Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 10993 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any ISO 10993 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 10993 specific requirements:
STEP 1: Get your bearings
- The latest quick edition of the ISO 10993 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 813 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 improvements can be made.
Examples; 10 of the 813 standard requirements:
- Has the improved process and its steps been standardized?
- Has everyone on the team, including the team leaders, been properly trained?
- Is full participation by members in regularly held team meetings guaranteed?
- What is measured?
- How large is the gap between current performance and the customer-specified (goal) performance?
- Who controls the risk?
- Explorations of the frontiers of ISO 10993 will help you build influence, improve ISO 10993, optimize decision making, and sustain change
- Is there a ISO 10993 management charter, including stakeholder case, problem and goal statements, scope, milestones, roles and responsibilities, communication plan?
- How do we do risk analysis of rare, cascading, catastrophic events?
- What are the compelling stakeholder reasons for embarking on ISO 10993?
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 book in PDF containing 813 requirements, which criteria correspond to the criteria in...
Your ISO 10993 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 Self-Assessment and Scorecard you will develop a clear picture of which ISO 10993 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 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 projects with the 62 implementation resources:
- 62 step-by-step ISO 10993 Project Management Form Templates covering over 6000 ISO 10993 project requirements and success criteria:
Examples; 10 of the check box criteria:
- Procurement Management Plan: Are post milestone ISO 10993 project reviews (PMPR) conducted with the organization at least once a year?
- Responsibility Assignment Matrix: Are material costs reported within the same period as that in which BCWP is earned for that material?
- Procurement Management Plan: Has a Quality Assurance Plan been developed for the ISO 10993 project?
- Procurement Audit: Is the performance of the procurement function/unit regularly evaluated?
- Lessons Learned: How effectively and consistently was sponsorship for the ISO 10993 project conveyed?
- Activity Cost Estimates: Scope statement only direct or indirect costs as well?
- Activity Cost Estimates: Were sponsors and decision makers available when needed outside regularly scheduled meetings?
- Quality Management Plan: What is your organizations strategic planning process?
- Change Management Plan: What risks may occur upfront, during implementation and after implementation?
- Procurement Audit: Are there appropriate controls in place to ensure that the procurement ISO 10993 project complies with relevant legislation?
Step-by-step and complete ISO 10993 Project Management Forms and Templates including check box criteria and templates.
1.0 Initiating Process Group:
- 1.1 ISO 10993 project Charter
- 1.2 Stakeholder Register
- 1.3 Stakeholder Analysis Matrix
2.0 Planning Process Group:
- 2.1 ISO 10993 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 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 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 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 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 10993 project with this in-depth ISO 10993 Toolkit.
In using the Toolkit you will be better able to:
- Diagnose ISO 10993 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 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 investments work better.
This ISO 10993 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.