ISO 13485 Quality Management Systems - Requirements for Regulatory Purposes contains requirements ISO 9001 additionally it contains requirements for medical devices purpose for design, development, production, installation, servicing and related services to customers that comply with all relevant product and service oriented technical standards and regulations in this area of expertise. ISO 13485 also focuses more on how procedures regulate and control activity and process performance.
AIAB Accreditation requires that Certification Bodies for ISO 13485 conforms to the most recent versions of the following International Standards:
Certification Body applying for the ISO 13485 accreditation must be accredited by AIAB for ISO 9001 Quality Management Systems or be an applicant for accreditation with AIAB for ISO 9001 Quality Management Systems.
