Certain medical devices require more advanced technology than a remote, personal heart failure sensor. Other devices, on the other hand, can be as simple like an oral depressor. Every medical device has one feature: They benefit from being produced and designed in accordance with ISO 13485. The ISO 13485 international norm is the most commonly used method for measuring the effectiveness of the quality assurance system (QMS).
ISO 13485 Overview
This article will answer many common questions concerning ISO 13485 manufacturing, and the regulations that apply to QMS use by medical device manufacturers. See this iso 13485 for more answers.
What is ISO 13485?
ISO 13485 is the most widely used medical device QMS regulatory standard around the globe. It's designed to ensure QMS effectiveness while meeting demands of regulatory and consumer requirements. ISO 13485 is an international standard that harmonises QMS requirements across different countries.
ISO 13485 outlines guidelines for keeping quality management processes in place to assure the safe production and design of medical devices. It is not only required under ISO 13485, but also since it allows manufacturers of devices to minimize variation. This could result in economic benefits like reduced waste and improved efficiency of the process.
What Regions is ISO 13485 applicable?
All European Union member countries, Canada and Japan along with Australia are required to adhere to ISO 13485 in order to utilize the majority of medical devices. All members of the International Organization for Standardization are subject to this standard. (1) Check Occupational health and safety management systems - Requirements with guidance for use for more.
How does ISO 13485 differ from ISO 9001
ISO 13485, although it is a distinct document, is based on and directly linked to ISO 9001. This is the most awaited QMS standard. While both documents belong to the QMS standard family, ISO 9001 has a list of general requirements that requires an increased focus on customer satisfaction as well as continuous improvement. These issues are essential for every manufacturer. But they create specific challenges for manufacturers of medical devices since they are subjective and difficult to quantify.
ISO 13485 focuses on metrics which are more reliable in evaluating quality performance, rather than requiring medical devices companies to conform to the ISO 9001 requirements. These are metrics that relate to customer requirements and maintaining QMS efficiency. See ISO 17025 for info.
ISO 13485 differs significantly from ISO 9001 by two other aspects:
It puts more emphasis on the management of risk.
This document provides the additional requirements that must be documented.
Manufacturers of devices are certified to both standards, but they may not do so in accordance with the purpose of the standards. Despite the fact that both standards were once again in harmony however, different formats have emerged since ISO 9001 was restructured. The company needs to devise strategies to make sure that it is in line with both standards.