Medical device manufacturers must regularly conduct an audit of their ISO 13485 compliant quality management system. We can audit independent quality system reviews for companies that are already ISO 13485 certified. We can also help companies who are about to have their initial ISO 13485 certification audit by a Notified Body or certification body.
These ISO 13485 audits help determine the actual status of your current quality management system and processes:
We can do an off-site review of your current QA/RA documentation prior to your on-site ISO 13485 audit.
You can also contract us to conduct targeted ISO 13485 process audits in which we focus on specific areas where noncompliance issues have occurred, or on areas your internal auditors cannot audit due to conflicts of interest.
We can also implement ISO 9001 Quality Management Systems. Please contact us for more information on our ISO 13485 and ISO 9001 auditing service.