How should you Deal with the Latest Changes in ISO 13485 Standard?

According to the ISO experts, communication is one of the key factors in compliance with ISO 13485 Medical Device Manufacturing Standard. Lack of a strong communication structure, dependence on verbal agreements and failing to document the modifications may lead an organization to high costs and operational losses. A survey, conducted by the Society for Human Management (SHRM) asked 400 companies across the world about the consequences of poor communication. This survey estimated that an average of $62.4 million may each company face per year due to poor communication practices.

These days, gaining ISO 13485 certification has become immensely important for medical device manufacturing companies. The latest version of this standard was revised in 2016. This revised version of ISO 13485 has brought some changes to communication requirements, which Clause 7.2.3 includes.

How Clause 7.2.3 has changed in ISO 13485:2016 Standard?

In the earlier version, clause 7.2.3 stated that an organization should determine and avail effective opportunities for interacting with the customers regarding the following aspects:

• Product Information
• Inquiries, contracts, or order handling
• Customer feedback and complaints
• Advisory notes

Most companies fulfilled these requirements easily. Most of these methods were executed through telephone or email. Now, it’s important to learn what the latest changes in the ISO 13485 Standard are. The latest version has added a new requirement. This new requirement states, “The organization shall communicate with regulatory authorities in accordance with applicable regulatory requirements”. Does this excerpt provided by ISO sound a bit difficult to understand? Well, let us explain it to you.

The excerpt quoted above implies that an organization should keep the top management informed in the event when any significant compliant takes place, or issues any notifications regarding an update to the technical files, which are likely to violate the safety, quality, and efficiency of your products.

A Clear Insight into Clause 7.2.3

There are some common scenarios in which an organization needs to communicate with regulatory authorities. For instance, imagine you manufacture a diagnostic test kit for urinary tract infection in sales. You have received a report from your internal auditors and a fault is detected that may affect the reading of the diagnostic kit. In such a context, you should inform your local health service authority within 24 hours. Make sure you have informed before notifying the field safety to its distributors. Once the field safety is issued, the distributors will collaboratively aware of your organization.

Customer service is another element that plays a remarkable role in ISO 13485:2016 Standard. To be more specific, it is relevant to 7.2.3 clause of the medical device-manufacturing standard. Your customer services should be aligned with the communication process and the ISO 13485:2016 regulations. A medical device manufacturing company should demonstrate this compliance in the form of documentation of vital details of adverse events and complaints. In this context, it is important to note that the documented information should be passed to the appropriate department for processing with the local authority.

A Final Takeaway

If you want a robust communication process, it is important for you to assess existing communication tools. You should ensure continuous improvement as well. Looking for more than one method to make communication easier in the event of a crisis would be a wise decision. While transiting to the new version, you should update the quality manual and other documents relevant to the standard so that you can maintain your communication process efficiently even after the transition.

If you have never been certified to the ISO Medical Device Manufacturing Standard, then you should develop a clear understanding of each section of the standard including the communication process. Having a fair knowledge of the latest version will help you gain ISO 13485 Certification without any difficulty. Still, if you are not confident enough, you should consult with experienced ISO 13495 consultants. Consulting ISO professionals is a quite popular trend these days. This way, you will be able to make sure that you are walking in the right direction.