Manufacturers of medical devices and other organizations that hold an ISO 13485 certificate should therefore address the requirements of the new standard without delay, so that they can assess the extent of the changes that they need to implement in their existing quality management system and the time needed for said implementation. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings. If the transition is carried out within the scope of a surveillance audit, additional audit time needs to be scheduled. Since the official publication of ISO 13485:2016 on March 1, 2016, the transition of accredited certifications to the new ISO 13485:2016 can now be effected within the scope of a regular surveillance or recertification audit. ISO 13485 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture. The primary reason the new structure was not adopted was because the planning process for this standard began before ISO 9001:2015 and other quality standards, and the old standard structure of ISO 13485:2003 was well-aligned with the. Who is it for This course is for those intending to acquire the competence to audit an organisations entire MD-QMS to meet the requirements of ISO 13485. The necessary transition of your certificate is as follows: The publication of ISO 13485:2016 without the adoption of Annex L has created some problems for companies working with multiple quality management systems.
Iso 13485:2016 verification#
Validation of processes for sterile barrier systems and sterilizationÄefinition of the required competence of personnel involved in quality management documentation and verification of the effectiveness of training measuresįor more information about the changes, see our ISO 13485:2016 factsheet, which is available for download here. New requirements for complaint-handling processes Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global-MD and Exemplar Global-AU Competency Units is offering ISO 13485:2016 Internal Auditor Training for Medical Device Management Systems Virtual seminar fully covers the ISO 13485:2016 requirements that include the audit systems, the auditing process, audit instruments, the documentation process, conducting an audit, writing.
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Iso 13485:2016 software#
Validation of the computer software used in the quality management systemĮstablishment and maintenance of the technical documentation structured to the clauses of the standard for the technical file and design and development files One of the important changes of the revision is that the new ISO 13485 uses a risk management approach in all processes of the quality management system. The key changes of the new ISO 13485:2016