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
- 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 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 standard requirements:
- Are losses documented, analyzed, and remedial processes developed to prevent future losses?
- Are improvement team members fully trained on ISO 14971?
- Teaches and consults on quality process improvement, project management, and accelerated ISO 14971 techniques
- When a ISO 14971 manager recognizes a problem, what options are available?
- What are the agreed upon definitions of the high impact areas, defect(s), unit(s), and opportunities that will figure into the process capability metrics?
- How can we incorporate support to ensure safe and effective use of ISO 14971 into the services that we provide?
- What baselines are required to be defined and managed?
- Is the performance gap determined?
- How does the organization define, manage, and improve its ISO 14971 processes?
- How will we build a 100-year startup?
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 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 6000 ISO 14971 project requirements and success criteria:
Examples; 10 of the check box criteria:
- Activity Cost Estimates: How quickly can the task be done with the skills available?
- Probability and Impact Matrix: A determination to transfer a risk may be made during which step of risk management?
- Procurement Audit: Is the organization transparent about winning bids and prices?
- Initiating Process Group: Will the ISO 14971 project meet the client requirements, and will it achieve the business success criteria that justified doing the ISO 14971 project in the first place?
- Quality Audit: How does the organization know that its systems for assisting staff with their career planning and employment placements are appropriately effective and constructive?
- Change Request: Why were my requested changes rejected or not made?
- Decision Log: Do strategies and tactics aimed at less than full control reduce the costs of management or simply shift the cost burden?
- Procurement Audit: Does the procurement ISO 14971 project comply with European Communities regulations and rules?
- Responsibility Assignment Matrix: Which resource planning tool provides information on resource responsibility and accountability?
- Stakeholder Management Plan: Will the current technology alter during the life of the ISO 14971 project?
Step-by-step and complete ISO 14971 Project Management Forms and Templates including check box criteria and templates.
1.0 Initiating Process Group:
- 1.1 ISO 14971 project Charter
- 1.2 Stakeholder Register
- 1.3 Stakeholder Analysis Matrix
2.0 Planning Process Group:
- 2.1 ISO 14971 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 14971 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 14971 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 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.