ISO 13485:2016 Forms Package

A complete set of forms & tables to complete your ISO 13485 Quality Management System

$109.00

A proper QMS should have forms referenced in the procedures. This package of ISO 13485 Forms is a complete set of forms & tables to complete your ISO 13485 Quality Management System.

They are written in Microsoft Word and Excel format and are ready to customize for your organization.

The forms record the data to measure the effectiveness of a procedure. So every requirement will need to have a form.

These forms have been designed to be integrated with our Quality Manual and Procedures. Save by purchasing the Quality Manual, Procedures and Forms package.

Complete set of ISO 13485:2016 Forms

13485:2016 Forms
A-500-001 Quality Policy A-550-001Organization Chart A-710-001 Flow chart for ISO QM F-424-001 Master Document Lists F-424-002 Software Inventory F-424-003 Document Change Request F-424-004 Document Revision Checklist F-425-001 Quality Records Table F-500-001 QMS Measuring Monitoring and Analysis Table F-500-002 Key Process Master List F-542-001 QMS-Planning-Worksheet F-560-001 Management review agenda F-560-002 Management review checklist F-620-001 Action Plan for Training-Form F-620-002 Group Training Sign-In F-620-003 Job description form F-630-001 Equipment problem report F-630-002 Equipment maintenance record F-700-005 Clause-Inclusion/Exclusion worksheet F-710-001 Quality Planning Table-Form F-720-001 Client assessment memo F-722-001 Risk Management Plan F-722-002 Risk List F-730-001 Design Plan F-730-002 Design Review F-730-003 Design Change form F-740-001 Supplier Quality Report F-740-002 Supplier Corrective Action Request F-740-003 Approved Subcontractor List F-750-001 Process routing summary sheet F-750-002 Process routing detail sheet F-7510-005 Customer property control log F-7511-001 Storage inspection report F-756-001 Process validation worksheet F-759-001 Traceability serial number log F-760-001 Equipment List F-821-001 Customer satisfaction survey F-824-001 Audit Plan F-824-002 Internal Audit Report F-824-003 Procedure by Work Area F-824-004 Audit Checklist F-826-001 Product Realization Measuring Monitoring and Analysis Table F-830-001 Rejected Material-Disposition report-NCR F-841-001 Root Cause Analysis Action Plan F-852-001 Corrective Preventive Action Form T-001 Procedure Template T-002 Work Instruction Template T-003 Form Template

13485:2016 Forms

A-500-001 Quality Policy
A-550-001Organization Chart
A-710-001 Flow chart for ISO QM
F-424-001 Master Document Lists
F-424-002 Software Inventory
F-424-003 Document Change Request
F-424-004 Document Revision Checklist
F-425-001 Quality Records Table
F-500-001 QMS Measuring Monitoring and Analysis Table
F-500-002 Key Process Master List
F-542-001 QMS-Planning-Worksheet
F-560-001 Management review agenda
F-560-002 Management review checklist
F-620-001 Action Plan for Training-Form
F-620-002 Group Training Sign-In
F-620-003 Job description form
F-630-001 Equipment problem report
F-630-002 Equipment maintenance record
F-700-005 Clause-Inclusion/Exclusion worksheet
F-710-001 Quality Planning Table-Form
F-720-001 Client assessment memo
F-722-001 Risk Management Plan
F-722-002 Risk List
F-730-001 Design Plan
F-730-002 Design Review
F-730-003 Design Change form
F-740-001 Supplier Quality Report
F-740-002 Supplier Corrective Action Request
F-740-003 Approved Subcontractor List
F-750-001 Process routing summary sheet
F-750-002 Process routing detail sheet
F-7510-005 Customer property control log
F-7511-001 Storage inspection report
F-756-001 Process validation worksheet
F-759-001 Traceability serial number log
F-760-001 Equipment List
F-821-001 Customer satisfaction survey
F-824-001 Audit Plan
F-824-002 Internal Audit Report
F-824-003 Procedure by Work Area
F-824-004 Audit Checklist
F-826-001 Product Realization Measuring Monitoring and Analysis Table
F-830-001 Rejected Material-Disposition report-NCR
F-841-001 Root Cause Analysis Action Plan
F-852-001 Corrective Preventive Action Form
T-001 Procedure Template
T-002 Work Instruction Template
T-003 Form Template

13485:2016 Forms Sample

Procedures and Forms Matrix

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Which version is right for me?

Choose 13485:2016 to create a new 13485 Quality Management System
Choose 13485:2003 to 13485:2016 QMS instructions to modify your existing 13485 QMS to meet the 13485:2016 requirements
Choose 13485:2016 FDA QMS Upgrade to develop an integrated management system that is 13485 and FDA.QSR (21 CFR 820) compliant as of April 2016 (this is the reference date of the CFR)
Choose ISO 9001:2015 / 13485:2016 QMS to align ISO 13485:2016 (8 section format) with ISO 9001:2015 (10-Section Annex L Format).
- This QMS is for organizations (like Contract Manufacturers) who want ONE QMS for both ISO 9001:2015 and ISO 13485:2016.
- Quality Management System Templates covering both the ISO 9001:2015 (Annex L 10-section format) and ISO 13485:2016 (8-Section format) in ONE combined, Annex L manual.

If you plan to reconfigure your existing quality manual completely by yourself, you can use either of the Upgrade Instructions to create everything on your own. They will tell you where to make the changes but will NOT provide any procedure or form templates for the new requirements.

	13485:2016 Forms Package	13485:2016 Quality Manual & Procedures Package

ISO 13485:2016 Quality Manual (not sold separately)		N
ISO 13485:2016 Procedures & Attachments		N
ISO 13485:2016 Forms	N	N
ISO 13485:2016 Flow Charts		N
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