ISO 13485 - Quality Management System requirements
ISO 13485 Standard - 4.2.3 Control of Documents E-mail
ISO 13485 control of docuements
Documents must be controlled. This is a key element of a quality management system. In order to achieve document control, a method must be maintained. The main idea is to provide control over the documents under the quality management system and to eliminate any confusions and mixups of different documents from different sources. This method must be one of the organizationís quality procedures

ISO 13485 Standard - 4.2.4 Control of Records E-mail
ISO 13485 control of Records
Directly related to document control, I will now discuss record control requirements. The ISO 13485 Standard requires definition of what records are included in the quality management system and how they are controlled.


ISO 13485 Standardís table of contents The book is organized like the standard itself ó the table of contents is identical to the ISO 13485 Standardís table of contents ó making it user friendly, familiar, and unintimidating.† Each chapter contains the information, explanations, interpretations and examples regarding the requirements stated in the parallel standard clause.†


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