ISO 13408 Toolkit

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Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 13408 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any ISO 13408 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 13408 specific requirements:


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the ISO 13408 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 998 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 13408 improvements can be made.

Examples; 10 of the 998 standard requirements:

  1. Is the client eligible for payment of compensation for sterilization in case the first sterilization procedure was unsuccessful and client returns for a repeat sterilization procedure again?

  2. Does the biosecurity program and/or site specific biosecurity plan include provisions for procedures for cleaning, disinfection, or restriction of sharing of equipment where applicable?

  3. Are documented cleaning and disinfection procedures in place and effective, including verification activities, to ensure the cleanliness of the facility, utilities and equipment?

  4. Are reusable, heat sensitive, semi critical items that cannot be replaced by heat stable or disposable high level disinfected according to the manufacturers instructions?

  5. Are work surfaces decontaminated after completion of work and after any spill or splash of potentially infectious material with an appropriate disinfectant?

  6. Have employees been trained to allow the disinfectant to sit for the period of time required by the manufacturer to effectively disinfect the surface?

  7. Is personal protective clothing or equipment that employees are required to wear or use, of a type capable of being cleaned easily and disinfected?

  8. Is your staff trained and validated in proper hand hygiene and guarding techniques, aseptic techniques, cleanroom regulations and USP Guidelines?

  9. Do providers who have retired from service and had earlier been providing sterilization services need to be re trained before fresh empanelment?

  10. Is there a provision for drop back facility/overnight stay for sterilization clients from identified hard to reach and difficult areas?


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 13408 book in PDF containing 998 requirements, which criteria correspond to the criteria in...

Your ISO 13408 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 13408 Self-Assessment and Scorecard you will develop a clear picture of which ISO 13408 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 13408 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 13408 projects with the 62 implementation resources:

  • 62 step-by-step ISO 13408 Project Management Form Templates covering over 1500 ISO 13408 project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Activity Duration Estimates: Is the cost performance monitored to identify variances from the plan?

  2. Source Selection Criteria: What past performance information should be requested?

  3. Activity Duration Estimates: Are changes to the scope managed according to defined procedures?

  4. Change Request: Does the schedule include ISO 13408 project management time and change request analysis time?

  5. Quality Management Plan: Checking the completeness and appropriateness of the sampling and testing. Were the right locations/samples tested for the right parameters?

  6. Probability and Impact Assessment: Can this technology be absorbed with current level of expertise available in your organization?

  7. Procurement Audit: Proper and complete records of transactions and events are maintained?

  8. Stakeholder Analysis Matrix: How does the ISO 13408 project involve consultations or collaboration with other organizations?

  9. Project or Phase Close-Out: Were messages directly related to the release strategy or phases of the ISO 13408 project?

  10. Cost Management Plan: Is it standard practice to formally commit stakeholders to the ISO 13408 project via agreements?

 
Step-by-step and complete ISO 13408 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

  • 1.1 ISO 13408 project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:

  • 2.1 ISO 13408 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 13408 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 13408 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 13408 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 13408 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 13408 project with this in-depth ISO 13408 Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose ISO 13408 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 13408 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 13408 investments work better.

This ISO 13408 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.