When it comes to medical devices, there’s no room for mistakes. But we don’t live in a perfect world, and mistakes can happen—it’s only human. But when errors occur, fixing them becomes even more crucial. That’s why the ISO 13485 complaint section is such a hot topic in the industry. But before diving into the nitty-gritty, let’s first break down what ISO 13485 is all about.
Prefer video over text? Here’s a video version of the blog!
What is ISO 13485?
ISO 13485 is a big deal in the medical device world. It’s a globally recognized standard for quality management systems (QMS) that ensures companies meet both customer and regulatory expectations. One critical area covered by ISO 13485 is handling customer complaints, which is key to maintaining product safety, quality, and compliance.
In this blog, we’ll cover the must-know aspects of ISO 13485, focus on the complaint section, define different types of complaints, discuss the complaint handling process, provide an example of a complaint management SOP, and explain how a QMS like Isolocity can simplify it all.
What are Complaints?
A complaint is any expression of dissatisfaction related to a product’s quality, safety, performance, or regulatory compliance. In the context of ISO 13485, complaints specifically refer to issues users, customers, healthcare providers, or regulators raise after the product reaches the market.
Types of Complaints
Understanding the different types of complaints helps in prioritizing their resolution and setting appropriate corrective actions. Here are the main types of complaints:
- Quality Complaints: These relate to the product’s ability to meet its stated specifications. They could involve defects in the manufacturing process, material issues, or poor design that leads to malfunction.
- Safety Complaints: These complaints are about the product causing harm or risk to users, such as device failures, adverse events, or injuries.
- Performance Complaints: These are tied to the product not working as intended. It could include inaccuracies, delays, or failure to meet the required performance standards.
- Regulatory Complaints: These are complaints that point to non-compliance with regulatory requirements. They could involve the improper use of labelling, not meeting industry standards, or failure to follow safety protocols.
Sources of Complaints
Complaints can come from various channels. It’s important to capture all possible sources to ensure no issue goes unresolved:
- Customers or Users: Direct feedback from those using your product.
- Healthcare Providers: Doctors, nurses, or other professionals who notice product issues during use.
- Regulators: Health authorities or industry regulators might flag non-compliance issues.
- Internal Reviews: Your own audits and quality checks may uncover potential problems.
- Post-Market Surveillance: This involves ongoing monitoring of devices after they’ve hit the market.
Incident-Driven vs. Review-Driven Complaints
- Incident-Driven Complaints: These arise directly from an adverse event or product failure reported by a customer, healthcare provider, or regulatory body. These are often urgent and can have immediate safety implications.
- Review-Driven Complaints: These are identified during routine post-market surveillance, internal audits, or product reviews. They may not stem from a specific incident but rather from data trends that suggest a potential issue.
ISO 13485 Complaint Section
The complaint section is all about identifying, analyzing, and fixing any product-related issues that come up after your device hits the market. The whole point is to keep customers safe, stay compliant, and continue improving your product.
Here’s what the ISO 13485 complaint section covers:
- Complaint Recording and Tracking: You need a system to log and track complaints. This includes details like the complaint’s origin, description, and any product defects.
- Investigation: Once a complaint comes in, you need to investigate thoroughly. Review the product design, production process, and relevant documentation to find the root cause.
- Corrective and Preventive Actions (CAPA): After identifying the cause, put corrective actions in place to ensure the issue doesn’t happen again.
- Regulatory Reporting: Some complaints—especially those involving injuries, deaths, or serious incidents—need to be reported to regulatory bodies.
- Customer Communication: Keep the customer updated throughout the process.
Complaint Management Regulations
ISO 13485 isn’t the only standard you’ll need to think about when managing complaints. There are several global and regional regulations that dictate how complaints should be handled:
- FDA 21 CFR Part 820: In the U.S., medical device complaints must be logged, investigated, and reported to the FDA in certain circumstances.
- EU MDR (Medical Device Regulation): In Europe, the MDR mandates that manufacturers have a formal complaint-handling process and report certain complaints to the regulatory authorities.
- Health Canada: Canadian regulations require that all complaints related to medical device safety or efficacy be properly recorded and reported.
Service Level Agreements (SLAs) Based on Complaint Severity
Setting SLAs for complaint resolution is essential for maintaining customer satisfaction and regulatory compliance. The SLA timeline often depends on the seriousness of the complaint:
- Critical Complaints (e.g., safety issues): These need to be addressed immediately—often within 24 to 48 hours.
- Major Complaints (e.g., product defects): These should be resolved within a week or two, depending on the complexity.
- Minor Complaints (e.g., performance issues): These might have a longer SLA, such as 30 days, as they often involve less urgency.
How Isolocity QMS Can Make Your Life Easier
Isolocity QMS streamlines ISO 13485’s requirements, particularly in complaint management, by automating the process to ensure quick, efficient handling and ongoing compliance.
Here’s how Isolocity can help:
- Automated Complaint Tracking: Log, track, and assign complaints without anything slipping through the cracks.
- Integrated CAPA Management: Complaints and CAPA go hand in hand, ensuring corrective actions are quickly implemented.
- Stay Compliant: With built-in templates and workflows aligned with ISO 13485, you’re always ready for audits.
- Custom Reports: Generate detailed reports for both internal monitoring and regulatory submissions.
- Cloud-Based Access: Access records and reports from anywhere.
Let’s see one such complaint management in action.
Step-by-step process
Isolocity 3.0 is an extremely powerful QMS tool which can be used not only for complaints, but for any quality events that you can think of. Let’s create an example for complaints and see how that works out.
1. Click on create and then template. 
2. Select Quality events from the dropdown and fill other fields as required. For Form name, let’s consider customer complaints for the time being. 
3. Once you click on the create template button, you will get some additional options. So we can either create the template from scratch, duplicate an existing or take something from the public library. For our clarity, let’s build one from scratch.
4. You will have to start with a section, let’s name it administrative details. After doing that click on the “+” sign 
5. As you proceed, you will get several options. Based on your preferences, you can create your custom template
- List : Radio, dropdown, tags, checkbox etc
- Text: short or long text
- Number : numeric, currency, percentage, CoQ etc
- Date & Time : Date + time
- Toggle : Switch
- Task list : To assign tasks to users
- Supplier form : For supplier input
6. Let’s consider some standard fields
6.1. Administrative details:
6.1.1. Complaint number 
6.1.2. Date of complaint
6.1.3. Parts 
6.1.4. Error Code 
6.1.5. Received Via 
6.1.6. Customer 
6.2. Complaint information: (New section) 
6.2.1 Date received by QA
6.2.2. Complaint category 
6.2.3. Complaint severity 
6.2.4. Complaint Source : We are not using this as we are building this for customers only.
6.2.5. Investigation needed 
6.2.6. Product returned 
6.2.7. Retention sample examined 
6.2.8. Department 
6.2.9. Immediate action
6.2.10. Investigation
6.2.11. Root cause
6.2.12. Action/Corrections made:
6.3. Final approval (New section) 
6.3.1. CAPA needed
6.3.2. Reply sent to complainant?
6.3.3. Part received?
6.3.4. Recall required? 
6.3.5. Comments:
Once you are done with all the fields, click Save button. Also do remember to add subscribers if you have anyone in your mind.
And you are done with the customer complaint template. Now let’s see how that looks when you try to file a new customer complaint. But before doing so, you will have to approve the current template you have just created. So head over to the template section, open the template you have just created, and click on approve.
Now let’s go to the quality events module and see if you find that template. Open quality events and click on this + sign on the top right.
In the quality event type dropdown, search for the quality event you just created, and it will show up.
Select that template and start creating the customer complaint. For name, give it anything, let’s say, Incident 545.
Now as you start filling it up, you will see all the fields you entered in the template are popping up here. Not only that, they are also connected to internal modules, which you connected, for example, you will be able to look up parts or batches, look up customers, etc.
On the top you would notice, you can also escalate this to another quality event, for e.g., if you want to link it to CAPA or NCR, you can do it from here and all of them will be interlinked.
Conclusion
Complaint handling is a critical aspect of ISO 13485 compliance, but it doesn’t have to be overly complex. By setting up a clear process, automating where you can, and focusing on corrective actions, you’ll keep your customers happy and your products safe. And with a tool like Isolocity QMS, managing complaints becomes a streamlined process, helping you focus on continuous improvement and long-term success in the medical device industry.
