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Product:

ISO 13485 INTERNAL AUDIT PROCESS & DOCUMENTS PACKAGE 

 
Description:

Complete process and all documentation required for conducting effective internal audits of ISO 13485-based quality management systems, and recording results.  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.  Click here to see more details
 

Coverage: ISO 13485 section 8.2.2

Contents:

1. DIY Do It Yourself Boilerplate (ISO required) documented procedure defining internal audit process,
2. Detailed auditor training instruction and test, and templates for (ISO required) auditor training and competence records,
3. DIY Do It Yourself Boilerplate internal audits scheduling and status template,
4. 12 boilerplate internal audit forms (each includes audit prep, audit tips, audit questions, and [SO required] audit summary template), covering all ISO 13485 requirements. (All the customer needs to do is embed their pertinent 'planned arrangements'!)
5. Process “Owner’s Manual”, which contains all the plans, recommendations, and tips necessary for effective internal audit program implementation, management, and continual improvement.

Product Code: AFC-13485-10
        
Price: $375 USD

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