ISO 13485 45001 17025 Medical Devices Quality Management Systems
Some medical devices need higher-tech than a personal remote heart failure sensor. Some medical devices are as easy and simple as a tongue depressor. Every medical device has one thing in commun that they are all made and designed to meet the requirements of ISO 13485. The ISO 13485 international norm is the most commonly used method for evaluating the effectiveness an medical device manufacturer's quality assurance system (QMS).ISO 13485 Overview
This article provides answers to frequently asked questions concerning ISO 13485 manufacturing as well as the requirements of the FDA applicable to QMS usage by medical device companies. See this iso 13485 for more answers.
What exactly is ISO 13485, and how can it be of help to you?
ISO 13485 regulates medical device QMS systems around the world. It is focused on maintaining QMS effectiveness in ensuring that it meets regulatory and customer requirements and guaranteeing QMS compliance. ISO 13485 is an international standard that harmonises the requirements of QMS across countries.
ISO 13485 provides guidelines for QMS that are designed toward the safe manufacturing, production and distribution of medical devices. It is not only a requirement in ISO 13485, but also since it allows manufacturers of devices to reduce variation. This has economic benefits, such as lower waste and higher process efficiency.
Which Regions Is ISO 13485 Valid?
All European Union countries, Canada Japan Australia, Australia and numerous others are required to adhere to ISO 13485. This standard is applicable to all 165 member countries of the International Organization for Standardization. (1) Check iso 45001 for more.
What is the difference between ISO 13485 and ISO 9001? ISO 13485 differ from ISO 9001
ISO 13485 can be used as a stand-alone document, but was based on ISO 9001, which is the most widely recognized quality management system in the world. Both are part of the QMS family, but ISO 9001 has a more general set of requirements that requires a greater focus on the satisfaction of customers and constant improvement. These are crucial issues for all manufacturers, but they pose particular challenges to medical device makers since they are subjective and difficult to measure.
ISO 13485 is not about the requirement that medical device manufacturers comply with the ISO 9001 requirements. It is about setting up measures that will better gauge the performance of quality. They include measures that relate to satisfying customer demands and maintaining the efficiency of the QMS. See General requirements for the competence of testing and calibration laboratories for info.
Two other important differences distinguish ISO 13485 from ISO 9001:
It puts more emphasis on managing risk.
It outlines additional requirements for documented procedures.
Although device makers are able to obtain certifications to both standard but they might not be able do so because of the different interpretations of the intent of the two standards. In addition, the format of both standards have been changed in the time since ISO 9001 was restructured. If compliance with both standards is necessary, the company must plan strategies to meet every set of requirements.