ISO 10012 Toolkit

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Communicate regularly with Functional Managers, Project Management Steering Committee Members, Executive Sponsor and other project stakeholders to appraise all regarding status of the project, issues impeding progress, earned value and recovery plans for off track items/tasks.

More Uses of the ISO 10012 Toolkit:

  • Develop, review, and edit information Security Policies and procedures and provide guidance to clients regarding best practices.

  • Evaluate clients Cybersecurity program based upon a recognized framework or regulation as the NIST Cybersecurity Framework, HIPAA security rule, PCI Data Security standard, ISO standards, etc.

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

  • Follow your organizations Project Management and secure SDLC framework and processes to ensure structured and effective implementation and operations.

  • Ensure your business complies; cross functional collaboration between Manufacturing Engineering, production, purchasing, and product Development Teams.

  • Develop and manage the automation of KRIs and KPI reporting that align with operational/Business Risk areas and corporate risk.

  • Assure your design complies; clients turn to you for real solutions to real problems, ranging from one off regulatory projects to long term Managed Services.

  • Provide guidance on building and/or maturing Information security programs and the implementation of tools and technologies used for enterprise security.

  • Create and execute Test Plans/processes before every release to ensure new features behave as expected without breaking functionality of applications.

  • Oversee: design, manage, upgrade and deploy standardized hardware and software images and configurations for the end user computing environment in alignment with business requirement.

  • Confirm you research; lead security related implementations and projects by coordinating with technical and non technical teams to ensure success.

  • Coordinate: operationalization of a metrics and reporting function to continually report on meaningful security, risk and compliance metrics for operational and Executive Management.

  • Promote collaboration with your developers and vulnerability researchers to prioritize the attack tool planning and custom development.

  • Warrant that your organization assures product and process quality by designing testing methods; establishing standards and process capabilities and confirming Manufacturing Processes.

  • Ensure you rate; lead and/or lead technical considerations around projects and initiatives that require a Security Architecture and design component.

  • Evaluate: participation in the technical standardization activities of the international organization for standardization (ISO).

  • Standardize: design, implement, maintain a quality function that ensures parts are being produced at a high level of Customer Satisfaction.

  • Apply the appropriate management techniques given project specific needs, risks and differences in core team member skill levels.

  • Organize: work closely with business, technology, and compliance counterparts to understand Business Objectives, initiatives, and ensure alignment of Information security risk.

  • Arrange that your group demonstrates the business and financial acumen necessary to develop and present data based ideas and solutions in a clear, concise, organized manner.

  • Confirm your planning ensures the effective use of materials, equipment, and personnel in producing quality products at minimum costs.

  • Collaborate with the management team to improve marketing materials and expand your organizations marketing presence in the (specified) territory.

  • Become capable of becoming a key contributor to the implementation of system security solutions in a multi vendor, complex healthcare environment.

  • Manage work with equipment users, engineers, and other technicians in the proper operation and selection of test and measurement equipment.

  • Ensure you outperform; spearhead the multilateral negotiations on all the various aspects of the transaction commercial, legal, technical.

  • Pilot: source data from all the functional areas need to be properly modeled and transformed across the solution for effective analysis and reporting.

  • Ensure you guide; lead business and technology integration professionals advise upon, design, develop and/or deliver technology solutions that support best practice lead business changes.

  • Devise: effectively interact with production and Development Teams to maintain product supply and help introduce new products.

  • Establish and manage compliance with necessary IT Policies and Procedures for the smooth operations and recovery of the computing environment.

  • Ensure tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary.


Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 10012 Toolkit and guide. Address common challenges with best-practice templates, step-by-step Work Plans and maturity diagnostics for any ISO 10012 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 10012 specific requirements:

STEP 1: Get your bearings

Start with...

  • The latest quick edition of the ISO 10012 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 ISO 10012 improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. Is the Quality Assurance team identified?

  2. Is the scope of ISO 10012 cost analysis cost-effective?

  3. What training and qualifications will you need?

  4. How sensitive must the ISO 10012 strategy be to cost?

  5. What information do you gather?

  6. How will you measure success?

  7. Who do you want your customers to become?

  8. Is ISO 10012 dependent on the successful delivery of a current project?

  9. What are the record-keeping requirements of ISO 10012 activities?

  10. What is measured? Why?

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 10012 book in PDF containing 994 requirements, which criteria correspond to the criteria in...

Your ISO 10012 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 10012 Self-Assessment and Scorecard you will develop a clear picture of which ISO 10012 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 10012 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 10012 projects with the 62 implementation resources:

  • 62 step-by-step ISO 10012 Project Management Form Templates covering over 1500 ISO 10012 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 ISO 10012 project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the ISO 10012 project team have enough people to execute the ISO 10012 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 ISO 10012 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 ISO 10012 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 ISO 10012 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 10012 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 10012 project with this in-depth ISO 10012 Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose ISO 10012 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 10012 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 10012 investments work better.

This ISO 10012 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.