ISO 13485:2016
ISO 13485:2016, Medical devices – Quality management systems — Requirements for regulatory purposes
What’s ISO 13485:2016?
It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.
In addition, the standard can be used by supply chain organizations that are required by contract to confirm. ISO 13485 helps an organization design a quality management system that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market.
Why is ISO 13485:2016 important for your organization?
These days, medical device manufacturers often insist that their suppliers and service providers are certified to ISO 13485 as a pre-requisite for doing business. ISO 13485 certification is, therefore, an increasingly important differentiator for organizations looking to improve their marketability.
Whilst the primary objective of ISO 13485 certification is to facilitate harmonized QMS requirements for regulatory purposes within the medical device sector, companies also value ISO 13485 certification for the increased confidence that it gives patients and other stakeholders through its implicit promise of quality, consistency, and continual improvement.
How can we help you in regards to ISO 13485?
Whether you are looking to get certified against a globally recognized medical device QMS, or if it is towards compliance with the Medical Device Directive (MDD) 93/42/EEC or In Vitro Diagnostic Device Directive (IVDD) 98/79/EC, we provide a range of services including:
- gap analysis
- preliminary assessment
- assessment
- certification to the latest version
Standards
ISO 9001:2015
ISO 14001:2015
ISO 45001:2018
ISO 16949:2009
ISO 22000:2018
ISO 22301:2012
HACCP
ISO 27001:2018
ISO 28000:2007
ISO 29001:2010
ISO 50001:2011
ISO 55001:2014
ISO 20000-1:2011
SA 8000:2014
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