Six Mistakes to Avoid When You're Undergoing a Medical Device Quality System Audit

1 June 2021
 Categories: Business, Blog


It's essential that you pass medical device quality system audits to avoid trouble with the FDA and the ISO. You need to avoid mistakes that could compromise your facility's ability to pass these audits. The following are six mistakes to avoid when you're undergoing this process. 

1. Neglecting to make a checklist of the requirements you're expected to meet

It's hard to prepare for an audit if you and your staff are uncertain about which requirements you need to meet. That's why it's important to make a checklist of all of the requirements your facility needs to meet as part of the audit. This way, your staff will be focused and informed in preparation for the audit. 

2. Failing to invest enough in training your staff

The better trained your staff is, the higher the chances will be that you'll sail through all of your audits. Your staff members should be specifically trained in regulatory compliance. This training needs to be updated over time as regulations change. Make sure that your staff is having ongoing training to keep up with the changes. 

3. Not having regular documentation of standard operating procedures

Proper documentation at your facility can make audits more convenient and easy to get through without any problems. Document all procedures and activities in detail. Also, you need to make sure you're updating your standard operating procedures over time to both optimize them and keep up with regulatory changes. 

4. Getting behind schedule with everyday operations like compiling reports

Staying on top of everyday tasks like compiling reports is important when it comes to getting through audits. If your facility is constantly running behind on essential tasks, it's going to be more likely that your staff members will overlook a key detail that will create problems during an audit. 

5. Not putting enough time into preparing history files before your audit

One of the most important things for staff to focus on in preparation for an audit is gathering any relevant paperwork and evidence. Staff members should have all product history files that might be needed during the audit ready to present upon request. 

6. Continuing to use only hard copy records rather than digital records

If you're still relying heavily on hard copy records at your facility, it's time to change that. By now, you should have entirely switched over to electronic records for all of your design history files, bills of materials, and master records. 

For more information, contact medical device quality system auditing services.