Mastering ISO 17025 for Laboratory Excellence and Global Accreditation
You’re under pressure. Your lab is expected to deliver accurate, defensible results-every time. Stakeholders demand traceability, regulators are tightening oversight, and competing laboratories are gaining international recognition while yours remains on the sidelines. The cost of falling behind isn’t just reputational-it could mean lost contracts, failed audits, or even shutdowns. You’ve read the ISO 17025 standard, but it feels like deciphering a foreign language. Gaps remain in your understanding. Your team applies inconsistent practices. Documentation is messy. You’re not confident during internal reviews, let alone external assessments. The dream of global accreditation feels distant, expensive, and impossibly complex. But what if you could transform confusion into clarity, and uncertainty into action? What if you could lead your lab through a structured, proven path to compliance-without costly consultants or trial-and-error missteps? Imagine walking into your next audit with confidence, knowing your systems meet the highest global benchmarks. The Mastering ISO 17025 for Laboratory Excellence and Global Accreditation course is that transformation. This is not theory. It’s a precise roadmap to accreditation readiness in as little as 60 days, with fully aligned policies, validated processes, and documented competence-all structured so you can present a board-ready, auditor-proof quality management system. Take it from Dr. Lena Patel, Lead Quality Officer at a regional environmental testing lab in Malaysia: “We’d failed two preliminary assessments. After completing this course, we rebuilt our entire management framework in seven weeks. Our accreditation body approved us on the first formal audit. No conditions. No delays.” We’ve helped over 2,400 laboratory professionals across diagnostics, pharmaceuticals, calibration, and research institutes achieve compliance with confidence. This course eliminates ambiguity and replaces it with actionable precision. It’s been refined through real-world applications in over 40 countries. Here’s how this course is structured to help you get there.Course Format & Delivery Details Fully Self-Paced, On-Demand Access
This course is designed for professionals like you-busy, mission-critical, and responsible for real-world outcomes. You gain immediate online access upon enrollment, with zero fixed schedules or time commitments. Study at your pace, on your terms, from any device. Most learners complete the core compliance framework in 40–60 hours, with many implementing audit-ready changes within the first three weeks. Lifetime Access & Continuous Updates
Your investment includes lifetime access to all course materials. As ISO 17025 evolves and new guidance emerges, your content is automatically updated at no extra cost. Stay current without renewals, subscriptions, or surprise fees. Mobile-Friendly, 24/7 Global Access
Access your training securely from any smartphone, tablet, or laptop. Whether you’re in a lab office, at home, or overseeing field operations, your progress syncs in real time. Work where you are, whenever it fits. Direct Instructor Guidance & Support
You’re not alone. Enrolled learners receive structured support from our ISO 17025 compliance specialists-experts with decades of experience guiding labs through accreditation in regulated sectors. Ask targeted questions, submit process drafts, and receive detailed feedback to ensure your implementation is on track. Certificate of Completion from The Art of Service
Upon fulfilling all requirements, you’ll earn a formal Certificate of Completion issued by The Art of Service. This globally recognised credential demonstrates your mastery of ISO 17025 implementation and is valued by employers, clients, and regulators worldwide. No Hidden Fees. No Surprises. No Risk.
Pricing is straightforward, with no recurring fees or upsells. The one-time cost covers lifetime access, all updates, support, and your certificate. We accept Visa, Mastercard, and PayPal-secure and simple. Enrollment Confirmation & Access
After enrollment, you’ll receive a confirmation email. Your access details and course materials will be sent to you once your registration is processed and verified. There is no automated instant delivery-this ensures quality control and personal validation of every learner’s status. 100% Satisfied or Refunded Guarantee
We remove the risk. If you follow the course structure, engage with the materials, and still feel it hasn’t delivered value within 30 days, contact us for a full refund. No questions, no hassle. Your success is our measure of quality. Will This Work for Me?
Absolutely-even if: - You’re new to quality management and have never worked under ISO 17025
- Your lab is small, under-resourced, or managing multiple standards
- You’ve failed a preliminary audit or received non-conformities
- You’re not fluent in regulatory language or documentation practices
This course works even if your laboratory operates in a low-infrastructure environment or under tight regulatory scrutiny. Our step-by-step method has been tested in university labs, private testing facilities, government institutes, and field deployable units across continents. You’ll gain clarity, confidence, and control-regardless of where you start.
Module 1: Foundations of ISO 17025 and Laboratory Excellence - Introduction to ISO/IEC 17025:2017 and its global significance
- Understanding the difference between ISO 17025 and ISO 9001
- Key principles of impartiality and confidentiality in testing and calibration
- Role of accreditation bodies and ILAC-MRA recognition
- Why ISO 17025 is mandatory for technical competence, not just quality
- Overview of clause structure: Clauses 4 to 8 explained
- Identifying your laboratory’s scope of accreditation
- Determining applicability of requirements based on lab type and size
- Establishing leadership commitment from the outset
- Mapping stakeholder expectations to ISO 17025 compliance
Module 2: Organizational Requirements and Governance Framework - Defining legal identity and organizational structure
- Demonstrating organizational independence and freedom from bias
- Managing commercial, financial, and societal pressures on impartiality
- Developing a documented impartiality policy
- Identifying threats to impartiality and implementing safeguards
- Roles and responsibilities of top management in compliance
- Establishing a governance model for sustainable accreditation
- Creating a compliance accountability framework
- Linking quality objectives to laboratory performance metrics
- Setting up a management review process aligned with ISO 17025
Module 3: Documented Management System Architecture - Choosing between full documentation and integrated quality systems
- Developing a quality manual: essential vs. optional elements
- Creating a document hierarchy: policies, procedures, work instructions
- Version control and record retention strategies
- Approval, review, and obsolescence processes for documents
- Digitizing document management for audit readiness
- Ensuring document availability at point of use
- Controlling external documents (standards, regulations, methods)
- Secure archiving and retrieval of quality records
- Developing a records management plan compliant with Clause 8.6
Module 4: Risk-Based Thinking and Decision Making - Understanding risk-based thinking in ISO 17025 context
- Identifying technical and operational risks to result validity
- Using risk assessment matrices for laboratory processes
- Linking risk identification to preventive actions
- Documenting risk decisions and leadership involvement
- Implementing mitigation controls for high-risk processes
- Monitoring risk effectiveness through key indicators
- Integrating risk reviews into management meetings
- Responding to emerging risks during method validation
- Training staff on risk awareness and escalation paths
Module 5: Resource Management: Personnel Competence and Training - Determining personnel requirements based on lab scope
- Establishing qualification criteria for technical roles
- Developing a competency evaluation framework
- Using training needs analysis for individual staff
- Creating role-specific training plans and curricula
- Validating initial and ongoing competence through observation
- Implementing supervision strategies for junior staff
- Documenting training records and certifications
- Maintaining awareness of technical developments
- Using internal audits as competence development tools
Module 6: Facility and Environmental Conditions Control - Assessing facility requirements for impartial testing
- Maintaining environmental controls: temperature, humidity, vibration
- Designing secure areas for sample handling and storage
- Preventing cross-contamination in shared spaces
- Monitoring and recording environmental parameters
- Responding to deviations from required conditions
- Planning for emergency shutdowns and safety protocols
- Managing housekeeping and workspace organisation
- Ensuring safety equipment is available and functional
- Conducting facility readiness checks before accreditation audits
Module 7: Equipment Management and Measurement Traceability - Developing an equipment inventory with criticality ratings
- Implementing calibration schedules based on risk and usage
- Selecting accredited calibration providers with valid scope
- Verifying calibration certificates for ISO 17025 compliance
- Establishing measurement traceability to SI units
- Handling out-of-calibration equipment and result impact assessment
- Managing software used in measurements and data processing
- Controlling equipment software changes and version updates
- Using interim checks to verify equipment performance
- Creating equipment history records and maintenance logs
Module 8: Method Validation and Development - Differentiating between method validation, verification, and transfer
- Selecting international, regional, or manufacturer methods
- Validating non-standard methods with documented rationale
- Determining required validation parameters: accuracy, precision, LOD, LOQ
- Conducting linearity and working range studies
- Evaluating measurement uncertainty during validation
- Handling modifications to published methods
- Documenting technical justification for method choices
- Creating method validation reports for auditor review
- Maintaining a method currency tracking system
Module 9: Sampling Procedures and Chain of Custody - Designing sampling plans based on statistical principles
- Defining sampling methods within the scope of accreditation
- Validating sampling techniques for accuracy and representativeness
- Documenting sampling conditions and environmental data
- Implementing chain of custody protocols for legal defensibility
- Labelling, sealing, and storing samples to prevent tampering
- Handling client-supplied samples and responsibility boundaries
- Training field personnel on standardised sampling procedures
- Managing storage conditions for sample stability
- Documenting sample disposal in compliance with regulations
Module 10: Handling and Identification of Test and Calibration Items - Developing unique item identification systems
- Tracking items through each stage of testing process
- Managing item condition upon receipt and pre-test checks
- Preventing damage during handling and storage
- Documenting any discrepancies at intake
- Setting acceptance criteria for test items
- Managing client specifications and special instructions
- Ensuring traceability from sample to final report
- Using barcoding or digital tracking where applicable
- Establishing secure storage for sensitive or hazardous items
Module 11: Technical Record Keeping and Data Integrity - Defining what constitutes a technical record
- Ensuring completeness, legibility, and authenticity of records
- Implementing ALCOA+ principles: attributable, legible, contemporaneous, original, accurate
- Controlled data entry and error correction procedures
- Managing handwritten vs. digital records
- Ensuring secure access and authorisation levels
- Protecting records from unauthorised changes
- Backup and recovery strategies for digital data
- Retention periods based on regulatory and client requirements
- Audit trail implementation for electronic systems
Module 12: Reporting of Results and Statement of Conformity - Designing test reports that meet ISO 17025 requirements
- Ensuring clarity, accuracy, and unambiguous presentation
- Including mandatory fields: accreditation logo, scope number, uncertainty
- Drafting statements of compliance with specification limits
- Defining decision rules for pass/fail determinations
- Documenting technical responsibility for results
- Handling revisions and reissued reports
- Delivering reports securely to authorised recipients
- Using electronic signatures with legal validity
- Training client-facing staff on report interpretation protocols
Module 13: Measurement Uncertainty Estimation - Understanding the necessity of uncertainty in all reported results
- Identifying sources of uncertainty in test and calibration processes
- Using GUM (Guide to the Expression of Uncertainty in Measurement)
- Combining standard uncertainties into expanded uncertainty
- Selecting appropriate coverage factors (k=2)
- Documenting uncertainty budgets for each method
- Simplifying uncertainty for routine testing environments
- Updating uncertainty estimates after method or equipment changes
- Training technical staff to calculate and interpret uncertainty
- Presenting uncertainty in test reports without confusion
Module 14: Proficiency Testing and Interlaboratory Comparisons - Understanding the role of proficiency testing in accreditation
- Selecting PT schemes relevant to your scope of testing
- Participating in round-robin studies and key comparisons
- Analysing PT results using z-scores and other performance indicators
- Responding to unsatisfactory results with root cause analysis
- Implementing corrective actions based on PT findings
- Demonstrating participation annually as required by auditors
- Using PT data to validate method performance
- Planning PT participation in your annual quality calendar
- Maintaining records of PT enrolment and performance
Module 15: Internal Auditing for Accreditation Readiness - Understanding the purpose and types of internal audits
- Selecting and training competent internal auditors
- Developing an annual internal audit schedule
- Creating audit checklists based on ISO 17025 clauses
- Conducting process-based audits across lab functions
- Collecting objective evidence during audit interviews
- Writing non-conformity statements that are clear and objective
- Tracking corrective actions until closure
- Reporting audit findings to management
- Using audit trends to drive continual improvement
Module 16: Management Review and Continual Improvement - Setting the frequency and agenda for management reviews
- Preparing reports on key performance indicators
- Evaluating effectiveness of the quality system
- Reviewing audit results, PT outcomes, and customer feedback
- Analysing resource adequacy and training effectiveness
- Assessing compliance with regulatory requirements
- Reviewing risks and opportunities identified
- Setting new quality objectives and action plans
- Documenting review decisions and action assignments
- Ensuring follow-up on management review actions
Module 17: Handling Complaints and Non-Conformities - Establishing a formal complaint handling procedure
- Logging, acknowledging, and investigating all complaints
- Determining root causes of client dissatisfaction
- Implementing corrective actions to prevent recurrence
- Communicating resolutions to complainants
- Reporting complaint trends to management
- Defining non-conformity vs. incident vs. deviation
- Documenting technical and system non-conformities
- Conducting impact assessments on affected results
- Using non-conformities as opportunities for improvement
Module 18: Preparing for External Accreditation Assessment - Understanding the accreditation body’s assessment process
- Receiving and interpreting the assessment scope and timeline
- Preparing the pre-assessment documentation package
- Conducting a readiness gap analysis
- Hosting technical assessors during on-site visits
- Preparing staff for technical questioning and process walkthroughs
- Organising document access and record retrieval systems
- Scheduling laboratory observations and witnessing tests
- Developing responses to assessor observations
- Tracking accreditation body non-conformities and appeals
Module 19: Maintaining Accreditation and Surveillance Audits - Understanding the post-accreditation surveillance cycle
- Preparing for annual and biennial surveillance audits
- Demonstrating ongoing compliance with updated clauses
- Managing scope changes and extensions to accreditation
- Submitting updated technical records and PT results
- Handling witness testing requirements
- Updating your quality manual and procedures as needed
- Reporting major changes to your accreditation body
- Documenting continual improvement initiatives
- Reinforcing staff awareness of accreditation responsibilities
Module 20: Integration with Other Standards and Systems - Integrating ISO 17025 with ISO 9001 quality management
- Aligning with ISO 15189 in medical laboratories
- Combining with Good Laboratory Practice (GLP) requirements
- Harmonising internal processes with ISO/IEC 17065
- Mapping ISO 17025 to regulatory frameworks (FDA, EMA, NABL)
- Using a unified document control system
- Consolidating audit schedules and management reviews
- Training staff on integrated compliance expectations
- Reducing duplication in record keeping and reporting
- Creating a single source of truth for quality performance
Module 21: Digital Transformation and Future-Proofing Your Lab - Evaluating Laboratory Information Management Systems (LIMS)
- Digitising workflows for paperless compliance
- Ensuring electronic records meet ALCOA+ and 21 CFR Part 11
- Automating document control and approval workflows
- Using dashboards for real-time compliance monitoring
- Integrating calibration and maintenance tracking
- Securing data against breaches and unauthorised access
- Planning for cloud-based system scalability
- Training staff on digital workflow adoption
- Preparing for digital audits and remote assessments
Module 22: Certification, Recognition, and Career Advancement - Understanding the value of your Certificate of Completion
- How the credential is recognised by employers and regulators
- Adding the certification to your professional profiles (LinkedIn, CV)
- Leveraging your expertise for promotions or consulting roles
- Using the certificate to support lab-wide accreditation projects
- Accessing alumni resources and networking opportunities
- Receiving updates on new accreditation guidance
- Progress tracking and gamified learning milestones
- Downloading and sharing your digital certificate
- Your next steps: from compliance to leadership in laboratory excellence
- Introduction to ISO/IEC 17025:2017 and its global significance
- Understanding the difference between ISO 17025 and ISO 9001
- Key principles of impartiality and confidentiality in testing and calibration
- Role of accreditation bodies and ILAC-MRA recognition
- Why ISO 17025 is mandatory for technical competence, not just quality
- Overview of clause structure: Clauses 4 to 8 explained
- Identifying your laboratory’s scope of accreditation
- Determining applicability of requirements based on lab type and size
- Establishing leadership commitment from the outset
- Mapping stakeholder expectations to ISO 17025 compliance
Module 2: Organizational Requirements and Governance Framework - Defining legal identity and organizational structure
- Demonstrating organizational independence and freedom from bias
- Managing commercial, financial, and societal pressures on impartiality
- Developing a documented impartiality policy
- Identifying threats to impartiality and implementing safeguards
- Roles and responsibilities of top management in compliance
- Establishing a governance model for sustainable accreditation
- Creating a compliance accountability framework
- Linking quality objectives to laboratory performance metrics
- Setting up a management review process aligned with ISO 17025
Module 3: Documented Management System Architecture - Choosing between full documentation and integrated quality systems
- Developing a quality manual: essential vs. optional elements
- Creating a document hierarchy: policies, procedures, work instructions
- Version control and record retention strategies
- Approval, review, and obsolescence processes for documents
- Digitizing document management for audit readiness
- Ensuring document availability at point of use
- Controlling external documents (standards, regulations, methods)
- Secure archiving and retrieval of quality records
- Developing a records management plan compliant with Clause 8.6
Module 4: Risk-Based Thinking and Decision Making - Understanding risk-based thinking in ISO 17025 context
- Identifying technical and operational risks to result validity
- Using risk assessment matrices for laboratory processes
- Linking risk identification to preventive actions
- Documenting risk decisions and leadership involvement
- Implementing mitigation controls for high-risk processes
- Monitoring risk effectiveness through key indicators
- Integrating risk reviews into management meetings
- Responding to emerging risks during method validation
- Training staff on risk awareness and escalation paths
Module 5: Resource Management: Personnel Competence and Training - Determining personnel requirements based on lab scope
- Establishing qualification criteria for technical roles
- Developing a competency evaluation framework
- Using training needs analysis for individual staff
- Creating role-specific training plans and curricula
- Validating initial and ongoing competence through observation
- Implementing supervision strategies for junior staff
- Documenting training records and certifications
- Maintaining awareness of technical developments
- Using internal audits as competence development tools
Module 6: Facility and Environmental Conditions Control - Assessing facility requirements for impartial testing
- Maintaining environmental controls: temperature, humidity, vibration
- Designing secure areas for sample handling and storage
- Preventing cross-contamination in shared spaces
- Monitoring and recording environmental parameters
- Responding to deviations from required conditions
- Planning for emergency shutdowns and safety protocols
- Managing housekeeping and workspace organisation
- Ensuring safety equipment is available and functional
- Conducting facility readiness checks before accreditation audits
Module 7: Equipment Management and Measurement Traceability - Developing an equipment inventory with criticality ratings
- Implementing calibration schedules based on risk and usage
- Selecting accredited calibration providers with valid scope
- Verifying calibration certificates for ISO 17025 compliance
- Establishing measurement traceability to SI units
- Handling out-of-calibration equipment and result impact assessment
- Managing software used in measurements and data processing
- Controlling equipment software changes and version updates
- Using interim checks to verify equipment performance
- Creating equipment history records and maintenance logs
Module 8: Method Validation and Development - Differentiating between method validation, verification, and transfer
- Selecting international, regional, or manufacturer methods
- Validating non-standard methods with documented rationale
- Determining required validation parameters: accuracy, precision, LOD, LOQ
- Conducting linearity and working range studies
- Evaluating measurement uncertainty during validation
- Handling modifications to published methods
- Documenting technical justification for method choices
- Creating method validation reports for auditor review
- Maintaining a method currency tracking system
Module 9: Sampling Procedures and Chain of Custody - Designing sampling plans based on statistical principles
- Defining sampling methods within the scope of accreditation
- Validating sampling techniques for accuracy and representativeness
- Documenting sampling conditions and environmental data
- Implementing chain of custody protocols for legal defensibility
- Labelling, sealing, and storing samples to prevent tampering
- Handling client-supplied samples and responsibility boundaries
- Training field personnel on standardised sampling procedures
- Managing storage conditions for sample stability
- Documenting sample disposal in compliance with regulations
Module 10: Handling and Identification of Test and Calibration Items - Developing unique item identification systems
- Tracking items through each stage of testing process
- Managing item condition upon receipt and pre-test checks
- Preventing damage during handling and storage
- Documenting any discrepancies at intake
- Setting acceptance criteria for test items
- Managing client specifications and special instructions
- Ensuring traceability from sample to final report
- Using barcoding or digital tracking where applicable
- Establishing secure storage for sensitive or hazardous items
Module 11: Technical Record Keeping and Data Integrity - Defining what constitutes a technical record
- Ensuring completeness, legibility, and authenticity of records
- Implementing ALCOA+ principles: attributable, legible, contemporaneous, original, accurate
- Controlled data entry and error correction procedures
- Managing handwritten vs. digital records
- Ensuring secure access and authorisation levels
- Protecting records from unauthorised changes
- Backup and recovery strategies for digital data
- Retention periods based on regulatory and client requirements
- Audit trail implementation for electronic systems
Module 12: Reporting of Results and Statement of Conformity - Designing test reports that meet ISO 17025 requirements
- Ensuring clarity, accuracy, and unambiguous presentation
- Including mandatory fields: accreditation logo, scope number, uncertainty
- Drafting statements of compliance with specification limits
- Defining decision rules for pass/fail determinations
- Documenting technical responsibility for results
- Handling revisions and reissued reports
- Delivering reports securely to authorised recipients
- Using electronic signatures with legal validity
- Training client-facing staff on report interpretation protocols
Module 13: Measurement Uncertainty Estimation - Understanding the necessity of uncertainty in all reported results
- Identifying sources of uncertainty in test and calibration processes
- Using GUM (Guide to the Expression of Uncertainty in Measurement)
- Combining standard uncertainties into expanded uncertainty
- Selecting appropriate coverage factors (k=2)
- Documenting uncertainty budgets for each method
- Simplifying uncertainty for routine testing environments
- Updating uncertainty estimates after method or equipment changes
- Training technical staff to calculate and interpret uncertainty
- Presenting uncertainty in test reports without confusion
Module 14: Proficiency Testing and Interlaboratory Comparisons - Understanding the role of proficiency testing in accreditation
- Selecting PT schemes relevant to your scope of testing
- Participating in round-robin studies and key comparisons
- Analysing PT results using z-scores and other performance indicators
- Responding to unsatisfactory results with root cause analysis
- Implementing corrective actions based on PT findings
- Demonstrating participation annually as required by auditors
- Using PT data to validate method performance
- Planning PT participation in your annual quality calendar
- Maintaining records of PT enrolment and performance
Module 15: Internal Auditing for Accreditation Readiness - Understanding the purpose and types of internal audits
- Selecting and training competent internal auditors
- Developing an annual internal audit schedule
- Creating audit checklists based on ISO 17025 clauses
- Conducting process-based audits across lab functions
- Collecting objective evidence during audit interviews
- Writing non-conformity statements that are clear and objective
- Tracking corrective actions until closure
- Reporting audit findings to management
- Using audit trends to drive continual improvement
Module 16: Management Review and Continual Improvement - Setting the frequency and agenda for management reviews
- Preparing reports on key performance indicators
- Evaluating effectiveness of the quality system
- Reviewing audit results, PT outcomes, and customer feedback
- Analysing resource adequacy and training effectiveness
- Assessing compliance with regulatory requirements
- Reviewing risks and opportunities identified
- Setting new quality objectives and action plans
- Documenting review decisions and action assignments
- Ensuring follow-up on management review actions
Module 17: Handling Complaints and Non-Conformities - Establishing a formal complaint handling procedure
- Logging, acknowledging, and investigating all complaints
- Determining root causes of client dissatisfaction
- Implementing corrective actions to prevent recurrence
- Communicating resolutions to complainants
- Reporting complaint trends to management
- Defining non-conformity vs. incident vs. deviation
- Documenting technical and system non-conformities
- Conducting impact assessments on affected results
- Using non-conformities as opportunities for improvement
Module 18: Preparing for External Accreditation Assessment - Understanding the accreditation body’s assessment process
- Receiving and interpreting the assessment scope and timeline
- Preparing the pre-assessment documentation package
- Conducting a readiness gap analysis
- Hosting technical assessors during on-site visits
- Preparing staff for technical questioning and process walkthroughs
- Organising document access and record retrieval systems
- Scheduling laboratory observations and witnessing tests
- Developing responses to assessor observations
- Tracking accreditation body non-conformities and appeals
Module 19: Maintaining Accreditation and Surveillance Audits - Understanding the post-accreditation surveillance cycle
- Preparing for annual and biennial surveillance audits
- Demonstrating ongoing compliance with updated clauses
- Managing scope changes and extensions to accreditation
- Submitting updated technical records and PT results
- Handling witness testing requirements
- Updating your quality manual and procedures as needed
- Reporting major changes to your accreditation body
- Documenting continual improvement initiatives
- Reinforcing staff awareness of accreditation responsibilities
Module 20: Integration with Other Standards and Systems - Integrating ISO 17025 with ISO 9001 quality management
- Aligning with ISO 15189 in medical laboratories
- Combining with Good Laboratory Practice (GLP) requirements
- Harmonising internal processes with ISO/IEC 17065
- Mapping ISO 17025 to regulatory frameworks (FDA, EMA, NABL)
- Using a unified document control system
- Consolidating audit schedules and management reviews
- Training staff on integrated compliance expectations
- Reducing duplication in record keeping and reporting
- Creating a single source of truth for quality performance
Module 21: Digital Transformation and Future-Proofing Your Lab - Evaluating Laboratory Information Management Systems (LIMS)
- Digitising workflows for paperless compliance
- Ensuring electronic records meet ALCOA+ and 21 CFR Part 11
- Automating document control and approval workflows
- Using dashboards for real-time compliance monitoring
- Integrating calibration and maintenance tracking
- Securing data against breaches and unauthorised access
- Planning for cloud-based system scalability
- Training staff on digital workflow adoption
- Preparing for digital audits and remote assessments
Module 22: Certification, Recognition, and Career Advancement - Understanding the value of your Certificate of Completion
- How the credential is recognised by employers and regulators
- Adding the certification to your professional profiles (LinkedIn, CV)
- Leveraging your expertise for promotions or consulting roles
- Using the certificate to support lab-wide accreditation projects
- Accessing alumni resources and networking opportunities
- Receiving updates on new accreditation guidance
- Progress tracking and gamified learning milestones
- Downloading and sharing your digital certificate
- Your next steps: from compliance to leadership in laboratory excellence
- Choosing between full documentation and integrated quality systems
- Developing a quality manual: essential vs. optional elements
- Creating a document hierarchy: policies, procedures, work instructions
- Version control and record retention strategies
- Approval, review, and obsolescence processes for documents
- Digitizing document management for audit readiness
- Ensuring document availability at point of use
- Controlling external documents (standards, regulations, methods)
- Secure archiving and retrieval of quality records
- Developing a records management plan compliant with Clause 8.6
Module 4: Risk-Based Thinking and Decision Making - Understanding risk-based thinking in ISO 17025 context
- Identifying technical and operational risks to result validity
- Using risk assessment matrices for laboratory processes
- Linking risk identification to preventive actions
- Documenting risk decisions and leadership involvement
- Implementing mitigation controls for high-risk processes
- Monitoring risk effectiveness through key indicators
- Integrating risk reviews into management meetings
- Responding to emerging risks during method validation
- Training staff on risk awareness and escalation paths
Module 5: Resource Management: Personnel Competence and Training - Determining personnel requirements based on lab scope
- Establishing qualification criteria for technical roles
- Developing a competency evaluation framework
- Using training needs analysis for individual staff
- Creating role-specific training plans and curricula
- Validating initial and ongoing competence through observation
- Implementing supervision strategies for junior staff
- Documenting training records and certifications
- Maintaining awareness of technical developments
- Using internal audits as competence development tools
Module 6: Facility and Environmental Conditions Control - Assessing facility requirements for impartial testing
- Maintaining environmental controls: temperature, humidity, vibration
- Designing secure areas for sample handling and storage
- Preventing cross-contamination in shared spaces
- Monitoring and recording environmental parameters
- Responding to deviations from required conditions
- Planning for emergency shutdowns and safety protocols
- Managing housekeeping and workspace organisation
- Ensuring safety equipment is available and functional
- Conducting facility readiness checks before accreditation audits
Module 7: Equipment Management and Measurement Traceability - Developing an equipment inventory with criticality ratings
- Implementing calibration schedules based on risk and usage
- Selecting accredited calibration providers with valid scope
- Verifying calibration certificates for ISO 17025 compliance
- Establishing measurement traceability to SI units
- Handling out-of-calibration equipment and result impact assessment
- Managing software used in measurements and data processing
- Controlling equipment software changes and version updates
- Using interim checks to verify equipment performance
- Creating equipment history records and maintenance logs
Module 8: Method Validation and Development - Differentiating between method validation, verification, and transfer
- Selecting international, regional, or manufacturer methods
- Validating non-standard methods with documented rationale
- Determining required validation parameters: accuracy, precision, LOD, LOQ
- Conducting linearity and working range studies
- Evaluating measurement uncertainty during validation
- Handling modifications to published methods
- Documenting technical justification for method choices
- Creating method validation reports for auditor review
- Maintaining a method currency tracking system
Module 9: Sampling Procedures and Chain of Custody - Designing sampling plans based on statistical principles
- Defining sampling methods within the scope of accreditation
- Validating sampling techniques for accuracy and representativeness
- Documenting sampling conditions and environmental data
- Implementing chain of custody protocols for legal defensibility
- Labelling, sealing, and storing samples to prevent tampering
- Handling client-supplied samples and responsibility boundaries
- Training field personnel on standardised sampling procedures
- Managing storage conditions for sample stability
- Documenting sample disposal in compliance with regulations
Module 10: Handling and Identification of Test and Calibration Items - Developing unique item identification systems
- Tracking items through each stage of testing process
- Managing item condition upon receipt and pre-test checks
- Preventing damage during handling and storage
- Documenting any discrepancies at intake
- Setting acceptance criteria for test items
- Managing client specifications and special instructions
- Ensuring traceability from sample to final report
- Using barcoding or digital tracking where applicable
- Establishing secure storage for sensitive or hazardous items
Module 11: Technical Record Keeping and Data Integrity - Defining what constitutes a technical record
- Ensuring completeness, legibility, and authenticity of records
- Implementing ALCOA+ principles: attributable, legible, contemporaneous, original, accurate
- Controlled data entry and error correction procedures
- Managing handwritten vs. digital records
- Ensuring secure access and authorisation levels
- Protecting records from unauthorised changes
- Backup and recovery strategies for digital data
- Retention periods based on regulatory and client requirements
- Audit trail implementation for electronic systems
Module 12: Reporting of Results and Statement of Conformity - Designing test reports that meet ISO 17025 requirements
- Ensuring clarity, accuracy, and unambiguous presentation
- Including mandatory fields: accreditation logo, scope number, uncertainty
- Drafting statements of compliance with specification limits
- Defining decision rules for pass/fail determinations
- Documenting technical responsibility for results
- Handling revisions and reissued reports
- Delivering reports securely to authorised recipients
- Using electronic signatures with legal validity
- Training client-facing staff on report interpretation protocols
Module 13: Measurement Uncertainty Estimation - Understanding the necessity of uncertainty in all reported results
- Identifying sources of uncertainty in test and calibration processes
- Using GUM (Guide to the Expression of Uncertainty in Measurement)
- Combining standard uncertainties into expanded uncertainty
- Selecting appropriate coverage factors (k=2)
- Documenting uncertainty budgets for each method
- Simplifying uncertainty for routine testing environments
- Updating uncertainty estimates after method or equipment changes
- Training technical staff to calculate and interpret uncertainty
- Presenting uncertainty in test reports without confusion
Module 14: Proficiency Testing and Interlaboratory Comparisons - Understanding the role of proficiency testing in accreditation
- Selecting PT schemes relevant to your scope of testing
- Participating in round-robin studies and key comparisons
- Analysing PT results using z-scores and other performance indicators
- Responding to unsatisfactory results with root cause analysis
- Implementing corrective actions based on PT findings
- Demonstrating participation annually as required by auditors
- Using PT data to validate method performance
- Planning PT participation in your annual quality calendar
- Maintaining records of PT enrolment and performance
Module 15: Internal Auditing for Accreditation Readiness - Understanding the purpose and types of internal audits
- Selecting and training competent internal auditors
- Developing an annual internal audit schedule
- Creating audit checklists based on ISO 17025 clauses
- Conducting process-based audits across lab functions
- Collecting objective evidence during audit interviews
- Writing non-conformity statements that are clear and objective
- Tracking corrective actions until closure
- Reporting audit findings to management
- Using audit trends to drive continual improvement
Module 16: Management Review and Continual Improvement - Setting the frequency and agenda for management reviews
- Preparing reports on key performance indicators
- Evaluating effectiveness of the quality system
- Reviewing audit results, PT outcomes, and customer feedback
- Analysing resource adequacy and training effectiveness
- Assessing compliance with regulatory requirements
- Reviewing risks and opportunities identified
- Setting new quality objectives and action plans
- Documenting review decisions and action assignments
- Ensuring follow-up on management review actions
Module 17: Handling Complaints and Non-Conformities - Establishing a formal complaint handling procedure
- Logging, acknowledging, and investigating all complaints
- Determining root causes of client dissatisfaction
- Implementing corrective actions to prevent recurrence
- Communicating resolutions to complainants
- Reporting complaint trends to management
- Defining non-conformity vs. incident vs. deviation
- Documenting technical and system non-conformities
- Conducting impact assessments on affected results
- Using non-conformities as opportunities for improvement
Module 18: Preparing for External Accreditation Assessment - Understanding the accreditation body’s assessment process
- Receiving and interpreting the assessment scope and timeline
- Preparing the pre-assessment documentation package
- Conducting a readiness gap analysis
- Hosting technical assessors during on-site visits
- Preparing staff for technical questioning and process walkthroughs
- Organising document access and record retrieval systems
- Scheduling laboratory observations and witnessing tests
- Developing responses to assessor observations
- Tracking accreditation body non-conformities and appeals
Module 19: Maintaining Accreditation and Surveillance Audits - Understanding the post-accreditation surveillance cycle
- Preparing for annual and biennial surveillance audits
- Demonstrating ongoing compliance with updated clauses
- Managing scope changes and extensions to accreditation
- Submitting updated technical records and PT results
- Handling witness testing requirements
- Updating your quality manual and procedures as needed
- Reporting major changes to your accreditation body
- Documenting continual improvement initiatives
- Reinforcing staff awareness of accreditation responsibilities
Module 20: Integration with Other Standards and Systems - Integrating ISO 17025 with ISO 9001 quality management
- Aligning with ISO 15189 in medical laboratories
- Combining with Good Laboratory Practice (GLP) requirements
- Harmonising internal processes with ISO/IEC 17065
- Mapping ISO 17025 to regulatory frameworks (FDA, EMA, NABL)
- Using a unified document control system
- Consolidating audit schedules and management reviews
- Training staff on integrated compliance expectations
- Reducing duplication in record keeping and reporting
- Creating a single source of truth for quality performance
Module 21: Digital Transformation and Future-Proofing Your Lab - Evaluating Laboratory Information Management Systems (LIMS)
- Digitising workflows for paperless compliance
- Ensuring electronic records meet ALCOA+ and 21 CFR Part 11
- Automating document control and approval workflows
- Using dashboards for real-time compliance monitoring
- Integrating calibration and maintenance tracking
- Securing data against breaches and unauthorised access
- Planning for cloud-based system scalability
- Training staff on digital workflow adoption
- Preparing for digital audits and remote assessments
Module 22: Certification, Recognition, and Career Advancement - Understanding the value of your Certificate of Completion
- How the credential is recognised by employers and regulators
- Adding the certification to your professional profiles (LinkedIn, CV)
- Leveraging your expertise for promotions or consulting roles
- Using the certificate to support lab-wide accreditation projects
- Accessing alumni resources and networking opportunities
- Receiving updates on new accreditation guidance
- Progress tracking and gamified learning milestones
- Downloading and sharing your digital certificate
- Your next steps: from compliance to leadership in laboratory excellence
- Determining personnel requirements based on lab scope
- Establishing qualification criteria for technical roles
- Developing a competency evaluation framework
- Using training needs analysis for individual staff
- Creating role-specific training plans and curricula
- Validating initial and ongoing competence through observation
- Implementing supervision strategies for junior staff
- Documenting training records and certifications
- Maintaining awareness of technical developments
- Using internal audits as competence development tools
Module 6: Facility and Environmental Conditions Control - Assessing facility requirements for impartial testing
- Maintaining environmental controls: temperature, humidity, vibration
- Designing secure areas for sample handling and storage
- Preventing cross-contamination in shared spaces
- Monitoring and recording environmental parameters
- Responding to deviations from required conditions
- Planning for emergency shutdowns and safety protocols
- Managing housekeeping and workspace organisation
- Ensuring safety equipment is available and functional
- Conducting facility readiness checks before accreditation audits
Module 7: Equipment Management and Measurement Traceability - Developing an equipment inventory with criticality ratings
- Implementing calibration schedules based on risk and usage
- Selecting accredited calibration providers with valid scope
- Verifying calibration certificates for ISO 17025 compliance
- Establishing measurement traceability to SI units
- Handling out-of-calibration equipment and result impact assessment
- Managing software used in measurements and data processing
- Controlling equipment software changes and version updates
- Using interim checks to verify equipment performance
- Creating equipment history records and maintenance logs
Module 8: Method Validation and Development - Differentiating between method validation, verification, and transfer
- Selecting international, regional, or manufacturer methods
- Validating non-standard methods with documented rationale
- Determining required validation parameters: accuracy, precision, LOD, LOQ
- Conducting linearity and working range studies
- Evaluating measurement uncertainty during validation
- Handling modifications to published methods
- Documenting technical justification for method choices
- Creating method validation reports for auditor review
- Maintaining a method currency tracking system
Module 9: Sampling Procedures and Chain of Custody - Designing sampling plans based on statistical principles
- Defining sampling methods within the scope of accreditation
- Validating sampling techniques for accuracy and representativeness
- Documenting sampling conditions and environmental data
- Implementing chain of custody protocols for legal defensibility
- Labelling, sealing, and storing samples to prevent tampering
- Handling client-supplied samples and responsibility boundaries
- Training field personnel on standardised sampling procedures
- Managing storage conditions for sample stability
- Documenting sample disposal in compliance with regulations
Module 10: Handling and Identification of Test and Calibration Items - Developing unique item identification systems
- Tracking items through each stage of testing process
- Managing item condition upon receipt and pre-test checks
- Preventing damage during handling and storage
- Documenting any discrepancies at intake
- Setting acceptance criteria for test items
- Managing client specifications and special instructions
- Ensuring traceability from sample to final report
- Using barcoding or digital tracking where applicable
- Establishing secure storage for sensitive or hazardous items
Module 11: Technical Record Keeping and Data Integrity - Defining what constitutes a technical record
- Ensuring completeness, legibility, and authenticity of records
- Implementing ALCOA+ principles: attributable, legible, contemporaneous, original, accurate
- Controlled data entry and error correction procedures
- Managing handwritten vs. digital records
- Ensuring secure access and authorisation levels
- Protecting records from unauthorised changes
- Backup and recovery strategies for digital data
- Retention periods based on regulatory and client requirements
- Audit trail implementation for electronic systems
Module 12: Reporting of Results and Statement of Conformity - Designing test reports that meet ISO 17025 requirements
- Ensuring clarity, accuracy, and unambiguous presentation
- Including mandatory fields: accreditation logo, scope number, uncertainty
- Drafting statements of compliance with specification limits
- Defining decision rules for pass/fail determinations
- Documenting technical responsibility for results
- Handling revisions and reissued reports
- Delivering reports securely to authorised recipients
- Using electronic signatures with legal validity
- Training client-facing staff on report interpretation protocols
Module 13: Measurement Uncertainty Estimation - Understanding the necessity of uncertainty in all reported results
- Identifying sources of uncertainty in test and calibration processes
- Using GUM (Guide to the Expression of Uncertainty in Measurement)
- Combining standard uncertainties into expanded uncertainty
- Selecting appropriate coverage factors (k=2)
- Documenting uncertainty budgets for each method
- Simplifying uncertainty for routine testing environments
- Updating uncertainty estimates after method or equipment changes
- Training technical staff to calculate and interpret uncertainty
- Presenting uncertainty in test reports without confusion
Module 14: Proficiency Testing and Interlaboratory Comparisons - Understanding the role of proficiency testing in accreditation
- Selecting PT schemes relevant to your scope of testing
- Participating in round-robin studies and key comparisons
- Analysing PT results using z-scores and other performance indicators
- Responding to unsatisfactory results with root cause analysis
- Implementing corrective actions based on PT findings
- Demonstrating participation annually as required by auditors
- Using PT data to validate method performance
- Planning PT participation in your annual quality calendar
- Maintaining records of PT enrolment and performance
Module 15: Internal Auditing for Accreditation Readiness - Understanding the purpose and types of internal audits
- Selecting and training competent internal auditors
- Developing an annual internal audit schedule
- Creating audit checklists based on ISO 17025 clauses
- Conducting process-based audits across lab functions
- Collecting objective evidence during audit interviews
- Writing non-conformity statements that are clear and objective
- Tracking corrective actions until closure
- Reporting audit findings to management
- Using audit trends to drive continual improvement
Module 16: Management Review and Continual Improvement - Setting the frequency and agenda for management reviews
- Preparing reports on key performance indicators
- Evaluating effectiveness of the quality system
- Reviewing audit results, PT outcomes, and customer feedback
- Analysing resource adequacy and training effectiveness
- Assessing compliance with regulatory requirements
- Reviewing risks and opportunities identified
- Setting new quality objectives and action plans
- Documenting review decisions and action assignments
- Ensuring follow-up on management review actions
Module 17: Handling Complaints and Non-Conformities - Establishing a formal complaint handling procedure
- Logging, acknowledging, and investigating all complaints
- Determining root causes of client dissatisfaction
- Implementing corrective actions to prevent recurrence
- Communicating resolutions to complainants
- Reporting complaint trends to management
- Defining non-conformity vs. incident vs. deviation
- Documenting technical and system non-conformities
- Conducting impact assessments on affected results
- Using non-conformities as opportunities for improvement
Module 18: Preparing for External Accreditation Assessment - Understanding the accreditation body’s assessment process
- Receiving and interpreting the assessment scope and timeline
- Preparing the pre-assessment documentation package
- Conducting a readiness gap analysis
- Hosting technical assessors during on-site visits
- Preparing staff for technical questioning and process walkthroughs
- Organising document access and record retrieval systems
- Scheduling laboratory observations and witnessing tests
- Developing responses to assessor observations
- Tracking accreditation body non-conformities and appeals
Module 19: Maintaining Accreditation and Surveillance Audits - Understanding the post-accreditation surveillance cycle
- Preparing for annual and biennial surveillance audits
- Demonstrating ongoing compliance with updated clauses
- Managing scope changes and extensions to accreditation
- Submitting updated technical records and PT results
- Handling witness testing requirements
- Updating your quality manual and procedures as needed
- Reporting major changes to your accreditation body
- Documenting continual improvement initiatives
- Reinforcing staff awareness of accreditation responsibilities
Module 20: Integration with Other Standards and Systems - Integrating ISO 17025 with ISO 9001 quality management
- Aligning with ISO 15189 in medical laboratories
- Combining with Good Laboratory Practice (GLP) requirements
- Harmonising internal processes with ISO/IEC 17065
- Mapping ISO 17025 to regulatory frameworks (FDA, EMA, NABL)
- Using a unified document control system
- Consolidating audit schedules and management reviews
- Training staff on integrated compliance expectations
- Reducing duplication in record keeping and reporting
- Creating a single source of truth for quality performance
Module 21: Digital Transformation and Future-Proofing Your Lab - Evaluating Laboratory Information Management Systems (LIMS)
- Digitising workflows for paperless compliance
- Ensuring electronic records meet ALCOA+ and 21 CFR Part 11
- Automating document control and approval workflows
- Using dashboards for real-time compliance monitoring
- Integrating calibration and maintenance tracking
- Securing data against breaches and unauthorised access
- Planning for cloud-based system scalability
- Training staff on digital workflow adoption
- Preparing for digital audits and remote assessments
Module 22: Certification, Recognition, and Career Advancement - Understanding the value of your Certificate of Completion
- How the credential is recognised by employers and regulators
- Adding the certification to your professional profiles (LinkedIn, CV)
- Leveraging your expertise for promotions or consulting roles
- Using the certificate to support lab-wide accreditation projects
- Accessing alumni resources and networking opportunities
- Receiving updates on new accreditation guidance
- Progress tracking and gamified learning milestones
- Downloading and sharing your digital certificate
- Your next steps: from compliance to leadership in laboratory excellence
- Developing an equipment inventory with criticality ratings
- Implementing calibration schedules based on risk and usage
- Selecting accredited calibration providers with valid scope
- Verifying calibration certificates for ISO 17025 compliance
- Establishing measurement traceability to SI units
- Handling out-of-calibration equipment and result impact assessment
- Managing software used in measurements and data processing
- Controlling equipment software changes and version updates
- Using interim checks to verify equipment performance
- Creating equipment history records and maintenance logs
Module 8: Method Validation and Development - Differentiating between method validation, verification, and transfer
- Selecting international, regional, or manufacturer methods
- Validating non-standard methods with documented rationale
- Determining required validation parameters: accuracy, precision, LOD, LOQ
- Conducting linearity and working range studies
- Evaluating measurement uncertainty during validation
- Handling modifications to published methods
- Documenting technical justification for method choices
- Creating method validation reports for auditor review
- Maintaining a method currency tracking system
Module 9: Sampling Procedures and Chain of Custody - Designing sampling plans based on statistical principles
- Defining sampling methods within the scope of accreditation
- Validating sampling techniques for accuracy and representativeness
- Documenting sampling conditions and environmental data
- Implementing chain of custody protocols for legal defensibility
- Labelling, sealing, and storing samples to prevent tampering
- Handling client-supplied samples and responsibility boundaries
- Training field personnel on standardised sampling procedures
- Managing storage conditions for sample stability
- Documenting sample disposal in compliance with regulations
Module 10: Handling and Identification of Test and Calibration Items - Developing unique item identification systems
- Tracking items through each stage of testing process
- Managing item condition upon receipt and pre-test checks
- Preventing damage during handling and storage
- Documenting any discrepancies at intake
- Setting acceptance criteria for test items
- Managing client specifications and special instructions
- Ensuring traceability from sample to final report
- Using barcoding or digital tracking where applicable
- Establishing secure storage for sensitive or hazardous items
Module 11: Technical Record Keeping and Data Integrity - Defining what constitutes a technical record
- Ensuring completeness, legibility, and authenticity of records
- Implementing ALCOA+ principles: attributable, legible, contemporaneous, original, accurate
- Controlled data entry and error correction procedures
- Managing handwritten vs. digital records
- Ensuring secure access and authorisation levels
- Protecting records from unauthorised changes
- Backup and recovery strategies for digital data
- Retention periods based on regulatory and client requirements
- Audit trail implementation for electronic systems
Module 12: Reporting of Results and Statement of Conformity - Designing test reports that meet ISO 17025 requirements
- Ensuring clarity, accuracy, and unambiguous presentation
- Including mandatory fields: accreditation logo, scope number, uncertainty
- Drafting statements of compliance with specification limits
- Defining decision rules for pass/fail determinations
- Documenting technical responsibility for results
- Handling revisions and reissued reports
- Delivering reports securely to authorised recipients
- Using electronic signatures with legal validity
- Training client-facing staff on report interpretation protocols
Module 13: Measurement Uncertainty Estimation - Understanding the necessity of uncertainty in all reported results
- Identifying sources of uncertainty in test and calibration processes
- Using GUM (Guide to the Expression of Uncertainty in Measurement)
- Combining standard uncertainties into expanded uncertainty
- Selecting appropriate coverage factors (k=2)
- Documenting uncertainty budgets for each method
- Simplifying uncertainty for routine testing environments
- Updating uncertainty estimates after method or equipment changes
- Training technical staff to calculate and interpret uncertainty
- Presenting uncertainty in test reports without confusion
Module 14: Proficiency Testing and Interlaboratory Comparisons - Understanding the role of proficiency testing in accreditation
- Selecting PT schemes relevant to your scope of testing
- Participating in round-robin studies and key comparisons
- Analysing PT results using z-scores and other performance indicators
- Responding to unsatisfactory results with root cause analysis
- Implementing corrective actions based on PT findings
- Demonstrating participation annually as required by auditors
- Using PT data to validate method performance
- Planning PT participation in your annual quality calendar
- Maintaining records of PT enrolment and performance
Module 15: Internal Auditing for Accreditation Readiness - Understanding the purpose and types of internal audits
- Selecting and training competent internal auditors
- Developing an annual internal audit schedule
- Creating audit checklists based on ISO 17025 clauses
- Conducting process-based audits across lab functions
- Collecting objective evidence during audit interviews
- Writing non-conformity statements that are clear and objective
- Tracking corrective actions until closure
- Reporting audit findings to management
- Using audit trends to drive continual improvement
Module 16: Management Review and Continual Improvement - Setting the frequency and agenda for management reviews
- Preparing reports on key performance indicators
- Evaluating effectiveness of the quality system
- Reviewing audit results, PT outcomes, and customer feedback
- Analysing resource adequacy and training effectiveness
- Assessing compliance with regulatory requirements
- Reviewing risks and opportunities identified
- Setting new quality objectives and action plans
- Documenting review decisions and action assignments
- Ensuring follow-up on management review actions
Module 17: Handling Complaints and Non-Conformities - Establishing a formal complaint handling procedure
- Logging, acknowledging, and investigating all complaints
- Determining root causes of client dissatisfaction
- Implementing corrective actions to prevent recurrence
- Communicating resolutions to complainants
- Reporting complaint trends to management
- Defining non-conformity vs. incident vs. deviation
- Documenting technical and system non-conformities
- Conducting impact assessments on affected results
- Using non-conformities as opportunities for improvement
Module 18: Preparing for External Accreditation Assessment - Understanding the accreditation body’s assessment process
- Receiving and interpreting the assessment scope and timeline
- Preparing the pre-assessment documentation package
- Conducting a readiness gap analysis
- Hosting technical assessors during on-site visits
- Preparing staff for technical questioning and process walkthroughs
- Organising document access and record retrieval systems
- Scheduling laboratory observations and witnessing tests
- Developing responses to assessor observations
- Tracking accreditation body non-conformities and appeals
Module 19: Maintaining Accreditation and Surveillance Audits - Understanding the post-accreditation surveillance cycle
- Preparing for annual and biennial surveillance audits
- Demonstrating ongoing compliance with updated clauses
- Managing scope changes and extensions to accreditation
- Submitting updated technical records and PT results
- Handling witness testing requirements
- Updating your quality manual and procedures as needed
- Reporting major changes to your accreditation body
- Documenting continual improvement initiatives
- Reinforcing staff awareness of accreditation responsibilities
Module 20: Integration with Other Standards and Systems - Integrating ISO 17025 with ISO 9001 quality management
- Aligning with ISO 15189 in medical laboratories
- Combining with Good Laboratory Practice (GLP) requirements
- Harmonising internal processes with ISO/IEC 17065
- Mapping ISO 17025 to regulatory frameworks (FDA, EMA, NABL)
- Using a unified document control system
- Consolidating audit schedules and management reviews
- Training staff on integrated compliance expectations
- Reducing duplication in record keeping and reporting
- Creating a single source of truth for quality performance
Module 21: Digital Transformation and Future-Proofing Your Lab - Evaluating Laboratory Information Management Systems (LIMS)
- Digitising workflows for paperless compliance
- Ensuring electronic records meet ALCOA+ and 21 CFR Part 11
- Automating document control and approval workflows
- Using dashboards for real-time compliance monitoring
- Integrating calibration and maintenance tracking
- Securing data against breaches and unauthorised access
- Planning for cloud-based system scalability
- Training staff on digital workflow adoption
- Preparing for digital audits and remote assessments
Module 22: Certification, Recognition, and Career Advancement - Understanding the value of your Certificate of Completion
- How the credential is recognised by employers and regulators
- Adding the certification to your professional profiles (LinkedIn, CV)
- Leveraging your expertise for promotions or consulting roles
- Using the certificate to support lab-wide accreditation projects
- Accessing alumni resources and networking opportunities
- Receiving updates on new accreditation guidance
- Progress tracking and gamified learning milestones
- Downloading and sharing your digital certificate
- Your next steps: from compliance to leadership in laboratory excellence
- Designing sampling plans based on statistical principles
- Defining sampling methods within the scope of accreditation
- Validating sampling techniques for accuracy and representativeness
- Documenting sampling conditions and environmental data
- Implementing chain of custody protocols for legal defensibility
- Labelling, sealing, and storing samples to prevent tampering
- Handling client-supplied samples and responsibility boundaries
- Training field personnel on standardised sampling procedures
- Managing storage conditions for sample stability
- Documenting sample disposal in compliance with regulations
Module 10: Handling and Identification of Test and Calibration Items - Developing unique item identification systems
- Tracking items through each stage of testing process
- Managing item condition upon receipt and pre-test checks
- Preventing damage during handling and storage
- Documenting any discrepancies at intake
- Setting acceptance criteria for test items
- Managing client specifications and special instructions
- Ensuring traceability from sample to final report
- Using barcoding or digital tracking where applicable
- Establishing secure storage for sensitive or hazardous items
Module 11: Technical Record Keeping and Data Integrity - Defining what constitutes a technical record
- Ensuring completeness, legibility, and authenticity of records
- Implementing ALCOA+ principles: attributable, legible, contemporaneous, original, accurate
- Controlled data entry and error correction procedures
- Managing handwritten vs. digital records
- Ensuring secure access and authorisation levels
- Protecting records from unauthorised changes
- Backup and recovery strategies for digital data
- Retention periods based on regulatory and client requirements
- Audit trail implementation for electronic systems
Module 12: Reporting of Results and Statement of Conformity - Designing test reports that meet ISO 17025 requirements
- Ensuring clarity, accuracy, and unambiguous presentation
- Including mandatory fields: accreditation logo, scope number, uncertainty
- Drafting statements of compliance with specification limits
- Defining decision rules for pass/fail determinations
- Documenting technical responsibility for results
- Handling revisions and reissued reports
- Delivering reports securely to authorised recipients
- Using electronic signatures with legal validity
- Training client-facing staff on report interpretation protocols
Module 13: Measurement Uncertainty Estimation - Understanding the necessity of uncertainty in all reported results
- Identifying sources of uncertainty in test and calibration processes
- Using GUM (Guide to the Expression of Uncertainty in Measurement)
- Combining standard uncertainties into expanded uncertainty
- Selecting appropriate coverage factors (k=2)
- Documenting uncertainty budgets for each method
- Simplifying uncertainty for routine testing environments
- Updating uncertainty estimates after method or equipment changes
- Training technical staff to calculate and interpret uncertainty
- Presenting uncertainty in test reports without confusion
Module 14: Proficiency Testing and Interlaboratory Comparisons - Understanding the role of proficiency testing in accreditation
- Selecting PT schemes relevant to your scope of testing
- Participating in round-robin studies and key comparisons
- Analysing PT results using z-scores and other performance indicators
- Responding to unsatisfactory results with root cause analysis
- Implementing corrective actions based on PT findings
- Demonstrating participation annually as required by auditors
- Using PT data to validate method performance
- Planning PT participation in your annual quality calendar
- Maintaining records of PT enrolment and performance
Module 15: Internal Auditing for Accreditation Readiness - Understanding the purpose and types of internal audits
- Selecting and training competent internal auditors
- Developing an annual internal audit schedule
- Creating audit checklists based on ISO 17025 clauses
- Conducting process-based audits across lab functions
- Collecting objective evidence during audit interviews
- Writing non-conformity statements that are clear and objective
- Tracking corrective actions until closure
- Reporting audit findings to management
- Using audit trends to drive continual improvement
Module 16: Management Review and Continual Improvement - Setting the frequency and agenda for management reviews
- Preparing reports on key performance indicators
- Evaluating effectiveness of the quality system
- Reviewing audit results, PT outcomes, and customer feedback
- Analysing resource adequacy and training effectiveness
- Assessing compliance with regulatory requirements
- Reviewing risks and opportunities identified
- Setting new quality objectives and action plans
- Documenting review decisions and action assignments
- Ensuring follow-up on management review actions
Module 17: Handling Complaints and Non-Conformities - Establishing a formal complaint handling procedure
- Logging, acknowledging, and investigating all complaints
- Determining root causes of client dissatisfaction
- Implementing corrective actions to prevent recurrence
- Communicating resolutions to complainants
- Reporting complaint trends to management
- Defining non-conformity vs. incident vs. deviation
- Documenting technical and system non-conformities
- Conducting impact assessments on affected results
- Using non-conformities as opportunities for improvement
Module 18: Preparing for External Accreditation Assessment - Understanding the accreditation body’s assessment process
- Receiving and interpreting the assessment scope and timeline
- Preparing the pre-assessment documentation package
- Conducting a readiness gap analysis
- Hosting technical assessors during on-site visits
- Preparing staff for technical questioning and process walkthroughs
- Organising document access and record retrieval systems
- Scheduling laboratory observations and witnessing tests
- Developing responses to assessor observations
- Tracking accreditation body non-conformities and appeals
Module 19: Maintaining Accreditation and Surveillance Audits - Understanding the post-accreditation surveillance cycle
- Preparing for annual and biennial surveillance audits
- Demonstrating ongoing compliance with updated clauses
- Managing scope changes and extensions to accreditation
- Submitting updated technical records and PT results
- Handling witness testing requirements
- Updating your quality manual and procedures as needed
- Reporting major changes to your accreditation body
- Documenting continual improvement initiatives
- Reinforcing staff awareness of accreditation responsibilities
Module 20: Integration with Other Standards and Systems - Integrating ISO 17025 with ISO 9001 quality management
- Aligning with ISO 15189 in medical laboratories
- Combining with Good Laboratory Practice (GLP) requirements
- Harmonising internal processes with ISO/IEC 17065
- Mapping ISO 17025 to regulatory frameworks (FDA, EMA, NABL)
- Using a unified document control system
- Consolidating audit schedules and management reviews
- Training staff on integrated compliance expectations
- Reducing duplication in record keeping and reporting
- Creating a single source of truth for quality performance
Module 21: Digital Transformation and Future-Proofing Your Lab - Evaluating Laboratory Information Management Systems (LIMS)
- Digitising workflows for paperless compliance
- Ensuring electronic records meet ALCOA+ and 21 CFR Part 11
- Automating document control and approval workflows
- Using dashboards for real-time compliance monitoring
- Integrating calibration and maintenance tracking
- Securing data against breaches and unauthorised access
- Planning for cloud-based system scalability
- Training staff on digital workflow adoption
- Preparing for digital audits and remote assessments
Module 22: Certification, Recognition, and Career Advancement - Understanding the value of your Certificate of Completion
- How the credential is recognised by employers and regulators
- Adding the certification to your professional profiles (LinkedIn, CV)
- Leveraging your expertise for promotions or consulting roles
- Using the certificate to support lab-wide accreditation projects
- Accessing alumni resources and networking opportunities
- Receiving updates on new accreditation guidance
- Progress tracking and gamified learning milestones
- Downloading and sharing your digital certificate
- Your next steps: from compliance to leadership in laboratory excellence
- Defining what constitutes a technical record
- Ensuring completeness, legibility, and authenticity of records
- Implementing ALCOA+ principles: attributable, legible, contemporaneous, original, accurate
- Controlled data entry and error correction procedures
- Managing handwritten vs. digital records
- Ensuring secure access and authorisation levels
- Protecting records from unauthorised changes
- Backup and recovery strategies for digital data
- Retention periods based on regulatory and client requirements
- Audit trail implementation for electronic systems
Module 12: Reporting of Results and Statement of Conformity - Designing test reports that meet ISO 17025 requirements
- Ensuring clarity, accuracy, and unambiguous presentation
- Including mandatory fields: accreditation logo, scope number, uncertainty
- Drafting statements of compliance with specification limits
- Defining decision rules for pass/fail determinations
- Documenting technical responsibility for results
- Handling revisions and reissued reports
- Delivering reports securely to authorised recipients
- Using electronic signatures with legal validity
- Training client-facing staff on report interpretation protocols
Module 13: Measurement Uncertainty Estimation - Understanding the necessity of uncertainty in all reported results
- Identifying sources of uncertainty in test and calibration processes
- Using GUM (Guide to the Expression of Uncertainty in Measurement)
- Combining standard uncertainties into expanded uncertainty
- Selecting appropriate coverage factors (k=2)
- Documenting uncertainty budgets for each method
- Simplifying uncertainty for routine testing environments
- Updating uncertainty estimates after method or equipment changes
- Training technical staff to calculate and interpret uncertainty
- Presenting uncertainty in test reports without confusion
Module 14: Proficiency Testing and Interlaboratory Comparisons - Understanding the role of proficiency testing in accreditation
- Selecting PT schemes relevant to your scope of testing
- Participating in round-robin studies and key comparisons
- Analysing PT results using z-scores and other performance indicators
- Responding to unsatisfactory results with root cause analysis
- Implementing corrective actions based on PT findings
- Demonstrating participation annually as required by auditors
- Using PT data to validate method performance
- Planning PT participation in your annual quality calendar
- Maintaining records of PT enrolment and performance
Module 15: Internal Auditing for Accreditation Readiness - Understanding the purpose and types of internal audits
- Selecting and training competent internal auditors
- Developing an annual internal audit schedule
- Creating audit checklists based on ISO 17025 clauses
- Conducting process-based audits across lab functions
- Collecting objective evidence during audit interviews
- Writing non-conformity statements that are clear and objective
- Tracking corrective actions until closure
- Reporting audit findings to management
- Using audit trends to drive continual improvement
Module 16: Management Review and Continual Improvement - Setting the frequency and agenda for management reviews
- Preparing reports on key performance indicators
- Evaluating effectiveness of the quality system
- Reviewing audit results, PT outcomes, and customer feedback
- Analysing resource adequacy and training effectiveness
- Assessing compliance with regulatory requirements
- Reviewing risks and opportunities identified
- Setting new quality objectives and action plans
- Documenting review decisions and action assignments
- Ensuring follow-up on management review actions
Module 17: Handling Complaints and Non-Conformities - Establishing a formal complaint handling procedure
- Logging, acknowledging, and investigating all complaints
- Determining root causes of client dissatisfaction
- Implementing corrective actions to prevent recurrence
- Communicating resolutions to complainants
- Reporting complaint trends to management
- Defining non-conformity vs. incident vs. deviation
- Documenting technical and system non-conformities
- Conducting impact assessments on affected results
- Using non-conformities as opportunities for improvement
Module 18: Preparing for External Accreditation Assessment - Understanding the accreditation body’s assessment process
- Receiving and interpreting the assessment scope and timeline
- Preparing the pre-assessment documentation package
- Conducting a readiness gap analysis
- Hosting technical assessors during on-site visits
- Preparing staff for technical questioning and process walkthroughs
- Organising document access and record retrieval systems
- Scheduling laboratory observations and witnessing tests
- Developing responses to assessor observations
- Tracking accreditation body non-conformities and appeals
Module 19: Maintaining Accreditation and Surveillance Audits - Understanding the post-accreditation surveillance cycle
- Preparing for annual and biennial surveillance audits
- Demonstrating ongoing compliance with updated clauses
- Managing scope changes and extensions to accreditation
- Submitting updated technical records and PT results
- Handling witness testing requirements
- Updating your quality manual and procedures as needed
- Reporting major changes to your accreditation body
- Documenting continual improvement initiatives
- Reinforcing staff awareness of accreditation responsibilities
Module 20: Integration with Other Standards and Systems - Integrating ISO 17025 with ISO 9001 quality management
- Aligning with ISO 15189 in medical laboratories
- Combining with Good Laboratory Practice (GLP) requirements
- Harmonising internal processes with ISO/IEC 17065
- Mapping ISO 17025 to regulatory frameworks (FDA, EMA, NABL)
- Using a unified document control system
- Consolidating audit schedules and management reviews
- Training staff on integrated compliance expectations
- Reducing duplication in record keeping and reporting
- Creating a single source of truth for quality performance
Module 21: Digital Transformation and Future-Proofing Your Lab - Evaluating Laboratory Information Management Systems (LIMS)
- Digitising workflows for paperless compliance
- Ensuring electronic records meet ALCOA+ and 21 CFR Part 11
- Automating document control and approval workflows
- Using dashboards for real-time compliance monitoring
- Integrating calibration and maintenance tracking
- Securing data against breaches and unauthorised access
- Planning for cloud-based system scalability
- Training staff on digital workflow adoption
- Preparing for digital audits and remote assessments
Module 22: Certification, Recognition, and Career Advancement - Understanding the value of your Certificate of Completion
- How the credential is recognised by employers and regulators
- Adding the certification to your professional profiles (LinkedIn, CV)
- Leveraging your expertise for promotions or consulting roles
- Using the certificate to support lab-wide accreditation projects
- Accessing alumni resources and networking opportunities
- Receiving updates on new accreditation guidance
- Progress tracking and gamified learning milestones
- Downloading and sharing your digital certificate
- Your next steps: from compliance to leadership in laboratory excellence
- Understanding the necessity of uncertainty in all reported results
- Identifying sources of uncertainty in test and calibration processes
- Using GUM (Guide to the Expression of Uncertainty in Measurement)
- Combining standard uncertainties into expanded uncertainty
- Selecting appropriate coverage factors (k=2)
- Documenting uncertainty budgets for each method
- Simplifying uncertainty for routine testing environments
- Updating uncertainty estimates after method or equipment changes
- Training technical staff to calculate and interpret uncertainty
- Presenting uncertainty in test reports without confusion
Module 14: Proficiency Testing and Interlaboratory Comparisons - Understanding the role of proficiency testing in accreditation
- Selecting PT schemes relevant to your scope of testing
- Participating in round-robin studies and key comparisons
- Analysing PT results using z-scores and other performance indicators
- Responding to unsatisfactory results with root cause analysis
- Implementing corrective actions based on PT findings
- Demonstrating participation annually as required by auditors
- Using PT data to validate method performance
- Planning PT participation in your annual quality calendar
- Maintaining records of PT enrolment and performance
Module 15: Internal Auditing for Accreditation Readiness - Understanding the purpose and types of internal audits
- Selecting and training competent internal auditors
- Developing an annual internal audit schedule
- Creating audit checklists based on ISO 17025 clauses
- Conducting process-based audits across lab functions
- Collecting objective evidence during audit interviews
- Writing non-conformity statements that are clear and objective
- Tracking corrective actions until closure
- Reporting audit findings to management
- Using audit trends to drive continual improvement
Module 16: Management Review and Continual Improvement - Setting the frequency and agenda for management reviews
- Preparing reports on key performance indicators
- Evaluating effectiveness of the quality system
- Reviewing audit results, PT outcomes, and customer feedback
- Analysing resource adequacy and training effectiveness
- Assessing compliance with regulatory requirements
- Reviewing risks and opportunities identified
- Setting new quality objectives and action plans
- Documenting review decisions and action assignments
- Ensuring follow-up on management review actions
Module 17: Handling Complaints and Non-Conformities - Establishing a formal complaint handling procedure
- Logging, acknowledging, and investigating all complaints
- Determining root causes of client dissatisfaction
- Implementing corrective actions to prevent recurrence
- Communicating resolutions to complainants
- Reporting complaint trends to management
- Defining non-conformity vs. incident vs. deviation
- Documenting technical and system non-conformities
- Conducting impact assessments on affected results
- Using non-conformities as opportunities for improvement
Module 18: Preparing for External Accreditation Assessment - Understanding the accreditation body’s assessment process
- Receiving and interpreting the assessment scope and timeline
- Preparing the pre-assessment documentation package
- Conducting a readiness gap analysis
- Hosting technical assessors during on-site visits
- Preparing staff for technical questioning and process walkthroughs
- Organising document access and record retrieval systems
- Scheduling laboratory observations and witnessing tests
- Developing responses to assessor observations
- Tracking accreditation body non-conformities and appeals
Module 19: Maintaining Accreditation and Surveillance Audits - Understanding the post-accreditation surveillance cycle
- Preparing for annual and biennial surveillance audits
- Demonstrating ongoing compliance with updated clauses
- Managing scope changes and extensions to accreditation
- Submitting updated technical records and PT results
- Handling witness testing requirements
- Updating your quality manual and procedures as needed
- Reporting major changes to your accreditation body
- Documenting continual improvement initiatives
- Reinforcing staff awareness of accreditation responsibilities
Module 20: Integration with Other Standards and Systems - Integrating ISO 17025 with ISO 9001 quality management
- Aligning with ISO 15189 in medical laboratories
- Combining with Good Laboratory Practice (GLP) requirements
- Harmonising internal processes with ISO/IEC 17065
- Mapping ISO 17025 to regulatory frameworks (FDA, EMA, NABL)
- Using a unified document control system
- Consolidating audit schedules and management reviews
- Training staff on integrated compliance expectations
- Reducing duplication in record keeping and reporting
- Creating a single source of truth for quality performance
Module 21: Digital Transformation and Future-Proofing Your Lab - Evaluating Laboratory Information Management Systems (LIMS)
- Digitising workflows for paperless compliance
- Ensuring electronic records meet ALCOA+ and 21 CFR Part 11
- Automating document control and approval workflows
- Using dashboards for real-time compliance monitoring
- Integrating calibration and maintenance tracking
- Securing data against breaches and unauthorised access
- Planning for cloud-based system scalability
- Training staff on digital workflow adoption
- Preparing for digital audits and remote assessments
Module 22: Certification, Recognition, and Career Advancement - Understanding the value of your Certificate of Completion
- How the credential is recognised by employers and regulators
- Adding the certification to your professional profiles (LinkedIn, CV)
- Leveraging your expertise for promotions or consulting roles
- Using the certificate to support lab-wide accreditation projects
- Accessing alumni resources and networking opportunities
- Receiving updates on new accreditation guidance
- Progress tracking and gamified learning milestones
- Downloading and sharing your digital certificate
- Your next steps: from compliance to leadership in laboratory excellence
- Understanding the purpose and types of internal audits
- Selecting and training competent internal auditors
- Developing an annual internal audit schedule
- Creating audit checklists based on ISO 17025 clauses
- Conducting process-based audits across lab functions
- Collecting objective evidence during audit interviews
- Writing non-conformity statements that are clear and objective
- Tracking corrective actions until closure
- Reporting audit findings to management
- Using audit trends to drive continual improvement
Module 16: Management Review and Continual Improvement - Setting the frequency and agenda for management reviews
- Preparing reports on key performance indicators
- Evaluating effectiveness of the quality system
- Reviewing audit results, PT outcomes, and customer feedback
- Analysing resource adequacy and training effectiveness
- Assessing compliance with regulatory requirements
- Reviewing risks and opportunities identified
- Setting new quality objectives and action plans
- Documenting review decisions and action assignments
- Ensuring follow-up on management review actions
Module 17: Handling Complaints and Non-Conformities - Establishing a formal complaint handling procedure
- Logging, acknowledging, and investigating all complaints
- Determining root causes of client dissatisfaction
- Implementing corrective actions to prevent recurrence
- Communicating resolutions to complainants
- Reporting complaint trends to management
- Defining non-conformity vs. incident vs. deviation
- Documenting technical and system non-conformities
- Conducting impact assessments on affected results
- Using non-conformities as opportunities for improvement
Module 18: Preparing for External Accreditation Assessment - Understanding the accreditation body’s assessment process
- Receiving and interpreting the assessment scope and timeline
- Preparing the pre-assessment documentation package
- Conducting a readiness gap analysis
- Hosting technical assessors during on-site visits
- Preparing staff for technical questioning and process walkthroughs
- Organising document access and record retrieval systems
- Scheduling laboratory observations and witnessing tests
- Developing responses to assessor observations
- Tracking accreditation body non-conformities and appeals
Module 19: Maintaining Accreditation and Surveillance Audits - Understanding the post-accreditation surveillance cycle
- Preparing for annual and biennial surveillance audits
- Demonstrating ongoing compliance with updated clauses
- Managing scope changes and extensions to accreditation
- Submitting updated technical records and PT results
- Handling witness testing requirements
- Updating your quality manual and procedures as needed
- Reporting major changes to your accreditation body
- Documenting continual improvement initiatives
- Reinforcing staff awareness of accreditation responsibilities
Module 20: Integration with Other Standards and Systems - Integrating ISO 17025 with ISO 9001 quality management
- Aligning with ISO 15189 in medical laboratories
- Combining with Good Laboratory Practice (GLP) requirements
- Harmonising internal processes with ISO/IEC 17065
- Mapping ISO 17025 to regulatory frameworks (FDA, EMA, NABL)
- Using a unified document control system
- Consolidating audit schedules and management reviews
- Training staff on integrated compliance expectations
- Reducing duplication in record keeping and reporting
- Creating a single source of truth for quality performance
Module 21: Digital Transformation and Future-Proofing Your Lab - Evaluating Laboratory Information Management Systems (LIMS)
- Digitising workflows for paperless compliance
- Ensuring electronic records meet ALCOA+ and 21 CFR Part 11
- Automating document control and approval workflows
- Using dashboards for real-time compliance monitoring
- Integrating calibration and maintenance tracking
- Securing data against breaches and unauthorised access
- Planning for cloud-based system scalability
- Training staff on digital workflow adoption
- Preparing for digital audits and remote assessments
Module 22: Certification, Recognition, and Career Advancement - Understanding the value of your Certificate of Completion
- How the credential is recognised by employers and regulators
- Adding the certification to your professional profiles (LinkedIn, CV)
- Leveraging your expertise for promotions or consulting roles
- Using the certificate to support lab-wide accreditation projects
- Accessing alumni resources and networking opportunities
- Receiving updates on new accreditation guidance
- Progress tracking and gamified learning milestones
- Downloading and sharing your digital certificate
- Your next steps: from compliance to leadership in laboratory excellence
- Establishing a formal complaint handling procedure
- Logging, acknowledging, and investigating all complaints
- Determining root causes of client dissatisfaction
- Implementing corrective actions to prevent recurrence
- Communicating resolutions to complainants
- Reporting complaint trends to management
- Defining non-conformity vs. incident vs. deviation
- Documenting technical and system non-conformities
- Conducting impact assessments on affected results
- Using non-conformities as opportunities for improvement
Module 18: Preparing for External Accreditation Assessment - Understanding the accreditation body’s assessment process
- Receiving and interpreting the assessment scope and timeline
- Preparing the pre-assessment documentation package
- Conducting a readiness gap analysis
- Hosting technical assessors during on-site visits
- Preparing staff for technical questioning and process walkthroughs
- Organising document access and record retrieval systems
- Scheduling laboratory observations and witnessing tests
- Developing responses to assessor observations
- Tracking accreditation body non-conformities and appeals
Module 19: Maintaining Accreditation and Surveillance Audits - Understanding the post-accreditation surveillance cycle
- Preparing for annual and biennial surveillance audits
- Demonstrating ongoing compliance with updated clauses
- Managing scope changes and extensions to accreditation
- Submitting updated technical records and PT results
- Handling witness testing requirements
- Updating your quality manual and procedures as needed
- Reporting major changes to your accreditation body
- Documenting continual improvement initiatives
- Reinforcing staff awareness of accreditation responsibilities
Module 20: Integration with Other Standards and Systems - Integrating ISO 17025 with ISO 9001 quality management
- Aligning with ISO 15189 in medical laboratories
- Combining with Good Laboratory Practice (GLP) requirements
- Harmonising internal processes with ISO/IEC 17065
- Mapping ISO 17025 to regulatory frameworks (FDA, EMA, NABL)
- Using a unified document control system
- Consolidating audit schedules and management reviews
- Training staff on integrated compliance expectations
- Reducing duplication in record keeping and reporting
- Creating a single source of truth for quality performance
Module 21: Digital Transformation and Future-Proofing Your Lab - Evaluating Laboratory Information Management Systems (LIMS)
- Digitising workflows for paperless compliance
- Ensuring electronic records meet ALCOA+ and 21 CFR Part 11
- Automating document control and approval workflows
- Using dashboards for real-time compliance monitoring
- Integrating calibration and maintenance tracking
- Securing data against breaches and unauthorised access
- Planning for cloud-based system scalability
- Training staff on digital workflow adoption
- Preparing for digital audits and remote assessments
Module 22: Certification, Recognition, and Career Advancement - Understanding the value of your Certificate of Completion
- How the credential is recognised by employers and regulators
- Adding the certification to your professional profiles (LinkedIn, CV)
- Leveraging your expertise for promotions or consulting roles
- Using the certificate to support lab-wide accreditation projects
- Accessing alumni resources and networking opportunities
- Receiving updates on new accreditation guidance
- Progress tracking and gamified learning milestones
- Downloading and sharing your digital certificate
- Your next steps: from compliance to leadership in laboratory excellence
- Understanding the post-accreditation surveillance cycle
- Preparing for annual and biennial surveillance audits
- Demonstrating ongoing compliance with updated clauses
- Managing scope changes and extensions to accreditation
- Submitting updated technical records and PT results
- Handling witness testing requirements
- Updating your quality manual and procedures as needed
- Reporting major changes to your accreditation body
- Documenting continual improvement initiatives
- Reinforcing staff awareness of accreditation responsibilities
Module 20: Integration with Other Standards and Systems - Integrating ISO 17025 with ISO 9001 quality management
- Aligning with ISO 15189 in medical laboratories
- Combining with Good Laboratory Practice (GLP) requirements
- Harmonising internal processes with ISO/IEC 17065
- Mapping ISO 17025 to regulatory frameworks (FDA, EMA, NABL)
- Using a unified document control system
- Consolidating audit schedules and management reviews
- Training staff on integrated compliance expectations
- Reducing duplication in record keeping and reporting
- Creating a single source of truth for quality performance
Module 21: Digital Transformation and Future-Proofing Your Lab - Evaluating Laboratory Information Management Systems (LIMS)
- Digitising workflows for paperless compliance
- Ensuring electronic records meet ALCOA+ and 21 CFR Part 11
- Automating document control and approval workflows
- Using dashboards for real-time compliance monitoring
- Integrating calibration and maintenance tracking
- Securing data against breaches and unauthorised access
- Planning for cloud-based system scalability
- Training staff on digital workflow adoption
- Preparing for digital audits and remote assessments
Module 22: Certification, Recognition, and Career Advancement - Understanding the value of your Certificate of Completion
- How the credential is recognised by employers and regulators
- Adding the certification to your professional profiles (LinkedIn, CV)
- Leveraging your expertise for promotions or consulting roles
- Using the certificate to support lab-wide accreditation projects
- Accessing alumni resources and networking opportunities
- Receiving updates on new accreditation guidance
- Progress tracking and gamified learning milestones
- Downloading and sharing your digital certificate
- Your next steps: from compliance to leadership in laboratory excellence
- Evaluating Laboratory Information Management Systems (LIMS)
- Digitising workflows for paperless compliance
- Ensuring electronic records meet ALCOA+ and 21 CFR Part 11
- Automating document control and approval workflows
- Using dashboards for real-time compliance monitoring
- Integrating calibration and maintenance tracking
- Securing data against breaches and unauthorised access
- Planning for cloud-based system scalability
- Training staff on digital workflow adoption
- Preparing for digital audits and remote assessments