Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 1 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any ISO 1 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 1 specific requirements:
STEP 1: Get your bearings
- The latest quick edition of the ISO 1 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 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 1 improvements can be made.
Examples; 10 of the standard requirements:
- Certainly, the essential purpose of a CMS is to avoid non-compliant behaviour. But how can this goal be achieved through particular compliance measures?
- How long will the consisting hard and software fulfil the companys requirements, on the one hand, and the customers requirements, on the other hand?
- The central laboratory must ensure that POCT is performing instrument maintenance, calibrations, and ongoing quality control/QA checks. ?
- Is all relevant information coherent with standard IT terms, especially hardand software components, data filing and data security?
- Do the respective insurances offer enough protection against the risks or recovery for the event that they would materialise?
- If risks/risk measures are defined legally, do the corresponding insurances live up to the standards the law stipulates?
- Pillars of governance are in place: Compliance, Accountability, Transparency, and Justice/Equity, Direction, Control?
- Is there a confirmation by the insurance broker, especially with respect to the General Terms and Conditions (GTC)?
- Pillars of governance: Compliance, Accountability, Transparency, and Justice/Equity, Direction, Control others?
- Are reports with patient data time-stamped and can reports be retrieved from the system after being delivered?
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 1 book in PDF containing requirements, which criteria correspond to the criteria in…
Your ISO 1 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 1 Self-Assessment and Scorecard you will develop a clear picture of which ISO 1 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 1 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 1 projects with the 62 implementation resources:
- 62 step-by-step ISO 1 Project Management Form Templates covering over 6000 ISO 1 project requirements and success criteria:
Examples; 10 of the check box criteria:
- Project Schedule: Are quality inspections and review activities listed in the ISO 1 project schedule(s)?
- Scope Management Plan: What is the most common tool for helping define the detail?
- Risk Management Plan: Can the risk be avoided by choosing a different alternative?
- Procurement Management Plan: Are post milestone ISO 1 project reviews (PMPR) conducted with the organization at least once a year?
- Planning Process Group: What types of differentiated effects are resulting from the ISO 1 project and to what extent?
- Procurement Audit: Could the bidders assess the economic risks the successful bidder would be responsible for, thus limiting the inclusion of extra charges for risk?
- Schedule Management Plan: Are the processes for schedule assessment and analysis defined?
- Cost Management Plan: Are milestone deliverables effectively tracked and compared to ISO 1 project plan?
- Assumption and Constraint Log: Have you eliminated all duplicative tasks or manual efforts, where appropriate?
- Project Scope Statement: Is this process communicated to the customer and team members?
Step-by-step and complete ISO 1 Project Management Forms and Templates including check box criteria and templates.
1.0 Initiating Process Group:
- 1.1 ISO 1 project Charter
- 1.2 Stakeholder Register
- 1.3 Stakeholder Analysis Matrix
2.0 Planning Process Group:
- 2.1 ISO 1 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 1 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 1 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 1 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 1 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 1 project with this in-depth ISO 1 Toolkit.
In using the Toolkit you will be better able to:
- Diagnose ISO 1 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 1 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 1 investments work better.
This ISO 1 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.