ISO 14155 Toolkit

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Critical functional team leadership role, assuming the responsibility and accountability for direct management of specific projects, and accountability for delivery of all projects under the assigned program.

More Uses of the ISO 14155 Toolkit:

  • Develop and implement systems to ensure products or services are designed and produced to meet or exceed customer and Regulatory Requirements expectations.

  • Direct: monitor project scope, schedule and costs to ensure all remain on track with the contract and with financial performance targets.

  • Ensure your group assures that quality of services meets internal and external Customer Requirements.

  • Follow compliance with applicable corporate and divisional Policies and Procedures.

  • Provide Quality Assurance support and management level representation during audits and inspections.

  • Ensure you present; lead business critical new Product Development projects and provide regulatory oversight to maintain lifecycle ensuring that your organization of the art requirements are maintained.

  • Analyze and develop action plans for investigational sites, vendor and administrative issues.

  • Support international Marketing And Sales efforts along with distributor relationships.

  • Prepare for and lead audits and inspections by sponsors or regulatory departments.

  • Be accountable for reviewing and recommending changes for Design Control processes and manufacturing procedures to maintain quality and Regulatory Compliance.

  • Manage work with Research and Development to determine proper product mix and potential new product needs.

  • Confirm your operation identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates effectiveness and appropriateness.

  • Confirm your project provides expertise for defining data clarification and validation processes to ensure data validity and integrity.

  • Orchestrate: act as a key regulatory advisor to provide Strategy and Leadership by partnering with operating units on the implementation and training of Regulatory Requirements.

  • Lead and contributes to industry and professional meetings to maintain competency on regulatory policy issues.

  • Ensure you govern; understand, assimilate, and interpret sources of information with appropriate guidance/direction from Development Teams.

  • Negotiate with functional areas on project outcomes and deliverables to meet conflicting demands.

  • Secure that your group holds team member accountable to agreed upon project dates and with an appropriate quality level.

  • Confirm your corporation supports leadership to ensure quality and completeness of project design history files, Risk Management files, validation packages, and change orders.

  • Establish the principles of product and Service Quality evaluation and control for the system.

  • Ensure appropriate Regulatory Compliance in all relevant laboratory activities.

  • Be accountable for ensuring compliance with the current regulatory procedures and where needed, generate new and/or update procedures when new Regulatory Requirements are determined to go into effect.

  • Assure your design participates in the collection of project requirements analyzing Business Needs.

  • Acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements.

  • Adapt and execute should strategic goals shift during the life of the project.

  • Warrant that your venture provides effective oversight to the execution of the Quality Plan, Risk Management activities and post market surveillance activities.

  • Be accountable for ensuring compliance with the current regulatory procedures and updating the procedures when new Regulatory Requirements are determined to go into effect.

  • Be accountable for driving improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained.

  • Assure that your organization establishes and maintains good relationships with reputable outside laboratories needed to perform activities that cannot practically be done by your organization.

  • Establish that your strategy provides ongoing coaching and development for staff assigned to safety projects.


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 999 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 999 standard requirements:

  1. How do you take a forward-looking perspective in identifying ISO 14155 research related to market response and models?

  2. What methods are feasible and acceptable to estimate the impact of reforms?

  3. How do you think the partners involved in ISO 14155 would have defined success?

  4. What is the estimated value of the project?

  5. How is ISO 14155 project cost planned, managed, monitored?

  6. Is there any way to speed up the process?

  7. Which information does the ISO 14155 Business Case need to include?

  8. What are the processes for audit reporting and management?

  9. Are the ISO 14155 benefits worth its costs?

  10. Are you maintaining a past-present-future perspective throughout the ISO 14155 discussion?

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 994 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. Cost Management Plan: Eac -estimate at completion, what is the total job expected to cost?

  2. Activity Cost Estimates: In which phase of the Acquisition Process cycle does source qualifications reside?

  3. Project Scope Statement: Will all ISO 14155 project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the ISO 14155 project team have enough people to execute the ISO 14155 project plan?

  5. Source Selection Criteria: What are the guidelines regarding award without considerations?

  6. Scope Management Plan: Are Corrective Actions taken when actual results are substantially different from detailed ISO 14155 project plan (variances)?

  7. Initiating Process Group: During which stage of Risk planning are risks prioritized based on probability and impact?

  8. Cost Management Plan: Is your organization certified as a supplier, wholesaler, regular dealer, or manufacturer of corresponding products/supplies?

  9. Procurement Audit: Was a formal review of tenders received undertaken?

  10. Activity Cost Estimates: What procedures are put in place regarding bidding and cost comparisons, if any?

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

1.0 Initiating Process Group:

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



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.