ISO 13485 CONTROL OF NONCONFORMING PRODUCT PROCESS & DOCUMENTS PACKAGE

Complete process for the identification, segregation, processing, and recordkeeping of product that ‘does not meet requirements’. 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, and your document number. All AccuFast Consulting boilerplate documents contain notes and tips for the completion of the documentation and implementation of the process.
 

ISO 13485 section 8.3

1. DIY Do It Yourself Boilerplate (ISO required) documented procedure defining this process,
2. DIY Do It Yourself Boilerplate NC tag template (ISO required record),
3. DIY Do It Yourself Boilerplate NC tracking log,