ISO 5 Toolkit

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Be accountable for providing regulatory intelligence by monitoring changing regulations, assessing impacts, and developing strategies as appropriate to influence and/or implement changing regulations for continued product compliance and safety excellence.

More Uses of the ISO 5 Toolkit:

  • Control: actively lead problem identification, Problem Solving, and change initiatives in cooperation with other teams and functions.

  • Be accountable for maintaining and optimizing the Quality Management System to support operational strategy, assure compliance with Customer Requirements and achieve organization objectives.

  • Develop and refine Standard Operating Procedures related to Human Factors Engineering, with close connection to the Product Development Process and Quality Management System.

  • Manage assembly equipment procurement to ensure equipment design concept challenges are successful and milestone dates are met.

  • Develop and direct formative usability studies during concept development and summative usability studies for human factors validation.

  • Coordinate and maintain an accurate and reliable Qualification (Training) Database and the maintenance of related Records.

  • Control: act as eyes and ears of the quality department to promote and coordinate good manufacturing practices (cGMP) and related good documentation practices (gdp) throughout all phases of Product Development and manufacturing.

  • Manage work with the Enterprise Response Center and Enterprise Emergency Management teams to create processes and support ongoing maintenance and communications for the tools.

  • Warrant that your organization complies; Continuous Learning actively identifies new areas for learning; regularly creates and takes advantage of learning opportunities; uses newly gained knowledge and skill on the job and learning through the application.

  • Oversee: monitor processes, Policies and Procedures and recommend improvements in production methods, equipment, operating procedures, Working Conditions (safety, quality, productivity, and cost) and Cost Effectiveness.

  • Assure your team uses Project Management skills to manage the project scope, time, and cost, develop the team, track and report progress against the plan, and take action to drive successful closing of all assigned projects.

  • Lead: actively lead corporate/cross facility teams to develop and implement new and improved systems as best practices and quality systems as need.

  • Be accountable for ensuring product risks are effectively communicated, understood, and mitigated to acceptable levels through Effective Communication and documentation processes.

  • Support maintenance of the Enterprise Emergency Management services catalog and integrating Enterprise Emergency Management into the Enterprise Security Services digital presence.

  • Be certain that your strategy interacts with others generally require influencing, instructing, and negotiating with individuals to gain understanding, cooperation and action.

  • Coordinate and maintain the accurate and reliable retention, and maintenance of all QMS Quality Records and QMS Control Logs.

  • Be certain that your project gathers and records data according to SOP and protocol guidelines, and performs technical evaluation of data to analyze, interpret, and provide written reports on results.

  • Coordinate: complete records in conformance with good documentation practices and QMS processes to record inspections, shipping and receiving.

  • Maximize the integration of ERP (Enterprise Resource Planning) system tools into all areas of organization daily activities.

  • Formulate: work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays.

  • Be accountable for assessing deliverables at the end of each week, lead considerations on how the CFT can improve for next week and starting to plan next weeks sprint.

  • Devise: work closely with Customer Service, quality, scheduling and various other departments to ensure production and quality of products meets specifications and delivery times.

  • Ensure you anticipate; engaged positive mindset, proactive, aware, intuitive, attentive, inquisitive, Continuous Improvement, growth, learning, conceptual thinker, creative, problem solver.

  • Take decisive proactive actions to prevent or minimize the effects of problems on project performance for assigned projects.

  • Take initiative to find work when necessary and identify Continuous Improvement initiative and working with Shift Supervisor.

  • Create documentation for production operators, maintenance technicians, and calibration departments to be able to operate and maintain equipment.

  • Coordinate, direct and lead engineering efforts to ensure optimum engineering of projects/programs to meet customer and manufacturing requirements.

  • Manage: adaptability demonstrated flexibility to move to the work; adjusts to changes in work structure, processes and requirements.

  • Warrant that your venture follows the quality escalation procedure in case of on the line issues which need to be escalated to a cross functional team or management.

  • Secure that your design verifies that each production job has the correct material blend and all hoppers or loading barrels are filled prior to end of shift.

 

Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 5 Toolkit and guide. Address common challenges with best-practice templates, step-by-step Work Plans and maturity diagnostics for any ISO 5 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 5 specific requirements:


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the ISO 5 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 5 improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. If your customer were your grandmother, would you tell her to buy what you're selling?

  2. What activities does the governance board need to consider?

  3. What is the context?

  4. Do you have a ISO 5 success story or case study ready to tell and share?

  5. How do you implement and manage your work processes to ensure that they meet design requirements?

  6. How do you identify and analyze stakeholders and interests?

  7. Can you maintain your growth without detracting from the factors that have contributed to your success?

  8. Have the concerns of stakeholders to help identify and define potential barriers been obtained and analyzed?

  9. How do you assess the ISO 5 pitfalls that are inherent in implementing it?

  10. What should be considered when identifying available resources, constraints, and deadlines?


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

Your ISO 5 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 5 Self-Assessment and Scorecard you will develop a clear picture of which ISO 5 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 5 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 5 projects with the 62 implementation resources:

  • 62 step-by-step ISO 5 Project Management Form Templates covering over 1500 ISO 5 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 5 project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the ISO 5 project team have enough people to execute the ISO 5 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 5 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 5 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:


2.0 Planning Process Group:

  • 2.1 ISO 5 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 5 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 5 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 5 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 5 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 5 project with this in-depth ISO 5 Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose ISO 5 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 5 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 5 investments work better.

This ISO 5 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.