ISO 13485 45001 17025 Medical Devices Quality Management Systems

Some medical devices need greater technology than a personal remote heart failure sensor. Some medical devices are as basic and simple like an oral depressor. But all medical devices have one thing they all have in their commonality: they gain tremendously by being developed and manufactured in accordance with ISO 13485. The ISO 13485 international standards is the best method of determining the effectiveness of medical device manufacturers' quality management systems (QMS)
ISO 13485 Overview
This article addresses the most frequently asked questions regarding ISO 13485 manufacturing. It also addresses regulations that concern the use of QMS by medical device companies. See this iso 13485 pdf for more answers.

What exactly is ISO 13485?
ISO 13485 refers to the most popular QMS for medical devices regulation standard. It is focused on ensuring QMS effectiveness and satisfying the requirements of customers and regulatory agencies. ISO 13485 is designed to be a worldwide standardised model of international QMS requirements, as diverse countries have different standards.

The guidelines for ensuring effective quality control processes that are outlined in ISO 13485 are all geared toward the safe manufacturing, design and distribution of efficient medical devices. A QMS that meets the requirements of ISO 13485 is a legal obligation. It also assists device manufacturers reduce variation. This could result in economic advantages such as less waste and improved efficiency of the process.

Where is ISO 13485 Applied?
All European Union countries, Canada Japan Australia, Australia and many others must adhere to ISO 13485. This standard is applicable to all 165 member nations of the International Organization for Standardization. (1) Check iso 45001 for more.

What is it that makes ISO 13485 different than ISO 9001
ISO 13485 can be used as a separate document, however it was developed based on ISO 9001, which is the most well-known quality management standard in the world. Both documents are part of the QMS standard family, ISO 9001 has a list of general requirements that requires an increased focus on customer satisfaction and continual improvement. While these are important issues for every manufacturer, they present unique challenges for medical device manufacturers because they are typically too subjective and therefore difficult to gauge.

ISO 13485 does not require medical device companies meet the strict requirements of ISO 9001. Instead, it's designed to assist companies achieve metrics that help gauge their quality performance. These metrics are related to satisfaction of customers' needs as well as the efficiency and effectiveness of the QMS. See ISO 17025 for info.

ISO 13485 differs from ISO 9001 in two important ways:
It places more importance on managing risk.
It contains additional specifications that must be met to be documented procedures.
Manufacturers of devices can be certified according to both standards, but they are not required to do so based upon the intent of the standards. Although both standards were at peace, differences in their formats have developed after ISO 9001 was restructured. The company must develop strategies to meet both sets of requirements if conformance is required.