ISO 13485 Toolkit

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Provide guidance and support for product and Process Changes by working with the Cross Functional Team to determine the implantation requirements based on applicable Industry Standards and regulations.

More Uses of the ISO 13485 Toolkit:

  • Arrange that your group contributes to Cost Estimates and production schedules by compiling labor, tooling, and Manufacturing Cost and improve results.

  • Arrange that your strategy initiates and completes technical activities leading to new or improved processes for current and next generation programs and to meet Strategic Goals and objectives of your organization.

  • Collaborate with the manufacturing team to develop Test Plans, protocols, batch records, and reports to ensure designs and processes meet product specifications, Regulatory Requirements and standards.

  • Generate and execute Test Plans and protocols, derived from feasibility assessments, product functional/performance requirements, Risk Analysis, etc.

  • Create manual and Automated Test protocols from technical designs, specifications, and requirements at sub system and system level.

  • Create Automated Testing solutions from technical designs, interface specifications, and requirements at sub system and system level.

  • Be accountable for during that time your organization has successfully serviced thousands of customer orders and employed thousands of contract employees at hundreds of different customer work sites.

  • Ensure that Software Applications and related infrastructures are validated for intended use by a controlled and documented process.

  • Pilot: there would also be a system this person would put in so you know how many units you have at any given time and at your fingertips.

  • Oversee and lead the QMS processes of Internal Auditing, Complaint Handling and Adverse Events, Corrective / Preventive Action, Document and Records Control.

  • Ensure raw materials are properly issued, staged, and returned to warehouse with proper paperwork (when not consumed in production).

  • Identify: review and assess the impact of equipment that fails calibration, and documenting calibration requirements for newly acquired equipment.

  • Develop departmental standards and guidelines for Change Control inputs and requirements needed to support Change Control packets.

  • Confirm your strategy communicates with other departments to ensure account order timelines, customer inquiries, and overall satisfaction exceeds expectations.

  • Participate and collaborate objectively with Team Members to achieve consistent processes while identifying Process Improvements to drive efficiency and compliance.

  • Manage work with Design Engineers to translate System Requirements and system Risk Analyses into component level requirements, designs and Risk Management approaches.

  • Warrant that your strategy complies; monitors Manufacturing Processes for compliance with Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP) requirements.

  • Warrant that your planning provides manufacturing management with the necessary technical expertise to identify operational requirements with respect to current and future manufacturing strategies.

  • Facilitate Change Control activities with cross Functional Stakeholders to create schedules and monitor the deliverables against the timeline.

  • Confirm your strategy compares quantity and part number of items received with procurement data and other specifications to ensure completeness and accuracy of order.

  • Manage: interface with operations to assure that quality considerations and requirements are adequately covered in manufacturing procedures, equipment selection, design, validation and training.

  • Make sure that your business complies; Stress Management functioning effectively when under pressure and maintaining self control in the face of hostility or provocation.

  • Audit: Problem Solving and troubling shooting skills are used to identify root causes and take fast effective action to resolve the problems affecting production.

  • Arrange that your team provides the team with oversight and guidance of equipment set up, monitoring, and process adjustments to optimize product cost, material variances and line efficiencies.

  • Audit: batch record review and finished goods release while ensuring that product specifications and organization and Regulatory Requirements are met.

  • Orchestrate: quality tools Problem Solving methodologies / statistical Process Control / Process Capability / ISO 13485 / Design Of Experiments / sampling plans.

  • Coordinate: continually improve the budgeting process through education of department managers on financial issues impacting department budgets.

  • Audit: review information provided from the Call Center, field organization and Customer Feedback systems and provide evaluation as to whether service events constitute complaints.

  • Develop documentation as Test Plans, protocols, reports, and traceability matrices to meet Compliance Standards with the defined processes.

  • Methodize: monitor competition by gathering current marketplace information on pricing, products, new products, merchandising techniques, etc.


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 999 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 999 standard requirements:

  1. How to cause the change?

  2. What are the necessary qualifications?

  3. Why the need?

  4. What ISO 13485 improvements can be made?

  5. What causes extra work or rework?

  6. Is ISO 13485 realistic, or are you setting yourself up for failure?

  7. Who makes the ISO 13485 decisions in your organization?

  8. Risk events: what are the things that could go wrong?

  9. Are losses documented, analyzed, and remedial processes developed to prevent future losses?

  10. Is there a Work Around that you can use?

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 994 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. Cost Management Plan: Eac -estimate at completion, what is the total job expected to cost?

  2. Activity Cost Estimates: In which phase of the Acquisition Process cycle does source qualifications reside?

  3. Project Scope Statement: Will all ISO 13485 project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the ISO 13485 Project Team have enough people to execute the ISO 13485 Project Plan?

  5. Source Selection Criteria: What are the guidelines regarding award without considerations?

  6. Scope Management Plan: Are Corrective Actions taken when actual results are substantially different from detailed ISO 13485 Project Plan (variances)?

  7. Initiating Process Group: During which stage of Risk planning are risks prioritized based on probability and impact?

  8. Cost Management Plan: Is your organization certified as a supplier, wholesaler, regular dealer, or manufacturer of corresponding products/supplies?

  9. Procurement Audit: Was a formal review of tenders received undertaken?

  10. Activity Cost Estimates: What procedures are put in place regarding bidding and cost comparisons, if any?

Step-by-step and complete ISO 13485 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

2.0 Planning Process Group:

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.