What is ISO 13485?
ISO 13485 is the world's most prominent international standard for quality in the medical sector. ISO stands for the International Organization for Standardization, a union born in London in 1946 and now resides in Geneva. It is an independent and non-governmental agency consisting of 167 member bodies worldwide.
Through member consensus, ISO seeks solutions to global problems and industry innovation. ISO 13485 comprises a set of regulatory requirements for quality management systems (QMS) for any entity involved with medical devices and services.
What does ISO 13485 entail?
Such an entity needs to display its ability to "provide medical devices and related services that consistently meet customer and applicable regulatory requirements." According to ISO. This includes all producers regardless of size or type. It encompasses any organization involved in any part of an item's life cycle, from design and development to production. These QMS considerations extend to storage, distribution, installation, servicing, or associated activities, such as tech support.
The most recent version is ISO 13845:2016, integrated in March 2016. It oversees management and training responsibilities, includes improvements in facility requirements, and focuses on risk. It also places an onus on traceability, control of suppliers, product cleanliness, and complaint handling. In addition, the required documentation and data analysis can help all fabricators become more efficient while improving quality.
The undeniable importance of QMS
Such stringency is necessary when involving the myriad medical tools and devices that decide life or death. Virtually all of these items, or the components that power and protect them, are products of machining processes. For example, complex diagnostic machines like MRI and CT scanners are filled with machined electronics and enrobed with machined exterior parts. So are the screens and monitors in offices. All the tiny screws, fasteners, and other structural components are also machined. As are implantable devices and tools that must be fully biocompatible and fail-proof.
When these things work flawlessly, and save lives, it's thanks to the diligence of overseeing bodies and the dedication of engineers like ours. And to find out how we can best serve you in the medical industry, contact us or get a free quote today!