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ISO 13485:2016 Premium Documentation Toolkit – 140+ Documents!

Original price was: 1.025,00 $.Current price is: 99,00 $.

This is the most comprehensive ISO 9001document toolkit currently available.

The documents are created in Microsoft Office format and are ready to be tailored to your organization’s specific needs. As well as standard format and contents, the ISO 27001 template documents include example text that is clearly highlighted to illustrate the type of information that needs to be given regarding your organization. Full example documents are also included to help you with your implementation.

Description

ISO 13485:2016 Premium Toolkit

This is the most comprehensive ISO 13485:2016 document toolkit currently available.

The documents are created in Microsoft Office format and are ready to be tailored to your organization’s specific needs. As well as standard format and contents, the ISO 13485 template documents include example text that is clearly highlighted to illustrate the type of information that needs to be given regarding your organization. Full example documents are also included to help you with your implementation.

Written by a qualified auditor with over 20 years of experience in Quality Management, our toolkit provides years of experience and knowledge in an easy-to-implement 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 13485:2016 toolkit?

  • 140+ template documents – including policies, procedures, controls, checklists, tools, and other useful documentation
  • Available as an instant download after purchase

140+ Templates

Medical Devices Quality Management System Documentation pack

A full and comprehensive documentation pack to help clients, consultants and service providers achieve ISO 9001:2015 successfully.

Pack folder structure:

  • QMS-FlowCharts
  • QMS-Forms
  • QMS-Procedures
  • QMS-Quality-Manual

List of all documents:

  1. Quality Policy.Doc
  2. Organization Chart.Doc
  3. Flow Chart For Iso Qm.Pdf
  4. Software Inventory.Doc
  5. Document Change Request.Doc
  6. Document Revision Checklist.Doc
  7. Quality Records Table-V2.Doc
  8. Qms Measuring Monitoring And Analysis Table.Doc
  9. Key Process Master List.Doc
  10. Qms-Planning-Worksheet.Doc
  11. Management Review Agenda.Doc
  12. Management Review Checklist.Doc
  13. Action Plan For Training-Form.Doc
  14. Group Training Sign-In.Doc
  15. Job Description Form.Doc
  16. Equipment Problem Report.Doc
  17. Equipment Maintenance Record.Doc
  18. Clause-Inclusionexclusion Worksheet.Doc
  19. Quality Planning Table-Form.Doc
  20. Client Assessment Memo.Doc
  21. Risk Management Plan.Doc
  22. Risk List.Doc
  23. Design Plan.Doc
  24. Design Review.Doc
  25. Design Change Form.Doc
  26. Supplier Quality Report.Doc
  27. Supplier Corrective Action Request.Doc
  28. Approved Subcontractor List.Doc
  29. Process Routing Summary Sheet.Doc
  30. Process Routing Detail Sheet.Doc
  31. Customer Property Control Log.Doc
  32. Storage Inspection Report.Doc
  33. Process Validation Worksheet.Doc
  34. Traceability Serial Number Log.Doc
  35. Equipment List.Xls
  36. Customer Satisfaction Survey.Doc
  37. Audit Plan.Doc
  38. Internal Audit Report.Doc
  39. Procedure By Work Area.Doc
  40. Audit Checklist.Doc
  41. Product Realization Measuring Monitoring And Analysis Table.Doc
  42. Rejected Material-Disposition Report-Ncr.Doc
  43. Root Cause Analysis Action Plan.Doc
  44. Corrective Preventive Action Form.Doc
  45. Clause 4-Qms.Pdf
  46. Clause 4-Qms.Sdr
  47. Clause 4-Qms.Vsd
  48. Documentation Requirements.Pdf
  49. Documentation Requirements.Sdr
  50. Documentation Requirements.Vsd
  51. Clause 5-Management Responsibility.Pdf
  52. Clause 5-Management Responsibility.Sdr
  53. Clause 5-Management Responsibility.Vsd
  54. Business Process Map.Vsd
  55. Business Process Map.Pdf
  56. Business Process Map.Sdr
  57. Management-Customer Focus.Vsd
  58. Management-Customerfocus.Pdf
  59. Management-Customerfocus.Sdr
  60. Operating Principles.Pdf
  61. Operating Principles.Vsd
  62. Operatingprinciples.Sdr
  63. P-D-C-A Objectives Planning.Pdf
  64. P-D-C-A Objectives Planning.Sdr
  65. P-D-C-A Objectives Planning.Vsd
  66. Organization-Chart.Sdr
  67. Organization Chart.Pdf
  68. Organization Chart.Vsd
  69. Clause 6- Resourcemanagement.Sdr
  70. Clause 6-Resource Management.Pdf
  71. Clause 6-Resource Management.Vsd
  72. Contributors-5Ms.Pdf
  73. Contributors-5Ms.Sdr
  74. Contributors-5Ms.Vsd
  75. Clause 7- Product Realization.Pdf
  76. Clause 7- Product Realization.Vsd
  77. Clause 7-Productrealization.Sdr
  78. Process Flow Chart.Pdf
  79. Process Flow Chart.Vsd
  80. Processflowchart.Sdr
  81. Product Realization Quality Plan.Pdf
  82. Product Realization Quality Plan.Vsd
  83. Productrealizationqualityplan.Sdr
  84. Customer Processes.Pdf
  85. Customer Processes.Vsd
  86. Customerprocesses.Sdr
  87. Design Development.Pdf
  88. Design Development.Vsd
  89. Designdevelopment.Sdr
  90. Stage Gate Idea-To-Launch.Pdf
  91. Stage Gate Idea-To-Launch.Vsd
  92. Stagegate Idea-To-Launch.Sdr
  93. Purchasing.Pdf
  94. Purchasing.Sdr
  95. Purchasing.Vsd
  96. Process Control.Pdf
  97. Process Control.Sdr
  98. Process Control.Vsd
  99. Process Steps-Control Points.Pdf
  100. Process Steps-Control Points.Vsd
  101. Processsteps-Control Points.Sdr
  102. Identification Traceability.Pdf
  103. Identification Traceability.Vsd
  104. Identificationtraceability.Sdr
  105. Clause 8 – Measure-Improve.Pdf
  106. Clause 8 – Measure-Improve.Vsd
  107. Clause 8 -Measure-Improve.Sdr
  108. Continual Improvement.Pdf
  109. Continual Improvement.Sdr
  110. Continual Improvement.Vsd
  111. Corrective Action.Pdf
  112. Corrective Action.Sdr
  113. Corrective Action.Vsd
  114. 2016 Checklist.Xls
  115. 2016 Procedures Forms Matrix.Xls
  116. 2016 Quality Systems Manual.Docx
  117. List And Description Of Quality Management System Flow Charts.Docx
  118. Document Control.Doc
  119. Control Of Quality Records.Doc
  120. Management Responsibility-V2.Doc
  121. Competence, Awareness And Training.Doc
  122. Infrastructure.Doc
  123. Workenvironment-Contaminationcontrol.Doc
  124. Planning Of Product Realization Processes.Doc
  125. Customer Related Processes.Doc
  126. Risk Management.Doc
  127. Design And Development.Doc
  128. Purchasing.Doc
  129. Controlproductionservice-V2.Doc
  130. Customer Property.Doc
  131. Preservation Of Product.Doc
  132. Validation Of Processes For Product Realization.Doc
  133. Identification And Traceability.Doc
  134. Control Of Measuring And Monitoring Devices.Doc
  135. Post Production Feedback.Doc
  136. Internal Audits.Doc
  137. Monitoringmeasuringanalysis-Products-Processes.Doc
  138. Control Of Nonconforming Product.Doc
  139. Advisorynotices-Productrecall.Doc
  140. Statistical Techniques.Doc
  141. Root Cause Analysis.Doc
  142. Corrective Action.Doc
  143. Preventive Action.Doc
  144. Procedures-Forms-Fc-Matrix.Xlsx
  145. Procedure Template.Doc
  146. Work Instruction Template.Doc
  147. Form Template.Doc

 

All GovernanaceDocs documents are developed based on well-known standards such as NIST CSF, ISO 27001, ISO9001, ISO 22301, PCI-DSS and HIPAA.

Hence, You just need to download and selected document and add your company name and logo.

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