13485:2003 Quality Management System Requirements
13485 is a medical device quality systems standard that supplements
ISO 9001. The additional requirements relate to design controls,
process controls (including environmental controls), special
processes, traceability, record retention, and regulatory actions,
which are more critical for the medical device industry.
ISO 13485 is not a product standard, but a process standard. A
quality system that complies with the ISO 13485 standard is
insufficient; you must also comply with all relevant product and
service oriented technical standards and regulations.
Alpha Quality Assurance can help you set
up, monitor and conform to an ISO 13485 quality system.
What is the difference between ISO 13485 and ISO 13488?
ISO 9001, ISO 13485 and EN 46001 are applicable to manufacturers
and service providers that perform their own design activities. ISO
9002, ISO 13488 and EN 46002 are for manufacturers and service
providers without design activities.
Who can be certified to ISO 13485:2003?
- Companies who currently
manufacture private label medical devices, but want to
eventually place these devices under their name on the market in
the European Union
- Consultants that design, manufacture, and assemble medical and
in vitro diagnostic medical devices.
of in vitro diagnostic medical devices that want to distinguish themselves, and prepare for future
IVD regulatory obligations to enter the EU.