ISO 13485 CONTROL OF QUALITY SYSTEM RECORDS PROCESS & DOCUMENT

This ISO 13485-compliant boilerplate procedure in Microsoft Word meets all ISO 13485 requirements for this REQUIRED DOCUMENTED PROCEDURE.  To complete this boilerplate, you the customer will simply need to insert the information specific to your organization, such as your logo, the specific recordkeeping practices of your organization, and your document number.  All AccuFast Consulting boilerplate documents contain notes and tips for the completion of the document and implementation of the process.            
 

ISO 13485 section 4.2.4 + All Notes 

DIY Do It Yourself Boilerplate (ISO required) documented procedure defining all strategies and controls for controlling the records necessary for the quality management system (QMS).