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:
- Meeting the challenge: are missed ISO 13485 opportunities costing us money?
- Is there any reason to believe the opposite of my current belief?
- Who needs to know about ISO 13485 ?
- Which ISO 13485 goals are the most important?
- What error proofing will be done to address some of the discrepancies observed in the ‘as is’ process?
- How do we go about Comparing ISO 13485 approaches/solutions?
- Who else should we help?
- What are your current levels and trends in key ISO 13485 measures or indicators of product and process performance that are important to and directly serve your customers?
- Customer Measures: How Do Customers See Us?
- Do you, as a leader, bounce back quickly from setbacks?
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:
- 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?
- Schedule Management Plan: Perform reality checks on schedules – are all tasks included?
- Cost Management Plan: Have the key functions and capabilities been defined and assigned to each release or iteration?
- Responsibility Assignment Matrix: What Are Some Important ISO 13485 project Communications Management Tools?
- Procurement Management Plan: Are adequate resources provided for the quality assurance function?
- Quality Audit: How does the organization know that its Governance system is appropriately effective and constructive?
- Probability and Impact Matrix: Which of your ISO 13485 projects should be selected when compared with other ISO 13485 projects?
- Initiating Process Group: Do you understand the quality and control criteria that must be achieved for successful ISO 13485 project completion?
- Cost Management Plan: Milestones – What are the key dates in executing the contract plan?
- Decision Log: How consolidated and comprehensive a story can we tell by capturing currently available incident data in a central location and through a log of key decisions during an incident?
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.