Certain medical devices are more complicated than others, for example, remote-controlled heart failure sensor. Others are as basic as a tongue defender. Every medical device has one thingin common: they are greatly benefited from being made and designed according to ISO 13485. ISO 13485 is the ISO 13485 international standard, which is widely utilized to determine the effectiveness and efficiency of a medical device maker's quality management system (QMS), is the most widely used.
ISO 13485 Overview
This article will answer the most frequently asked questions regarding ISO 13485 manufacturing. See this iso 13485 for more answers.
What exactly is ISO 13485 and what does it mean?
ISO 13485 is the most widely used medical device QMS regulatory standard worldwide. It was created to ensure QMS effectiveness and to meet the needs of customers and regulators. ISO 13485, which is the global standard that governs QMS requirements on international markets, was created to align different standards across different countries.
ISO 13485 provides guidelines for quality management , which are geared towards the secure manufacturing, production and distribution of medical devices. A QMS compliant with ISO 13485 is a regulatory obligation. However it also makes commercial sense because it can help manufacturers of devices to reduce variation. This can result in economic benefits for device manufacturers in terms of lower waste and greater process efficiency.
What regions is ISO 13485 applicable?
The countries that are members of the European Union, Canada, Japan and Australia are required to adhere to ISO 13485 for most medical devices. The standard applies to all 165 member countries 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 stand-alone document, but it is built on and is directly connected to ISO 9001, the world's top quality management standard for quality management. Both are both part of the QMS family, but ISO 9001 has a more general set of requirements that demands a greater emphasis on customer satisfaction and continuous improvement. While these are crucial issues for all manufacturers, they pose particular challenges for medical device manufacturers since they tend to be subjective and are therefore difficult to measure.
ISO 13485 focuses on metrics that are more precise in gauging quality performance instead of requiring medical device companies to conform to the ISO 9001 requirements. These include metrics related to the needs of the customer and maintaining QMS efficiency. See ISO 17025 for info.
ISO 13485 differs significantly from ISO 9001 by two other reasons:
It puts more emphasis on managing risk.
It also contains additional conditions for documentation.
Device manufacturers can be certified to both standards. However, they are not required to do so based upon the intent of the standards. Despite the fact that both standards were once again in harmony, differences in their formats have developed since ISO 9001 was restructured. An organization must develop strategies to ensure that they are in compliance with both standards.