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as9100 iso 13485 iso 9001 qms software iso 9001 compliance software api q1 iatf 16949 lms learning management system qms preventive maintenance pm software vendor qualification vendor management supplier management supply chain supplier qualification supplier re-evaluation vendor selection vendor qualification plan supplier qualification plan alibration software calibration asset tracking asset management as 9100 certification cfr 21 part 11 compliant re-certification safety training employee training records training management software cfr 21 part 11 corrective and preventive actions closed loop corrective actions training effectiveness employee training training requirements training plan employee certification document lifecycle management electronic signatures self-paced training spc statistical process control in-process inspection inspection plan control plan product test plan statistical analysis fair final inspection capa iso/ts 16949 audit management capa software corrective actions fmea fmea risk management swot quality management system risk analysis context of the organization interested parties nonconformance management iso 14001 ems safety incident tracking document control incoming inspection