ISO 13485 BATCH RECORDS, IDENTIFICATION, TRACEABILITY & PRESERVATION PROCESS & DOCUMENTS PACKAGE 

Boilerplate strategies and processes for the developing and maintaining product batch records, maintaining identification, traceability, and preserving product throughout product realization and delivery.  This ISO 13485-compliant boilerplate procedure in Microsoft Word meets all ISO 13485 requirements for these ISO sections.  To complete these boilerplates, you the customer will simply need to insert the information specific to your organization such as your logo, the specific processes and strategies, and add your document numbers.  All AccuFast Consulting boilerplate documents contain notes and tips for the completion of the document and implementation of the process.    
 

ISO 13485 sections 7.5.1.1b & g, 7.5.3, 7.5.4 & 7.5.5 

DIY Do It Yourself Boilerplate documented procedure for batch records, identification, traceability, and preservation of product