ISO 13485 Toolkit

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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

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 993 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 993 standard requirements:

  1. Does the procedure that defines & controls formal design reviews specify when reviews are required, participants, decisions made, and follow-up actions and is under revision control?

  2. Does the contract review procedure define the processes used to assure order commitments can and are met on time, completely and is there evidence of proper implementation?

  3. What evidence is available that your organization evaluates and selects suppliers based on ability to supply product in accordance with your organizations requirements?

  4. Is there a procedure defining means to monitor supplier performance and the need for re-assessment and/or corrective action and is there is evidence of implementation?

  5. Are procedures in place that define the content, location and retention of quality system records and process control records, and are records of compliance available?

  6. Has the establishment of a procedure on requirements and responsibilities, record maintenance and information exchange with external parties been implemented?

  7. How do you conduct your review of the system to ensure that all areas of the system are functioning and improvements are happening where planned and expected?

  8. Is there a procedure that defines the identification of product and materials at receiving and incoming inspection, and is there evidence of compliance?

  9. Is there a procedure that defines the identification of product and materials throughout the manufacturing process and is there evidence of compliance?

  10. Is there a procedure defining actions required if equipment is found out of calibration and is there evidence that corresponding actions are recorded?


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 993 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 1500 ISO 13485 project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Team Directory: Process decisions: are contractors adequately prosecuting the work?

  2. Project Schedule: Eliminate unnecessary activities. Are there activities that came from a template or previous ISO 13485 project that are not applicable on this phase of this ISO 13485 project?

  3. Stakeholder Analysis Matrix: Who has been involved in the area (thematic or geographic) in the past?

  4. Procurement Audit: Is the foreseen budget compared with similar ISO 13485 projects or procurements yet realised (historical standards)?

  5. Variance Analysis: Is work properly classified as measured effort, LOE, or apportioned effort and appropriately separated?

  6. Procurement Audit: Are there policies regarding special approval for capital expenditures?

  7. Team Performance Assessment: What structural changes have you made or are you preparing to make?

  8. Risk Audit: Are end-users enthusiastically committed to the ISO 13485 project and the system/product to be built?

  9. Source Selection Criteria: Does an evaluation need to include the identification of strengths and weaknesses?

  10. Probability and Impact Matrix: What is the level of experience available with your organization?

 
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.

 

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.