ISO 13485 RISK MANAGEMENT PROCESS & DOCUMENTS PACKAGE

Complete strategy and process for risk planning and management throughout product realization and maintaining records.  This ISO 13485-compliant boilerplate procedure and these recordkeeping templates in Microsoft Word meet all ISO 13485 requirements for this ISO section.  To complete these boilerplates, the customer will simply need to insert the information specific to your organization such as your logo, and add 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 7.1 + all Notes

1. DIY Do It Yourself Boilerplate documented procedure for risk management
2. DIY Do It Yourself Boilerplate (ISO required record) template for recording risk planning and management activities