Some medical devices require greater technology than a personal remote heart failure sensor. Others are as simple as a tongue depressor. However, all medical devices share one thing in common: they all benefit in the process of being created and produced to conform to ISO 13485. The ISO 13485 international standards is the best way to determine the efficacy of a medical devices manufacturer's QMS. (QMS)
ISO 13485 Overview
This article will address the most frequently asked questions regarding ISO 13485 manufacturing. See this iso 13485 pdf for more answers.
What is ISO 13485?
ISO 13485 is the most popular medical device QMS regulation standard worldwide. It is focused on ensuring QMS effectiveness while complying with the regulatory and consumer requirements. Since different countries often use different requirements, ISO 13485 is intended to provide a globally harmonized model of QMS requirements that can be used for international markets.
ISO 13485 outlines guidelines for managing quality processes to guarantee the safety of manufacturing and design of medical devices. A QMS that is in compliance with ISO 13485 is a legal requirement. It also helps device manufacturers reduce variation. This in turn provides economic benefits in the form of less scrap and general process efficiencies.
Is ISO 13485 a valid standard in which areas?
All European Union members, Canada Japan, Australia, and other countries are required to adhere to ISO 13485 when manufacturing most medical devices. The members of the International Organization for Standardization are subject to this standard. (1) Check iso 45001 for more.
What is ISO 13485 different from ISO 9001?
ISO 13485 stands alone, but it has a direct link to ISO 9001. Although both fall within the same QMS family of standards, ISO 9001 is a general set of requirements which require greater attention to constant improvement and customer satisfaction. These issues are vital for every manufacturer. They do present distinct issues for manufacturers of medical devices due to their subjective nature and are difficult to quantify.
ISO 13485 does not require medical device companies to adhere to the requirements of ISO 9001. Instead, it is designed to help them achieve metrics that better assess their performance on quality. These measures are linked to customer satisfaction needs as well as the effectiveness and efficacy of the QMS. See ISO 17025 for info.
Two other significant differences separate ISO 13485 from ISO 9001:
It focuses more on the management of risk.
It also contains additional conditions that must be fulfilled in order to document procedures.
Both standards can be used to verify the quality of devices, although they are not required to. However, the intent of both standards may permit them to receive certifications. In addition, the format of both standards have been changed in the time since ISO 9001 was restructured. The company needs to devise strategies to ensure compliance to both standards.