Certain medical devices are more intricate than others, such as remote-controlled heart failure sensor. Some medical devices are as basic and simple like an oral depressor. All medical devices have one common feature they all benefit from being manufactured and designed to conform with ISO 13485. ISO 13485 is the ISO 13485 international standard, that is widely used to assess the effectiveness and efficacy of a medical device maker's quality management system (QMS) is the most commonly utilized.
ISO 13485 Overview
This article will answer frequently asked questions related to ISO 13485 manufacturing. See this iso 13485 for more answers.
What is ISO 13485 and what does it mean?
ISO 13485 refers to the most popular QMS for medical devices regulation standard. It's designed to ensure QMS effectiveness while also meeting the customer and regulatory needs. Since various countries typically have various requirements, ISO 13485 is intended to create a global model of QMS requirements for international markets.
ISO 13485 outlines guidelines for maintaining quality management processes that ensure the safe design and manufacture of medical devices. A QMS that is ISO 13485 compliant is a requirement. This assists device manufacturers reduce variation. This could lead to financial benefits like reduced scrap and increased process efficiency.
Where is ISO 13485 Applied?
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 members of the International Organization for Standardization. (1) Check iso 45001 for more.
How can ISO 13485 different to ISO 9001
ISO 13485, although it is a distinct document, is based on and directly related to ISO 9001. This is the most awaited quality management standard. Both documents are part of the QMS guidelines. But, ISO 9001 is a set general requirements that require more attention to continuous improvement and satisfaction of customers. These issues are essential for all manufacturers. However, they present particular challenges for manufacturers of medical devices since they are subjective and hard to measure.
ISO 13485 does not require medical device companies meet the subjective aspects of ISO 9001. Instead, it's purpose is to assist companies achieve metrics that help gauge their quality performance. These metrics are related to the satisfaction of customer demands as well as ensuring the effectiveness and efficacy of the QMS. See General requirements for the competence of testing and calibration laboratories for info.
ISO 13485 differs from ISO 9001 in two additional significant ways:
It is more important to focus 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 however, they aren't required to. But, the purpose of both standards could allow them to opt to obtain certifications. Furthermore that, even though both standards have been restructured in 2015, they follow different formats. The company needs to devise strategies to ensure compliance to both standards.