ISO 17025 Toolkit

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Work closely with product Engineering teams to comprehend new product functionality to facilitate the development and implementation of methods for integration with Test Automation equipment and Test Scripts.

More Uses of the ISO 17025 Toolkit:

  • Make sure that your organization identifies departure from the Quality Management System (QMS) and initiates actions to investigate and prevent occurrences.

  • Oversee and manage laboratory notebook issuance, activity notebook issuance, and document archival.

  • Ensure you supervise; recommend, implement and direct others to modify operational methods and practices along with overall strategy to enhance department effectiveness.

  • Coordinate: direct writing and review Standard Operating Procedures (Sops) to ensure compliance, efficiency and clarity.

  • Prepare laboratory and staff for accreditation/inspection; schedule practice inspections.

  • Ensure that results meet client expectations, Quality Control of data is consistent, non conformities are minimized.

  • Communicate with customers, legal departments, accreditation departments, vendors, management.

  • Regulate, control and improve the quality of all processes throughout the business and the final product testing.

  • Ensure you conceptualize; load, pour and pound a fusion accurately, and to oversee other employees load and pour according to Standard Operating Procedures.

  • Lead Process Mapping exercises to better understand and develop opportunities to streamline processes and remove non value add steps.

  • Confirm your organization maintains compliance with applicable government regulations in all research and analytical activities.

  • Contribute to the creation and implementation of best practice Capacity Planning vision, strategy, policies, Processes And Procedures to aid and improve operational performance.

  • Ensure test data generation, delivery, and storage methods are appropriate to meet or exceed Quality Standards and stakeholder expectations.

  • Formulate: evaluation and implementations of new instrument and systems technology to support laboratory testing, compliance, and Data integrity.

  • Support your organizations mission, vision, values and goals in performance of daily activities.

  • Promote a safety culture by communicating and upholding safety and environment policies and programs.

  • Help department to coordinate training to operating procedure changes or new system implementation.

  • Secure that your organization maintains a safe work environment by participating in specialized training and review of safety manuals and SOPs.

  • Ensure you guide; lead the team to achieve Quality Management System targets for customers and business goals.

  • Develop: work closely with operations, Quality Engineering, Manufacturing Engineering, and production to implement the calibration program.

  • Ensure your organization maintains accurate records of the processing and analysis in a computerized Laboratory Information Management System (LIMS).

  • Drive: each member of the team is expected to challenge and to be challenged, to create, and to innovate.

  • Develop: act in partnership with the Quality Management to lead all iso 17025 and regulatory audits related to the laboratory operation.

  • Create service contracts for calibrated laboratory equipment and schedule calibration, maintenance, and repairs performed by outside vendors.

  • Confirm your organization prepares Status Reports on the overall progress of activities the laboratory evaluation.

 

Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 17025 Toolkit and guide. Address common challenges with best-practice templates, step-by-step Work Plans and maturity diagnostics for any ISO 17025 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 17025 specific requirements:


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the ISO 17025 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 996 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 17025 improvements can be made.

Examples; 10 of the 996 standard requirements:

  1. Does the laboratory show responsibility to the customer for the subcontractors work, except in the case where the customer or a regulatory authority specifies which subcontractor is to be used?

  2. Does your organization have procedures in place to ensure the proper use of equipment to generate data including, handling, transport, storage, use and Planned Maintenance of the equipment?

  3. Does the test report or calibration certificate contain or provide reference to all of the relevant test points and uncertainties used in determining the overall test result?

  4. Are the results of control samples or standards reviewed by a technically competent person for consistency between operators and test runs, and to monitor any drift?

  5. Is the jurisdiction organized as recorded on your Organizational Chart for inspection functions, including administration, support staff, and field inspection staff?

  6. What are the key and specific elements that should be considered in the hierarchical structure of a self assessment model for testing and calibration laboratories?

  7. Is senior management committed to a Quality System, including compliance with ISO 17025, and agreed that resources will be provided to establish and maintain it?

  8. Does your organization have a written procedure and training program for carrying out calibration of working thermometers with adequate applied Quality Controls?

  9. Is there restricted access to your organization with appropriate security in place to prevent unauthorised access to hazardous areas and confidential material?

  10. Are the results of control samples or standards recorded and periodically evaluated to identify any requirements for further validation or competency training?


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 17025 book in PDF containing 996 requirements, which criteria correspond to the criteria in...

Your ISO 17025 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 17025 Self-Assessment and Scorecard you will develop a clear picture of which ISO 17025 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 17025 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 17025 projects with the 62 implementation resources:

  • 62 step-by-step ISO 17025 Project Management Form Templates covering over 1500 ISO 17025 project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Activity Duration Estimates: What are crucial elements of successful ISO 17025 project plan execution?

  2. Probability and Impact Assessment: Will new information become available during the ISO 17025 project?

  3. Risk Register: What are the main aims, objectives of the policy, strategy, or service and the intended outcomes?

  4. Variance Analysis: Are overhead cost budgets established for each department which has authority to incur overhead costs?

  5. Project Portfolio management: Agility. how do organizations re-align portfolio when Strategic Objectives change?

  6. Risk Audit: Assessing risk with analytical procedures: do systemsthinking tools help auditors focus on diagnostic patterns?

  7. Human Resource Management Plan: Are internal ISO 17025 project status meetings held at reasonable intervals?

  8. Project Scope Statement: Are the input requirements from the team members clearly documented and communicated?

  9. Procurement Audit: Do buyers obtain price quotations or bids from two or more suppliers on significant purchases if catalog or advertised prices are not available?

  10. Change Management Plan: Has the priority for this ISO 17025 project been set by the Business UnIt Management Team?

 
Step-by-step and complete ISO 17025 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 17025 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 17025 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 17025 project with this in-depth ISO 17025 Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose ISO 17025 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 17025 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 17025 investments work better.

This ISO 17025 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.