Quality Management - Medical Devices
ISO 13485 is an internationally published standard that defines requirements within quality management systems for manufacturers, suppliers, contract service and distributors of medical devices and equipment. The main objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical devices sector. ISO 13485 Cerification Standard has been based on the requirements of ISO 9001 standard and has the same structure in terms of clauses. Even some clauses of ISO 13485 have been referred to ISO 9001.
The ISO 13485 standard is for medical devices – quality management systems – requirements for regulatory purposes, is the basis for regulatory compliance in local and most global markets. Exporting medical Devices to various countries is mandatory. ISO 13485 Certification is an objective evidence of compliance of the requirements, regardless of the type or size of the organization.
This standard 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 requirements and regulatory requirements applicable to medical devices and services
- Demonstrate that you produce safer and more effective medical devices
- Outline how to review and improve processes across your organisation
- Increased access to more markets worldwide with certification
- Meet regulatory requirements and customer expectations
- Increase efficiency, cut costs and monitor supply chain performance
- 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