Compliance Management | Suppliers | Cancer Care | Elekta

Compliance Management

Supplier Quality & Compliance Overview

Elekta is ISO 13485 certified and MDSAP (Medical Device Single Audit Program) certified. Under MDSAP, we are audited against the requirements of ISO 13485 as well as the regional medical device regulations governed by the following governmental agencies:

  • Australia - TGA
  • Japan – MHLW
  • Brazil – ANVISA
  • United States - FDA Regulation
  • Canada – SOR

Our supplier code of conduct can be found here.

Manufacturing Medical Devices in a regulated Industry means that we need to comply with legal requirements and are subject to external scrutiny like audits and inspections. ISO1385 and other regulations have requirements which also apply to our management of suppliers and supplied products and services. As a supplier to Elekta you will be assigned a Supplier Category which will determine the required evidence and management for your approval and ongoing management. For Supplier Categories such as Medical Device and Critical parts, this will include the requirement for a QAA (Quality Assurance Agreement), Approval Audit, ISO13485/ISO9001 certification and the meeting of other relevant regulatory requirements. Your compliance status is then managed using a performance and risk based approach, which is likely to include surveillance audits. Your assigned SDQ Engineer will be able to support you with any questions you have concerning your approval and compliance status.