We can assist your warehouse from its current state to a compliant process. With our warehouse processes and documentation, you will be ready to audit against ISO:13485 in record time.
Our services include:
- quality management software
- process improvement (if requested)
- process documentation
- warehouse staff training; and
- web based quality manual for your warehouse
- internal audit; and
- assistance with the final certification process.
Objective of ISO 13485:2016
ISO 13485:2016 specifies requirements for a quality management system where a business needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
ISO 13485 ensures a better understanding of:
- involvement of top management
- risk management
- warehouse processes
- clear definition of responsibilities and authorities in the warehouse
- application of the requirements of quality
- improving internal and external communication
- creating the framework for adherance to standards; and
- creating the framework for internal audits and record keeping.
Are your warehouse medical device processes compliant?
Do you need a proven system to achive ISO:13485?