An ongoing commitment to conducting your business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of your products and services.

More Uses of the ISO 7 Toolkit:


• Ensure your venture oversees the development, implementation and maintenance of Quality Assurance systems and activities.
  
  

• Warrant that your organization identifies risks or areas of non compliance; suggests and oversees implementation of Corrective Actions.
  
  

• Help Quality Control and assurance unit to maintain equipment calibration, qualification and maintenance program.
  
  

• Audit: immediate notification of production management of deviations to established processes or procedures.
  
  

• Perform tasks in a manner consistent with the safety policies, Quality Systems, and Gmp Requirements.
  
  

• Perform competency assessments of operators on an ongoing basis to ensure the knowledge/skills from training are continuously applied.
  
  

• Make sure that your design assures that products, processes, facilities and systems conform to Quality Standards and GMP regulations.
  
  

• Confirm your organization ensures GMP Regulatory Compliance via partnership with Quality Control, facilities engineering and manufacturing personnel.
  
  

• Collaborate with manufacturing, GMP Operations Management, and quality teams to manage schedules necessary to clean the GMP controlled environment and support areas to comply with Gmp Requirements.
  
  

• Arrange that your enterprise takes initiative to identify opportunities for Process Improvement and implementation.
  
  

• Become capable of qualifying equipment and performing routine maintenance on equipment.
  
  

• Ensure all equipment being used for the project is adequately labeled with the status of the equipment.
  
  

• Warrant that your design complies; monitors Production Processes and associated Business Operations for compliance with GMP guidelines.
  
  

• Direct: Corrective and preventive action (CAPA) reports, nonconformance reports, equipment Impact Assessments, etc.
  
  

• Ensure safe behavior and safe equipment utilization of facilities team and outside contractors.
  
  

• Confirm your operation provides Quality Assurance support of project related activities for manufacture of clinical and/or process developmental products through Document Control, document review and specification management.
  
  

• Govern: daily/weekly/monthly cleaning of rooms and equipment and fill out appropriate preventative maintenance forms and check lists.
  
  

• Perform timely consumption of materials and completion of quality documentation in appropriate systems.
  
  

• Establish: actively lead all environmental, Health And Safety activities of the plant.
  
  

• Devise: monitor compliance of maintenance and cleaning procedures of equipment and instruments used in GMP processes by periodically reviewing and signing off on maintenance and cleaning log for each equipment.
  
  

• Be certain that your organization oversees the development, implementation and maintenance of the archiving system for all documentation.
  
  

• Establish that your strategy oversees the development, implementation and follows procedures for review of inspection, testing and evaluation of clinical and process developmental products.
  
  

• Ensure tasks are executed with a method of prioritization interpret production schedules and complete tasks accordingly.
  
  

• Confirm your design ensures GMP Regulatory Compliance via partnership with process development, facilities and manufacturing personnel.
  
  

• Provide feedback to trainees to ensure all skills / knowledge have been acquired and communicate any skill/knowledge gaps that require additional training.
  
  

• Confirm your organization complies; audits manufacturing facilities, equipment, processes, procedures, records, and employees for compliance with GMP and GLP standards and to ensure that products are safe for use.
  
  

• Audit: implement IT training program and ensure that it meets all Regulatory Requirements.
  
  

• Arrange that your strategy oversees the development, implementation and maintenance of the quality training systeM And All training activities.
  
  

• Confirm your design complies; always ensure Critical Thinking with the goal of optimizing and improving processes/procedures.
  
  

• Govern: creative and open minded who fosters an environment in which sharing of ideas is encouraged.
  
  


Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 7 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any ISO 7 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 7 specific requirements:

STEP 1: Get your bearings

Start with...


• The latest quick edition of the ISO 7 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 7 improvements can be made.

Examples; 10 of the 999 standard requirements:


1. What information qualified as important?
   
   

2. Is pre-qualification of suppliers carried out?
   
   

3. Are there regulatory / compliance issues?
   
   

4. How do you keep improving ISO 7?
   
   

5. What could cause you to change course?
   
   

6. Is a ISO 7 breakthrough on the horizon?
   
   

7. What knowledge, skills and characteristics mark a good ISO 7 project manager?
   
   

8. Is there an opportunity to verify requirements?
   
   

9. Do the ISO 7 decisions you make today help your organization in three years time?
   
   

10. In the past year, what have you done (or could you have done) to increase the accurate perception of your company/brand as ethical and honest?
    
    


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


Your ISO 7 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 7 Self-Assessment and Scorecard you will develop a clear picture of which ISO 7 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 7 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 7 projects with the 62 implementation resources:


• 62 step-by-step ISO 7 Project Management Form Templates covering over 1500 ISO 7 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 7 project issues be unconditionally tracked through the issue resolution process?
   
   

4. Closing Process Group: Did the ISO 7 project team have enough people to execute the ISO 7 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 7 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 7 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:


• 1.1 ISO 7 project Charter

• 1.2 Stakeholder Register

• 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:


• 2.1 ISO 7 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 7 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 7 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 7 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 7 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 7 project with this in-depth ISO 7 Toolkit.

In using the Toolkit you will be better able to:


• Diagnose ISO 7 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 7 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 7 investments work better.

This ISO 7 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.