Mediacl Device ISO 13485-2009 Quality and Procedure Manual (ISO 13485-2003/ISO 9001-2009 Quality and Procedure Manual, 3)

This all in one Quality and Procedure Manual meets ISO 13485 - 2003 as well as ISO 9001-2008 Standard requirements and is specifically designed for the Medical Devices Engineering and Manufacturing Industries. The Hardcopy Manual contains the following: Policies and Objective addressing each Standard requirement (Quality Manual). Procedures for each and every section of the Standard (Procedure Manual), including Configuration and Risk Management Procedures. Control Forms, complete set of 42 State of the Art Control Forms, supporting records and verification requirements. Quality Policy and Mission Statement. Step by Step Instruction Guide How to Implement. Certificate for Self Declaration of Conformance. CD Rom, in MS Word 7.0, contains all of the above documentation.And as a final addition to the quality and procedure manual we have included our best selling Internal Audit Checklist free of charge for a limited time, a value of $110.00.