Some medical devices can be as complicated as remote, custom-designed heart sensor for failure. Others are as basic as a tongue protector. Every medical device has one thing: They are greatly benefited from being made and designed to conform to ISO 13485. The ISO 13485 international standard is the most commonly used means of measuring the efficiency of a medical device's QMS. (QMS).
ISO 13485 Overview
The aim of this piece is to address frequently asked questions regarding ISO 13485 manufacturing and the related regulatory requirements that apply to medical device companies that use QMS. See this iso 13485 pdf for more answers.
What is ISO 13485 exactly?
ISO 13485 refers to the most popular QMS for medical devices regulation standard. It was created to ensure QMS effectiveness while meeting the needs of customers and regulators. ISO 13485, which is an international standard for QMS requirements on international markets, was designed to ensure that different standards are aligned across nations.
ISO 13485 outlines the guidelines for quality management. They are intended to help make sure that medical devices are safe to be manufactured, designed and distributed. A QMS that meets the requirements of ISO 13485 is a legal requirement. It also helps device makers reduce variations. This results in economic benefits, like less waste and higher process efficiency.
In Which Regions is ISO 13485 Applicable?
All members of the European Union, Canada, Japan and Australia are required to adhere to ISO 13485 for most medical devices. The standard is applicable 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 can be used as a separate document, however it was based on ISO 9001, which is the most widely recognized quality management standard in the world. ISO 9001, although both are part of the QMS family of standards is a set of common standards. This requires a greater attention to customer satisfaction and continual improvement. These are important for all manufacturers. However, they present specific challenges for medical device manufacturers since they are subjective and difficult to quantify.
ISO 13485 is not about the requirement that medical device manufacturers comply with the ISO 9001 requirements. It is focused on establishing standards that allow for better measurement of the performance of quality. These are metrics that relate to the requirements of customers and maintaining QMS efficiency. See ISO 17025 for info.
ISO 13485 differs significantly from ISO 9001 by two other reasons:
It focuses more on the management of risk.
It contains additional requirements for documentation.
Both standards are able to certify device manufacturers, although they are not required to. But, the purpose of both standards could permit manufacturers to obtain certifications. Moreover the formats of both standards have changed since ISO 9001 was restructured. If both standards are mandatory it is recommended that the business develop strategies for ensuring that they are in line to each set.