The system is maintained and continually improved through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive action and management review.
Iso 13485 quality manual iso#
Document the justification for any exclusions that are made.Ĥ.1 General requirements Your company has established, documented and implemented a Quality Management System (QMS) in accordance with the requirements of ISO 13485:2003 and ISO 9001:2000. If none, document that there are no exclusions. The system is structured to comply with the conditions set forth in the International Standard ISO 13485:2003 and the ISO 9001:2000ġ.2 Application Your Company has determined that the following requirements are not applicable to the operations at this site and are documented as exclusions:
Iso 13485 quality manual manual#
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,
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 quality manual 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.