If your medical device company is considering implementing the ISO 13485 quality system, you’re probably still in the early phases of familiarizing yourself with the requirements.

Most companies perceive the internal audit process as a complex and time-consuming requirement. Granted, it can seem quite intimidating if you’re just getting started. But once you acclimatize to the process, you’ll breeze through it and wonder what all the fuss was about.

The internal audit serves the purpose of assiduously examining your internal processes and improving weaknesses as they are discovered. The end goal being to ensure that you’re running a tight ship.

Here’s how you can structure the ISO 13485 internal audit and streamline internal processes like a pro.

1. Don’t Put Your Employees on the Spot

An unannounced ISO 13485 internal audit never goes down well. Not only will your employees feel unprepared and intimidated, but they’ll also get the feeling that management doesn’t trust them.

Instead, announce the audit in advance so your employees can prepare beforehand. This will also help them conclude any unfinished improvements so everything is executed seamlessly.

2. Schedule Audits of Individual Processes

Once you’ve familiarized your team with the date and time of the internal audit, kick-start the planning phase.

We suggest scheduling audits of individual processes to facilitate the process. In addition, examine previous audit reports to identify weaknesses and create a follow-up strategy accordingly.

Adequate planning will go a long way in ensuring the process owner and your organization benefit from the internal audit.

3. Proceed With the Audit

company audit

Prior to proceeding with the audit, give the plan a look-over to ensure everything looks good. Once you’ve ascertained that each component of the internal audit is in order, it’s all systems go.

Discuss the audit plan with the auditor to give them sufficient time to decide whether your internal processes are in compliance with the requirements of the quality management system. They’ll review your documentation, conduct interviews, and make fact-based observations to determine whether ISO 13485 requirements are being met.

If there are any discrepancies or shortcomings, the auditor will notify you. This commonly happens when there is insufficient evidence.

4. Have a Closing Meeting With the Process Owner

Following the internal audit, the auditor holds a closing meeting with the project owner to provide and discuss the results.

Each observation and evaluation is deliberated in detail to ensure the organization is meeting the standards that have been put in place.

By the end of the meeting, a written report is produced. This document commonly includes a summary of the proceedings.

5. Address Problems and Ensure Adequate Follow-Up

The primary purpose of an internal audit is to determine where your company stands with regard to the quality management system and take action accordingly. Simply procuring the results and leaving them untouched won’t do you any good.

Instead, address the problems that were highlighted in the audit and ensure adequate follow-up. This will help your organization stay on track and better internal processes.

Make a list of the areas of improvement and create SMART (specific, measurable, attainable, realistic, and time-bound) solutions accordingly. In addition, prioritize accountability by making sure new strategies are being implemented.

ISO 13485 registration is a prerequisite for companies that wish to offer their products/services outside the U.S. Even if your company has nationwide reach, implementing ISO 13485 requirements can help you develop an edge and improve overall quality, efficiency, customer satisfaction, employee engagement, and company image.

At Barile Consulting, we can help you get started! We offer expert ISO 13485 consultants services for medical device manufacturing companies across the U.S.

Give us a call at 440-628-8271 and we’ll take it from there!