ISO 14971 Toolkit

Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 14971 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any ISO 14971 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 14971 specific requirements:

STEP 1: Get your bearings

Start with...


• The latest quick edition of the ISO 14971 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 996 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 14971 improvements can be made.

Examples; 10 of the 996 standard requirements:


1. How does ISO 14971 emphasize the role of risk management in ensuring that medical device maintenance and repair activities are aligned with the device's intended use and patient safety, and what are the specific requirements for manufacturers to establish procedures for maintenance and repair that minimize the likelihood of device failure or malfunction?
   
   

2. How do the principles of risk-based medical device usability engineering, such as fault tree analysis and failure mode and effects analysis (FMEA), support the identification and prioritization of potential hazards and hazardous situations, and what are the benefits of integrating these approaches with traditional risk management methods?
   
   

3. In what ways does the standard highlight the importance of considering the entire lifecycle of a medical device, from design and development to production and distribution, when assessing and mitigating supply chain risks, and how can manufacturers ensure that supply chain risks are integrated into their overall risk management strategy?
   
   

4. What emerging trends and technologies, such as artificial intelligence, blockchain, and the Internet of Things, are likely to reshape the risk management landscape for combination products, and what opportunities and challenges do these advancements present for manufacturers seeking to implement a comprehensive risk management process?
   
   

5. What is the significance of clinical trials in evaluating the impact of changes to medical devices, such as design modifications or software updates, on the overall risk profile of the device, and how do these trials inform the risk assessment and evaluation process to ensure that these changes do not introduce new risks or hazards?
   
   

6. What are the key training and competency requirements outlined in ISO 14971 for personnel involved in the design, manufacturing, and maintenance of medical devices, and how do these requirements ensure that personnel have the necessary skills and knowledge to identify and mitigate risks associated with modifications or upgrades?
   
   

7. How does the establishment of a risk acceptance criteria, including the definition of acceptable risk levels and the determination of risk evaluation metrics, influence the risk analysis process, and what are the implications of not having a clear and well-defined risk acceptance criteria on the overall risk management process?
   
   

8. What is the role of Hazard Identification in the risk analysis process, including the identification of potential hazards, the evaluation of their likelihood and severity, and the prioritization of hazards for further analysis, and how do the results of Hazard Identification inform the overall risk management process?
   
   

9. In what ways do the varying regulatory requirements and expectations between pharmaceuticals and medical devices create complexity and uncertainty for manufacturers seeking to implement a comprehensive risk management process for combination products, and what strategies can be employed to reconcile these differences?
   
   

10. In what ways can the application of risk-based medical device usability engineering principles support the development of more effective and targeted risk communication strategies, such as instructions for use and labeling, and what are the implications for enhancing user understanding and safe use of medical devices?
    
    


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 14971 book in PDF containing 996 requirements, which criteria correspond to the criteria in...


Your ISO 14971 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 14971 Self-Assessment and Scorecard you will develop a clear picture of which ISO 14971 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 14971 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 14971 projects with the 62 implementation resources:


• 62 step-by-step ISO 14971 Project Management Form Templates covering over 1500 ISO 14971 project requirements and success criteria:


Examples; 10 of the check box criteria:


1. Risk Audit: Is your organization able to present documentary evidence in support of compliance?
   
   

2. Procurement Audit: Are behaviour modification applied to change procurement of goods and services if procurement is not functioning properly?
   
   

3. Contract Close-Out: Have all contract records been included in the ISO 14971 project archives?
   
   

4. Lessons Learned: What are your lessons learned that you will keep in mind for the next ISO 14971 project you participate in?
   
   

5. Human Resource Management Plan: Have ISO 14971 project management standards and procedures been identified / established and documented?
   
   

6. Risk Audit: Are requirements fully understood by the team and customers?
   
   

7. Stakeholder Analysis Matrix: Do the stakeholders goals and expectations support or conflict with the ISO 14971 project goals?
   
   

8. Change Management Plan: What are you trying to achieve as a result of communication?
   
   

9. Quality Audit: It is inappropriate to seek information about the Audit Panels preliminary views including questions like why do you ask that?
   
   

10. Schedule Management Plan: Are assumptions being identified, recorded, analyzed, qualified and closed?


 
Step-by-step and complete ISO 14971 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:


• 1.1 ISO 14971 project Charter

• 1.2 Stakeholder Register

• 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:


• 2.1 ISO 14971 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 14971 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 14971 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 14971 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 14971 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 14971 project with this in-depth ISO 14971 Toolkit.

In using the Toolkit you will be better able to:


• Diagnose ISO 14971 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 14971 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 14971 investments work better.

This ISO 14971 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.