Quality Management - Medical Devices ISO 13485:2016
ISO 13485 certification, an international standard that defines quality management system (QMS) requirements for manufacturers of medical devices. The primary objective of the standard is to facilitate harmonised QMS requirements for regulatory purposes within the medical device sector.
It is applicable to manufacturers of medical devices and to those organisations that support medical device manufacturers. Manufacturers have a duty to ensure that devices consistently meet customer requirements and meet all applicable regulatory requirements.
However, it includes particular requirements for medical devices and excludes some of the requirements for ISO 9001. In particular, the requirements for customer satisfaction and continual improvement have been modified to make them more appropriate for regulatory purposes.
Demonstrate that you produce safer and more effective medical devices
Meet regulatory requirements and customer expectations
Outline how to review and improve processes across your organisation
Increase efficiency, cut costs and monitor supply chain performance
Increased access to more markets worldwide with certification
Acceptance of Proposal and Contract Signature
Gap Analysis (Optional): Pre-assessment of your system to evaluate the current state against requirements of the standard.
Audit Stage 1: Initial Visit to verify the establishment and implementation of the Management System; 4- Audit Stage 2: Certification audit (certificate issued after successful certification audit)
Decision making Stage and Certification Issuance
1st Surveillance Audits (After 1 year of registration) to evaluate the maintenance and the Continual Improvement of Management System
2nd Surveillance Audits (After 2 year of registration) to evaluate the maintenance and the Continual Improvement of Management System
Re-Certification (after 3 Years of initial registration), Signing an other contract
