Simtek EMS Ltd is certified to the latest standards for both ISO 9001 and ISO 13485 by AJA Registrars.
ISO 9001
ISO 9001 (Accredited by UKAS and ANAB) is internationally recognised as providing a framework for a quality management system that can be easily interpreted for all areas of industry and commerce.
Why ISO 9001?
ISO 9001 provides a framework for monitoring and measuring process performance and operations ensuring increased efficiency and improved customer satisfaction.
Benefits to you
Now demanded by many ‘Blue-Chip‘ companies and Government Departments, ISO 9001 certification provides these organisations and your existing customers with confidence that you should be able to provide a consistent and improving quality product or service.
ISO 13485
ISO 13485 is now the Management System that forms the foundation of regulatory compliance in countries around the world and is the only internationally recognised standard focused solely on Medical Devices.
Why ISO 13495?
ISO 13495 provides a framework for monitoring and measuring process performance and operations related to the design, manufacture and distribution of Medical Devices ensuring increased efficiency and improved customer satisfaction. It also ensures that you focus on the specific regulatory requirements associated with Medical Devices to support conformance with National Medical Device Directives.
Benefits to you
Your customers can purchase your Medical Devices and Services in the knowledge that you have the capability to provide product and services of a consistent quality and comply with the related local and international regulatory requirements.
AJA Registrars is accredited for a large in a range of industrial and commercial sectors and operates throughout the globe, ensuring that we have the expertise to fully understand your operations and your customer needs.
AJA Registrars is accredited for most types of device from Non-Active, Non-Implantable devices through to In Vitro Diagnostic Medical Devices and have experience and knowledge of the regulatory requirements throughout Europe and the rest of the world.
Source: www.ajaregistrars.co.uk
