Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 13485 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any ISO 13485 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 13485 specific requirements:
STEP 1: Get your bearings
- The latest quick edition of the ISO 13485 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 703 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 13485 improvements can be made.
Examples; 10 of the 703 standard requirements:
- What are the revised rough estimates of the financial savings/opportunity for ISO 13485 improvements?
- Has implementation been effective in reaching specified objectives?
- Has the improvement team collected the ‘voice of the customer’ (obtained feedback; qualitative and quantitative)?
- How do we know that any ISO 13485 analysis is complete and comprehensive?
- How can we measure the performance?
- Are gaps between current performance and the goal performance identified?
- How do we foster innovation?
- Design Thinking: Integrating Innovation, ISO 13485, and Brand Value
- Where is it measured?
- how do senior leaders actions reflect a commitment to the organizations ISO 13485 values?
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 13485 book in PDF containing 703 requirements, which criteria correspond to the criteria in…
Your ISO 13485 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 13485 Self-Assessment and Scorecard you will develop a clear picture of which ISO 13485 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 13485 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 13485 projects with the 62 implementation resources:
- 62 step-by-step ISO 13485 Project Management Form Templates covering over 6000 ISO 13485 project requirements and success criteria:
Examples; 10 of the check box criteria:
- Project Portfolio management: How does the organization ensure that ISO 13485 project and program benefits and risks are being managed to optimize the overall value creation from the portfolio?
- Quality Management Plan: Explain the procedures used to verify the data quality of the data being reviewed?
- Team Member Performance Assessment: Should a Ratee get a copy of all the Raters documents about the employees performance?
- Human Resource Management Plan: Do all stakeholders know how to access this repository and where to find the ISO 13485 project documentation?
- Scope Management Plan: Are corrective actions taken when actual results are substantially different from detailed ISO 13485 project plan (variances)?
- Change Request: What must be taken into consideration when introducing change control programs?
- WBS Dictionary: Is each control account assigned to a single organizational element directly responsible for the work and identifiable to a single element of the CWBS?
- Team Operating Agreement: Do you use a parking lot for any items that are important but outside of the agenda?
- Probability and Impact Assessment: What are the uncertainties associated with the technology selected for the ISO 13485 project?
- Schedule Management Plan: Are all payments made according to the contract(s)?
Step-by-step and complete ISO 13485 Project Management Forms and Templates including check box criteria and templates.
1.0 Initiating Process Group:
- 1.1 ISO 13485 project Charter
- 1.2 Stakeholder Register
- 1.3 Stakeholder Analysis Matrix
2.0 Planning Process Group:
- 2.1 ISO 13485 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 13485 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 13485 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 13485 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 13485 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 13485 project with this in-depth ISO 13485 Toolkit.
In using the Toolkit you will be better able to:
- Diagnose ISO 13485 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 13485 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 13485 investments work better.
This ISO 13485 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.