For organizations aiming to implement a smooth implementation of ISO 13485, the process is somewhat complicated because the ISO, unlike many other regulatory bodies, does not disclose a lot of data to learn from.

Based on our many years of experience as ISO 13485 certification consultants, we often come across mistakes repeated by many companies in the medical device industry. We’re discussing some of them below:

1. Doing it Because You ‘Have’ to

Many companies see ISO 13485 as nothing more than their ticket to access bigger, more lucrative markets. This approach then leads them to implement the standard because they have to, not because they recognize its wide range of benefits.

From the very beginning, focus on the bigger picture. Consider how other aspects of your business can benefit from better quality management and stronger controls as well.

2. Poor Internal Auditing

This should be a fairly obvious point, but unfortunately, it isn’t Properly conducted internal audits enable you to identify where your business is lagging and take steps to remedy that. They’re also a major requirement for obtaining and retaining your ISO 13485 certification.

You can’t be complacent when it comes to internal auditing. Conduct it regularly and conduct it well.

3. Wasting Customer Feedback

You waste customer feedback when you fail to learn from it. If your customers are taking the time to get in touch with you, you should take the time to listen to them. Sometimes it can be praise, and at other times, it can be a complaint. However, almost every single time, it is valuable.

ISO 13485 provides clear requirements on developing procedures for the correct management of customer feedback. It expects your company to be proactive when seeking feedback and then handle it correctly.

4. Ignoring the Risks

ISO 13485:2016 places a much greater emphasis than its earlier versions on incorporating risk assessment and risk management into every aspect of your business processes. Failing to adequately assess risk and not having procedures in place to mitigate it is a common mistake. Another one is the inadequate documentation of risk assessment.

Similar to seeking customer feedback, be proactive with your risk assessments. Dealing with different levels of risks requires different measures. Be sure to document the assessment processes and the corrective actions taken.

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For over 15 years, our team of experts at Barile Consulting has provided ISO 9001 consulting services, AS9100D consulting services, and ISO 13485 consulting and certification to countless companies from many industries.

Contact us today and let us help you implement the highest standards of quality.