ISO 14971 Toolkit

Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 14971 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any ISO 14971 related project.



Download the Toolkit and in Three Steps you will be guided from idea to implementation results.



The Toolkit contains the following practical and powerful enablers with new and updated ISO 14971 specific requirements:



STEP 1: Get your bearings



Start with...




• The latest quick edition of the ISO 14971 Self Assessment book in PDF containing 49 requirements to perform a quickscan, get an overview and share with stakeholders.




Organized in a data driven improvement cycle RDMAICS (Recognize, Define, Measure, Analyze, Improve, Control and Sustain), check the…




• Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation




Then find your goals...



STEP 2: Set concrete goals, tasks, dates and numbers you can track



Featuring 998 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which ISO 14971 improvements can be made.



Examples; 10 of the 998 standard requirements:




1. Do the information materials supplied by the manufacturer correspond with the contents of the report and are all discrepancies identified in the reports conclusions?
   
   

2. Does increasing influence of sensor output data on clinical decision making affect benefit/risk and therefore the level of verification and validation necessary?
   
   

3. Does the software device provide vital signs monitoring and alarms for potentially life threatening situations in which medical intervention is necessary?
   
   

4. How do you incorporate a clients perspective regarding benefits and risks to enable regulators to make decisions most congruent with patient preferences?
   
   

5. Are there any especially significant events, coverage, retention or accounting changes that have occurred that must be considered when making analyses?
   
   

6. Where is your organization on the curve; what is it doing to reinvent itself and ensure it stays in the zone of rapid growth for as long as possible?
   
   

7. How often does your organization include a medical device cyber security evaluation during the selection decision phase of the procurement process?
   
   

8. How do you use any risk management process without in-depth understanding of your products and process, probability and frequencies?
   
   

9. What equipment and devices are available for clients to prevent harm from falls or to manage clients who are at risk of falling?
   
   

10. Which specific engineering approaches have already been applied to the development of crisis and disaster management systems?
    
    




Complete the self assessment, on your own or with a team in a workshop setting. Use the workbook together with the self assessment requirements spreadsheet:




• The workbook is the latest in-depth complete edition of the ISO 14971 book in PDF containing 998 requirements, which criteria correspond to the criteria in...




Your ISO 14971 self-assessment dashboard which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next:




• The Self-Assessment Excel Dashboard; with the ISO 14971 Self-Assessment and Scorecard you will develop a clear picture of which ISO 14971 areas need attention, which requirements you should focus on and who will be responsible for them:
  
  


• Shows your organization instant insight in areas for improvement: Auto generates reports, radar chart for maturity assessment, insights per process and participant and bespoke, ready to use, RACI Matrix

• Gives you a professional Dashboard to guide and perform a thorough ISO 14971 Self-Assessment

• Is secure: Ensures offline data protection of your Self-Assessment results

• Dynamically prioritized projects-ready RACI Matrix shows your organization exactly what to do next:





 



STEP 3: Implement, Track, follow up and revise strategy



The outcomes of STEP 2, the self assessment, are the inputs for STEP 3; Start and manage ISO 14971 projects with the 62 implementation resources:




• 62 step-by-step ISO 14971 Project Management Form Templates covering over 1500 ISO 14971 project requirements and success criteria:




Examples; 10 of the check box criteria:




1. Cost Management Plan: Are staff skills known and available for each task?
   
   

2. Risk Audit: How do you compare to other jurisdictions when managing the risk of ....?
   
   

3. Responsibility Assignment Matrix: The staff interests Ð is the group or the person interested in working for this ISO 14971 project?
   
   

4. Activity Duration Estimates: How do functionality, system outputs, performance, reliability, and maintainability requirements affect quality planning?
   
   

5. Risk Management Plan: My ISO 14971 project leader has suddenly left your organization, what do you do?
   
   

6. Activity Resource Requirements: What are constraints that you might find during the Human Resource Planning process?
   
   

7. Team Member Status Report: How does this product, good, or service meet the needs of the ISO 14971 project and your organization as a whole?
   
   

8. Project Scope Statement: Is an issue management process documented and filed?
   
   

9. Risk Register: Amongst the action plans and recommendations that you have to introduce are there some that could stop or delay the overall program?
   
   

10. Stakeholder Management Plan: Do ISO 14971 project teams & team members report on status / activities / progress?




 
Step-by-step and complete ISO 14971 Project Management Forms and Templates including check box criteria and templates.



1.0 Initiating Process Group:




• 1.1 ISO 14971 project Charter

• 1.2 Stakeholder Register

• 1.3 Stakeholder Analysis Matrix




2.0 Planning Process Group:




• 2.1 ISO 14971 project Management Plan

• 2.2 Scope Management Plan

• 2.3 Requirements Management Plan

• 2.4 Requirements Documentation

• 2.5 Requirements Traceability Matrix

• 2.6 ISO 14971 project Scope Statement

• 2.7 Assumption and Constraint Log

• 2.8 Work Breakdown Structure

• 2.9 WBS Dictionary

• 2.10 Schedule Management Plan

• 2.11 Activity List

• 2.12 Activity Attributes

• 2.13 Milestone List

• 2.14 Network Diagram

• 2.15 Activity Resource Requirements

• 2.16 Resource Breakdown Structure

• 2.17 Activity Duration Estimates

• 2.18 Duration Estimating Worksheet

• 2.19 ISO 14971 project Schedule

• 2.20 Cost Management Plan

• 2.21 Activity Cost Estimates

• 2.22 Cost Estimating Worksheet

• 2.23 Cost Baseline

• 2.24 Quality Management Plan

• 2.25 Quality Metrics

• 2.26 Process Improvement Plan

• 2.27 Responsibility Assignment Matrix

• 2.28 Roles and Responsibilities

• 2.29 Human Resource Management Plan

• 2.30 Communications Management Plan

• 2.31 Risk Management Plan

• 2.32 Risk Register

• 2.33 Probability and Impact Assessment

• 2.34 Probability and Impact Matrix

• 2.35 Risk Data Sheet

• 2.36 Procurement Management Plan

• 2.37 Source Selection Criteria

• 2.38 Stakeholder Management Plan

• 2.39 Change Management Plan




3.0 Executing Process Group:




• 3.1 Team Member Status Report

• 3.2 Change Request

• 3.3 Change Log

• 3.4 Decision Log

• 3.5 Quality Audit

• 3.6 Team Directory

• 3.7 Team Operating Agreement

• 3.8 Team Performance Assessment

• 3.9 Team Member Performance Assessment

• 3.10 Issue Log




4.0 Monitoring and Controlling Process Group:




• 4.1 ISO 14971 project Performance Report

• 4.2 Variance Analysis

• 4.3 Earned Value Status

• 4.4 Risk Audit

• 4.5 Contractor Status Report

• 4.6 Formal Acceptance




5.0 Closing Process Group:




• 5.1 Procurement Audit

• 5.2 Contract Close-Out

• 5.3 ISO 14971 project or Phase Close-Out

• 5.4 Lessons Learned




 



Results



With this Three Step process you will have all the tools you need for any ISO 14971 project with this in-depth ISO 14971 Toolkit.



In using the Toolkit you will be better able to:




• Diagnose ISO 14971 projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices

• Implement evidence-based best practice strategies aligned with overall goals

• Integrate recent advances in ISO 14971 and put process design strategies into practice according to best practice guidelines




Defining, designing, creating, and implementing a process to solve a business challenge or meet a business objective is the most valuable role; In EVERY company, organization and department.



Unless you are talking a one-time, single-use project within a business, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'



This Toolkit empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make ISO 14971 investments work better.



This ISO 14971 All-Inclusive Toolkit enables You to be that person.



 



Includes lifetime updates



Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.