Audit Checklists and Guidelines for ISO 13485-2003 Medical Devices Quality Management System (Medical Device Quality Control, 2)

This audit checklist was designed for organizations that are in need for assessing and for auditing Quality Management Systems based on the international Standard ISO 13485-2003.The audit checklist addresses all 61 main and sub clauses and the 328 shall requirements of the ISO 13485 -2003 Standard.A simple rating system is included that enables the user to record compliance measurement based on the audit findings.The Hard Copy Audit Checklist and Guide contains the following: Introduction Description how to apply and use the audit checklist Short introduction into audit requirements, discerning minor verses major or critical nonconformities, and how to tally respective findings and rate the overall performance Audit Checklist with 385 questions addressing each shall requirements stated in the Standard Rating Chart CD ROM MS Word 7.0, contains all the above documentation, including the ChecklistsThe Downloadable Audit Checklist and Guide for ISO 13485 Medical Devices Standard contains the following: Introduction Description how to apply and use the audit checklist Short introduction into audit requirements, discerning minor verses major or critical nonconformities, and how to tally respective findings and rate the overall performance Audit Checklist with 385 questions addressing each shall requirements stated in the Standard Rating Chart