delivery and rework. Adds requirements for records related to the issuance of — advisory notices. Adds the requirement to include determination of — appropriate methods, including statistical 8.4 Analysis of data techniques and the extent of their use. Adds detail to list of inputs. — Adds the requirement to verify that the corrective action — does not have an adverse effect. 8.5.2 Corrective action Added requirement for corrective action to be taken — without undue delay. Adds the requirement to verify that the preventive action — 8.5.3 Preventive action does not have an adverse effect. Appendix A ISO 13485: 2016 vs. ISO 13485: 2003 Comparison Table Amendment Record Version # Submitted Date Summary of Changes 1 10/2016 Initial issue 2 3
delivery and rework. — Adds requirements for records related to the issuance of advisory notices. 8.4 Analysis of data — Adds the requirement to include determination of appropriate methods, including statistical techniques and the extent of their use. — Adds detail to list of inputs. 8.5.2 Corrective action — Adds the requirement to verify that the corrective action does not have an adverse effect. — Added requirement for corrective action to be taken without undue delay. 8.5.3 Preventive action — Adds the requirement to verify that the preventive action does not have an adverse effect. Appendix A ISO 13485: 2016 vs. ISO 13485: 2003 Comparison Table Amendment Record Version # Submitted Date Summary of Changes 1 10/2016 Initial issue 2 3
isr_13485_delta_checklist.docx