Make the most out of cloud storage, while maintaining strict security standards concerning your business data
Has your organization management ensured that the integrity of the Quality Management System Is maintained when changes to the Quality Management System are planned and implemented?
Does your organization have procedures for safe handling, transport, storage and use of equipment to prevent its contamination or deterioration?
...Find the answers to these, and more, questions with this ISO 15189 Toolkit:
- Set standards for any program or service and enforce those standards.
- Push through a new approach when your organization and standards developed to reduce spiralling IT costs makes adding new tools and vendors a significant challenge.
- Implement your organizations sustainability standards throughout the value chain.
- Implement your firms sustainability standards throughout the value chain.
- Confirm your providers security standards and policies are sufficient to build trust.
- Strengthen your standards addressing quality control.
- Maintain your quality standards between its.
- Maintain your quality standards between the sites.
- Come up with your organization model in which companies in an industry can agree on common standards and operate together successfully.
HOW THIS TOOLKIT WORKS:
Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 15189 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any ISO 15189 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 15189 specific requirements:
STEP 1: Get your bearings
- The latest quick edition of the ISO 15189 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 997 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 15189 improvements can be made.
Examples; 10 of the 997 standard requirements:
- Are current instructions on the use, safety and maintenance of equipment, including any relevant manuals and directions for use provided by the manufacturer of the equipment and readily available?
- Has your organization selected and approved suppliers based on ability to supply external services, equipment, reagents and consumable supplies in accordance with your organizations requirements?
- Does your organization have a documented procedure concerning verbal requests for examinations that includes providing confirmation by request form or electronic equivalent within a given time?
- Does your organization have a documented procedure for the selection and purchasing of external services, equipment, reagents and consumable supplies that affect the quality of its service?
- Are current instructions for use, safety and maintenance of equipment, including any relevant manuals and directions for use that have been provided by the manufacturer, readily available?
- Do agreements take into account the request, the examination and the report and specify the information needed on the request to ensure appropriate examination and result interpretation?
- When the laboratory changes an examination procedure or pre examination procedure, does the laboratory review associated reference intervals and clinical decision values, as appropriate?
- Has your organization taken appropriate immediate actions and, as appropriate, corrective action or preventive action to ensure continuing compliance with the requirements of ISO 15189?
- Does the laboratory have a documented procedure that defines the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records?
- Does your organization have documented policies and procedures for the selection and use of external services, equipment and consumable supplies that affect the quality of its service?
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 15189 book in PDF containing 997 requirements, which criteria correspond to the criteria in...
Your ISO 15189 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 15189 Self-Assessment and Scorecard you will develop a clear picture of which ISO 15189 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 15189 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 15189 projects with the 62 implementation resources:
- 62 step-by-step ISO 15189 Project Management Form Templates covering over 1500 ISO 15189 project requirements and success criteria:
Examples; 10 of the check box criteria:
- Executing Process Group: How will professionals learn what is expected from them what the deliverables are?
- Project Charter: Strategic fit: what is the strategic initiative identifier for this ISO 15189 project?
- Activity Duration Estimates: Are tools and techniques defined for gathering, integrating and distributing ISO 15189 project outputs?
- Procurement Audit: Were technical requirements set strict enough to guarantee the desired performance without being unnecessarily tight to exclude favourable bids that do not comply with all requirements?
- Quality Audit: Is the continuing professional education of key personnel account fored in detail?
- Procurement Management Plan: Are updated ISO 15189 project time & resource estimates reasonable based on the current ISO 15189 project stage?
- Risk Audit: Does the adoption of a business risk audit approach change internal control documentation and testing practices?
- Cost Management Plan: Have adequate resources been provided by management to ensure ISO 15189 project success?
- Team Member Performance Assessment: What were the challenges that resulted for training and assessment?
- Initiating Process Group: During which stage of Risk planning are risks prioritized based on probability and impact?
Step-by-step and complete ISO 15189 Project Management Forms and Templates including check box criteria and templates.
1.0 Initiating Process Group:
- 1.1 ISO 15189 project Charter
- 1.2 Stakeholder Register
- 1.3 Stakeholder Analysis Matrix
2.0 Planning Process Group:
- 2.1 ISO 15189 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 15189 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 15189 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 15189 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 15189 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 15189 project with this in-depth ISO 15189 Toolkit.
In using the Toolkit you will be better able to:
- Diagnose ISO 15189 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 15189 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 15189 investments work better.
This ISO 15189 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.
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Checklists:ISO 15189 Checklist Report on ISO.pdf
Checklists:ISO 15189 Checklist Report on QUALITY.pdf
Checklists:ISO 15189 Checklist Report on TEST.pdf
Checklists:ISO 15189 Checklist Report on EQUIPMENT.pdf
Checklists:ISO 15189 Checklist Report on SYSTEM.pdf
Checklists:ISO 15189 Checklist Report on ORGANIZATION.pdf
Checklists:ISO 15189 Checklist Report on LABORATORY.pdf
Checklists:ISO 15189 Checklist Report on REVIEW.pdf
Checklists:ISO 15189 Checklist Report on RESULTS.pdf
Checklists:ISO 15189 Checklist Report on STAFF.pdf
Checklists:ISO 15189 Checklist Report on MANAGEMENT.pdf
Checklists:ISO 15189 Checklist Report on PROCEDURE.pdf
Checklists:ISO 15189 Checklist Report on DOCUMENTED.pdf
STEP 1 Get your bearings:
STEP 1 Get your bearings:ISO_15189_Quick_Exploratory_Self-Assessment_Guide.pdf
STEP 1 Get your bearings:ISO 15189 Self-Assessment Pre-Filled EXAMPLE.xlsx
STEP 2 Set concrete goals tasks dates and numbers you can track:
STEP 2 Set concrete goals tasks dates and numbers you can track:ISO 15189 Self-Assessment.xlsx
STEP 2 Set concrete goals tasks dates and numbers you can track:ISO_15189.pdf
..and the Project Management resources in 'STEP 3: Implement, Track, follow up and revise strategy' as described above.
Who This Toolkit Is For
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These skills will enrich every part of your life.
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