Quality System Audit Checklist. There was a particular emphasis on the use of the ISO 9001/2, EN 46001/2 audit check list provided by this author of this report. Resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits. IMSXpress ISO 13485 Internal Audit and Gap Analysis checklist is a stand-alone product as well as part of IMSXpress Quality Management and Document Control software.
Internal Audit Checklist The Internal Audit Checklist is the list of questions required to ensure the management system is implemented and maintained. The listing includes more than 100 questions to ensure each requirement of the ISO 9001 standard is implemented and maintained within the Quality Management System, and includes the ability for the company to add additional questions to suit additional company needs. This document is an appendix to the main document, which is sold separately:.
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