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Medical Device quality Management Systems
Accreditation for Medical Device QMS
ISO 13485 stipulates requirements for a quality management system for the design and development, manufacturing and servicing of medical devices. It can also be used to assess the organization’s ability to meet customer and regulatory requirements.
A Certification Body applying for ISO 13485 accreditation must conform to ISO/IEC 17021, IAF MD9 and other additional International requirements as detailed in Specific Requirements for Accreditation for MDQMS Scheme.
Certification Bodies interested to apply for an Accreditation scheme for MDQMS can send an email at info@iabaccreditation.com demanding for following Application documents.
Accreditation Application for Medical Devices Quality Management System: IAB-APL-CAB-MDQMS
General Criteria for Accreditation Requirements: IAB-GEN-CAB-01
General Criteria for Conditions for the Use of IAB Accreditation Symbol: IAB-GEN-CAB-02
Accreditation Requirements for Medical Devices Quality Management System:IAB-CAB-MDQMS
Applicable Fees: IAB-CAB-MS-FEES
Documentation Checklist as per ISO/IEC 17021-1 and IAF MD9
Prior to demanding Application Set, Please read Specific Accreditation requirements for Certification of Medical Device Quality Management System in accordance with ISO 13485 and other guiding documents in the publication area.