ISO 13485 Audit Checklist (Medical Devices Quality Management Systems, Vol. 1)

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 policy and procedure requirements. This audit checklist addresses each standard shall requirement, and includes sample audits and a rating sheet for rating the results. A CD Rom in MS Word 7.0 is included making it easy to download on PC and performing the audit in digital format, results can be emailed this way immediately to customer and/or third party auditing bodies. A team of experienced Manufacturing and Quality Engineers, supported our efforts with input and suggestions. An easy to use and time and error saving tool for any Medical Device Organization.