Quality System Toolkit

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Provide expertise in Quality Assurance and Process Improvement tools and methods to the other functions of your organization to support them in the Continuous Improvement activities to ensure compliance with the policies of the Quality System.

More Uses of the Quality System Toolkit:

  • Provide risk Management Support to quality subsystems of health hazard evaluation/health Risk Assessment process, risk Management Review, Quality System Management Review, and post Market Surveillance.

  • Determine an appropriate level of testing, verification and/or validation for new automation platforms and methods, develop corresponding plans and summary reports commensurate with Quality Systems requirements.

  • Identify and record any problems relating to the product, process, or Quality Systems; Control further processing and delivery of nonconforming product until the deficiency is corrected.

  • Develop, implement, communicate and maintain a quality plan to bring your organizations Quality Systems and Policies into compliance with Quality System Requirements.

  • Continue to develop, implement, communicate, and maintain the Processing Quality Control program to ensure the products are manufactured in compliance with organization Quality System and/or Customer Expectations.

  • Contribute to Technical Requirements, architecture, specifications, and design documentation compliant with your established Quality System and Design Controls.

  • Confirm your enterprise participates in Design Review with cross functional teams to ensure that conformance to specifications, Design For Inspection, reliability, and Quality System objectives are met.

  • Develop training in quality, Problem Solving and Continuous Improvement activities to raise the level of Quality Systems competence in Manufacturing Operations.

  • Be accountable for ensuring a Quality System Design which provides good system performance, an effective Human Machine Interface, optimal operational cost, and flexibility for future change.

  • Confirm your project complies; audits Quality Systems for deficiency identification and correction, ensures that corrective measures meet acceptable Quality Standards and that documentation is compliant with requirements.

  • Audit: conduct and/or support Root Cause investigations, develop and implement corrective and preventative actions for Quality System and product related nonconformances.

  • Coordinate: plan, lead, manage, Process Control and activities related to Quality Systems management, to assure customer standards and regulations compliance, and Continuous Improvement.

  • Ensure your project complies; plans, conducts, or leads activities and projects concerned with Quality Systems, Process Control, Quality Assurance, Risk Analysis, Process Improvement, and validation of manufacturing and Business Processes in a regulated environment.

  • Confirm your group supports the design, implementation and maintenance of the Quality Systems, procedures, and policies to ensure compliance with the current regulations and all applicable Regulatory Requirements.

  • Assure that systems and procedures used are documented, implemented, and effectively used and are consistent with the policies contained in the Quality Systems manual and its supporting documentation.

  • Ensure quality through adherence to the Quality Systems Manual, applicable Standard Work Instructions and other standards invoked internally or contractually.

  • Ensure your design complies; implements and maintains Quality Systems to capture, monitor, and manage product and process quality to Support Organization tactical and strategic business goals and objectives.

  • Warrant that your business assess engine components and tools, Supplier Quality Systems, supplier selection, and Strategic Sourcing Process Development with the objective of overall Quality Improvement and resolution of supplier Quality Issues.

  • Warrant that your team determines and implements best Strategic Direction for Quality Systems function with regard to organization, competencies, human and fiscal Resource Planning, Quality Planning and Quality Systems Best Practices.

  • Secure that your organization provides oversight and leadership to manage multiple complex projects and initiatives that deliver high Quality Systems on schedule, on budget, to the committed scope.

  • Evaluate and verify supplier Process Controls and Supplier Quality Systems, analyze product failures, facilitate writing and/or approve results of Corrective Actions of suppliers.

  • Warrant that your team contributes to the development of high Quality Systems and products by ensuring adoption of standards, Best Practices, Processes And Procedures at every phase of the Software Development lifecycle; requirements to release.

  • Take responsibility for all aspects of your Supply Chain, working with suppliers to ensure complete compliance with your Quality Systems, and ethical policies while optimizing your costs and overall efficiencies.

  • Confirm your planning maintains compliance with established government and organization Safety Regulations, environmental and emergency procedures and Quality System Requirements.

  • Supervise: design, implement and maintain a program for internal Quality System training; manage the performance of process audits of departments to ensure compliance with Quality System, organization procedures, and applicable regulations.

  • Direct: document and respond to inquiries from existing and prospective external SharePoint platform users and provide User Support regarding procedures for correctly interfacing with Data Reporting functions.

  • Lead the development and implementation of innovative and beneficial programs/projects aimed at improving Customer Satisfaction, Quality Systems, and Operational Efficiency.

  • Be accountable for working closely with the Quality Management (owner of Quality Systems and associated audits) to identify critical Audit Process and/or compliance gaps and take appropriate actions.

  • Confirm your business advises on and participates in the monitoring of statistical quality data; identifies areas for improvement in the Quality System based on trends; generates reports to communicate outcomes of quality activities.

  • Provide Quality Systems technical expertise and/or support to facilities, suppliers, and other functional teams in large complex facilities or where highly regulated products are produced.


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

STEP 1: Get your bearings

Start with...

  • The latest quick edition of the Quality System 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 Quality System improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. Who is going to spread your message?

  2. What would have to be true for the option on the table to be the best possible choice?

  3. Does a good decision guarantee a good outcome?

  4. Why will customers want to buy your organizations products/services?

  5. Are the Quality System Requirements complete?

  6. Where can you go to verify the info?

  7. What is the cause of any Quality System gaps?

  8. How can skill-level changes improve Quality System?

  9. What is the recognized need?

  10. Why improve in the first place?

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 Quality System book in PDF containing 994 requirements, which criteria correspond to the criteria in...

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

  • 62 step-by-step Quality System Project Management Form Templates covering over 1500 Quality System 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 Quality System project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the Quality System Project Team have enough people to execute the Quality System 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 Quality System 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 Quality System 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 Quality System 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 Quality System project or Phase Close-Out
  • 5.4 Lessons Learned



With this Three Step process you will have all the tools you need for any Quality System project with this in-depth Quality System Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose Quality System 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 Quality System 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 Quality System investments work better.

This Quality System 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.