Certain medical devices are as complicated as a remoteand a customized heart failure sensor. Some are as simple as a tongue protector. But all medical devices have one feature in common: they all benefit in the process of being created and produced to conform to ISO 13485. ISO 13485 is the ISO 13485 international standards is the best way to determine the efficiency of a manufacturer's QMS. (QMS)
ISO 13485 Overview
This article will provide answers to the most frequently asked questions regarding ISO 13485 manufacturing, and the regulations that govern QMS's use by manufacturers of medical devices. See this iso 13485 for more answers.
What exactly is ISO 13485, and how can it benefit you?
ISO 13485 refers to the most popular medical device QMS regulation standard. It's a commitment to ensuring QMS effectiveness while also meeting the customer and regulatory needs. ISO 13485 is designed to be a globally standardised model for international requirements for QMS, since diverse countries have different standards.
ISO 13485 outlines guidelines for maintaining quality management processes that ensure the safe design and manufacture of medical devices. In addition to being a legal requirement, an ISO 13485-compliant QMS makes good business sense because it helps device manufacturers minimize variations. This in turn provides financial benefits in the form of less scrap and general process efficiencies.
Is ISO 13485 a valid standard in which regions?
All European Union member countries, Canada and Japan and Australia are required to adhere to ISO 13485 in order to use the majority of medical devices. All 165 members of the International Organization for Standardization are subject to this standard. (1) Check iso 45001 for more.
How does ISO 13485 differ from ISO 9001
ISO 13485, although it is a distinct document, was based upon and directly related to ISO 9001. This is the most awaited quality management standard. Both documents fall under the QMS standards. But, ISO 9001 is a set general requirements that require more attention to continuous improvement and satisfaction of customers. These issues are crucial for every manufacturer. However medical device makers have specific challenges as they are subjective and thus difficult to gauge.
ISO 13485 focuses more on providing metrics to measure quality performance, rather than requiring medical device firms to follow the ISO 9001 requirements. These include metrics that measure satisfaction of customers and ensure the quality of the QMS. See General requirements for the competence of testing and calibration laboratories for info.
ISO 13485 differs significantly from ISO 9001 by two other factors:
It focuses on the management of risk.
This document details additional requirements to be documented.
Manufacturers of devices can get certifications to both standards, however they may decide not to based on the intent of both standards. Furthermore, while the two standards are now more compatible, there have been some differences in their formats since ISO 9001 was restructured back in 2015. The company needs to develop strategies to comply with both sets of requirements , if compliance is required.