ISO 13485 Toolkit

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. How does the organization demonstrate that it has implemented a post-market surveillance system that is capable of collecting, analyzing, and acting on feedback from customers, users, and other stakeholders to identify potential issues with its medical devices?
   
   

2. How does ISO 13485 require medical device manufacturers to evaluate the provider's process for verifying the device's safety and performance after installation and commissioning, and what documentation is required to support this evaluation?
   
   

3. What are the requirements for providers to have a process for controlling and maintaining records of the installation and commissioning activities, and how does this process need to align with the manufacturer's quality management system?
   
   

4. How do auditing and certification bodies ensure that their audit processes are transparent, consistent, and repeatable, and that they are based on a thorough risk assessment of the medical device manufacturer's quality management system?
   
   

5. How does ISO 13485 require medical device manufacturers to evaluate the provider's training and competence of personnel performing installation and commissioning activities, and what documentation is required to support this evaluation?
   
   

6. How do organizations manage regulatory submission communications, including communications with regulatory agencies, Notified Bodies, and other stakeholders, and what procedures are in place to ensure effective and timely communication?
   
   

7. What are the requirements for providers to have a process for managing and controlling the confidentiality and privacy of sensitive information, and how does this process need to align with the manufacturer's quality management system?
   
   

8. How does ISO 13485 require medical device manufacturers to evaluate the provider's process for controlling and verifying the installation and commissioning activities, and what documentation is required to support this evaluation?
   
   

9. How should medical device manufacturers ensure that laboratory testing and inspection activities are aligned with the overall quality management system, and what measures should be taken to ensure laboratory process integration?
   
   

10. How does the standard address the issue of storage and warehousing of medical devices that require special labeling or packaging, and what are the requirements for ensuring that these labels and packages are correct and intact?
    
    


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. Activity Duration Estimates: Consider the common sources of risk on information technology ISO 13485 projects and suggestions for managing them. Which suggestions do you find most useful?
   
   

2. Planning Process Group: To what extent has a PMO contributed to raising the quality of the design of the ISO 13485 project?
   
   

3. Project or Phase Close-Out: Have business partners been involved extensively, and what data was required for them?
   
   

4. Lessons Learned: If issue escalation was required, how effectively were issues resolved?
   
   

5. Procurement Audit: Is the approval graduated according to the amount disbursed?
   
   

6. Stakeholder Management Plan: Is there a formal process for updating the ISO 13485 project baseline?
   
   

7. Probability and Impact Matrix: What will be the likely political situation during the life of the ISO 13485 project?
   
   

8. Activity Duration Estimates: List five reasons why organizations outsource. Why is there a growing trend in outsourcing, especially in the government?
   
   

9. Requirements Management Plan: Do you have an appropriate arrangement for meetings?
   
   

10. Risk Management Plan: Are the required plans included, such as nonstructural flood risk management plans?


 
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.