ISO 13485 QUALITY SYSTEM DOCUMENTATION PACKAGE

Complete ISO 13485:2003-compliant quality management system program!  Encompasses all required and recommended documents and records (DIY Do It Yourself / Boilerplate) templates necessary for a complete, effective, and 100% ISO 13485 compliant quality management system!  All product delivered as Microsoft Word or Excel. 
 

ISO 13485 – Most Sections!  (Note: Some requirements in ISO 13485 are so product and application specific that a generic DIY Do It Yourself / Boilerplate / Template would not be value-added.)  

1.  DIY Do It Yourself / Boilerplate / Template (ISO 13485 required) Quality Policy Manual template (AFC-13485-1)
2.  DIY Do It Yourself / Boilerplate / Template (ISO 13485 required) Procedure and templates for control of quality system documents (AFC-13485-2)
3.  DIY Do It Yourself / Boilerplate / Template (ISO 13485 required) Procedure for control of quality system records  (AFC-13485-3)
4.  DIY Do It Yourself / Boilerplate / Template Procedure and template for management review  (AFC-13485-4)
5.  DIY Do It Yourself / Boilerplate / Template Procedure and templates for competence, training and awareness (AFC-13485-5)
6.  DIY Do It Yourself / Boilerplate / Template (ISO 13485 required) Procedure and templates for risk management (AFC-13485-13)
7.  DIY Do It Yourself / Boilerplate / Template Procedure and template for (product and customer) requirements review (AFC-13485-6)
8.  DIY Do It Yourself / Boilerplate / Template Procedure and template for design and development controls (AFC-13485-7)
9.  DIY Do It Yourself / Boilerplate / Template (ISO 13485 required) Procedure and templates for batch records, identification, traceability & preservation  (AFC-13485-14)
10. DIY Do It Yourself / Boilerplate / Template Procedure and templates for control of measuring equipment & calibrations (AFC-13485-8)
11. DIY Do It Yourself / Boilerplate / Template Procedure and models for measuring, analysis, and improvement (AFC-13485-9)
12. DIY Do It Yourself / Boilerplate / Template Procedure (ISO 13485 required) and templates for internal audit program (AFC-13485-10)
13. DIY Do It Yourself / Boilerplate / Template Procedure (ISO 13485 required) and templates for control of nonconforming product (AFC-13485-11)
14. DIY Do It Yourself / Boilerplate / Template Procedure (ISO 13485 required) and templates for corrective and preventive actions (AFC-13485-12)
15. QMS “Owner’s Manual”, which contains recommendations and tips for addressing the other ISO 13485 requirements not address in the AFC products, and where a documented procedure is not required!  Also, tips for effective process implementation, management, and continual improvement.