ISO 13485 is
an internationally recognized quality management system for the design and
manufacture of medical devices. It is based on the ISO 9001 standard, but with
additional requirements specific to the medical device industry. There are a
number of steps involved in get ISO 13485 certification.
Understand
the requirements
The first
step to getting an ISO 13485 certificate is to understand the requirements of
the standard. You can purchase a copy of the standard from the ISO website or
from a number of other sources. Once you have a copy of the standard, take some
time to read through it and identify the requirements that are applicable to
your organization.
Implement
the quality management system
The next
step is to implement a quality management system that meets the requirements of
the ISO 13485 standard. This will involve developing policies and procedures,
and putting in place the necessary infrastructure to support the quality
management system.
Choose a
certification body
Once you
have implemented the quality management system, the next step is to choose a
certification body. There are a number of certification bodies that offer ISO 13485 Certification. When choosing a certification body, it is important to
make sure that they are accredited by a recognized accreditation body.
Submit an
application
Once you
have chosen a certification body, you will need to submit an application. The
application will include information about your organization and your quality
management system.
Get
Audited
After your
application has been reviewed, you will be scheduled for an audit. The audit
will be conducted by a team of auditors from the certification body. The
purpose of the audit is to verify that your quality management system meets the
requirements of the ISO 13485 standard.
Receive
certification
If the
assessors determine that your organization meets the requirements of ISO 13485,
you will be issued a certificate. The certificate is typically valid for three
years and can be renewed by undergoing another on-site assessment.
ISO 13485
Certification Cost
ISO 13485
certification cost can vary depending on a number of factors, such as the size
and complexity of your organization, the number of sites that need to be
certified, and the certification body that you choose. Generally speaking, ISO
13485 certification costs range from a few thousand dollars to tens of
thousands of dollars.
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