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What is an ISO 13485 Compliance QMS?

By Romeo Elias on Mon, Dec 19, 2022 @ 11:20 AM

Topics: ISO 13485

If you operate a business in the medical devices industry, then you’re probably familiar with ISO 13485. That’s the international standard framework that defines an effective quality management system (QMS) for FDA-regulated medical device companies. ISO 13485 also provides the blueprint for compliance with regulations in the EU, the UK, Canada, Japan, Australia, and numerous other countries. Specifically, ISO 13485 compliance aligns with the EU’s Medical Device Directive (MDD) and Medical Device Regulation (MDR).
Medical devices sold in the United States must comply with the FDA Quality System Regulation (QSR), also known as Current Good Manufacturing Practice (CGMP). Earlier this year, the FDA issued a proposed rule to align QSR more closely with ISO 13485:2016 and to incorporate it by reference. In other words, medical device manufacturers around the globe should align their quality management practices around ISO 13485 going forward.
ISO 13485:2016 is the most recent version of the standard. It’s modeled after the ISO 9001 framework, which defines QMS best practices for monitoring, measuring, and controlling the quality of an organization’s products and services. As with other ISO standards, this one is updated periodically. The current version supersedes previous editions of ISO 13485, published in 1996 and 2003.


What’s in ISO 13485?
An ISO 13485 quality management system provides a structured framework for delivering quality products and services to the customer, supported by clearly defined procedures, documentation, work instructions, and policies.
The ISO 13485 standard consists of eight sections, the first three of which are introductory. The five most substantive sections address the following elements of a QMS:
- General requirements for a QMS for medical devices, as well as documentation requirements.
- Management responsibilities, including periodic reviews of the quality system and making any necessary improvements.
- Resource management, refers to the human resources and technologies required to make the QMS successful.
- Product realization, – that is, the product lifecycle, from inception and product design to rollout, customer support, and monitoring.
- Measurement, analysis, and improvement. This includes mechanisms for gathering feedback and measuring outcomes, as well as for managing complaints and non-conformances.
ISO 13485 stipulates that certain documentation is mandatory for compliance. Most organizations will also need to incorporate additional documentation into their QMS, depending on the company’s specific needs and applicable regulatory requirements.


The Right Technology Supports Successful ISO 13485 Compliance
As highlighted in section five of the ISO 13485 standard, medical device companies must allocate adequate resources to make their QMS fully successful and compliant. That includes maintaining sufficient staff necessary to perform quality management functions, as well as the right technology to support ISO 13485 compliance.
Implementing QMS software might seem like a daunting undertaking, but it’s an essential component of a smoothly operating quality management system. When it’s done correctly, it can save considerable time and energy by simplifying document management, automating workflows, and centralizing data in a single location. 
When they’re first starting out, many companies make do with paper-based systems. Customer complaints, non-conformances, and other important elements of the organization’s QMS process must be handled manually in this case. Very often, that means building manual spreadsheets or homegrown databases to manage documents and workflows. That can consume a great deal of time, and it’s easy for things to slip through the cracks. 
Version control can be especially challenging if you’re working with manual systems. Every time a document is updated, older versions must be marked as obsolete, then archived in case they’re needed at a future time. It can be difficult to consistently make sure that no one is working with an outdated document revision. That task usually falls to a single person whose time is occupied by tracking and managing a multitude of quality management documents. 
Modern cloud-based QMS software vastly simplifies these processes by automatically managing all of your quality documentation. It ensures that users are consistently working with the most up-to-date version. It also manages approvals and workflows by routing tasks to the appropriate party at the right time. If a task is not completed on time, QMS software can trigger reminders and escalate the issue to a supervisor to ensure that action is taken promptly.
Mobile QMS apps make it easy for users throughout your organization to enter important data using a phone or tablet device, wherever they might happen to be. By eliminating paper systems, QMS software increases accuracy, saves time, and provides a clear audit trail showing exactly what was changed, when, and by whom. 


ISO 13485 Compliance Without Compromise 
The best QMS software will allow you to adapt the technology quickly and easily to conform to the way you work. Like most other international standards, ISO 13485 provides a framework, not a rigid top-down system that companies are compelled to adopt wholesale. As such, it can be adapted to fit the way your company works. In fact, it should be tailored to suit your organization’s unique needs.
The Intellect QMS platform is designed for extreme configurability, making it the most adaptable product on the market for ISO 13485 compliance.
Companies that manufacture medical devices should also look for a QMS vendor with solid experience in FDA-regulated industries. Intellect’s team of experts works with each of our clients to fully understand their business processes, including what works well and what doesn’t. We have deep experience with quality management, – including the medical device industry. When you work with Intellect, you’re not just buying software, – you’re getting a partner who understands your needs and will be with you along every step of your journey.
To learn more about Intellect QMS and ISO 13485 compliance, contact our team today.

Romeo Elias

Written by Romeo Elias

Romeo Elias is the President and Chief Executive Officer (CEO) of Intellect, an award winning leader in the SaaS enterprise software industry with a focus on enterprise Quality Management Software and Business Process Management (BPM). Romeo is a visionary executive, thought leader and advocate for business friendly software that requires No Programming and empowers everyone to innovate. Romeo has overseen Intellect's growth from its founding in 2000 to a high growth software company with hundreds of happy customers. Romeo is a patented inventor, entrepreneur advisor, and board member of Intellect. Prior to Intellect, Romeo worked in the consumer electronics space, overseeing the engineering design and development of handheld electronics, and previously was the founder of a web development firm. He received his BS in Mechanical Engineering from the University of California, San Diego and MS in Manufacturing Engineering from UCLA.