This system addresses the design, development, production, installation, and servicing of the company’s products. The manual is divided into eight sections that correlate to the Quality Management System sections of ISO. Each section begins with a policy statement. ISO/TR 14969 is a Technical Report intended to provide guidance for the application of ISO 13485. 0.4 Compatibility with other management systems This International Standard follows the format of ISO 9001 for the convenience of users in the medical device. BSI is committed to ensuring a smooth assessment for all clients wishing to certify to ISO, whether you are new to the standard or transitioning from ISO / EN ISO. This document allows you to detail how you intend to meet the additional requirements of the new standard, so should be used in conjunction with ISO.
BS EN ISO 13485-2016,Medical Devices—Quality Management Systems—Requirements For Regulatory Purposes (British Standard)
BS EN ISO13485-2016 PDF can be downloaded free of charge on this website.BS EN ISO13485-2016 replaces BS EN ISO 13485-2012.
This International Standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be considered as a process. Often the output from one process directly forms the input to the next process.
For an organization to function effectively, it needs to identify and manage numerous linked processes.The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the”process approach.“
Download BS EN ISO 13485-2016 pdf
BS EN ISO 13485-2016,Medical Devices—Quality Management Systems—Requirements For Regulatory Purposes (British Standard)
BS EN ISO13485-2016 PDF can be downloaded free of charge on this website.BS EN ISO13485-2016 replaces BS EN ISO 13485-2012.
This International Standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be considered as a process. Often the output from one process directly forms the input to the next process.
For an organization to function effectively, it needs to identify and manage numerous linked processes.The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the”process approach.“
Download BS EN ISO 13485-2016 pdf
