ISO 13485 45001 17025 Medical Devices Quality Management Systems

Some medical devices may be as complex as a personalized remote-controlled heart rate sensor. Other devices, on contrary, could be as easy like an oral depressor. All medical devices greatly benefit from conforming to ISO 13485. ISO 13485 is 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 the most frequently asked questions regarding ISO 13485 manufacturing, and the regulations that regulate QMS usage by medical device manufacturers. See this Medical devices - Quality management systems - Requirements for regulatory purposes for more answers.

What is ISO 13485, and how can it benefit you?
ISO 13485 regulates medical device QMS systems across the globe. It is focused on maintaining QMS effectiveness as well as providing for the needs of both customers and regulators. ISO 13485, which is an international standard that governs QMS requirements in international markets, was created to ensure that different standards are aligned across countries.

ISO 13485 outlines guidelines to ensure the safety of manufacturing, production, and distribution of efficient medical devices. In addition to being a regulatory requirement and ISO 13485-compliant QMS is a good business decision since it assists device makers in reducing variation. This results in financial advantages for device makers through lower waste and greater process efficiency.

What Regions is ISO 13485 applicable?
All European Union members, Canada Japan, Australia, and other countries are required to adhere to ISO 13485 when manufacturing most medical devices. The standard is applicable to all 165 member nations of the International Organization for Standardization (ISO). (1) Check Occupational health and safety management systems - Requirements with guidance for use for more.

What makes ISO 13485 Different From ISO 9001?
ISO 13485 stands alone, but it has a direct link to ISO 9001. ISO 9001, although both are part of the QMS group of standards, is a set of common standards. This calls for a more intense focus to customer satisfaction and continual improvement. These aspects are vital for every manufacturer. However medical device makers have specific challenges as they are subjective and therefore difficult to gauge.

ISO 13485 focuses more on the use of metrics to assess the quality of performance, instead of making medical device manufacturers adhere to the ISO 9001 requirements. These are metrics that relate to customer requirements and maintaining QMS effectiveness. See ISO 17025 for info.

ISO 13485 differs significantly from ISO 9001 by two other aspects:
It emphasizes the importance of managing risk.
This document details additional requirements to be documented.
Device manufacturers may be granted certifications to both standards, they could opt not to do so due to different intentions. Additionally, while both standards were more harmonized, variations in their format have been observed since ISO 9001 was restructured in the year 2015. The company must develop strategies to comply with both sets of requirements , if compliance is required.