ISO 13485 45001 17025 Medical Devices Quality Management Systems
Some medical devices are as complicated as a remote-controlled, customized heart failure sensor. Some medical devices are as basic and easy like an oral depressor. Every medical device has one thing in commun they are all made and designed to conform with ISO 13485. The internationally recognized ISO 13485 standard is widely utilized to assess the efficiency of a manufacturer's quality control system (QMS).ISO 13485 Overview
This article will answer the most frequently asked questions regarding ISO 13485 manufacturing, and the regulations that regulate QMS's use by medical device manufacturers. See this iso 13485 for more answers.
What exactly is ISO 13485, and how can it benefit you?
ISO 13485, the most commonly used QMS for medical devices regulations around the globe is ISO 13485. It's designed to ensure QMS effectiveness while also meeting the customer and regulatory needs. ISO 13485 is designed to be a global standard template for international QMS requirements, as diverse countries have different standards.
ISO 13485 outlines guidelines to ensure safe production, design and distribution of efficient medical devices. Alongside being a requirement of the regulatory system having a QMS that is ISO 13485 compliant is good for business because it assists device makers in reducing variation. This, in turn, provides economic benefits in the form of less scrap, and overall efficiency of the process.
Is ISO 13485 a valid standard in which areas?
All members of the European Union, Canada, Japan and Australia must follow ISO 13485 for most medical devices. The standard applies to all 165 members of the International Organization for Standardization (ISO). (1) Check Occupational health and safety management systems - Requirements with guidance for use for more.
What is ISO 13485 Different From ISO 9001?
ISO 13485 is a standalone document. However, it is closely related to ISO 9001 which is the most widely used quality management system standard. ISO 9001, although both are within the QMS family of standards , is a set of common requirements. This demands a greater attention to satisfaction of customers and constant improvement. These are important concerns for all manufacturers, but they pose unique challenges for medical device makers since they are subjective and hard to quantify.
ISO 13485 focuses more on measuring quality performance, rather than demanding medical device companies to comply with the ISO 9001 requirements. This includes metrics that evaluate customer satisfaction and maintain the effectiveness of the QMS. See ISO 17025 for info.
ISO 13485 differs significantly from ISO 9001 by two other factors:
It focuses on the management of risk.
It also lists the additional requirements to document procedures.
While device manufacturers can receive certificates to both standards, they could opt not to do so due to differences in their intent. Additionally, while both standards were more in line, changes in their formats have been seen in the past since ISO 9001 was restructured in 2015. If compliance with both standards is necessary, the company must plan strategies to meet every set of requirements.