ISO 15189 Toolkit

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Drive for results (service, quality, and Continuous Improvement) ensure procedures and processes are in place that lead to delivery of quality results and continually reassess the effectiveness to achieve Continuous Improvement.

More Uses of the ISO 15189 Toolkit:

  • Develop and maintain organized records that demonstrate compliance to all organization processes, regulations, and your organizations QMS.

  • Investigate deviations from established procedures to ensure effective Corrective Action.

  • Identify: direct and delegate Quality Assurance workflows, tasks and special projects.

  • Confirm your organization ensures that all policies, procedures, and records are reviewed and approved.

  • Confirm your organization ensures that all team members are provided with complete process and theory training.

  • Be certain that your organization performs staining; routine and special stains efficiently with highest quality.

  • Support the implementation and sustainment of the Quality Management System.

  • Ensure you officiate; lead the quality committee meetings with quality team and department heads to establish and optimize procedures, policies, functions, and operations between departments to attain quality goals.

  • Develop: work closely with cross functional team members during new product transfer to ensure that all quality and operational details are considered and implemented during validation.

  • Confirm your organization ensures department metrics are gathered, analyzed and reported concerning the status of department operations.

  • Warrant that your organization provides direction and coordinates facility specific Quality Improvement Program activities and related Quality training programs and initiatives.

  • Follow established policies, procedures, and objectives, Continuous Quality Improvement objectives, safety, environmental, and/or control standards.

  • Perform sample issue investigation and resolution to support Sample Operations.

  • Supervise: conduct departmental meetings and ensures appropriate departmental communication.

  • Perform trending analysis (Quality Metrics) on a routine basis by identifying, generating and publishing metrics and reports related to the Quality System performance and reporting anomalies to management.

  • Oversee: work closely with the quality and regulatory teams to performance qualify any new or relocated equipment.

  • Manage a team of direct reports and provide applicable guidance, coaching, hiring and evaluation for Quality Assurance.

  • Make sure that your organization develops and maintains organized records that demonstrate compliance to all organization processes, regulations, and your organizations QMS.

  • Arrange that your organization fosters a unified culture and promote a positive work environment by collaboration, cooperation, sharing of information and mutual teamwork.

  • Assure your organization attends department meetings and organization in service trainings to improve knowledge on testing and systems.

  • Ensure that all work performed by external contractors is completed and documented in accordance with IT Quality System in coordination with equipment management.

  • Drive for results and continual improvement ensure procedures and processes are in place that lead to the delivery of quality results and continually assess the effectiveness to drive continual improvement.

  • Collaborate with other members of management to formulate and establish quality and regulatory compliant policies/procedures/goals for your organization business.

  • Establish that your organization participates in inspection readiness activities and is significantly involved in inspections by regulatory departments.

  • Arrange that your organization performs trending analysis (Quality Metrics) on a routine basis by identifying, generating and publishing metrics and reports related to the Quality System performance and reporting anomalies to management.


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

Start with...

  • 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 995 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 995 standard requirements:

  1. Do the Policies and Procedures for reviews leading to a contract for environmental testing and/or calibration ensure that your organization has the capability and resources to meet the requirements?

  2. 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?

  3. Do procedures ensure the reference standards used for calibration of tools are traceable to primary standards of an NIST-accredited organization, or an accepted foreign or international standard?

  4. Does the Technical Management, which has overall responsibility for the technical operations and the provision of the resources needed, ensure the required quality of organization operations?

  5. 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?

  6. Does your organization have a documented procedure for identification, collection, indexing, access, storage, maintenance, amendment and safe disposal of quality and technical records?

  7. Does your organization establish and maintain procedures for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records?

  8. Does your organization have procedures and appropriate facilities for avoiding deterioration, loss or damage to the test or calibration item during storage, handling and preparation?

  9. Is the Quality Manager responsible for the design, implementation and operation of Quality Control that ensures POCT conforms to the Quality Standards of the central organization?

  10. Have adverse incidents and accidents that can be attributed directly to specific equipment investigated and reported to the manufacturer and appropriate authorities, as required?

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 995 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:

  1. Procurement Audit: How do you ensure whether the goods were supplied or works executed in time and properly recorded in measurement books and stock/works registers after inspection?

  2. Source Selection Criteria: How can solicitation Schedules be improved to yield more effective price competition?

  3. Initiating Process Group: What input will you be required to provide the ISO 15189 project team?

  4. WBS Dictionary: Does the contractors system include procedures for measuring the performance of critical subcontractors?

  5. Scope Management Plan: Have adequate procedures been put in place for ISO 15189 project communication and Status Reporting across ISO 15189 project boundaries (for example interdependent Software Development among interfacing systems)?

  6. Project or Phase Close-Out: Were the outcomes different from the already stated planned?

  7. Cost Management Plan: Have lessons learned been conducted after each ISO 15189 project release?

  8. Project Management Plan: Are there any windfall benefits that would accrue to the ISO 15189 project sponsor or other parties?

  9. Scope Management Plan: What is your organizations history in doing similar activities?

  10. Monitoring and Controlling Process Group: Specific - is the Objective Clear in terms of what, how, when, and where the situation will be changed?

Step-by-step and complete ISO 15189 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 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.