What is ISO 13485:2016 Certification?
ISO 13485:2016 is a new revision to the ISO 13485 standard which specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Other key changes include:
- Risk based approach for QMS
- Risk based approach for outsourced processes
- Risk based approach to design controls
- Increases in expectations
- Compliances with all applicable ISO standards
- Increased structure for validation, verification and design transfer
- Corrective and preventive action
Benefits of ISO 13485:2016 certification implementation:
- Expanding customer base in the global market since many countries and customer require medical devices that are ISO certified.
- Meet regulatory requirments
- Reduce risk
- Provide a harmonized model for quality management system
How will Planet ISO help your Organization achieve AS 9100 Rev D Certification?
Planet ISO will visit your business and go through your entire quality management system and make improvements to ensure a successful ISO 13485:2016 Certification. From sales, purchasing, calibration and HR, we’ll look at all facets of your business with a hands on turn-key approach.
Our Turn-Key Implementation Approach:
Just as we help small businesses with continual improvement, Planet ISO is focused on continually improving as well. With many years in the industry we have the tools, resources and experience needed to help get your business certified in a matter of months. We are not trying to build a “Monument to Quality”. Our job is to get you certified with as little resources required on end of your organization and without hindering the performance of the existing processes established throughout your organization.