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ISO 13485 PDF FREE MANUAL
ISO 13485 PDF FREE ISO
ISO 13485 PDF FREE ZIP

Section 1: Scope 1.1 General Describe the scope of your QMS: The quality manual outlines the policies, procedures and requirements of the Quality Management System. (IF ANY OTHER INFORMATION IS AVAILABLE, THAT WOULD FURTHER ENHANCE THE COMPANY INTRODUCTION, PREFERABLY ELECTRONICALLY,

USE REPLACE FUNCTION – ENTER “ YOUR COMPANY ” IN FIND SPACE, ENTER YOUR COMPANY NAME IN REPLACE SPACE – SYSTEM SHOULD MAKE CHANGES THROUGHOUT THE ENTIRE DOCUMENT.

President: NOTES: DELETE AFTER EACH TASK IS COMPLETED. The manual is used to familiarize them with the controls that have been implemented and to assure them that the integrity of the Quality Management System is maintained and focused on customer satisfaction and continuous improvement. This manual is used externally to introduce our Quality Management System to our customers and other external organizations or individuals.

ISO 13485 PDF FREE ISO

This manual is used internally to guide the company’s employees through the various requirements of the ISO standard that must be met and maintained in order to ensure customer satisfaction, continuous improvement and provide the necessary instructions that create an empowered work force. The manual also provides procedures or references for all activities comprising the Quality Management System to ensure compliance to the necessary requirements of the standard. This manual describes the Quality Management System, delineates authorities, inter relationships and responsibilities of the personnel responsible for performing within the system. Note: ISO 13485 has not been updated to ISO 9001:2008 yet. Each policy statement is followed by specific information pertaining to the procedures that describe the methods used to implement the necessary requirements.

Each section begins with a policy statement expressing Your Company’s obligation to implement the basic requirements of the referenced Quality Management System section. The manual is divided into eight sections that correlate to the Quality Management System sections of ISO 13485:2003 and ISO 9001:2000. This system addresses the design, development, production, installation, and servicing of the company’s products. The Quality Management System of Your Company meets the requirements of the international standard ISO 13485:2003 and ISO 9001:2000. Introduction Your Company developed and implemented a Quality Management System in order to document the company’s best business practices, better satisfy the requirements and expectations of its customers and improve the overall management of the company. This Quality Manual is designed to accommodate both ISO 9001 & ISO 13485, but if you only want ISO13485–please delete highlighted items. At a minimum, the blue text should be replaced with your information. Review the text replace text to match your quality system requirements.

ISO 13485 PDF FREE ZIP

ISO 13485:20:2000 Quality Systems Manual Street Address City, State Zip *This manual is to be used as a template in developing your 13485 Quality Manual.