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. 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.
Harmonization of the standard allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation.
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 2020 and 2022, respectively.
Find out more about MDR transition and IVDR transition.
IAS can now offer UQAS-accredited ISO 13485 certification to ISO 13485:2016 and to EN ISO 13485:2016.
ISO 13485 Certification is an activity of verifying the organization through planned and informed ISO audits to confirm that the organization complies with the standard requirement of ISO 13485.
ISO 13485 certification for medical devices is an internationally recognized quality standard which affirms the requirements of the Quality Management System standard for Medical Devices (QMS) for the design and manufacture of Medical Devices anywhere in the world.
ISO 13485 certification is a symbol of the stability and continuity of your organization’s performance to reach and outshine customer expectations. Nowadays Customers are not ready to take a chance, to reduce the risk of purchasing low-quality products they always look for best quality ISO certified products and services. ISO 13485 certification for business is a powerful tool to increase the credibility of the organization by showing that your products or services meet the expectations of your customer.
ISO 13485 certifications help to expand your business locally and in overseas markets and also definitely help to impress your clients with the quality of the business and its products and services.
IAS is one of the highly performing as ISO Certification Bodies in Iraq. IAS conducts auditing and providing ISO 13485 certification in Iraq and also for various standards in Iraq. It also delivers ISO Lead Auditor Training, ISO 13485 Internal Auditor Trainings, and ISO 13485 Awareness/Foundation Training in Iraq. All these certification and Training services by IAS for the country is managed from its office in Iraq.