Some medical devices can be as complex as a remote-controlled, customized heart rate monitor. Other devices, on contrary, could be as easy as an oral depressor. However, all medical devices share one thing in their commonality: they gain tremendously in the process of being created and produced in alignment with ISO 13485. The ISO 13485 international norm is the most commonly used method for evaluating the effectiveness an medical device manufacturer's quality assurance system (QMS).
ISO 13485 Overview
The aim of this article is to provide answers to frequently asked questions about ISO 13485 manufacturing and the applicable regulatory requirements to companies that manufacture medical devices using QMS. See this iso 13485 pdf for more answers.
What is ISO 13485?
ISO 13485 refers to the most popular medical device QMS regulation standard. It is focused on maintaining QMS effectiveness and satisfying the requirements of customers and regulatory agencies. ISO 13485 is designed to be a worldwide standardised model of international QMS requirements as various countries have their own standards.
ISO 13485 outlines the guidelines for quality management. They are intended to ensure that medical devices can be safely designed, manufactured and distributed. A QMS that meets the requirements of ISO 13485 is a regulatory necessity. But, it also makes business sense because it can help manufacturers reduce variations. This results in financial benefits for the device manufacturers by reducing scrap and overall process efficiencies.
Which Regions Are ISO 13485 Valid?
All European Union countries, Canada Japan Australia, Australia and many others must adhere to ISO 13485. All members of the International Organization for Standardization are required to comply with this standard. (1) Check iso 45001 for more.
How is ISO 13485 Different From ISO 9001?
ISO 13485 is a standalone document. However, it is based and is directly related ISO 9001 which is the most widely used quality management system standard. ISO 9001, although both fall within the QMS family of standards is an identical set of standards. This demands a greater focus to customer satisfaction and continuous improvement. While these are important issues for all manufacturers, they pose unique challenges for medical device manufacturers since they tend to be subjective and are therefore difficult to measure.
ISO 13485 is not about making medical device manufacturers conform to ISO 9001 requirements. It is about establishing metrics that can better measure the quality of performance. These include metrics that help to satisfy the needs of customers and maintain the QMS's effectiveness. See ISO 17025 for info.
ISO 13485 is different from ISO 9001 in two important ways:
It focuses more on risk management.
It also provides additional requirements for documented processes.
Although device makers are able to obtain certificates for both standards but they might not be able to achieve this due to the differing requirements in the intended purpose of the two standards. While both standards are in sync and their formats were different, differences have emerged in the years since ISO 9001 was restructured. The company must develop strategies to comply with the two sets of requirements in case compliance is required.