in their endeavors to work on their cycles. 

It likewise permits those responsible for a process to wrap up any enhancements they are presently dealing with, so they can get a reasonable perspective on the effect of those changes; likewise, process owners might wish to make unique solicitations for the auditor to search for specific data connected with other planned upgrades.

Step-2: Plan the Individual Process Audits

Since everybody has thought of when to expect an audit, you’ll have to plan and schedule (with more accuracy) the audits of every individual process. This permits both auditor and auditee to figure out an opportunity that works for both, and an agreeable timetable. This is additionally a great chance to go over past audit reports to figure out what follow-up may be required and to discuss any regions that either party might want to give additional consideration to. Setting aside some margin to design the audit well is the most effective way to ensure that both the organization and the process owner will profit from the audit process.

Step-3: Direct the Audit

To start, the auditor and process proprietor ought to meet to talk about the audit plan and ensure it is finished and all set. Then, at that point, the auditor can go to work assembling the proof they need to decide if the process is working as it ought to, as indicated by the QMS, and assuming it is delivering the ideal outcomes. 

This data can be accumulated through dissecting key cycle information, checking on records, conversing with employees, or observing the actual process. During the process, it is significant that the ISO 13485 Lead Auditor can bring up any areas that don’t have adequate proof that they are working true to form. Or any regions they notice that could be gotten to the next level.

Step-4: Report on the Audit

When the audit is finished, the auditor ought to hold an end meeting with the owner to impart any discoveries immediately. Like any shortcomings all the while, especially certain perceptions, or any regions that are working true to form, yet could be gotten to the next level. Before long, a composed report ought to be given as documentation.

Step-5: Follow back to Issues or Enhancements

Obviously, very much like some other piece of the QMS, follow-up is vital to a fruitful audit. Assuming issues were found, and corrective moves made, it is basic to follow up and be certain that the issues were really tended to. 

In the event that improvement projects were implemented in light of risks found during the audit. Gathering information to see exactly how much the process has further developed will persuade employees and management to search for additional amazing open doors for development.


You can decide to consider the ISO 13485 Internal Audit to be a means to an end for keeping up with compliance, or you can involve the internal audit as a method for observing and enhancing your organization’s cycles.

Since ISO 13485 puts a heavy emphasis on process improvement internal the QMS, this ought to be a critical inspiration for your organization, as well also different advantages that accompany improvement, as further developed productivity in regard to costs and time. Conduct your internal audit to carry worth to your QMS, and to your organization.