ISO 13485 CONTROL OF QUALITY SYSTEM DOCUMENTS PROCESS & DOCUMENTS PACKAGE       

This ISO 13485-compliant boilerplate procedure in MicrosoftWord 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 processes and controls for controlling quality system related documents, 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 4.2.3 + All Notes 

1. DIY Do It Yourself Boilerplate (ISO required) documented procedure defining all strategies and controls for controlling the documents necessary for the quality management system (QMS).
2. DIY Do It Yourself Boilerplate template for QMS procedures and work instruction.
3. DIY Do It Yourself Boilerplate template for (QMS) forms.
4. DIY Do It Yourself Boilerplate Index of Controlled QMS Documents.