Integrated Quality Management System
The iso 13485 singapore Quality Manual is to establish and clarify the terms and conditions of the quality management system. These are the top level of policy – representing the protocols of the company to obtain quality assurance and customer satisfaction. All departmental policies and written procedures comply with the parallel and superior policy at a high level. Any changes to policies and procedures should be examined to ensure that there is no conflict with this quality manual. The manual also includes procedures or references for all activities, including the QMS to describe the compliance of companies with the norm.
An iso 13485 singapore Manual is used internally to guide the employees of the company thanks to the requirements of ISO standards that must be respected and maintained to ensure customer satisfaction, continuous improvement, and the creation of an authorized workforce.
Requirements for ISO 13485 Manual
- Identify the necessary processes for the quality management system and their application in the organization and document them on the process diagram at the end of this section of the quality manual.
- Determine the sequence and interaction of these processes and illustrate the process flow diagram.
- Criteria and methods needed for processing and process control to be effective and documented in quality plans, work instructions, and specific table monitoring and analysis.
- Ensure the continuous availability of resources and information needed to achieve planned results and continuous improvement of these processes.
- Monitoring systems measure and analyze these established processes.
- Processes established to identify and implement the necessary actions to achieve planned results and continuous improvement of these processes.