ISO 13485 Toolkit – Comprehensive 140+ Templates!
Được phát hành Qua governance docs
- Địa điểmUnited States
- Trạng tháiTrong kho
- Loại hìnhMới
This is the most comprehensive ISO 13485 toolkit currently available.
The ISO 13485 Toolkit is designed in Microsoft Office format and can be customized to meet your organization’s unique requirements. Along with a standard format and content, the ISO 13485 template documents feature sample text that is distinctly marked to show the kind of information that your organization needs to provide. Complete example documents are also included to assist you with implementation.
Authored by an experienced auditor with over two decades in Quality Management, our toolkit distills a wealth of expertise into a user-friendly format.
With quality and quantity included, this award-winning toolkit covers everything an organization will need, so you can use it first to become certified to the standard, and then to develop and continually improve your Medical Devices Quality Management System.
What is included within the ISO 13485 toolkit?
Over 140 template documents, encompassing policies, procedures, controls, checklists, tools, and various other valuable documentation.
Available as an instant download after purchase
140+ Templates
Medical Devices Quality Management System Documentation pack
A complete and thorough set of documentation designed to assist clients, consultants, and service providers in successfully achieving ISO 9001:2015 certification.
Pack folder structure:
QMS-FlowCharts
QMS-Forms
QMS-Procedures
QMS-Quality-Manual
List of all documents:
Quality Policy.Doc
Organization Chart.Doc
Flow Chart For Iso Qm.Pdf
Software Inventory.Doc
Document Change Request.Doc
Document Revision Checklist.Doc
Quality Records Table-V2.Doc
Qms Measuring Monitoring And Analysis Table.Doc
Key Process Master List.Doc
Qms-Planning-Worksheet.Doc
Management Review Agenda.Doc
Management Review Checklist.Doc
Action Plan For Training-Form.Doc
Group Training Sign-In.Doc
Job Description Form.Doc
Equipment Problem Report.Doc
Equipment Maintenance Record.Doc
Clause-Inclusionexclusion Worksheet.Doc
Quality Planning Table-Form.Doc
Client Assessment Memo.Doc
Risk Management Plan.Doc
Risk List.Doc
Design Plan.Doc
Design Review.Doc
Design Change Form.Doc
Supplier Quality Report.Doc
Supplier Corrective Action Request.Doc
Approved Subcontractor List.Doc
Process Routing Summary Sheet.Doc
Process Routing Detail Sheet.Doc
Customer Property Control Log.Doc
Storage Inspection Report.Doc
Process Validation Worksheet.Doc
Traceability Serial Number Log.Doc
Equipment List.Xls
Customer Satisfaction Survey.Doc
Audit Plan.Doc
Internal Audit Report.Doc
Procedure By Work Area.Doc
Audit Checklist.Doc
Product Realization Measuring Monitoring And Analysis Table.Doc
Rejected Material-Disposition Report-Ncr.Doc
Root Cause Analysis Action Plan.Doc
Corrective Preventive Action Form.Doc
Clause 4-Qms.Pdf
Clause 4-Qms.Sdr
Clause 4-Qms.Vsd
Documentation Requirements.Pdf
Documentation Requirements.Sdr
Documentation Requirements.Vsd
Clause 5-Management Responsibility.Pdf
Clause 5-Management Responsibility.Sdr
Clause 5-Management Responsibility.Vsd
Business Process Map.Vsd
Business Process Map.Pdf
Business Process Map.Sdr
Management-Customer Focus.Vsd
Management-Customerfocus.Pdf
Management-Customerfocus.Sdr
Operating Principles.Pdf
Operating Principles.Vsd
Operatingprinciples.Sdr
P-D-C-A Objectives Planning.Pdf
P-D-C-A Objectives Planning.Sdr
P-D-C-A Objectives Planning.Vsd
Organization-Chart.Sdr
Organization Chart.Pdf
Organization Chart.Vsd
Clause 6- Resourcemanagement.Sdr
Clause 6-Resource Management.Pdf
Clause 6-Resource Management.Vsd
Contributors-5Ms.Pdf
Contributors-5Ms.Sdr
Contributors-5Ms.Vsd
Clause 7- Product Realization.Pdf
Clause 7- Product Realization.Vsd
Clause 7-Productrealization.Sdr
Process Flow Chart.Pdf
Process Flow Chart.Vsd
Processflowchart.Sdr
Product Realization Quality Plan.Pdf
Product Realization Quality Plan.Vsd
Productrealizationqualityplan.Sdr
Customer Processes.Pdf
Customer Processes.Vsd
Customerprocesses.Sdr
Design Development.Pdf
Design Development.Vsd
Designdevelopment.Sdr
Stage Gate Idea-To-Launch.Pdf
Stage Gate Idea-To-Launch.Vsd
Stagegate Idea-To-Launch.Sdr
Purchasing.Pdf
Purchasing.Sdr
Purchasing.Vsd
Process Control.Pdf
Process Control.Sdr
Process Control.Vsd
Process Steps-Control Points.Pdf
Process Steps-Control Points.Vsd
Processsteps-Control Points.Sdr
Identification Traceability.Pdf
Identification Traceability.Vsd
Identificationtraceability.Sdr
Clause 8 – Measure-Improve.Pdf
Clause 8 – Measure-Improve.Vsd
Clause 8 -Measure-Improve.Sdr
Continual Improvement.Pdf
Continual Improvement.Sdr
Continual Improvement.Vsd
Corrective Action.Pdf
Corrective Action.Sdr
Corrective Action.Vsd
2016 Checklist.Xls
2016 Procedures Forms Matrix.Xls
2016 Quality Systems Manual.Docx
List And Description Of Quality Management System Flow Charts.Docx
Document Control.Doc
Control Of Quality Records.Doc
Management Responsibility-V2.Doc
Competence, Awareness And Training.Doc
Infrastructure.Doc
Workenvironment-Contaminationcontrol.Doc
Planning Of Product Realization Processes.Doc
Customer Related Processes.Doc
Risk Management.Doc
Design And Development.Doc
Purchasing.Doc
Controlproductionservice-V2.Doc
Customer Property.Doc
Preservation Of Product.Doc
Validation Of Processes For Product Realization.Doc
Identification And Traceability.Doc
Control Of Measuring And Monitoring Devices.Doc
Post Production Feedback.Doc
Internal Audits.Doc
Monitoringmeasuringanalysis-Products-Processes.Doc
Control Of Nonconforming Product.Doc
Advisorynotices-Productrecall.Doc
Statistical Techniques.Doc
Root Cause Analysis.Doc
Corrective Action.Doc
Preventive Action.Doc
Procedures-Forms-Fc-Matrix.Xlsx
Procedure Template.Doc
Work Instruction Template.Doc
Form Template.Doc
All the docuemnts of this toolkit are developed based on ISO 13485:2016 Standard.
Hence, You just need to download and selected document and add your company name and logo.
Visit us - https://governancedocs.com/pro....duct/iso-13485-toolk
