ISO 14971 Toolkit

Downloadable Resources, Instant Access

Head ISO 14971: own how your brand can be applied to existing and future programming with external partners.

More Uses of the ISO 14971 Toolkit:

  • Ensure you build custom User Interfaces backed by blockchain based Smart Contracts to support a variety of architectures or Use Cases.

  • Initiate ISO 14971: work closely with the management, Corporate Strategy, directors and/or vps throughout thE Business in diverse Corporate Strategy and Corporate Development projects.

  • Evaluate ISO 14971: quickly develop functional prototypes that demonstrate technologies that are feasible for development in the time and budget available.

  • Methodize ISO 14971: design and influence with empathy for your customers.

  • Confirm your business develops and maintains testing standards, procedures, and guidelines to ensure consistent Testing Procedures.

  • Reorganize building strategic working relationships in a multi functional environment.

  • Devise ISO 14971: counsel provide Industrial Engineering support in terms of simulation, equipment and manning capacity modeling, facility design and Productivity Improvements.

  • Direct ISO 14971: high level technical expertise with the latest survey products and solutions and related surveying applications.

  • Ensure you are skilled in modern Java Development.

  • Confirm your venture complies; partners with offshore team and other Internal Stakeholders to ensure that systems are designed developed and implemented from your organization point of view.

  • Stay current with IT knowledge by proactively learning new technology areas and researching or identifying Industry Trends.

  • Be certain that your organization applies System Engineering principles to develop cost effective, reliable, high Quality Systems that satisfy Customer Needs and drivE Business strategies.

  • Ensure you account for; lead engineering considerations, technical evaluations, Design Review, and other project considerations.

  • Initiate escalation of critical process deviations and measures to ensure the production goals in according with the Project leader.

  • Be able to manage multiple projects and quickly respond to and act upon critical feedback.

  • Provide weekly Status Reports to Leadership Team highlighting progress, top issues/risks, and next steps.

  • Orchestrate ISO 14971: participation and influence in review and execution of engineering change orders or deviations impacting material availability, material obsolescence, product configuration, Product Performance, and production throughput.

  • Provide a direct communication link with organization management and coordinate with all departments for quality problem resolutions.

  • Head ISO 14971: secure for managing responsibility of providing testimony for current litigation involving Electronic Discovery and all it matters.

  • Oversee the Design And Delivery of data and metrics, reports, dashboards, and insights that analyze Business Functions and key operations and Performance Metrics.

  • Guide ISO 14971: how csp should build out portfolios with Data Analytics / AI Solutions that integrate with 5g, IoT and Edge Computing.

  • Control ISO 14971: in Machine Learning, cognitive automation, analytics, Chatbots, Natural Language Processing, Business Process management and intelligent Data Capture.

  • Primary engineering responsibility is for mechanical Design Support of optical handling equipment, optical testing equipment, processing support equipment and facilities/ machine upgrades.

  • Provide security and Compliance Requirements for Software Development Projects.

  • Apply the highest quality standard in all areas of responsibility; ensure compliance with Quality System.

  • Ensure you govern; broad array of Platform Applications/feature and supporting ITSM/ITAM/ITOM technologies.

  • Analyze audit Security Incident logs for individual or multiple Network Devices for unauthorized information and processes and unauthorized Network Access.

  • Ensure you run; lead the identity and Access management initiatives across your organization to establish Least Privilege principle for critical asset and information.

  • Establish ISO 14971: operational oversight of Engineering Services team and daily activities; performs Code Review, technical mentoring, and directly contributes to Application Development.

  • Supervise ISO 14971: partner with Security Incident response team, soc and Security Engineering to resolve and close the investigation of incidents with postmortem and remediation plans.


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 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 14971 improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. Where can you break convention?

  2. What counts that you are not counting?

  3. Does ISO 14971 appropriately measure and monitor risk?

  4. Can management personnel recognize the monetary benefit of ISO 14971?

  5. Are ISO 14971 changes recognized early enough to be approved through the regular process?

  6. Do several people in different organizational units assist with the ISO 14971 process?

  7. What qualifications are needed?

  8. Is there a clear ISO 14971 case definition?

  9. What evidence is there and what is measured?

  10. Is it economical; do you have the time and money?

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 994 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: 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 14971 project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the ISO 14971 Project Team have enough people to execute the ISO 14971 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 14971 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 14971 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

2.0 Planning Process Group:

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



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.