ISO 13485 / ISO 9001
Certification of Quality Management Systems
TÜV Product Service is a leading certification company and is the largest notified body covering the medical device sector (identification number 0123). We have certified over 2,000 management systems in the medical device area and can combine certification for the different requirements of many markets, including Europe, Canada, Taiwan and Japan, into one audit.
ISO 13485 and ISO 9001
Formal certification of your quality management system, specifically for medical devices to ISO 13485: 2003 will help you to market your products and services, and also to improve the efficiency of your organisation. Our experienced audit team has the goal of adding value to your business by identifying improvement opportunities in addition to risks from any non-conforming areas. ISO 13485 certification from TÜV Product Service is one of the most recognised and respected in the global medical device market.
ISO 13485: 2003 has been harmonised against the three Directives (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices) so certification to this standard by an accredited certification body such as TÜV Product Service automatically demonstrates compliance with specific clauses in the regulations.
ISO 9001 quality system standard
Whereas the ISO 13485 is a standard specific to medical device quality systems (with many additional requirements to ISO 9001), ISO 9001 is still widely recognised and respected in the market as a sign of a quality and customer focus. ISO 9001 certification can be an important marketing tool and TÜV Product Service can provide combined ISO9001 and ISO13485 certification in one audit.
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In addition to ISO 13485 and ISO 9001 certification, TÜV Product Service provides a full range of testing, certification and training solutions with specific medical and health experience in:
| Benefits of using TÜV Product Service for ISO 13485 certification |
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