8 Tips to Help You Meet ISO 13485 Standards

For medical device companies, meeting ISO 13485 standards is necessary for many reasons. The standard was written to support medical device manufacturers in designing a Quality Management System that establishes and maintains the effectiveness of their processes. As a standard centered around safety and quality, keeping up with its expectations can help your company avoid regulatory fines. It also can help streamline business, increase customer satisfaction, and improve your product quality. In this article, we’ll break down ISO 13485 and its benefits, as well as outline eight tips to help you stay compliant.

What is ISO 13485?

ISO 13485 is an international standard created by the International Organization for Standardization (ISO) for organizations that design, produce, install, and distribute medical devices and other related services. Perhaps the medical device industry’s most popular international standard for quality management, ISO 13485 provides a framework for manufacturers to demonstrate a commitment to the quality and safety guidelines of medical devices.

In the medical devices industry, quality management goes hand-in-hand with safety. Therefore, requirements like the ones set out by ISO 13485 are strictly enforced throughout every stage of a medical device’s life cycle.

Benefits of ISO 13485 Certification

Aside from simplifying the audit process, keeping up with ISO 13485 standards offers many benefits. Here are a few of the most significant ones:

Continuous improvement

Continuous improvement is one of the core principles of an ISO quality management system. When a QMS is adopted in any organization, it leads to an overall cultural change. With an emphasis placed on quality your team will naturally start prioritizing improvement. Additionally, setting up systematic processes can eliminate process complications and reduce workload, leading to higher performance, strategic leadership, and employee engagement. These changes can deliver higher-quality products.

Demonstrating a commitment to quality

ISO 13485 is the globally recognized standard for quality in the medical device industry. This certification is proof to the customers that the organization follows high-quality standards and that they have a standard in place to ensure it. ISO 13485 implementation in any organization can serve as a powerful marketing tool by demonstrating a company’s commitment to quality processes and products.

Customer satisfaction

ISO 13485 is built on quality management principles, one of which is safeguarding and prioritizing customer satisfaction. Customers know what they want and what they need, and many of them will not even entertain a company that isn’t ISO-certified. Additionally, ensuring the satisfaction of your existing customers keeps them coming back and opens your doors to new customers. This translates directly to increased revenue.

Total process integration

ISO 13485 lays out demanding requirements when it comes to documentation. One of the upsides of this is that you end up with a central repository of information that makes it possible for your team to access key information when they need it, making collaboration a smoother process.

With the benefits of implementing ISO 13495 outlined, let’s look at eight ways to make meeting its requirements easier for your team:

1. Maintain thorough audit trails

In order to simplify an ISO 13495 audit, it’s helpful to have detailed audit trails at your disposal. This means that every creation, modification, or deletion of any record should be automatically stored in an audit history file. This documentation should be retained for a period and needs to be available for ISO auditors to review and copy if required. Pay special attention to CAPA, risk, and supplier records since those are the documents specifically noted in ISO 13495 regulatory requirements.

2. Complete a comprehensive internal audit

The purpose of the internal audit is to examine your processes more closely and try to identify areas for improvement before it's time to bring in a credited auditor. In terms of ISO 13495, an internal audit can help your company spot holes in its quality procedures and remedy high-risk areas of your processes rather than spending time on areas that are already perfectly compliant. Just be sure to follow up when the internal audit has been completed to remedy any potential issues that could cause a lapse in compliance.

3. Educate your team on the guidelines of ISO 13495

Without a united front, it’s easy to fall behind on ISO regulations. Take time to read the guidelines thoroughly and make sure you understand what’s required of you to become certified and then pass that information on to the rest of your team. You all need to be on the same page and understand how ISO certification might change business processes in order to make meeting its guidelines possible.

You can view a preview and purchase the complete ISO 13485 document from ISO’s website here. 

4. Build a single source of truth

To pass ISO 13485 certification and remain compliant, your company needs to build a single source of truth for your processes, systems, and policies that will withstand any future growth, merger, or acquisition. If your data and documentation are scattered and not centralized, things will inevitably fall through the cracks, making it impossible to pass audits or reference older information. 

5. Meet CAPA standards

Failure to meet CAPA standards is the number one trigger for ISO citations in the medical device industry. Therefore, it’s important to prioritize the CAPA process. To ensure your company meets CAPA standards, refer to ISO 13485 8.5.3 (prevention) and ISO 13485 8.5.2 (correction) and build your CAPA standards around their recommendations. Read them here.

6. Accurately track employee training

Proving employee training is one of the most important pieces of ISO certification. On its website, ISO outlines training requirements as:Everyone on your team with any type of effect on product quality should have thorough training and experience to currently perform their assigned tasks. This training must be documented and provable to an auditor.

7. Develop Medical Device Reporting (MDR) procedures

Medical Device Reporting (MDR) is a post-market surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. Under ISO13485:2016, medical device companies must also meet the guidelines of MDR, including submitting events and annual reports. With that in mind, make it a priority to develop thorough MDR procedures to avoid potential compliance issues.

8. Use a digital QMS – not a paper-based system

Digital quality management systems designed for life sciences companies are built using the ISO 13485 framework for quality control, operational efficiency, regulatory compliance, and the safe manufacture of medical devices. Quality management software automates all your quality activities and enables you to link documents from different quality processes together for game changing visibility, traceability and control. It can also help to guarantee that the highest quality business processes are followed to ensure you are meeting the needs of customers, stakeholders, and ISO requirements.

A comprehensive QMS should provide essential functions such as document control, training management, and the ability to expand to other areas (like CAPA) as you get closer to product approval. And as your company grows, your QMS needs to grow with you. A robust QMS should offer essential components for risk management, testing, and other procedures to streamline product submission. When you implement a suitable QMS for your medical device company, you’re instantly one step closer to obtaining, and keeping, ISO 13485 certification.

Gaining ISO 13485 accreditation is highly beneficial, and it doesn’t have to be a painful experience. By following these eight tips, your company can build the foundation needed to not only meet ISO 13485 standards, but create a culture of quality that works to streamline business, increase customer satisfaction, and improve your product quality.

Check out our other resources on meeting ISO and FDA standards and regulations:

• How Medical Device Companies Can Maintain FDA 21 CFR Part 820 Compliance
• The 5 Fastest Ways to Fail an ISO Audit
• 5 Ways to Prepare For The New UK Medical Device Regulations