ISO 13485

Published for the first time in 1996, ISO 13485 is the global standard for medical device quality management systems established by the international standards organization (ISO).

The ISO has published several international standards documents that relate to medical device manufacturers. ISO 13485:2016 is the latest version of this guidance document which outlines the international standards for quality management systems (QMS) at medical device companies. Establishing and maintaining a quality management system in compliance with the standards set out in ISO 13485, and thereby obtaining an ISO 13485 certification, is an important step in broadening your access to global medical device markets, especially in Europe, where ISO standards are harmonized with the most important European Regulations for medical device companies.

ISO 13485 Companies Gain International Traction

ISO 13485 certification is a requirement for medical device companies that wish to market their products in Europe and around the world. If your medical device company is focused only on the United States market, you can get by without a certification but you still need to comply with 21 CFR Part 820. Based on the large overlap between ISO 13485 and 21 CFR Part 820, it's worth the extra effort to get the ISO certificate and expand the reach of your company.

In Europe, obtaining an ISO 13485 certificate is often a necessary precursor to getting approved for CE marking, which allows you to sell medical devices in Europe. If you're looking to sell medical devices in Canada, you'll need a special kind of ISO certification called CMDCAS.

Differences Between ISO 13485 And FDA QSR

While ISO 13485 certification is a requirement for marketing medical devices in both Canada and the European Union, the USA regulates medical device quality systems through the FDA regulatory document 21 CFR Part 820. The latest revision of ISO 13485 was conducted with the participation of the FDA, and as a result, the two documents are very similar in certain areas. For example, the sections in each document that discuss Design Controls (21 CFR Part 820.30 and ISO 13485 Section 7.3) are almost identical.

Despite some similarities, ISO 13485 and FDA QSR don't overlap completely in their requirements. The FDA QSR places a stronger emphasis on post-market monitoring and the complaints-handling process - a QMS that is ISO 13485-certified may not meet the complaint handling requirements of the FDA regulations. On the other hand, ISO 13485 demands a more risk-based approach to QMS. Some quality systems that comply with 21 CFR Part 820 lack the risk-based components that would qualify them for ISO 13485 certification.

Find out more about the difference between ISO 13485 and FDA QSR.

Steps To Obtaining ISO 13485 Certification

Obtaining an ISO 13485 certification can be explained as a simple process. Follow these steps to get started:

1. Create a quality plan - certification starts with developing a quality plan to meet the requirements of the standard. Plan out how your quality system will function, what roles are required and who will perform them.
2. Identify target markets and work toward compliance - determine where you would like to market your medical devices and establish compliance with other medical device regulations in those jurisdictions.
3. Implement design controls - design controls are needed from the beginning of the product development process and should be established and documented as early on as possible.
4. Establish document controls - train your staff to follow a consistent and uniform system for updating the QMS and maintaining its compliance with ISO 13485.
5. Build a CAPA system - along with Design Controls, CAPA forms the core processes of your QMS. Ensure that your CAPA procedures are well defined and functional.
6. Schedule audits with a Notified Bodies - organizations called Notified Bodies are assigned to audit medical device companies for compliance with ISO 13485. Certification audits are conducted in two stages, and manufacturers are expected to be fully compliant with the standard following the Stage 2 audit.

ISO 13485 Helps You Rethink Your Quality Processes

The best thing about ISO 13485 is that it forces you to think at a high level about your quality system and get everything working together to optimize your results. Here a few items that are unique to ISO as compared to 21 CFR Part 820:

Quality Manual - 21 CFR Part 820 mentions nothing about a quality manual, but it's a main feature of any ISO 13485 quality system. A quality manual explains the scope of your QMS, describes the policies and procedures related to managing the QMS itself, and importantly, describes the connections between the processes that make up your QMS.

Management Review - 21 CFR Part 820 mentions the need for management review, but ISO 13485 goes a step further and outlines exactly what items should be included in a management review: results of audits, customer feedback, process performance and product conformity, status of CAPA items, follow-up from previous reviews, changes that could affect the QMS, recommendations for improvement, and any new or revised regulatory requirements.

Greenlight Guru's QMS Software A Proven Asset For Obtaining ISO 13485 Certification

The QMS requirements laid out in ISO 13485 correspond heavily with those of 21 CFR Part 820, and that's a great thing. Not only will you save time and resources by applying your efforts to comply with both standards, you'll also be able to use Greenlight Guru to build one QMS that complies with 21 CFR Part 820 and conforms to ISO 13485.

Greenlight Guru helps you address documentation requirements for both standards, allowing you to organize and securely store your quality policy and objectives documents, quality manual, and all other materials generated through application of your QMS.

Greenlight Guru's document control functionality creates a single source of truth at your medical device company that makes audits a breeze and keeps your team members on the same page, enabling them to easily reference the most up-to-date versions of every document you own.