ISO 13485: Are we taking our company in the direction of better and revenue or cheaper and cost?

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.

 

https://store.theartofservice.com/ISO-13485-toolkit-best-practice-templates-step-by-step-work-plans-and-maturity-diagnostics/

 

The Toolkit contains the following practical and powerful enablers with new and updated ISO 13485 specific requirements:

STEP 1: Get your bearings

Start with…

  • 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:

  1. Are roles and responsibilities formally defined?

  2. What is our ISO 13485 Strategy?

  3. What are the barriers to increased ISO 13485 production?

  4. How do we create Buy-in?

  5. How can we best use all of our knowledge repositories to enhance learning and sharing?

  6. Are we taking our company in the direction of better and revenue or cheaper and cost?

  7. What is an unallowable cost?

  8. How do you measure the Operational performance of your key work systems and processes, including productivity, cycle time, and other appropriate measures of process effectiveness, efficiency, and innovation?

  9. How do your measurements capture actionable ISO 13485 information for use in exceeding your customers expectations and securing your customers engagement?

  10. How would one define ISO 13485 leadership?

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:

  1. Stakeholder Management Plan: What potential impact does the ISO 13485 project have on the stakeholder?
  2. Scope Management Plan: What is the organizations history in doing similar activities?
  3. Stakeholder Management Plan: What action will be taken once reports have been received?
  4. Project Schedule: Is the ISO 13485 project schedule available for all ISO 13485 project team members to review?
  5. Activity Duration Estimates: Which is the BEST thing to do to try to complete a ISO 13485 project two days earlier?
  6. Responsibility Assignment Matrix: The total budget for the contract (including estimates for authorized but unpriced work)?
  7. Initiating Process Group: Mitigate. What will you do to minimize the impact should the risk event occur?
  8. Activity Duration Estimates: Are changes to the scope managed according to defined procedures?
  9. Cost Management Plan: Do ISO 13485 project teams & team members report on status / activities / progress?
  10. Stakeholder Management Plan: Are regulatory inspections considered part of quality control?

 
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

 

Results

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:

 

https://store.theartofservice.com/ISO-13485-toolkit-best-practice-templates-step-by-step-work-plans-and-maturity-diagnostics/

 

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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