What's the difference between ISO 13485 and ISO 9001?
Do you need to adhere to both or just one of them?
Electronic Quality Management Systems for ISO 13485
— Comparing ISO 13485:2016 to ISO 9001:2015 reveals the actions medical device manufacturers must take to ensure product quality.
— A customer-driven QMS is essential for creating a culture of quality and ongoing improvement throughout most industries.
First, ISO 13485 adds to ISO 9001 with requirements for effective management, documentation, and measurement in producing safe medical devices.
Fortunately, you only need to worry about ISO 13485:2016 if you're going to make and distribute medical devices.
CE marking which proves conformity with safety standards for products sold in the European Economic Area for medical device manufacturers must either obtain 1.) a certification with a notified body or 2.) have a quality system in place.
Simply put, ISO 13485 serves as a quality system for the medical device industry, and it effectively covers ISO 9001 with limited additional requirements.
Understanding the differences, illustrates how these two standards illustrate expected qualitative results.
Medical Devices under ISO 13485 and ISO 9001…
How They Differ…
The scope of these quality standards is the primary difference!
*ISO 9001: is the international standard that defines specifications in quality management systems in any organization regardless of
industry, product or service, or company size.
*ISO 13485: applies specifically to comprehensive management systems that manufacture medical devices with significant focus on regulatory compliance with less flexibility in the organizational process.
Both standards:
* emphasize quality of employee competency and infrastructure…
* use Deming cycles (Plan-Do-Check-Act)
* focus on quality products through assessing the customer…
* address risk mitigation and assessment…
* clarify the standard’s role(s) in achieving a quality management system…
***Note that there are requirements for creating:
1.) a robust quality management system (QMS),
2.) management responsibility,
3.) resource management,
4.) product realization…
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