iso 13485 certification is a Quality Management System standard for Medical Devices, has been harmonized with European Medical Devices Directives i.e MDD, AIMDD, and IVDD. 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 Course
This type of ISO course is a voluntary certification course designed for professionals or individuals with proper experience to get certified as a Lead Auditor. This ISO course enables delegates to perform First Party Audits (Internal Audit), Second Party Audits (Supplier Audit) & Third Party Audits (External Audit) of an ISO management system. IAS, in partnership with our sister organization, Empowering Assurance Systems (EAS), offers CQI-IRCA Accredited ISO Lead Auditor Training.
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