Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 10993-5 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any ISO 10993-5 related project.

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

 

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The Toolkit contains the following practical and powerful enablers with new and updated ISO 10993-5 specific requirements:

STEP 1: Get your bearings

Start with…

  • The latest quick edition of the ISO 10993-5 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 615 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 10993-5 improvements can be made.

Examples; 10 of the 615 standard requirements:

  1. Will team members perform ISO 10993-5 work when assigned and in a timely fashion?

  2. How important is the completion of a recognized college or graduate-level degree program in the hiring decision?

  3. What other systems, operations, processes, and infrastructures (hiring practices, staffing, training, incentives/rewards, metrics/dashboards/scorecards, etc.) need updates, additions, changes, or deletions in order to facilitate knowledge transfer and improvements?

  4. Are the best solutions selected?

  5. Are there ISO 10993-5 problems defined?

  6. What are the compelling stakeholder reasons for embarking on ISO 10993-5?

  7. What error proofing will be done to address some of the discrepancies observed in the ‘as is’ process?

  8. What tools and technologies are needed for a custom ISO 10993-5 project?

  9. What is our competitive advantage?

  10. How can you measure ISO 10993-5 in a systematic way?

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 10993-5 book in PDF containing 615 requirements, which criteria correspond to the criteria in…

Your ISO 10993-5 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 10993-5 Self-Assessment and Scorecard you will develop a clear picture of which ISO 10993-5 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 10993-5 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 10993-5 projects with the 62 implementation resources:

  • 62 step-by-step ISO 10993-5 Project Management Form Templates covering over 6000 ISO 10993-5 project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Initiating Process Group: Are the changes in your ISO 10993-5 project being formally requested, analyzed, and approved by the appropriate decision makers?
  2. Activity Duration Estimates: If the optimistic estimate for an activity is 12days, and the pessimistic estimate is 18days, what is the standard deviation of this activity?
  3. Probability and Impact Assessment: Is the ISO 10993-5 project cutting across the entire organization?
  4. Issue Log: Are the ISO 10993-5 project Issues uniquely identified, including to which product they refer?
  5. Initiating Process Group: Who supports, improves, and oversees standardized processes related to the ISO 10993-5 project’s program?
  6. Human Resource Management Plan: Is the current culture aligned with the vision, mission, and values of the department?
  7. Quality Audit: Quality is about improvement and accountability. The immediate questions that arise out of that statement are: (i) improvement on what, and (ii) accountable to whom?
  8. Procurement Management Plan: How long will it take for the purchase cost to be the same as the lease cost?
  9. Project Portfolio management: Strategic fit. Are portfolios aligned to strategic business objectives?
  10. Cost Estimating Worksheet: Is it feasible to establish a control group arrangement?

 
Step-by-step and complete ISO 10993-5 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

  • 1.1 ISO 10993-5 project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix

2.0 Planning Process Group:

  • 2.1 ISO 10993-5 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 10993-5 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 10993-5 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 10993-5 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 10993-5 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 10993-5 project with this in-depth ISO 10993-5 Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose ISO 10993-5 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 10993-5 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 10993-5 investments work better.

This ISO 10993-5 All-Inclusive Toolkit enables You to be that person:

 

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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.

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