ISO 14155 Toolkit

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Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 14155 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any ISO 14155 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 14155 specific requirements:


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the ISO 14155 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 991 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 14155 improvements can be made.

Examples; 10 of the 991 standard requirements:

  1. How do you frame customer value more holistically beyond the point of care and the use of specific medical devices, in your portfolio, at a certain intervention point?

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

  3. Is an electronic method of collecting and storing quality systems information in your manufacturing process considered a medical device or a mobile medical app?

  4. What should sponsors and other regulated entities consider when deciding to validate outsourced electronic services that are used in clinical investigations?

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

  6. Is the intended use to capture the alarm data in the EHR, or to facilitate getting time sensitive information to a provider about a patient under care?

  7. Did the audit output, including the manufacturers report, demonstrate that the assessment addressed all required areas of the relevant Quality System?

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

  9. Does the ehr strictly capture and warehouse medical device data, or can clinical decision support rules factor in automatically collected data?

  10. Is there a procedure in place that defines when and how the manufacturer should be contacted in the event of a technical problem or breakdown?


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 14155 book in PDF containing 991 requirements, which criteria correspond to the criteria in...

Your ISO 14155 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 14155 Self-Assessment and Scorecard you will develop a clear picture of which ISO 14155 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 14155 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 14155 projects with the 62 implementation resources:

  • 62 step-by-step ISO 14155 Project Management Form Templates covering over 1500 ISO 14155 project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Project Schedule: The wbs is developed as part of a joint planning session. and how do you know that youhave done this right?

  2. Probability and Impact Matrix: Does the ISO 14155 project team have experience with the technology to be implemented?

  3. Requirements Traceability Matrix: How will it affect the stakeholders personally in career?

  4. Planning Process Group: Are there efficient coordination mechanisms to avoid overloading the counterparts, participating stakeholders?

  5. Project Schedule: How closely did the initial ISO 14155 project Schedule compare with the actual schedule?

  6. Project Schedule: Is there a Schedule Management Plan that establishes the criteria and activities for developing, monitoring and controlling the ISO 14155 project schedule?

  7. Team Member Performance Assessment: What types of learning are targeted (e.g., cognitive, affective, psychomotor, procedural)?

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

  9. Project or Phase Close-Out: Did the delivered product meet the specified requirements and goals of the ISO 14155 project?

  10. WBS Dictionary: Appropriate work authorization documents which subdivide the contractual effort and responsibilities, within functional organizations?

 
Step-by-step and complete ISO 14155 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

  • 1.1 ISO 14155 project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:

  • 2.1 ISO 14155 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 14155 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 14155 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 14155 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 14155 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 14155 project with this in-depth ISO 14155 Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose ISO 14155 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 14155 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 14155 investments work better.

This ISO 14155 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.