ISO 13485 CORRECTIVE & PREVENTIVE ACTIONS PROCESS & DOCUMENTS PACKAGE

Complete program for the taking and recording of formal corrective and preventive actions.  This ISO 13485-compliant boilerplate procedure in Microsoft Word meets all ISO 13485 requirements for TWO REQUIRED DOCUMENTED PROCEDURES.  To complete this boilerplate, you the customer will simply need to insert the information specific to your organization, such as your logo, the specific ‘trigger points’ for initiating CAs and PAs in your organization, and your document number.  All AccuFast Consulting boilerplate documents contain notes and tips for the completion of the documentation and implementation of the processes.  
 

ISO 13485 section 8.5.2 & 8.5.3 + all Notes

1. DIY Do It Yourself Boilerplate (ISO required) documented procedure defining corrective and preventive actions processes,
2. DIY Do It Yourself Boilerplate CAPA log template (ISO required record),
3. DIY Do It Yourself Boilerplate CAPA (processing) form template (ISO required record)