What is ISO 13485?
ISO 13485 is a
quality management system standard that is specific to the medical device
industry. It helps manufacturers create products that are safe and effective
for patients. To receive ISO 13485 certification, a company must demonstrate
that it has a comprehensive quality management system in place. This system
includes processes for the design, development, production, installation, and
servicing of medical devices.
Importance
ISO 13485
certification is of utmost importance for medical
device companies. It helps to ensure that products are safe and reliable for
patients. By obtaining this certification, companies demonstrate their
commitment to quality and patient safety. The certification also helps
companies to meet regulatory requirements in different countries. It is a
globally recognized standard that can help companies to expand their business
into new markets. In addition, it can help companies to improve their
operations and achieve better performance.
Benefits
Which Organizations
Can Apply?
ISO 13485 is
designed for organizations that design, develop, manufacture, install, or
service medical devices. This includes medical device manufacturers, suppliers
of medical device components and accessories, and contract manufacturers. It
does not apply to companies that only distribute medical devices.
How to Get ISO
13485 Certified?
The first step is
to assess your organization's readiness for certification. This involves
completing an ISO 13485 Gap Analysis to identify any areas where your quality
management system needs improvement. Once you have addressed these gaps, you
can apply for certification.
The certification
process involves submitting a completed application and supporting
documentation to an accredited certification body. The body will then evaluate
your organization against the requirements of ISO 13485. If you meet these
requirements, the body will award you certification.
Conclusion
ISO 13485
certification is a globally recognized standard that helps medical device
companies to improve their operations and achieve better performance. It
confirms that your organization has the necessary resources and systems in
place to produce safe and effective medical devices. To receive the
certification, a company must demonstrate that it has a comprehensive quality
management system in place, and should meet all the necessary certification
requirements.
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