paxphil.blogg.se - En iso 134852012 for software

New requirements for complaint-handling processes.

Establishment and maintenance of the technical documentation structured to the clauses of the standard for the technical file and design and development files.

Validation of the computer software used in the Quality Management System standard for Medical Devices.

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 standard for Medical Devices.

IAS can now offer UQAS-accredited ISO 13485 certification to ISO 13485:2016 and to EN ISO 13485:2016. The harmonization of EN ISO 13485:2016 is another step towards compliance to the recently published Medical Devices and IVD Regulations, which will supersede the current Directives in 20, respectively.įind out more about MDR transition and IVDR transition. Harmonization of the standard allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation. EN ISO 13485:2012 is now updated as ISO 13485:2016, in the EU Official Journal, with the date of ‘cessation of presumption of conformity’ of EN ISO 13485:2012 stated as 31 March 2019. ISO 13485:2016 is a Quality Management System standard for Medical Devices, has been harmonized with European Medical Devices Directives i.e MDD, AIMDD and IVDD. ISO 13485 standard and its Certification About ISO 13485 standard

ISO 22301 Internal Auditor Training Course.

ISO 17025 Internal Auditor Training Course.

ISO 45001 Internal Auditor Training Course.

ISO 45001 Migration Lead Auditor Training Course.ISO 27001:2022 Lead Auditor Training Course.