ISO 13485 Toolkit – Comprehensive 140+ Templates!

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

ISO 14001 Toolkit – Comprehensive 35+ Templates!

This ISO 14001 toolkit is the most extensive one available today.

It consists of documents in Microsoft Office format, ready to be customized to meet your organization’s specific requirements. Along with standard formats and contents, the ISO 14001 template documents feature example text that is clearly marked to show the type of information needed for your organization.

Complete example documents are also included to assist you in your implementation process. Created by a certified auditor with over 18 years of experience in Environmental Management, our toolkit combines years of expertise into an easy-to-use format.

Offering both quality and quantity, this award-winning toolkit provides everything an organization needs to achieve certification and to enhance and continuously improve its Environmental Management System (EMS).



What is included within the ISO 14001:2015 toolkit?
Over 35+ template documents, encompassing policies, procedures, controls, checklists, tools, and various other helpful documentation.
Available as an instant download after purchase
35+ Templates
Environmental Management System (EMS) Documentation pack

A complete pack of documentation templates designed to assist customers, consultants, and vendors in successfully achieving ISO 14001:2015 certification.

Pack folder structure:
P-EMS-01 EMS Policy
P-EMS-02 EMS Manual
P-EMS-03 Procedure for EMS Objectives
P-EMS-04 Procedure for Determining the Context and Interested parties
P-EMS-05 Procedure for Environmental Aspects, Risk and Opportunity
P-EMS-06 Procedure for OHS Communication, Participation and Consultation
P-EMS-07 Procedure for Compliance Obligation
P-EMS-08 Procedure for Competence, Training and Awareness
P-EMS-09 Procedure for Control of Documented Information
P-EMS-10 Procedure for Calibration
P-EMS-11 Procedure for Emergency preparedness and response
P-EMS-12 Procedure for Performance Monitoring and Evaluation of Compliance
P-EMS-13 Procedure for Internal Audit
P-EMS-14 Procedure for Management Review
P-EMS-15 Procedure for Continual Improvement
P-EMS-16 Procedure for Non-Conformity Reporting and Corrective action
P-EMS-17 Procedure for Control of Operation
P-EMS-18 Comprehensive Aspect and Impact Register
Comprehensive Aspect and Impact Register.xls
EMS Manual V1.0.docx
EMS Policy V1.0.docx
F-EMS-01 EMS Context Log and list of Interested Parties.docx
F-EMS-02 EMS objectives and targets master sheet.xlsx
F-EMS-03 Objective and target change request form.xls
F-EMS-04 Training Matrix.xlsx
F-EMS-05 Training needs analysis form.doc
F-EMS-06 MRM Minutes of Meeting.docx
F-EMS-07 Document Change Request Form.docx
F-EMS-08 Emergency management Team.docx
F-EMS-10 Internal Audit Schedule.xlsx
F-EMS-11 Internal Audit Report.xlsx
F-EMS-12 Corrective Action Report (CAR).docx
F-EMS-13 Lesson Learned Form.xls
P-EMS-01 Procedure for Determining the Context and Interested parties.docx
P-EMS-02 Procedure for EMS Objectives V1.0.docx
P-EMS-03 Procedure for EMS Communication, Participation and Consultation.docx
P-EMS-04 Procedure for Environmental Aspects, Risk and Opportunity.docx
P-EMS-05 Procedure for Compliance Obligation.docx
P-EMS-06 Procedure for Competence, Training and Awareness.docx
P-EMS-07 Procedure for Control of Documented Information.docx
P-EMS-08 Procedure for Control of Operations.docx
P-EMS-09 Procedure for Calibration.docx
P-EMS-10 Procedure for Emergency preparedness and response.docx
P-EMS-11 Procedure for Performance Monitoring and Evaluation of Compliance.docx
P-EMS-12 Procedure for Internal Audit.docx
P-EMS-13 Procedure for Management Review.docx
P-EMS-14 Procedure for Non Conformity Reporting and Corrective action.docx
P-EMS-15 Procedure for Continual Improvement.docx
R-EMS-01 Aspect Impact and Risk Opportunity Register.xlsx
R-EMS-02 Compliance Obligation Register.xlsx
R-EMS-03 Training Register.xlsx
R-EMS-04 External Document Register.docx
R-EMS-05 Document Master Register.xlsx
R-EMS-06 Calibration Register.docx
R-EMS-07 Calibration Monitoring and Production Software Validation Register.docx
T-EMS-01 SWOT Analysis Template.docx


All documents of this toolkit are developed based on ISO 14001:2015 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-14001-toolk

HIPAA Toolkit – Comprehensive 80+ Templates!

This is the most comprehensive HIPAA toolkit currently available to comply with HIPAA Regulation.

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, HIPAA 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 Information Security, 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 HIPAA compliance.

Visit: https://governancedocs.com/product/hipaa-toolkit/

ESG Toolkit – 20+ Comprehensive Templates!

This ESG Toolkit (Environmental, Social, and Governance Toolkit) is the most comprehensive resource currently available for implementing a structured and effective ESG framework in accordance with global sustainability standards.

Developed in Microsoft Office format, the documents are fully customizable to align with your organization’s unique sustainability goals and regulatory requirements. Each template is structured with standard content and includes clearly highlighted example text to guide users in documenting and implementing their ESG initiatives. Additionally, full example documents are included to support a smooth and efficient integration process.

This toolkit not only simplifies your ESG implementation but also serves as a vital resource for awareness and training in sustainable business practices. Designed for business leaders, compliance professionals, and sustainability consultants, it provides structured guidance to streamline your ESG journey. Whether you’re seeking to establish a strong ESG foundation or enhance existing sustainability efforts, this toolkit ensures you have the right tools and support for a seamless compliance process. Enhance Your ESG Implementation with Expert Support and Training.

Visit: https://governancedocs.com/product/esg-toolkit/