General Requirements to Understand while Preparing ISO 13485 Manual

The Quality Management System described in ISO 13485 manual must intended to meet the requirements of quality management system of ISO 13485 standard. It addresses Regulations quality system for the production of medical devices. The requirements of this manual will be communicated to all employees in whole or in part, depending on the scope of responsibilities of the employee and the impact on the quality system and product integrity.

The purpose of ISO 13485 manual is to establish and clarify the terms and conditions of the Quality Management System. These policies define intentional delivery of management to control the operation and activities in accordance with the framework established by ISO 9001 and ISO13485 standard. These are top - policy level represents the company's protocols in order to achieve quality assurance and customer satisfaction. All departmental policies and written procedures shall be consistent with these parallel and above - high-level policy. Any changes in policies and procedures should be reviewed to ensure that there are no conflicts with this quality manual.

ISO 13485 Manual for Medical Devices describes the company's quality management system and defines authorities and responsibilities scene of personnel within the system. The manual also includes procedures or references for all activities, including QMS to describe companies' compliance with the standard.

ISO 13485 manual used internally to guide employees of the company through the requirements of ISO standards that must be met and maintained to ensure customer satisfaction, continuous improvement, and create an empowered workforce.

The ISO 13485 manual is used externally to introduce QMS to customers and other external organizations or individuals. The manual familiarizes them with the controls that have been implemented, and assures them that the integrity of the QMS is maintained and focuses on customer satisfaction and continuous improvement.

Requirements for ISO 13485 Manual

• Identify the processes needed for the QMS and their application in the organization and documented on the process diagram at the end of this section of the ISO 13485 manual.
• Determined the sequence and interaction of these processes and illustrated the process flow diagram.
• Criteria and methods needed to ensure that the operation and control of processes are effective and documented in quality plans, work instructions and measurement, monitoring and analysis of specific table.
• Ensure the continued availability of resources and information necessary to achieve planned results and continual improvement of these processes.
• Surveillance systems measure and analyze these processes established.
• Established processes to identify and implement the actions necessary to achieve planned results and continual improvement of these processes.

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