ISO 9001 Toolkit

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Confirm your organization ensures the quality policy is understood, implemented and maintained at all levels of your organization through adequate organizational structure to ensure the devices are designed and produced in accordance with the requirements of the Quality System Regulation and ISO 9001.

More Uses of the ISO 9001 Toolkit:

  • Execute lean manufacturing techniques and design using a combination of engineering, project management, structured problem solving and influencing skills.

  • Collaborate with supervisor on the implementation or operation of compliance programs, ensuring organization is aware of any compliance requirements and issues.

  • Perform complex in process and final inspections of an electro mechanical nature using a variety of inspection methods and techniques to determine if a product meets quality standards.

  • Utilize root cause analysis to evaluate all systems for gaps, recommend action and professionally communicate to management the analysis to continually improve quality.

  • Engage in continuous knowledge development regarding sectors rules, regulations, best practices, tools, techniques, and performance standards.

  • Ensure that an internal audit program is adopted to verify that the QMS conforms to planned arrangements and is effectively implemented and maintained.

  • Initiate: strategically plan, develop, promote, and implement programs crafted to improve supplier performance and efficiency and reduce overall costs.

  • Establish that your organization supports engineering efforts by participating in design and process development projects representing quality and ensuring compliance to industry and customer requirements.

  • Steer: equipment qualification, maintenance and calibration research new equipment, methods, and procedures to support ongoing product improvements and new product initiatives.

  • Secure that your organization collects and analyzes data for root cause determination and implements continual improvement or problem solving methodologies to improve process performance, quality performance, compliance to requirements, improve customer satisfaction, reduce costs, or improve efficiency.

  • Drive: effectively manage the closed loop problem resolution process to minimize the impact of quality issues to the field/customer from proper material containment and screening to rigorous root cause identification and corrective action implementation to prevent recurrence.

  • Manage project budgets, conduct monthly invoicing, execute project change orders, and seek out invoice collections on multiple concurrent projects.

  • Be accountable for ensuring relevant standard requirements in accordance with ISO 9001, ISO 50001 and other applicable quality/compliance standards in the area of responsibility.

  • Warrant that your organization prioritizes tasks as necessary to assure product and process adherence to applicable specifications/ standards, customer, and internal requirements.

  • Ensure you pilot; build internal relationships, assessing the capabilities of suppliers and service providers, shifting spend to better performing entities and driving continuous improvement.

  • Make decisions regarding accurate application after analyzing remittance detail in comparison with customer open items and organization general ledgers, using established methods and procedures as guidelines for application.

  • Perform finished product evaluations for lot approval, ingredient and packaging evaluations, product development related testing, aql, concerns investigation and effectiveness testing.

  • Maintain engineering compliance to ISO 9001 and ISO 14000 standards and with organization affirmative action plan and organization safety procedures.

  • Audit: under direction, facilitates the development of a quality assurance program and oversees inspections and corrective action plans that meet or exceed maintenance and supply standards.

  • Ensure you account for; lead failure investigation and corrective action for customer related failures, and facilitate customer quality and reliability interactions.

  • Identify: interface with various internal groups (engineering, operations, quality assurance, regulatory, field personnel, marketing) concerning product and customer service issues.

  • Manage the interpretation of in process and analytical data to make quality evaluations, recommend actions for improvement, and assure resolution.

  • Develop high performing team and future leaders by coaching and improving individual capability through performance management systems and processes.

  • Collaborate with human resources department to ensure the implementation of consistent disciplinary action strategies in cases of compliance standard violations.


Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 9001 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any ISO 9001 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 9001 specific requirements:

STEP 1: Get your bearings

Start with...

  • The latest quick edition of the ISO 9001 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 992 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 9001 improvements can be made.

Examples; 10 of the 992 standard requirements:

  1. Do you have information on risk management with respect to organizational structure and impartiality for your organization that offers ISO 9001 registration services?

  2. Should a supporting model be created for lower organization levels with objectives and measures that feed into the higher level objectives and measures?

  3. How do you improve the ways in which projects are planned so that realistic and useful measurement of outcomes and value for money becomes possible?

  4. Have top management ensured that all responsibilities and authorities for relevant roles are assigned and communicated within your organization?

  5. Are nonconforming materials removed from the production areas and permanently identified or destroyed to preclude further usage?

  6. Is there an established and documented quality system, including a quality manual, which satisfies ISO 9000 series requirements?

  7. Does the enterprise comply to the ISO 9001 requirement upon product identification and classification within the enterprise?

  8. Does the enterprise comply to the ISO 9001 requirement upon having product traceability capability within the enterprise?

  9. Are procedures established to certify personnel and/or equipment for special processes as may be required contractually?

  10. Does ISO 9001 still apply to all organizations - big, small, different sectors and different items – products, services?

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 9001 book in PDF containing 992 requirements, which criteria correspond to the criteria in...

Your ISO 9001 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 9001 Self-Assessment and Scorecard you will develop a clear picture of which ISO 9001 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 9001 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 9001 projects with the 62 implementation resources:

  • 62 step-by-step ISO 9001 Project Management Form Templates covering over 1500 ISO 9001 project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Stakeholder Management Plan: Have adequate resources been provided by management to ensure ISO 9001 project success?

  2. Activity Duration Estimates: Does a procedure exist to ensure the ISO 9001 project work is completed in the appropriate sequence and on time?

  3. Change Management Plan: Is there an adequate supply of people for the new roles?

  4. Stakeholder Management Plan: Are enough systems & user personnel assigned to the ISO 9001 project?

  5. Risk Audit: Has risk management been considered when planning an event?

  6. Schedule Management Plan: Is a process for scheduling and reporting defined, including forms and formats?

  7. Cost Baseline: Is the requested change request a result of changes in other ISO 9001 project(s)?

  8. Procurement Audit: Does the strategy ensure that appropriate controls are in place to ensure propriety and regularity in delivery?

  9. Activity Attributes: Have constraints been applied to the start and finish milestones for the phases?

  10. Procurement Audit: Are contract changes after awarding properly justified and executed?

Step-by-step and complete ISO 9001 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

  • 1.1 ISO 9001 project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix

2.0 Planning Process Group:

  • 2.1 ISO 9001 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 9001 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 9001 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 9001 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 9001 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 9001 project with this in-depth ISO 9001 Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose ISO 9001 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 9001 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 9001 investments work better.

This ISO 9001 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.