Need Quality Management System (QMS) certification to meet new customer requirements?
Do you
need EU CE marking?
What is ISO 13485:2016?
ISO 13485 is the quality management system standard for medical devices.
This standard applies the ISO 9001:2015 process approach to quality, and replaces ISO 13485:2003 and ISO
13488:1996.
ISO 13485:2016 provides an effective base model for compliance with the EU CE marking Medical Devices Directives
(Annex II, V, VI) and Health Canada CMDCAS* (class II, III & IV devices) requirements. ISO 13485:2016 is also
considered to be fully compatible with the FDA QSR.
Note:
National/regional regulations
may allow design of devices to be excluded from the assessment activity of lower risk devices.
ISO SYSTEMS provides proven, proprietary implementation and training support to assure that your
organization meets applicable ISO 13485 requirements promptly and effectively. A certified ISO 13485 Quality
Management System will
ISO SYSTEMS ISO 13485 QMS Implementation Support is loaded with advantages for your organization.
We offer choices... you decide just how much support you need.
We take the time necessary to custom fit all applicable ISO 13485 requirements to your organization. No
"consultant" is as willing and able as ISO SYSTEMS to take the time to build a QMS to both reduce your
costs and "pass the audit," guaranteed!
At ISO SYSTEMS, we always offer No-Nonsense Pricing, all
expenses included. "Consultants" normally charge more than we do, and provide less than we do. ISO
Systems is a smaller business... dollar-for-dollar, we provide more support! We welcome comparison! ISO
Systems proven, proprietary implementation and training methods assure your organization meets all ISO
13485 requirements in minimal time and at lowest cost.
Your organization is very busy... everyone wears more than one hat. Time to implement a quality management
system is often limited. We take less time to get you certified. Quality system implementation is a "team
sport..." however, if your organization does not have the time, we can deliver a turn-key system, guaranteed to
get you certified.
Our methods never include one-size-fits-all, "cookie-cutter"
approaches. ISO 13485 quality systems requires process approaches, customer focus, and continual improvement.
You cannot get that from a cookie cutter. Most importantly, our quality management systems improve your bottom
line. "Cookie cutter" approaches do not work, and only add cost.
When we leave, the quality management
system is yours, not ours. We provide all the knowledge and experience your organization needs to effectively
manage and improve your certified QMS in the future. When we are finished, your organization owns your ISO 13485
quality management system.
ISO SYSTEMS is our association of experienced, creative, enthusiastic quality
professionals committed to building and improving quality systems while permanently reducing quality costs.
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