Check and review your organisation's ISO 13485 certification process.
Designing and determining the required documents.
Obtaining the ISO 13485 certificate.
ISO 13485 aligns with the earlier version of ISO 9001, which is an internationally recognised standard for Quality Management Systems established by ISO. The requirements set by ISO are recognised around the world for implementing a Quality Management System. Although ISO 13485 standard came out after the major update of ISO 9001, it does not align with a new revision of ISO 9001, as it was determined that the most recent changes in ISO 9001 were unnecessary for medical devices.
(1) Includes an internationally recognised EN ISO 13485 certified.
(2) More product opportunities.
(3) Extensive market access approval.
(4) Manufacturers or other sub-contractors of the medical devices have a chance to leverage their certified Quality Management System (QMS) status for a smooth and seamless transition into specialised Certification.
(5) Meaningful feedback on the effectiveness of the Quality Management System.
(1) Optional Preliminary Audit.
(2) Audit: Stage I.
(3) Audit: Stage II.
(4) Certification.
(1) What is ISO 13485 certification?
(2) What does the ISO 13485 require?
(3) Does ISO provide the certificate under ISO 13485?
(4) What is the latest version of ISO 13485
