The certification of a quality management system, specifically for medical devices, to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global 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 SÜD automatically demonstrates compliance with specific clauses in the regulations.
Benefits of ISO 13485:
- Formal certification, specifically for medical devices to ISO 13485: 2003 helps market products and services.
- Operating costs drop as rework is reduced and efficiencies increase.
Your advantages: |
- We provide objective recommendations for ongoing continuous improvement.
- We focus on the effectiveness of the system and its practicality in the local environment.
- We are a highly professional, independent, impartial and unbiased certification body.
- We have a qualified and experienced pool of auditors around the ASEAN region.
- The TÜV SÜD PSB certificate is recognized and accepted internationally.
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"The management understands the importance of impartiality in our certification of management systems. We will use all reasonable efforts to manage all possible conflicts of interest and ensure objectivity of our certification services".