Significance
ISO 13485 is the most accepted standard worldwide
for manufacturers of medical devices. It supports the
reduction of unexpected risks with regard to companies
that construct, produce and service medical
devices, or to organizations which use related products
or services. Besides the specific requirements,
ISO 13485 also contains definition of the important
terms such as “active medical devices” or “active
implantable medical devices”. The organization’s
reputation can be extensively increased in public by
a certification to this standard.
Benefits
- Evidence of adherence to legal and regulatory
or contractual requirements
- Minimize and manage risks
- Improved quality performance
- Error prevention instead of error correction
- Improved employee motivation
- Increased customer satisfaction
- Emphasize company competence
- Transparency and clarity of internal processes
- Time and cost savings
- Realization of quality policy and company goals
ISO 13485 under CMDCAS – for whom?
From the middle of 2003, ISO 13485 is an independent standard that can be used
without consideration of ISO 9001. The international standard is addressed to manufacturers
of medical devices and corresponding service providers who have to provide
evidence of fulfillment of national and international legal and regulatory requirements.
With a CMDCAS certificate recognized by the Canadian authorities, organizations manufacturing
medical devices of the risk classes II, III and IV according to the Canadian
MDR (Medical Devices Regulations) can receive the approval for the Canadian market.
Beside the typical medical device manufacturers, this also applies to manufacturers of
electrical toothbrushes.
DQS GmbH is one the few certification bodies worldwide, who the permission to issue
certificates to ISO 13485 according to the requirements of the Canadian Medical
Devices Conformity Assessment System. Since October 2003, DQS is accredited and
listed by the Canadian approving authority Health Canada as a CMDCAS recognized
registrar.
The successful certification to ISO 13485 helps organizations to demonstrate their
competitive and performance ability on the national and international markets. The
standard is also addressed to suppliers and other service providers within the valueadded
chain having to ensure compliance to their customers’ requirements.
ISO 13485 under CMDCAS - Product Information in PDF format
