Common questions:
Can Emergo issue our ISO 13485 certificate?
No - only accredited Notified Bodies/Registrars are authorized to audit and certify your company to the ISO 13485 standard.
How long does it take to achieve ISO 13485 certification if we have no system in place?
Implementation usually takes 4-6 months for companies with fewer than 50 employees. Larger firms with more than 50 employees and/or multiple locations require more written procedures and involve more people, so implementation usually takes 6-12 months. Complex manufacturing processes (example: sterilization) can also prolong the implementation process.
The timeframe for certification is also dependent upon the availability of Notified Body/Registrar auditors to audit and certify your company – in some markets it may take at least between 6-9 months to schedule an on-site audit so it is critical that these organizations be engaged as early as possible to verify their availability.
When will ISO 13485:2016 be mandatory?
March 1, 2019 is the end of the transition period for updating certificates to the new version. Manufacturers seeking ISO 13485 certification for the first time should implement systems and procedures that comply with new version requirements. Learn more about ISO 13485:2016.