Some medical devices are as complicated as a remote, personalized heart failure sensor. Some are as simple as a tongue defender. All medical devices have one thing in commun they all benefit from being manufactured and designed in accordance with ISO 13485. ISO 13485 is 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
The aim of this piece is to provide answers to frequently asked questions about ISO 13485 manufacturing and the regulations that relate to medical device companies that use QMS. See this iso 13485 for more answers.
What is ISO 13485 and what does it mean?
ISO 13485, the most widely used medical device QMS regulations in the world is ISO 13485. It is focused on maintaining QMS effectiveness while also meeting regulatory and customer requirements. Since various countries typically have various standards, ISO 13485 is intended to offer a universally harmonised model of QMS requirements 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 meets the requirements of ISO 13485 is a legal necessity. It also assists device makers reduce variations. This has economic benefits, such as lower waste and higher process efficiency.
Which regions are ISO 13485 Valid?
For most medical devices, compliance to ISO 13485 is required by all European Union members, Canada, Japan, Australia and numerous other countries. The standard is applicable to all the 165 member countries in the International Organization for Standardization. (1) Check Occupational health and safety management systems - Requirements with guidance for use for more.
What is ISO 13485 different to ISO 9001
ISO 13485 is a standalone document. However, it was based and is directly related ISO 9001 which is the most widely used quality management system standard. Both documents fall under QMS standards. However, ISO 9001 is a set general requirements that require more attention to continuous improvement and customer satisfaction. These issues are crucial for all manufacturers. However medical device manufacturers face specific challenges as they are subjective and thus difficult to gauge.
ISO 13485 focuses more on the use of metrics to assess quality performance, rather than making medical device manufacturers comply with the ISO 9001 requirements. These include metrics that measure satisfaction of customers and ensure the effectiveness of the QMS. See General requirements for the competence of testing and calibration laboratories for info.
ISO 13485 differs greatly from ISO 9001 in 2 other ways.
It focuses more on risk management.
There are additional conditions that must be fulfilled in order to document procedures.
Although device makers are able to obtain certifications to both standard however, they may not be able do so due to the differing requirements in the intended purpose of the two standards. Moreover the format of both standards have been changed after ISO 9001 was restructured. If both standards are needed, the company should plan strategies for ensuring that they are in line with both sets of standards.