Quality and safety should never be left up to chance, especially when it comes to medical devices. To help manufacturers and suppliers ensure compliance at scale, the International Organization for Standardization (ISO) published a set of quality management requirements in 1996, with the latest revision published in 2016.
While ISO 13485 certification is not mandatory for organizations that manufacture medical devices, it demonstrates to customers, vendors, and other stakeholders that quality is a top priority for the manufacturer. At Alltrista, we use ISO 14644 certified class 7 and class 8 cleanrooms to create medical and consumer products using methodologies that meet ISO standards and maintain strict ISO 13485 and cGMP standards across our facilities.
What is ISO 13485?
Instead of letting every country decide its own regulatory requirements, the ISO decided to publish one unified system of quality management requirements for the creation of medical devices. These requirements, called ISO 13485, ensure that any company involved in the design, manufacturing, installation, or servicing of medical devices meets consumer and regulatory safety and quality requirements.
To keep up with new changes in technology, these requirements are reviewed every five years and updated when applicable. Since its publication in 1996, ISO 13485 has been updated twice to reflect new changes in technology. Currently, the 2016 version is in use.
What Qualifies as a Medical Device Under ISO13485?
Per the ISO, a medical device is “a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.”
Why Does ISO 13485 Certification Matter?
People across the world have come to see ISO certification as a mark of trust. By adhering to ISO 13485 standards, you and your certified suppliers are letting the world know that your medical products are safe and effective.
Other benefits include:
Faster market access - By working with a manufacturer that meets ISO 13485’s standardized regulatory requirements, your company can enter the global market faster.
Better risk management – ISO 13485 outlines clear, systematic ways to recognize and address any risks around your medical devices throughout their entire lifecycle. This may minimize your risk of product recalls or lawsuits.
Organizational credibility - Customers may refuse to buy products if they are not ISO certified. By demonstrating ISO compliance, your customers know they can expect quality.
Efficiency - Following these requirements actually streamlines many design and manufacturing processes, reducing unnecessary waste and operating costs, while improving productivity.
Continuous improvement - Adherence to ISO guidelines creates a culture of continuous testing and improvement, so your business can achieve consistent quality improvements.
How Cleanroom Manufacturing Ensures ISO Compliance
Medical devices are often manufactured in controlled environments to help reduce the risk of contamination. At Alltrista, we operate class 7 and 8 cleanrooms that allow us to deliver plastic molding solutions of the highest quality and efficacy. Our cleanrooms use a combination of air filtration, humidity and temperature control, and disinfection to create a sterile environment. Personnel are also required to wear appropriate gowning and adhere to controlled entry and exit procedures to help minimize the risk of cross-contamination.
Quality Medical Device Manufacturing You Can Trust
Safe medical devices save lives, improve patient outcomes, and make daily life easier for millions of people every day. Your customers deserve to feel total confidence in the products they use, and the right manufacturing partner can ensure that confidence is earned.
Quality, innovation, and collaboration are at the heart of everything we do at Alltrista. As your trusted advisor, we help transform your problems into personalized, scalable solutions using advanced cleanroom technology. No matter your vision, our expert design team can turn it into a working reality. Contact us today to learn more about our ISO 13485-certified quality management system and how it can support your next medical manufacturing project.
