COURSE FORMAT & DELIVERY DETAILS Self-Paced, On-Demand Access with Immediate Start
This course is designed for professionals like you who demand flexibility and control. From the moment you enroll, you gain self-paced, on-demand access to the complete learning experience. There are no fixed start dates, no rigid schedules, and no time commitments. You decide when, where, and how fast you progress-making it easy to balance your professional responsibilities with career advancement. Realistic Completion Timeline and Fast-Track Results
Most learners complete the program in 6 to 8 weeks when dedicating 4 to 5 hours per week. However, because the course is fully self-directed, you can accelerate your progress and begin applying key principles to your laboratory operations in as little as 10 to 14 days. The structured flow ensures that even accelerated learners achieve deep comprehension and practical mastery, not just speed. Lifetime Access with Ongoing Future Updates
Enroll once and gain lifetime access to all course materials. This includes every future update to content, tools, templates, and guidance-delivered at no additional cost. Regulatory standards evolve, and so does this course. You’ll always have access to the most current, globally aligned practices for ISO IEC 17025 implementation, ensuring your knowledge remains relevant and authoritative for years to come. Available 24/7 on Any Device, Anywhere in the World
Access your course anytime, from any internet-connected device. Whether you’re reviewing materials on your desktop at work, refining your lab’s documentation on a tablet from home, or referencing checklists on your smartphone during an audit walkthrough, the system is fully mobile-friendly and optimized for uninterrupted, seamless learning across platforms. Direct Instructor Support and Expert Guidance
You are not learning in isolation. Throughout your journey, you have direct access to our team of ISO 17025 implementation specialists. Receive timely, detailed responses to your technical questions, clarification on complex clauses, and guidance on applying best practices in your specific laboratory environment-whether clinical, environmental, calibration, testing, or forensic. This support ensures you move forward with confidence, not confusion. Certificate of Completion Issued by The Art of Service
Upon successful completion, you will receive a Certificate of Completion issued by The Art of Service. This credential is recognized by professionals and organizations worldwide as a mark of excellence in process, compliance, and technical governance. Display it with pride on your LinkedIn profile, CV, or internal bio to validate your expertise in laboratory accreditation systems and demonstrate your commitment to global standards. Transparent, One-Time Pricing-No Hidden Fees
Our pricing is simple, upfront, and fair. What you see is exactly what you pay-no recurring charges, no surprise upgrades, and no hidden costs. You gain full access to every resource, tool, and support service included in the program. This transparency reflects our confidence in the value you will receive and our commitment to ethical, trustworthy education. Widely Accepted Payment Options for Global Learners
We accept all major payment methods, including Visa, Mastercard, and PayPal. This ensures a smooth, secure enrollment process no matter where you are located. Your transaction is protected with industry-standard encryption, and your data is handled with the highest level of privacy and integrity. 100% Money-Back Guarantee-Zero Risk Enrollment
We stand behind the quality and results of this program with a complete satisfaction guarantee. If at any point you feel the course does not meet your expectations, you can request a full refund. There are no time limits, no hoops to jump through, and no questions that delay your decision. This is our promise to you: total confidence in your investment, from enrollment to completion. What to Expect After Enrollment
After registering, you will receive a confirmation email acknowledging your enrollment. Shortly afterward, a separate message will deliver your secure access details once the course materials are fully prepared for your use. This ensures every learner receives a consistent, high-integrity experience with properly vetted content and functional access. Will This Work For Me? (Yes-Here’s Why)
You might be thinking: Is this course right for my role? My lab’s size? My technical background? Let us be clear-this program is built for real-world application by real professionals across disciplines. - Laboratory Managers use it to lead accreditation projects with clarity, save months in preparation time, and pass audits on the first attempt.
- Quality Officers apply the frameworks to overhaul documentation systems, align procedures with clause requirements, and reduce nonconformities by over 70% in internal assessments.
- Technical Staff leverage the practical tools to understand their responsibilities under ISO IEC 17025, improve data integrity, and support traceability efforts with confidence.
- Even newcomers to quality systems have successfully used this course to transition into accreditation roles, pass interviews, and contribute meaningfully within weeks.
This works even if you’ve tried other training and found it too theoretical, outdated, or disconnected from daily lab operations. This is not abstract theory-it’s a battle-tested implementation system used by labs across 40+ countries to achieve and maintain accreditation success. Recent testimonials confirm the transformation: - “After completing this course, I led my lab’s ISO 17025 transition with zero external consultants. We achieved full accreditation within 5 months-faster than any peer I know.” - Sarah M, Quality Manager, Environmental Testing Lab, UK
- “I had no formal training in quality management before. The step-by-step breakdown made complex clauses simple. Now I’m seen as the go-to person for compliance.” - Raj K, Lab Technician, India
- “Our previous audit failed on document control. This course gave us the exact templates and workflows we needed. Passed with zero findings last month.” - Elena R, Laboratory Director, Spain
This course works because it was engineered from real implementation experiences-not textbook ideals. Every template, checklist, and workflow has been tested in active laboratories across diverse sectors. You are not just learning-you are equipping yourself with tools that produce measurable outcomes. Your Learning Journey is Risk-Free, Value-Rich, and Career-Advancing
From the moment you begin, every resource is designed to reduce your effort, eliminate guesswork, and accelerate results. Combined with lifetime access, expert support, a globally recognized certificate, and a full money-back guarantee, this is a decision with all reward and no risk. You gain not just knowledge-but leverage, credibility, and career momentum.
EXTENSIVE & DETAILED COURSE CURRICULUM
Module 1: Foundations of ISO IEC 17025 and Laboratory Accreditation - Understanding the purpose and global impact of ISO IEC 17025
- Key differences between accreditation, certification, and registration
- The role of ILAC, APLAC, and mutual recognition arrangements
- How accreditation strengthens laboratory credibility and market position
- Overview of recognized accreditation bodies worldwide
- Why ISO IEC 17025 is mandatory for certain industries and clients
- The evolution of ISO IEC 17025 from previous editions
- Integration with other management standards: ISO 9001, ISO 15189, ISO 17043
- Establishing the business case for accreditation in your organization
- Identifying internal and external drivers for compliance
- Common misconceptions about the accreditation process
- Defining the scope of accreditation: what it includes and excludes
- The lifecycle of laboratory accreditation: from planning to surveillance
- Role of the laboratory within the broader quality ecosystem
- Introduction to technical vs managerial requirements in the standard
- Setting success metrics for your accreditation project
- Understanding the difference between compliance and excellence
- Using accreditation as a strategic growth tool
- How to communicate accreditation benefits to stakeholders
- Preparing leadership for cultural and operational shifts
Module 2: Management System Structure and Organizational Readiness - Establishing the laboratory’s organizational structure
- Defining roles, responsibilities, and authorities for key personnel
- Developing a quality policy aligned with ISO IEC 17025 requirements
- Creating and implementing a quality manual
- Documenting the management system scope
- Building a document control hierarchy: levels and types
- Developing a document control procedure that meets clause 8.3
- Approved document formats and metadata standards
- Revision control, version management, and approval workflows
- Retaining documents and records per regulatory requirements
- Best practices for electronic document management systems
- Transitioning from paper-based to digital systems
- Secure access controls and user permissions
- Audit trails and change logs for document integrity
- Preparing for internal document audits
- Conducting a baseline gap analysis
- Using readiness checklists to measure current compliance
- Creating an implementation roadmap with milestones
- Establishing a project team and assigning leads
- Setting up communication and status reporting protocols
Module 3: Personnel Competence and Training Frameworks - Defining technical personnel requirements per ISO IEC 17025
- Creating job descriptions with accreditation-aligned responsibilities
- Establishing education, training, technical skills, and experience criteria
- Developing a personnel training needs analysis
- Designing a competency assessment program
- Using observation, examination, and work product review methods
- Handling personnel with dual roles or shared responsibilities
- Managing personnel records: retention and confidentiality
- Creating a training calendar and annual development plans
- Supervision strategies for junior and new staff
- Validating technician competency for high-risk tests
- Handling temporary, external, or remote personnel
- Ensuring impartiality and avoiding conflicts of interest
- Training records and evidence of continual improvement
- Linking training outcomes to audit readiness
- Developing an internal training program for sustainability
- Onboarding new staff with accreditation compliance embedded
- Role of supervisors in maintaining ongoing competence
- Using performance reviews to support quality objectives
- Tracking training impact through KPIs and audit results
Module 4: Facility and Environmental Control Requirements - Designing laboratory facilities to support test integrity
- Preventing contamination, interference, and cross-contamination
- Environmental monitoring: temperature, humidity, vibration, etc.
- Calibrating and maintaining environmental control equipment
- Secure storage areas for hazardous and sensitive materials
- Adequate workspace for safe and accurate operations
- Workflow design to minimize errors and bottlenecks
- Lighting, ventilation, and ergonomics for technician safety
- Biohazard and chemical safety compliance integration
- Waste disposal and environmental compliance alignment
- Security measures for data, samples, and reagents
- Access control and visitor management policies
- Facility maintenance schedules and logs
- Emergency preparedness and response planning
- Documenting facilities in the quality manual
- Handling leased, shared, or off-site laboratory spaces
- Remote sampling locations and field testing considerations
- Site-specific risk assessments and mitigation plans
- Checklists for daily facility inspections
- Integration with internal audit programs
Module 5: Equipment Management, Calibration, and Traceability - Identifying critical equipment requiring calibration
- Developing an equipment inventory with unique identifiers
- Assigning responsibility for equipment use and care
- Establishing calibration schedules based on usage and risk
- Selecting accredited calibration service providers
- Evaluating calibration certificates for compliance
- Interpreting calibration results and measurement uncertainty
- Implementing corrective actions for out-of-tolerance equipment
- Using calibration status labels and tracking systems
- Managing software-controlled and automated equipment
- Verifying non-traditional equipment like LIMS and software tools
- Equipment maintenance and servicing logs
- Preventive maintenance planning and execution
- Handling equipment after repair or relocation
- Validation of in-house developed or modified equipment
- Ensuring metrological traceability to SI units
- Documenting traceability chains and national standards
- Managing reference materials and certified standards
- Proper storage, handling, and expiration control
- Using internal quality control to verify equipment performance
Module 6: Method Selection, Validation, and Verification - Differentiating between method validation and verification
- Selecting standard, published, or in-house test methods
- Validating non-standard methods per ISO IEC 17025 clause 7.2
- Determining method scope, applicability, and limitations
- Establishing validation parameters: accuracy, precision, sensitivity
- Linearity, range, detection limit, and quantitation limit
- Robustness and ruggedness testing under variable conditions
- Documentation requirements for validation studies
- Creating validation reports with complete technical evidence
- Review and approval of validation by technical authority
- Verification of standardized methods: requirements and evidence
- Handling modified or extended standard methods
- Documenting method changes and their impact
- Method equivalence and comparison studies
- Proficiency testing as evidence of method reliability
- Using interlaboratory comparisons to validate performance
- Handling client-developed or proprietary methods
- Risk-based approach to method selection
- Updating methods in response to scientific advances
- Ensuring staff are trained on current valid methods
Module 7: Sampling Procedures and Sample Integrity - Defining sampling plans based on statistical and technical requirements
- Developing documented sampling procedures for each method
- Ensuring sample representativeness and integrity
- Designing sampling kits and field collection protocols
- Preservation, storage, and transport conditions for samples
- Chain of custody documentation and electronic tracking
- Labeling samples with unique identifiers and metadata
- Handling confidential or sensitive samplings
- Sampling uncertainty and its impact on results
- Accepting or rejecting client-collected samples
- Distinguishing between sampling and testing responsibilities
- On-site versus laboratory-based sampling activities
- Training field personnel on standardized procedures
- Verifying sampling equipment before use
- Documenting environmental conditions at sampling point
- Controlling contamination during transport
- Time limits for sample analysis and stability requirements
- Client communication about sampling prerequisites
- Using sampling checklists and mobile data capture
- Integrating sampling data into LIMS and reporting systems
Module 8: Handling, Storage, and Protection of Test Items - Receiving protocols for samples and test items
- Verification of sample condition and acceptance criteria
- Quarantine and holding areas for pending testing
- Secure storage conditions to prevent degradation
- Tracking sample location and movement
- Access control for high-value or controlled substances
- Disposal procedures for expired or unused test items
- Documenting deviations in storage conditions
- Chain of custody for forensic and legal samples
- Client instructions for special handling requirements
- Contingency plans for power failures or equipment downtime
- Monitoring storage conditions with automated sensors
- Integration with inventory management systems
- Labeling standards for containers and refrigerated units
- Managing hazardous and biohazardous materials
- Documentation of sample preparation steps
- Preventing cross-contamination during processing
- Packaging standards for interlab transfers
- Retention periods for archived samples
- Re-testing procedures from retained samples
Module 9: Technical Record Keeping and Data Integrity - Requirements for complete, accurate, and secure records
- Distinguishing between quality records and technical records
- Elements of a complete technical record for each test
- Ensuring data authenticity and non-modifiability
- Preventing data manipulation and selective reporting
- Audit trail requirements for electronic records
- Best practices for handwritten notes and lab notebooks
- Signatures, initials, and date stamps on records
- Retention periods based on legal and technical needs
- Secure archiving and backup systems
- Access control for sensitive or confidential data
- GDPR, HIPAA, and other data privacy compliance links
- Metadata requirements for digital results
- Ensuring traceability from data to raw observations
- Handling data in transitional systems (paper to digital)
- Validation of data entry and software tools
- Internal audits of data management practices
- Use of data integrity checklists and red flags
- Correcting errors in records: procedure and evidence
- Documenting data recovery and restoration events
Module 10: Measurement Uncertainty and Result Validity - Understanding the concept of measurement uncertainty
- Why uncertainty is required for every accredited result
- Differentiating between error and uncertainty
- Top-down vs bottom-up approaches to uncertainty estimation
- Identifying uncertainty components: equipment, environment, operator
- Using control charts and historical data
- Applying GUM (Guide to the Expression of Uncertainty in Measurement)
- Simplified uncertainty models for routine testing
- Uncertainty budgets: structure and documentation
- Reporting uncertainty with test results
- When to update uncertainty calculations
- Tools and templates for uncertainty assessments
- Training staff on uncertainty interpretation
- Linking uncertainty to decision rules and compliance statements
- Uncertainty for qualitative and semi-quantitative methods
- Method-specific uncertainty evaluation examples
- Peer review of uncertainty calculations
- Regulatory expectations for uncertainty reporting
- Handling client questions about uncertainty
- Using uncertainty to improve method performance
Module 11: Quality Assurance and Internal Quality Control - Designing a comprehensive internal quality control program
- Using control samples, blanks, and spike recoveries
- Establishing control limits and trending analysis
- Implementing Levey-Jennings charts and Westgard rules
- Corrective actions for out-of-control signals
- Frequency of QC based on method stability and risk
- Proficiency testing: planning, selection, participation
- Evaluating PT results and addressing underperformance
- Using interlaboratory comparisons as QA tools
- Internal blind testing and sample reanalysis
- Rotating responsibilities to detect bias
- Reviewing QA data during management meetings
- Linking QA findings to process improvement
- Automating QC data collection and analysis
- Documenting QA activities and trends
- Corrective action triggers based on QA failures
- Using QA to support measurement traceability
- QA program review during management review
- Validating QA effectiveness with audit findings
- QA integration with LIMS and reporting systems
Module 12: Proficiency Testing and External Quality Assessment - Role of PT in demonstrating laboratory competence
- Identifying PT providers accredited to ISO IEC 17043
- Selecting appropriate PT schemes by discipline
- Scheduling PT participation based on test volume
- Assigning staff to conduct PT without bias
- Handling PT results: interpretation and reporting
- Corrective actions for unsatisfactory PT outcomes
- Documenting PT performance over time
- Using PT results in management reviews
- Peer comparison and benchmarking with PT data
- PT frequency requirements by accreditation body
- Alternative approaches when PT is not available
- Use of interlaboratory comparisons and round robins
- Customer requirements for PT participation
- Reporting PT status in accreditation applications
- Internal PT programs for self-assessment
- Using PT to validate new methods or equipment
- Training staff on PT best practices
- Archiving PT reports and certificates
- Linking PT to laboratory performance KPIs
Module 13: External Audits and Accreditation Assessments - Preparing for initial and surveillance assessments
- Understanding assessor roles and expectations
- Creating an audit readiness checklist
- Conducting mock audits with internal assessors
- Documenting compliance evidence for each clause
- Handling auditor requests and site tours
- Supporting technical staff during observation
- Document review and record presentation protocols
- Responding to findings and nonconformities
- Corrective action writing and submission timelines
- Pre-audit meetings and documentation walkthroughs
- Using audit preparation templates and timelines
- Training staff on audit communication skills
- Handling difficult questions or challenges
- Post-audit review and action planning
- Follow-up audit preparation
- Tracking resolution of findings to closure
- Using assessor feedback for improvement
- Building a culture of audit readiness
- Continuous improvement after accreditation
Module 14: Internal Audits and Continuous Improvement - Planning the internal audit schedule
- Selecting and training internal auditors
- Developing audit checklists based on ISO IEC 17025
- Conducting process-based and clause-based audits
- Writing clear, objective nonconformity statements
- Documenting evidence and interviews
- Reporting audit findings to management
- Assigning corrective actions and owners
- Verifying effectiveness of corrective actions
- Integrating audits with risk management
- Using audit data for management review
- Tracking audit trends over time
- Preventing recurrence of common findings
- Scheduling department-specific audits
- Conducting audits remotely or in hybrid environments
- Automating audit workflows with digital tools
- Reviewing auditor performance and competency
- Calibrating audit rigor across the organization
- Using internal audits to support external readiness
- Creating a feedback loop for continual improvement
Module 15: Management Review and Strategic Oversight - Scheduling and planning management review meetings
- Required inputs: audit results, customer feedback, PT data
- Performance metrics and KPIs for lab operations
- Resource adequacy and staffing levels
- Reviewing corrective and preventive actions
- Assessing changes in external and internal issues
- Evaluating risks and opportunities
- Reviewing quality objectives and progress
- Reporting on accreditation status and compliance
- Updating the quality policy and strategic direction
- Ensuring decision traceability and documentation
- Assigning action items from management review
- Tracking implementation of decisions
- Communicating outcomes to staff
- Balancing operational and strategic focus
- Using data dashboards for efficient review
- Involving cross-functional leadership
- Archiving management review records
- Frequency of reviews based on lab size and risk
- Linking management review to continual improvement
Module 16: Certification, Next Steps, and Sustaining Excellence - Final review before accreditation application
- Compiling the accreditation dossier
- Selecting an accreditation body
- Submitting the formal application
- Preparing for the document review phase
- Scheduling the on-site assessment
- Assigning roles during the assessment
- Handling the closing meeting and report
- Responding to nonconformities
- Timeline for accreditation decision
- Receiving the scope of accreditation
- Using the accreditation mark correctly
- Surveillance audit preparation
- Handling scope extensions and method additions
- Reassessment and renewal cycles
- Withdrawing or reducing scope
- Transitioning between accreditation bodies
- Marketing your accreditation to clients
- Leveraging the Certificate of Completion for career growth
- Continuing professional development in quality
Module 1: Foundations of ISO IEC 17025 and Laboratory Accreditation - Understanding the purpose and global impact of ISO IEC 17025
- Key differences between accreditation, certification, and registration
- The role of ILAC, APLAC, and mutual recognition arrangements
- How accreditation strengthens laboratory credibility and market position
- Overview of recognized accreditation bodies worldwide
- Why ISO IEC 17025 is mandatory for certain industries and clients
- The evolution of ISO IEC 17025 from previous editions
- Integration with other management standards: ISO 9001, ISO 15189, ISO 17043
- Establishing the business case for accreditation in your organization
- Identifying internal and external drivers for compliance
- Common misconceptions about the accreditation process
- Defining the scope of accreditation: what it includes and excludes
- The lifecycle of laboratory accreditation: from planning to surveillance
- Role of the laboratory within the broader quality ecosystem
- Introduction to technical vs managerial requirements in the standard
- Setting success metrics for your accreditation project
- Understanding the difference between compliance and excellence
- Using accreditation as a strategic growth tool
- How to communicate accreditation benefits to stakeholders
- Preparing leadership for cultural and operational shifts
Module 2: Management System Structure and Organizational Readiness - Establishing the laboratory’s organizational structure
- Defining roles, responsibilities, and authorities for key personnel
- Developing a quality policy aligned with ISO IEC 17025 requirements
- Creating and implementing a quality manual
- Documenting the management system scope
- Building a document control hierarchy: levels and types
- Developing a document control procedure that meets clause 8.3
- Approved document formats and metadata standards
- Revision control, version management, and approval workflows
- Retaining documents and records per regulatory requirements
- Best practices for electronic document management systems
- Transitioning from paper-based to digital systems
- Secure access controls and user permissions
- Audit trails and change logs for document integrity
- Preparing for internal document audits
- Conducting a baseline gap analysis
- Using readiness checklists to measure current compliance
- Creating an implementation roadmap with milestones
- Establishing a project team and assigning leads
- Setting up communication and status reporting protocols
Module 3: Personnel Competence and Training Frameworks - Defining technical personnel requirements per ISO IEC 17025
- Creating job descriptions with accreditation-aligned responsibilities
- Establishing education, training, technical skills, and experience criteria
- Developing a personnel training needs analysis
- Designing a competency assessment program
- Using observation, examination, and work product review methods
- Handling personnel with dual roles or shared responsibilities
- Managing personnel records: retention and confidentiality
- Creating a training calendar and annual development plans
- Supervision strategies for junior and new staff
- Validating technician competency for high-risk tests
- Handling temporary, external, or remote personnel
- Ensuring impartiality and avoiding conflicts of interest
- Training records and evidence of continual improvement
- Linking training outcomes to audit readiness
- Developing an internal training program for sustainability
- Onboarding new staff with accreditation compliance embedded
- Role of supervisors in maintaining ongoing competence
- Using performance reviews to support quality objectives
- Tracking training impact through KPIs and audit results
Module 4: Facility and Environmental Control Requirements - Designing laboratory facilities to support test integrity
- Preventing contamination, interference, and cross-contamination
- Environmental monitoring: temperature, humidity, vibration, etc.
- Calibrating and maintaining environmental control equipment
- Secure storage areas for hazardous and sensitive materials
- Adequate workspace for safe and accurate operations
- Workflow design to minimize errors and bottlenecks
- Lighting, ventilation, and ergonomics for technician safety
- Biohazard and chemical safety compliance integration
- Waste disposal and environmental compliance alignment
- Security measures for data, samples, and reagents
- Access control and visitor management policies
- Facility maintenance schedules and logs
- Emergency preparedness and response planning
- Documenting facilities in the quality manual
- Handling leased, shared, or off-site laboratory spaces
- Remote sampling locations and field testing considerations
- Site-specific risk assessments and mitigation plans
- Checklists for daily facility inspections
- Integration with internal audit programs
Module 5: Equipment Management, Calibration, and Traceability - Identifying critical equipment requiring calibration
- Developing an equipment inventory with unique identifiers
- Assigning responsibility for equipment use and care
- Establishing calibration schedules based on usage and risk
- Selecting accredited calibration service providers
- Evaluating calibration certificates for compliance
- Interpreting calibration results and measurement uncertainty
- Implementing corrective actions for out-of-tolerance equipment
- Using calibration status labels and tracking systems
- Managing software-controlled and automated equipment
- Verifying non-traditional equipment like LIMS and software tools
- Equipment maintenance and servicing logs
- Preventive maintenance planning and execution
- Handling equipment after repair or relocation
- Validation of in-house developed or modified equipment
- Ensuring metrological traceability to SI units
- Documenting traceability chains and national standards
- Managing reference materials and certified standards
- Proper storage, handling, and expiration control
- Using internal quality control to verify equipment performance
Module 6: Method Selection, Validation, and Verification - Differentiating between method validation and verification
- Selecting standard, published, or in-house test methods
- Validating non-standard methods per ISO IEC 17025 clause 7.2
- Determining method scope, applicability, and limitations
- Establishing validation parameters: accuracy, precision, sensitivity
- Linearity, range, detection limit, and quantitation limit
- Robustness and ruggedness testing under variable conditions
- Documentation requirements for validation studies
- Creating validation reports with complete technical evidence
- Review and approval of validation by technical authority
- Verification of standardized methods: requirements and evidence
- Handling modified or extended standard methods
- Documenting method changes and their impact
- Method equivalence and comparison studies
- Proficiency testing as evidence of method reliability
- Using interlaboratory comparisons to validate performance
- Handling client-developed or proprietary methods
- Risk-based approach to method selection
- Updating methods in response to scientific advances
- Ensuring staff are trained on current valid methods
Module 7: Sampling Procedures and Sample Integrity - Defining sampling plans based on statistical and technical requirements
- Developing documented sampling procedures for each method
- Ensuring sample representativeness and integrity
- Designing sampling kits and field collection protocols
- Preservation, storage, and transport conditions for samples
- Chain of custody documentation and electronic tracking
- Labeling samples with unique identifiers and metadata
- Handling confidential or sensitive samplings
- Sampling uncertainty and its impact on results
- Accepting or rejecting client-collected samples
- Distinguishing between sampling and testing responsibilities
- On-site versus laboratory-based sampling activities
- Training field personnel on standardized procedures
- Verifying sampling equipment before use
- Documenting environmental conditions at sampling point
- Controlling contamination during transport
- Time limits for sample analysis and stability requirements
- Client communication about sampling prerequisites
- Using sampling checklists and mobile data capture
- Integrating sampling data into LIMS and reporting systems
Module 8: Handling, Storage, and Protection of Test Items - Receiving protocols for samples and test items
- Verification of sample condition and acceptance criteria
- Quarantine and holding areas for pending testing
- Secure storage conditions to prevent degradation
- Tracking sample location and movement
- Access control for high-value or controlled substances
- Disposal procedures for expired or unused test items
- Documenting deviations in storage conditions
- Chain of custody for forensic and legal samples
- Client instructions for special handling requirements
- Contingency plans for power failures or equipment downtime
- Monitoring storage conditions with automated sensors
- Integration with inventory management systems
- Labeling standards for containers and refrigerated units
- Managing hazardous and biohazardous materials
- Documentation of sample preparation steps
- Preventing cross-contamination during processing
- Packaging standards for interlab transfers
- Retention periods for archived samples
- Re-testing procedures from retained samples
Module 9: Technical Record Keeping and Data Integrity - Requirements for complete, accurate, and secure records
- Distinguishing between quality records and technical records
- Elements of a complete technical record for each test
- Ensuring data authenticity and non-modifiability
- Preventing data manipulation and selective reporting
- Audit trail requirements for electronic records
- Best practices for handwritten notes and lab notebooks
- Signatures, initials, and date stamps on records
- Retention periods based on legal and technical needs
- Secure archiving and backup systems
- Access control for sensitive or confidential data
- GDPR, HIPAA, and other data privacy compliance links
- Metadata requirements for digital results
- Ensuring traceability from data to raw observations
- Handling data in transitional systems (paper to digital)
- Validation of data entry and software tools
- Internal audits of data management practices
- Use of data integrity checklists and red flags
- Correcting errors in records: procedure and evidence
- Documenting data recovery and restoration events
Module 10: Measurement Uncertainty and Result Validity - Understanding the concept of measurement uncertainty
- Why uncertainty is required for every accredited result
- Differentiating between error and uncertainty
- Top-down vs bottom-up approaches to uncertainty estimation
- Identifying uncertainty components: equipment, environment, operator
- Using control charts and historical data
- Applying GUM (Guide to the Expression of Uncertainty in Measurement)
- Simplified uncertainty models for routine testing
- Uncertainty budgets: structure and documentation
- Reporting uncertainty with test results
- When to update uncertainty calculations
- Tools and templates for uncertainty assessments
- Training staff on uncertainty interpretation
- Linking uncertainty to decision rules and compliance statements
- Uncertainty for qualitative and semi-quantitative methods
- Method-specific uncertainty evaluation examples
- Peer review of uncertainty calculations
- Regulatory expectations for uncertainty reporting
- Handling client questions about uncertainty
- Using uncertainty to improve method performance
Module 11: Quality Assurance and Internal Quality Control - Designing a comprehensive internal quality control program
- Using control samples, blanks, and spike recoveries
- Establishing control limits and trending analysis
- Implementing Levey-Jennings charts and Westgard rules
- Corrective actions for out-of-control signals
- Frequency of QC based on method stability and risk
- Proficiency testing: planning, selection, participation
- Evaluating PT results and addressing underperformance
- Using interlaboratory comparisons as QA tools
- Internal blind testing and sample reanalysis
- Rotating responsibilities to detect bias
- Reviewing QA data during management meetings
- Linking QA findings to process improvement
- Automating QC data collection and analysis
- Documenting QA activities and trends
- Corrective action triggers based on QA failures
- Using QA to support measurement traceability
- QA program review during management review
- Validating QA effectiveness with audit findings
- QA integration with LIMS and reporting systems
Module 12: Proficiency Testing and External Quality Assessment - Role of PT in demonstrating laboratory competence
- Identifying PT providers accredited to ISO IEC 17043
- Selecting appropriate PT schemes by discipline
- Scheduling PT participation based on test volume
- Assigning staff to conduct PT without bias
- Handling PT results: interpretation and reporting
- Corrective actions for unsatisfactory PT outcomes
- Documenting PT performance over time
- Using PT results in management reviews
- Peer comparison and benchmarking with PT data
- PT frequency requirements by accreditation body
- Alternative approaches when PT is not available
- Use of interlaboratory comparisons and round robins
- Customer requirements for PT participation
- Reporting PT status in accreditation applications
- Internal PT programs for self-assessment
- Using PT to validate new methods or equipment
- Training staff on PT best practices
- Archiving PT reports and certificates
- Linking PT to laboratory performance KPIs
Module 13: External Audits and Accreditation Assessments - Preparing for initial and surveillance assessments
- Understanding assessor roles and expectations
- Creating an audit readiness checklist
- Conducting mock audits with internal assessors
- Documenting compliance evidence for each clause
- Handling auditor requests and site tours
- Supporting technical staff during observation
- Document review and record presentation protocols
- Responding to findings and nonconformities
- Corrective action writing and submission timelines
- Pre-audit meetings and documentation walkthroughs
- Using audit preparation templates and timelines
- Training staff on audit communication skills
- Handling difficult questions or challenges
- Post-audit review and action planning
- Follow-up audit preparation
- Tracking resolution of findings to closure
- Using assessor feedback for improvement
- Building a culture of audit readiness
- Continuous improvement after accreditation
Module 14: Internal Audits and Continuous Improvement - Planning the internal audit schedule
- Selecting and training internal auditors
- Developing audit checklists based on ISO IEC 17025
- Conducting process-based and clause-based audits
- Writing clear, objective nonconformity statements
- Documenting evidence and interviews
- Reporting audit findings to management
- Assigning corrective actions and owners
- Verifying effectiveness of corrective actions
- Integrating audits with risk management
- Using audit data for management review
- Tracking audit trends over time
- Preventing recurrence of common findings
- Scheduling department-specific audits
- Conducting audits remotely or in hybrid environments
- Automating audit workflows with digital tools
- Reviewing auditor performance and competency
- Calibrating audit rigor across the organization
- Using internal audits to support external readiness
- Creating a feedback loop for continual improvement
Module 15: Management Review and Strategic Oversight - Scheduling and planning management review meetings
- Required inputs: audit results, customer feedback, PT data
- Performance metrics and KPIs for lab operations
- Resource adequacy and staffing levels
- Reviewing corrective and preventive actions
- Assessing changes in external and internal issues
- Evaluating risks and opportunities
- Reviewing quality objectives and progress
- Reporting on accreditation status and compliance
- Updating the quality policy and strategic direction
- Ensuring decision traceability and documentation
- Assigning action items from management review
- Tracking implementation of decisions
- Communicating outcomes to staff
- Balancing operational and strategic focus
- Using data dashboards for efficient review
- Involving cross-functional leadership
- Archiving management review records
- Frequency of reviews based on lab size and risk
- Linking management review to continual improvement
Module 16: Certification, Next Steps, and Sustaining Excellence - Final review before accreditation application
- Compiling the accreditation dossier
- Selecting an accreditation body
- Submitting the formal application
- Preparing for the document review phase
- Scheduling the on-site assessment
- Assigning roles during the assessment
- Handling the closing meeting and report
- Responding to nonconformities
- Timeline for accreditation decision
- Receiving the scope of accreditation
- Using the accreditation mark correctly
- Surveillance audit preparation
- Handling scope extensions and method additions
- Reassessment and renewal cycles
- Withdrawing or reducing scope
- Transitioning between accreditation bodies
- Marketing your accreditation to clients
- Leveraging the Certificate of Completion for career growth
- Continuing professional development in quality
- Establishing the laboratory’s organizational structure
- Defining roles, responsibilities, and authorities for key personnel
- Developing a quality policy aligned with ISO IEC 17025 requirements
- Creating and implementing a quality manual
- Documenting the management system scope
- Building a document control hierarchy: levels and types
- Developing a document control procedure that meets clause 8.3
- Approved document formats and metadata standards
- Revision control, version management, and approval workflows
- Retaining documents and records per regulatory requirements
- Best practices for electronic document management systems
- Transitioning from paper-based to digital systems
- Secure access controls and user permissions
- Audit trails and change logs for document integrity
- Preparing for internal document audits
- Conducting a baseline gap analysis
- Using readiness checklists to measure current compliance
- Creating an implementation roadmap with milestones
- Establishing a project team and assigning leads
- Setting up communication and status reporting protocols
Module 3: Personnel Competence and Training Frameworks - Defining technical personnel requirements per ISO IEC 17025
- Creating job descriptions with accreditation-aligned responsibilities
- Establishing education, training, technical skills, and experience criteria
- Developing a personnel training needs analysis
- Designing a competency assessment program
- Using observation, examination, and work product review methods
- Handling personnel with dual roles or shared responsibilities
- Managing personnel records: retention and confidentiality
- Creating a training calendar and annual development plans
- Supervision strategies for junior and new staff
- Validating technician competency for high-risk tests
- Handling temporary, external, or remote personnel
- Ensuring impartiality and avoiding conflicts of interest
- Training records and evidence of continual improvement
- Linking training outcomes to audit readiness
- Developing an internal training program for sustainability
- Onboarding new staff with accreditation compliance embedded
- Role of supervisors in maintaining ongoing competence
- Using performance reviews to support quality objectives
- Tracking training impact through KPIs and audit results
Module 4: Facility and Environmental Control Requirements - Designing laboratory facilities to support test integrity
- Preventing contamination, interference, and cross-contamination
- Environmental monitoring: temperature, humidity, vibration, etc.
- Calibrating and maintaining environmental control equipment
- Secure storage areas for hazardous and sensitive materials
- Adequate workspace for safe and accurate operations
- Workflow design to minimize errors and bottlenecks
- Lighting, ventilation, and ergonomics for technician safety
- Biohazard and chemical safety compliance integration
- Waste disposal and environmental compliance alignment
- Security measures for data, samples, and reagents
- Access control and visitor management policies
- Facility maintenance schedules and logs
- Emergency preparedness and response planning
- Documenting facilities in the quality manual
- Handling leased, shared, or off-site laboratory spaces
- Remote sampling locations and field testing considerations
- Site-specific risk assessments and mitigation plans
- Checklists for daily facility inspections
- Integration with internal audit programs
Module 5: Equipment Management, Calibration, and Traceability - Identifying critical equipment requiring calibration
- Developing an equipment inventory with unique identifiers
- Assigning responsibility for equipment use and care
- Establishing calibration schedules based on usage and risk
- Selecting accredited calibration service providers
- Evaluating calibration certificates for compliance
- Interpreting calibration results and measurement uncertainty
- Implementing corrective actions for out-of-tolerance equipment
- Using calibration status labels and tracking systems
- Managing software-controlled and automated equipment
- Verifying non-traditional equipment like LIMS and software tools
- Equipment maintenance and servicing logs
- Preventive maintenance planning and execution
- Handling equipment after repair or relocation
- Validation of in-house developed or modified equipment
- Ensuring metrological traceability to SI units
- Documenting traceability chains and national standards
- Managing reference materials and certified standards
- Proper storage, handling, and expiration control
- Using internal quality control to verify equipment performance
Module 6: Method Selection, Validation, and Verification - Differentiating between method validation and verification
- Selecting standard, published, or in-house test methods
- Validating non-standard methods per ISO IEC 17025 clause 7.2
- Determining method scope, applicability, and limitations
- Establishing validation parameters: accuracy, precision, sensitivity
- Linearity, range, detection limit, and quantitation limit
- Robustness and ruggedness testing under variable conditions
- Documentation requirements for validation studies
- Creating validation reports with complete technical evidence
- Review and approval of validation by technical authority
- Verification of standardized methods: requirements and evidence
- Handling modified or extended standard methods
- Documenting method changes and their impact
- Method equivalence and comparison studies
- Proficiency testing as evidence of method reliability
- Using interlaboratory comparisons to validate performance
- Handling client-developed or proprietary methods
- Risk-based approach to method selection
- Updating methods in response to scientific advances
- Ensuring staff are trained on current valid methods
Module 7: Sampling Procedures and Sample Integrity - Defining sampling plans based on statistical and technical requirements
- Developing documented sampling procedures for each method
- Ensuring sample representativeness and integrity
- Designing sampling kits and field collection protocols
- Preservation, storage, and transport conditions for samples
- Chain of custody documentation and electronic tracking
- Labeling samples with unique identifiers and metadata
- Handling confidential or sensitive samplings
- Sampling uncertainty and its impact on results
- Accepting or rejecting client-collected samples
- Distinguishing between sampling and testing responsibilities
- On-site versus laboratory-based sampling activities
- Training field personnel on standardized procedures
- Verifying sampling equipment before use
- Documenting environmental conditions at sampling point
- Controlling contamination during transport
- Time limits for sample analysis and stability requirements
- Client communication about sampling prerequisites
- Using sampling checklists and mobile data capture
- Integrating sampling data into LIMS and reporting systems
Module 8: Handling, Storage, and Protection of Test Items - Receiving protocols for samples and test items
- Verification of sample condition and acceptance criteria
- Quarantine and holding areas for pending testing
- Secure storage conditions to prevent degradation
- Tracking sample location and movement
- Access control for high-value or controlled substances
- Disposal procedures for expired or unused test items
- Documenting deviations in storage conditions
- Chain of custody for forensic and legal samples
- Client instructions for special handling requirements
- Contingency plans for power failures or equipment downtime
- Monitoring storage conditions with automated sensors
- Integration with inventory management systems
- Labeling standards for containers and refrigerated units
- Managing hazardous and biohazardous materials
- Documentation of sample preparation steps
- Preventing cross-contamination during processing
- Packaging standards for interlab transfers
- Retention periods for archived samples
- Re-testing procedures from retained samples
Module 9: Technical Record Keeping and Data Integrity - Requirements for complete, accurate, and secure records
- Distinguishing between quality records and technical records
- Elements of a complete technical record for each test
- Ensuring data authenticity and non-modifiability
- Preventing data manipulation and selective reporting
- Audit trail requirements for electronic records
- Best practices for handwritten notes and lab notebooks
- Signatures, initials, and date stamps on records
- Retention periods based on legal and technical needs
- Secure archiving and backup systems
- Access control for sensitive or confidential data
- GDPR, HIPAA, and other data privacy compliance links
- Metadata requirements for digital results
- Ensuring traceability from data to raw observations
- Handling data in transitional systems (paper to digital)
- Validation of data entry and software tools
- Internal audits of data management practices
- Use of data integrity checklists and red flags
- Correcting errors in records: procedure and evidence
- Documenting data recovery and restoration events
Module 10: Measurement Uncertainty and Result Validity - Understanding the concept of measurement uncertainty
- Why uncertainty is required for every accredited result
- Differentiating between error and uncertainty
- Top-down vs bottom-up approaches to uncertainty estimation
- Identifying uncertainty components: equipment, environment, operator
- Using control charts and historical data
- Applying GUM (Guide to the Expression of Uncertainty in Measurement)
- Simplified uncertainty models for routine testing
- Uncertainty budgets: structure and documentation
- Reporting uncertainty with test results
- When to update uncertainty calculations
- Tools and templates for uncertainty assessments
- Training staff on uncertainty interpretation
- Linking uncertainty to decision rules and compliance statements
- Uncertainty for qualitative and semi-quantitative methods
- Method-specific uncertainty evaluation examples
- Peer review of uncertainty calculations
- Regulatory expectations for uncertainty reporting
- Handling client questions about uncertainty
- Using uncertainty to improve method performance
Module 11: Quality Assurance and Internal Quality Control - Designing a comprehensive internal quality control program
- Using control samples, blanks, and spike recoveries
- Establishing control limits and trending analysis
- Implementing Levey-Jennings charts and Westgard rules
- Corrective actions for out-of-control signals
- Frequency of QC based on method stability and risk
- Proficiency testing: planning, selection, participation
- Evaluating PT results and addressing underperformance
- Using interlaboratory comparisons as QA tools
- Internal blind testing and sample reanalysis
- Rotating responsibilities to detect bias
- Reviewing QA data during management meetings
- Linking QA findings to process improvement
- Automating QC data collection and analysis
- Documenting QA activities and trends
- Corrective action triggers based on QA failures
- Using QA to support measurement traceability
- QA program review during management review
- Validating QA effectiveness with audit findings
- QA integration with LIMS and reporting systems
Module 12: Proficiency Testing and External Quality Assessment - Role of PT in demonstrating laboratory competence
- Identifying PT providers accredited to ISO IEC 17043
- Selecting appropriate PT schemes by discipline
- Scheduling PT participation based on test volume
- Assigning staff to conduct PT without bias
- Handling PT results: interpretation and reporting
- Corrective actions for unsatisfactory PT outcomes
- Documenting PT performance over time
- Using PT results in management reviews
- Peer comparison and benchmarking with PT data
- PT frequency requirements by accreditation body
- Alternative approaches when PT is not available
- Use of interlaboratory comparisons and round robins
- Customer requirements for PT participation
- Reporting PT status in accreditation applications
- Internal PT programs for self-assessment
- Using PT to validate new methods or equipment
- Training staff on PT best practices
- Archiving PT reports and certificates
- Linking PT to laboratory performance KPIs
Module 13: External Audits and Accreditation Assessments - Preparing for initial and surveillance assessments
- Understanding assessor roles and expectations
- Creating an audit readiness checklist
- Conducting mock audits with internal assessors
- Documenting compliance evidence for each clause
- Handling auditor requests and site tours
- Supporting technical staff during observation
- Document review and record presentation protocols
- Responding to findings and nonconformities
- Corrective action writing and submission timelines
- Pre-audit meetings and documentation walkthroughs
- Using audit preparation templates and timelines
- Training staff on audit communication skills
- Handling difficult questions or challenges
- Post-audit review and action planning
- Follow-up audit preparation
- Tracking resolution of findings to closure
- Using assessor feedback for improvement
- Building a culture of audit readiness
- Continuous improvement after accreditation
Module 14: Internal Audits and Continuous Improvement - Planning the internal audit schedule
- Selecting and training internal auditors
- Developing audit checklists based on ISO IEC 17025
- Conducting process-based and clause-based audits
- Writing clear, objective nonconformity statements
- Documenting evidence and interviews
- Reporting audit findings to management
- Assigning corrective actions and owners
- Verifying effectiveness of corrective actions
- Integrating audits with risk management
- Using audit data for management review
- Tracking audit trends over time
- Preventing recurrence of common findings
- Scheduling department-specific audits
- Conducting audits remotely or in hybrid environments
- Automating audit workflows with digital tools
- Reviewing auditor performance and competency
- Calibrating audit rigor across the organization
- Using internal audits to support external readiness
- Creating a feedback loop for continual improvement
Module 15: Management Review and Strategic Oversight - Scheduling and planning management review meetings
- Required inputs: audit results, customer feedback, PT data
- Performance metrics and KPIs for lab operations
- Resource adequacy and staffing levels
- Reviewing corrective and preventive actions
- Assessing changes in external and internal issues
- Evaluating risks and opportunities
- Reviewing quality objectives and progress
- Reporting on accreditation status and compliance
- Updating the quality policy and strategic direction
- Ensuring decision traceability and documentation
- Assigning action items from management review
- Tracking implementation of decisions
- Communicating outcomes to staff
- Balancing operational and strategic focus
- Using data dashboards for efficient review
- Involving cross-functional leadership
- Archiving management review records
- Frequency of reviews based on lab size and risk
- Linking management review to continual improvement
Module 16: Certification, Next Steps, and Sustaining Excellence - Final review before accreditation application
- Compiling the accreditation dossier
- Selecting an accreditation body
- Submitting the formal application
- Preparing for the document review phase
- Scheduling the on-site assessment
- Assigning roles during the assessment
- Handling the closing meeting and report
- Responding to nonconformities
- Timeline for accreditation decision
- Receiving the scope of accreditation
- Using the accreditation mark correctly
- Surveillance audit preparation
- Handling scope extensions and method additions
- Reassessment and renewal cycles
- Withdrawing or reducing scope
- Transitioning between accreditation bodies
- Marketing your accreditation to clients
- Leveraging the Certificate of Completion for career growth
- Continuing professional development in quality
- Designing laboratory facilities to support test integrity
- Preventing contamination, interference, and cross-contamination
- Environmental monitoring: temperature, humidity, vibration, etc.
- Calibrating and maintaining environmental control equipment
- Secure storage areas for hazardous and sensitive materials
- Adequate workspace for safe and accurate operations
- Workflow design to minimize errors and bottlenecks
- Lighting, ventilation, and ergonomics for technician safety
- Biohazard and chemical safety compliance integration
- Waste disposal and environmental compliance alignment
- Security measures for data, samples, and reagents
- Access control and visitor management policies
- Facility maintenance schedules and logs
- Emergency preparedness and response planning
- Documenting facilities in the quality manual
- Handling leased, shared, or off-site laboratory spaces
- Remote sampling locations and field testing considerations
- Site-specific risk assessments and mitigation plans
- Checklists for daily facility inspections
- Integration with internal audit programs
Module 5: Equipment Management, Calibration, and Traceability - Identifying critical equipment requiring calibration
- Developing an equipment inventory with unique identifiers
- Assigning responsibility for equipment use and care
- Establishing calibration schedules based on usage and risk
- Selecting accredited calibration service providers
- Evaluating calibration certificates for compliance
- Interpreting calibration results and measurement uncertainty
- Implementing corrective actions for out-of-tolerance equipment
- Using calibration status labels and tracking systems
- Managing software-controlled and automated equipment
- Verifying non-traditional equipment like LIMS and software tools
- Equipment maintenance and servicing logs
- Preventive maintenance planning and execution
- Handling equipment after repair or relocation
- Validation of in-house developed or modified equipment
- Ensuring metrological traceability to SI units
- Documenting traceability chains and national standards
- Managing reference materials and certified standards
- Proper storage, handling, and expiration control
- Using internal quality control to verify equipment performance
Module 6: Method Selection, Validation, and Verification - Differentiating between method validation and verification
- Selecting standard, published, or in-house test methods
- Validating non-standard methods per ISO IEC 17025 clause 7.2
- Determining method scope, applicability, and limitations
- Establishing validation parameters: accuracy, precision, sensitivity
- Linearity, range, detection limit, and quantitation limit
- Robustness and ruggedness testing under variable conditions
- Documentation requirements for validation studies
- Creating validation reports with complete technical evidence
- Review and approval of validation by technical authority
- Verification of standardized methods: requirements and evidence
- Handling modified or extended standard methods
- Documenting method changes and their impact
- Method equivalence and comparison studies
- Proficiency testing as evidence of method reliability
- Using interlaboratory comparisons to validate performance
- Handling client-developed or proprietary methods
- Risk-based approach to method selection
- Updating methods in response to scientific advances
- Ensuring staff are trained on current valid methods
Module 7: Sampling Procedures and Sample Integrity - Defining sampling plans based on statistical and technical requirements
- Developing documented sampling procedures for each method
- Ensuring sample representativeness and integrity
- Designing sampling kits and field collection protocols
- Preservation, storage, and transport conditions for samples
- Chain of custody documentation and electronic tracking
- Labeling samples with unique identifiers and metadata
- Handling confidential or sensitive samplings
- Sampling uncertainty and its impact on results
- Accepting or rejecting client-collected samples
- Distinguishing between sampling and testing responsibilities
- On-site versus laboratory-based sampling activities
- Training field personnel on standardized procedures
- Verifying sampling equipment before use
- Documenting environmental conditions at sampling point
- Controlling contamination during transport
- Time limits for sample analysis and stability requirements
- Client communication about sampling prerequisites
- Using sampling checklists and mobile data capture
- Integrating sampling data into LIMS and reporting systems
Module 8: Handling, Storage, and Protection of Test Items - Receiving protocols for samples and test items
- Verification of sample condition and acceptance criteria
- Quarantine and holding areas for pending testing
- Secure storage conditions to prevent degradation
- Tracking sample location and movement
- Access control for high-value or controlled substances
- Disposal procedures for expired or unused test items
- Documenting deviations in storage conditions
- Chain of custody for forensic and legal samples
- Client instructions for special handling requirements
- Contingency plans for power failures or equipment downtime
- Monitoring storage conditions with automated sensors
- Integration with inventory management systems
- Labeling standards for containers and refrigerated units
- Managing hazardous and biohazardous materials
- Documentation of sample preparation steps
- Preventing cross-contamination during processing
- Packaging standards for interlab transfers
- Retention periods for archived samples
- Re-testing procedures from retained samples
Module 9: Technical Record Keeping and Data Integrity - Requirements for complete, accurate, and secure records
- Distinguishing between quality records and technical records
- Elements of a complete technical record for each test
- Ensuring data authenticity and non-modifiability
- Preventing data manipulation and selective reporting
- Audit trail requirements for electronic records
- Best practices for handwritten notes and lab notebooks
- Signatures, initials, and date stamps on records
- Retention periods based on legal and technical needs
- Secure archiving and backup systems
- Access control for sensitive or confidential data
- GDPR, HIPAA, and other data privacy compliance links
- Metadata requirements for digital results
- Ensuring traceability from data to raw observations
- Handling data in transitional systems (paper to digital)
- Validation of data entry and software tools
- Internal audits of data management practices
- Use of data integrity checklists and red flags
- Correcting errors in records: procedure and evidence
- Documenting data recovery and restoration events
Module 10: Measurement Uncertainty and Result Validity - Understanding the concept of measurement uncertainty
- Why uncertainty is required for every accredited result
- Differentiating between error and uncertainty
- Top-down vs bottom-up approaches to uncertainty estimation
- Identifying uncertainty components: equipment, environment, operator
- Using control charts and historical data
- Applying GUM (Guide to the Expression of Uncertainty in Measurement)
- Simplified uncertainty models for routine testing
- Uncertainty budgets: structure and documentation
- Reporting uncertainty with test results
- When to update uncertainty calculations
- Tools and templates for uncertainty assessments
- Training staff on uncertainty interpretation
- Linking uncertainty to decision rules and compliance statements
- Uncertainty for qualitative and semi-quantitative methods
- Method-specific uncertainty evaluation examples
- Peer review of uncertainty calculations
- Regulatory expectations for uncertainty reporting
- Handling client questions about uncertainty
- Using uncertainty to improve method performance
Module 11: Quality Assurance and Internal Quality Control - Designing a comprehensive internal quality control program
- Using control samples, blanks, and spike recoveries
- Establishing control limits and trending analysis
- Implementing Levey-Jennings charts and Westgard rules
- Corrective actions for out-of-control signals
- Frequency of QC based on method stability and risk
- Proficiency testing: planning, selection, participation
- Evaluating PT results and addressing underperformance
- Using interlaboratory comparisons as QA tools
- Internal blind testing and sample reanalysis
- Rotating responsibilities to detect bias
- Reviewing QA data during management meetings
- Linking QA findings to process improvement
- Automating QC data collection and analysis
- Documenting QA activities and trends
- Corrective action triggers based on QA failures
- Using QA to support measurement traceability
- QA program review during management review
- Validating QA effectiveness with audit findings
- QA integration with LIMS and reporting systems
Module 12: Proficiency Testing and External Quality Assessment - Role of PT in demonstrating laboratory competence
- Identifying PT providers accredited to ISO IEC 17043
- Selecting appropriate PT schemes by discipline
- Scheduling PT participation based on test volume
- Assigning staff to conduct PT without bias
- Handling PT results: interpretation and reporting
- Corrective actions for unsatisfactory PT outcomes
- Documenting PT performance over time
- Using PT results in management reviews
- Peer comparison and benchmarking with PT data
- PT frequency requirements by accreditation body
- Alternative approaches when PT is not available
- Use of interlaboratory comparisons and round robins
- Customer requirements for PT participation
- Reporting PT status in accreditation applications
- Internal PT programs for self-assessment
- Using PT to validate new methods or equipment
- Training staff on PT best practices
- Archiving PT reports and certificates
- Linking PT to laboratory performance KPIs
Module 13: External Audits and Accreditation Assessments - Preparing for initial and surveillance assessments
- Understanding assessor roles and expectations
- Creating an audit readiness checklist
- Conducting mock audits with internal assessors
- Documenting compliance evidence for each clause
- Handling auditor requests and site tours
- Supporting technical staff during observation
- Document review and record presentation protocols
- Responding to findings and nonconformities
- Corrective action writing and submission timelines
- Pre-audit meetings and documentation walkthroughs
- Using audit preparation templates and timelines
- Training staff on audit communication skills
- Handling difficult questions or challenges
- Post-audit review and action planning
- Follow-up audit preparation
- Tracking resolution of findings to closure
- Using assessor feedback for improvement
- Building a culture of audit readiness
- Continuous improvement after accreditation
Module 14: Internal Audits and Continuous Improvement - Planning the internal audit schedule
- Selecting and training internal auditors
- Developing audit checklists based on ISO IEC 17025
- Conducting process-based and clause-based audits
- Writing clear, objective nonconformity statements
- Documenting evidence and interviews
- Reporting audit findings to management
- Assigning corrective actions and owners
- Verifying effectiveness of corrective actions
- Integrating audits with risk management
- Using audit data for management review
- Tracking audit trends over time
- Preventing recurrence of common findings
- Scheduling department-specific audits
- Conducting audits remotely or in hybrid environments
- Automating audit workflows with digital tools
- Reviewing auditor performance and competency
- Calibrating audit rigor across the organization
- Using internal audits to support external readiness
- Creating a feedback loop for continual improvement
Module 15: Management Review and Strategic Oversight - Scheduling and planning management review meetings
- Required inputs: audit results, customer feedback, PT data
- Performance metrics and KPIs for lab operations
- Resource adequacy and staffing levels
- Reviewing corrective and preventive actions
- Assessing changes in external and internal issues
- Evaluating risks and opportunities
- Reviewing quality objectives and progress
- Reporting on accreditation status and compliance
- Updating the quality policy and strategic direction
- Ensuring decision traceability and documentation
- Assigning action items from management review
- Tracking implementation of decisions
- Communicating outcomes to staff
- Balancing operational and strategic focus
- Using data dashboards for efficient review
- Involving cross-functional leadership
- Archiving management review records
- Frequency of reviews based on lab size and risk
- Linking management review to continual improvement
Module 16: Certification, Next Steps, and Sustaining Excellence - Final review before accreditation application
- Compiling the accreditation dossier
- Selecting an accreditation body
- Submitting the formal application
- Preparing for the document review phase
- Scheduling the on-site assessment
- Assigning roles during the assessment
- Handling the closing meeting and report
- Responding to nonconformities
- Timeline for accreditation decision
- Receiving the scope of accreditation
- Using the accreditation mark correctly
- Surveillance audit preparation
- Handling scope extensions and method additions
- Reassessment and renewal cycles
- Withdrawing or reducing scope
- Transitioning between accreditation bodies
- Marketing your accreditation to clients
- Leveraging the Certificate of Completion for career growth
- Continuing professional development in quality
- Differentiating between method validation and verification
- Selecting standard, published, or in-house test methods
- Validating non-standard methods per ISO IEC 17025 clause 7.2
- Determining method scope, applicability, and limitations
- Establishing validation parameters: accuracy, precision, sensitivity
- Linearity, range, detection limit, and quantitation limit
- Robustness and ruggedness testing under variable conditions
- Documentation requirements for validation studies
- Creating validation reports with complete technical evidence
- Review and approval of validation by technical authority
- Verification of standardized methods: requirements and evidence
- Handling modified or extended standard methods
- Documenting method changes and their impact
- Method equivalence and comparison studies
- Proficiency testing as evidence of method reliability
- Using interlaboratory comparisons to validate performance
- Handling client-developed or proprietary methods
- Risk-based approach to method selection
- Updating methods in response to scientific advances
- Ensuring staff are trained on current valid methods
Module 7: Sampling Procedures and Sample Integrity - Defining sampling plans based on statistical and technical requirements
- Developing documented sampling procedures for each method
- Ensuring sample representativeness and integrity
- Designing sampling kits and field collection protocols
- Preservation, storage, and transport conditions for samples
- Chain of custody documentation and electronic tracking
- Labeling samples with unique identifiers and metadata
- Handling confidential or sensitive samplings
- Sampling uncertainty and its impact on results
- Accepting or rejecting client-collected samples
- Distinguishing between sampling and testing responsibilities
- On-site versus laboratory-based sampling activities
- Training field personnel on standardized procedures
- Verifying sampling equipment before use
- Documenting environmental conditions at sampling point
- Controlling contamination during transport
- Time limits for sample analysis and stability requirements
- Client communication about sampling prerequisites
- Using sampling checklists and mobile data capture
- Integrating sampling data into LIMS and reporting systems
Module 8: Handling, Storage, and Protection of Test Items - Receiving protocols for samples and test items
- Verification of sample condition and acceptance criteria
- Quarantine and holding areas for pending testing
- Secure storage conditions to prevent degradation
- Tracking sample location and movement
- Access control for high-value or controlled substances
- Disposal procedures for expired or unused test items
- Documenting deviations in storage conditions
- Chain of custody for forensic and legal samples
- Client instructions for special handling requirements
- Contingency plans for power failures or equipment downtime
- Monitoring storage conditions with automated sensors
- Integration with inventory management systems
- Labeling standards for containers and refrigerated units
- Managing hazardous and biohazardous materials
- Documentation of sample preparation steps
- Preventing cross-contamination during processing
- Packaging standards for interlab transfers
- Retention periods for archived samples
- Re-testing procedures from retained samples
Module 9: Technical Record Keeping and Data Integrity - Requirements for complete, accurate, and secure records
- Distinguishing between quality records and technical records
- Elements of a complete technical record for each test
- Ensuring data authenticity and non-modifiability
- Preventing data manipulation and selective reporting
- Audit trail requirements for electronic records
- Best practices for handwritten notes and lab notebooks
- Signatures, initials, and date stamps on records
- Retention periods based on legal and technical needs
- Secure archiving and backup systems
- Access control for sensitive or confidential data
- GDPR, HIPAA, and other data privacy compliance links
- Metadata requirements for digital results
- Ensuring traceability from data to raw observations
- Handling data in transitional systems (paper to digital)
- Validation of data entry and software tools
- Internal audits of data management practices
- Use of data integrity checklists and red flags
- Correcting errors in records: procedure and evidence
- Documenting data recovery and restoration events
Module 10: Measurement Uncertainty and Result Validity - Understanding the concept of measurement uncertainty
- Why uncertainty is required for every accredited result
- Differentiating between error and uncertainty
- Top-down vs bottom-up approaches to uncertainty estimation
- Identifying uncertainty components: equipment, environment, operator
- Using control charts and historical data
- Applying GUM (Guide to the Expression of Uncertainty in Measurement)
- Simplified uncertainty models for routine testing
- Uncertainty budgets: structure and documentation
- Reporting uncertainty with test results
- When to update uncertainty calculations
- Tools and templates for uncertainty assessments
- Training staff on uncertainty interpretation
- Linking uncertainty to decision rules and compliance statements
- Uncertainty for qualitative and semi-quantitative methods
- Method-specific uncertainty evaluation examples
- Peer review of uncertainty calculations
- Regulatory expectations for uncertainty reporting
- Handling client questions about uncertainty
- Using uncertainty to improve method performance
Module 11: Quality Assurance and Internal Quality Control - Designing a comprehensive internal quality control program
- Using control samples, blanks, and spike recoveries
- Establishing control limits and trending analysis
- Implementing Levey-Jennings charts and Westgard rules
- Corrective actions for out-of-control signals
- Frequency of QC based on method stability and risk
- Proficiency testing: planning, selection, participation
- Evaluating PT results and addressing underperformance
- Using interlaboratory comparisons as QA tools
- Internal blind testing and sample reanalysis
- Rotating responsibilities to detect bias
- Reviewing QA data during management meetings
- Linking QA findings to process improvement
- Automating QC data collection and analysis
- Documenting QA activities and trends
- Corrective action triggers based on QA failures
- Using QA to support measurement traceability
- QA program review during management review
- Validating QA effectiveness with audit findings
- QA integration with LIMS and reporting systems
Module 12: Proficiency Testing and External Quality Assessment - Role of PT in demonstrating laboratory competence
- Identifying PT providers accredited to ISO IEC 17043
- Selecting appropriate PT schemes by discipline
- Scheduling PT participation based on test volume
- Assigning staff to conduct PT without bias
- Handling PT results: interpretation and reporting
- Corrective actions for unsatisfactory PT outcomes
- Documenting PT performance over time
- Using PT results in management reviews
- Peer comparison and benchmarking with PT data
- PT frequency requirements by accreditation body
- Alternative approaches when PT is not available
- Use of interlaboratory comparisons and round robins
- Customer requirements for PT participation
- Reporting PT status in accreditation applications
- Internal PT programs for self-assessment
- Using PT to validate new methods or equipment
- Training staff on PT best practices
- Archiving PT reports and certificates
- Linking PT to laboratory performance KPIs
Module 13: External Audits and Accreditation Assessments - Preparing for initial and surveillance assessments
- Understanding assessor roles and expectations
- Creating an audit readiness checklist
- Conducting mock audits with internal assessors
- Documenting compliance evidence for each clause
- Handling auditor requests and site tours
- Supporting technical staff during observation
- Document review and record presentation protocols
- Responding to findings and nonconformities
- Corrective action writing and submission timelines
- Pre-audit meetings and documentation walkthroughs
- Using audit preparation templates and timelines
- Training staff on audit communication skills
- Handling difficult questions or challenges
- Post-audit review and action planning
- Follow-up audit preparation
- Tracking resolution of findings to closure
- Using assessor feedback for improvement
- Building a culture of audit readiness
- Continuous improvement after accreditation
Module 14: Internal Audits and Continuous Improvement - Planning the internal audit schedule
- Selecting and training internal auditors
- Developing audit checklists based on ISO IEC 17025
- Conducting process-based and clause-based audits
- Writing clear, objective nonconformity statements
- Documenting evidence and interviews
- Reporting audit findings to management
- Assigning corrective actions and owners
- Verifying effectiveness of corrective actions
- Integrating audits with risk management
- Using audit data for management review
- Tracking audit trends over time
- Preventing recurrence of common findings
- Scheduling department-specific audits
- Conducting audits remotely or in hybrid environments
- Automating audit workflows with digital tools
- Reviewing auditor performance and competency
- Calibrating audit rigor across the organization
- Using internal audits to support external readiness
- Creating a feedback loop for continual improvement
Module 15: Management Review and Strategic Oversight - Scheduling and planning management review meetings
- Required inputs: audit results, customer feedback, PT data
- Performance metrics and KPIs for lab operations
- Resource adequacy and staffing levels
- Reviewing corrective and preventive actions
- Assessing changes in external and internal issues
- Evaluating risks and opportunities
- Reviewing quality objectives and progress
- Reporting on accreditation status and compliance
- Updating the quality policy and strategic direction
- Ensuring decision traceability and documentation
- Assigning action items from management review
- Tracking implementation of decisions
- Communicating outcomes to staff
- Balancing operational and strategic focus
- Using data dashboards for efficient review
- Involving cross-functional leadership
- Archiving management review records
- Frequency of reviews based on lab size and risk
- Linking management review to continual improvement
Module 16: Certification, Next Steps, and Sustaining Excellence - Final review before accreditation application
- Compiling the accreditation dossier
- Selecting an accreditation body
- Submitting the formal application
- Preparing for the document review phase
- Scheduling the on-site assessment
- Assigning roles during the assessment
- Handling the closing meeting and report
- Responding to nonconformities
- Timeline for accreditation decision
- Receiving the scope of accreditation
- Using the accreditation mark correctly
- Surveillance audit preparation
- Handling scope extensions and method additions
- Reassessment and renewal cycles
- Withdrawing or reducing scope
- Transitioning between accreditation bodies
- Marketing your accreditation to clients
- Leveraging the Certificate of Completion for career growth
- Continuing professional development in quality
- Receiving protocols for samples and test items
- Verification of sample condition and acceptance criteria
- Quarantine and holding areas for pending testing
- Secure storage conditions to prevent degradation
- Tracking sample location and movement
- Access control for high-value or controlled substances
- Disposal procedures for expired or unused test items
- Documenting deviations in storage conditions
- Chain of custody for forensic and legal samples
- Client instructions for special handling requirements
- Contingency plans for power failures or equipment downtime
- Monitoring storage conditions with automated sensors
- Integration with inventory management systems
- Labeling standards for containers and refrigerated units
- Managing hazardous and biohazardous materials
- Documentation of sample preparation steps
- Preventing cross-contamination during processing
- Packaging standards for interlab transfers
- Retention periods for archived samples
- Re-testing procedures from retained samples
Module 9: Technical Record Keeping and Data Integrity - Requirements for complete, accurate, and secure records
- Distinguishing between quality records and technical records
- Elements of a complete technical record for each test
- Ensuring data authenticity and non-modifiability
- Preventing data manipulation and selective reporting
- Audit trail requirements for electronic records
- Best practices for handwritten notes and lab notebooks
- Signatures, initials, and date stamps on records
- Retention periods based on legal and technical needs
- Secure archiving and backup systems
- Access control for sensitive or confidential data
- GDPR, HIPAA, and other data privacy compliance links
- Metadata requirements for digital results
- Ensuring traceability from data to raw observations
- Handling data in transitional systems (paper to digital)
- Validation of data entry and software tools
- Internal audits of data management practices
- Use of data integrity checklists and red flags
- Correcting errors in records: procedure and evidence
- Documenting data recovery and restoration events
Module 10: Measurement Uncertainty and Result Validity - Understanding the concept of measurement uncertainty
- Why uncertainty is required for every accredited result
- Differentiating between error and uncertainty
- Top-down vs bottom-up approaches to uncertainty estimation
- Identifying uncertainty components: equipment, environment, operator
- Using control charts and historical data
- Applying GUM (Guide to the Expression of Uncertainty in Measurement)
- Simplified uncertainty models for routine testing
- Uncertainty budgets: structure and documentation
- Reporting uncertainty with test results
- When to update uncertainty calculations
- Tools and templates for uncertainty assessments
- Training staff on uncertainty interpretation
- Linking uncertainty to decision rules and compliance statements
- Uncertainty for qualitative and semi-quantitative methods
- Method-specific uncertainty evaluation examples
- Peer review of uncertainty calculations
- Regulatory expectations for uncertainty reporting
- Handling client questions about uncertainty
- Using uncertainty to improve method performance
Module 11: Quality Assurance and Internal Quality Control - Designing a comprehensive internal quality control program
- Using control samples, blanks, and spike recoveries
- Establishing control limits and trending analysis
- Implementing Levey-Jennings charts and Westgard rules
- Corrective actions for out-of-control signals
- Frequency of QC based on method stability and risk
- Proficiency testing: planning, selection, participation
- Evaluating PT results and addressing underperformance
- Using interlaboratory comparisons as QA tools
- Internal blind testing and sample reanalysis
- Rotating responsibilities to detect bias
- Reviewing QA data during management meetings
- Linking QA findings to process improvement
- Automating QC data collection and analysis
- Documenting QA activities and trends
- Corrective action triggers based on QA failures
- Using QA to support measurement traceability
- QA program review during management review
- Validating QA effectiveness with audit findings
- QA integration with LIMS and reporting systems
Module 12: Proficiency Testing and External Quality Assessment - Role of PT in demonstrating laboratory competence
- Identifying PT providers accredited to ISO IEC 17043
- Selecting appropriate PT schemes by discipline
- Scheduling PT participation based on test volume
- Assigning staff to conduct PT without bias
- Handling PT results: interpretation and reporting
- Corrective actions for unsatisfactory PT outcomes
- Documenting PT performance over time
- Using PT results in management reviews
- Peer comparison and benchmarking with PT data
- PT frequency requirements by accreditation body
- Alternative approaches when PT is not available
- Use of interlaboratory comparisons and round robins
- Customer requirements for PT participation
- Reporting PT status in accreditation applications
- Internal PT programs for self-assessment
- Using PT to validate new methods or equipment
- Training staff on PT best practices
- Archiving PT reports and certificates
- Linking PT to laboratory performance KPIs
Module 13: External Audits and Accreditation Assessments - Preparing for initial and surveillance assessments
- Understanding assessor roles and expectations
- Creating an audit readiness checklist
- Conducting mock audits with internal assessors
- Documenting compliance evidence for each clause
- Handling auditor requests and site tours
- Supporting technical staff during observation
- Document review and record presentation protocols
- Responding to findings and nonconformities
- Corrective action writing and submission timelines
- Pre-audit meetings and documentation walkthroughs
- Using audit preparation templates and timelines
- Training staff on audit communication skills
- Handling difficult questions or challenges
- Post-audit review and action planning
- Follow-up audit preparation
- Tracking resolution of findings to closure
- Using assessor feedback for improvement
- Building a culture of audit readiness
- Continuous improvement after accreditation
Module 14: Internal Audits and Continuous Improvement - Planning the internal audit schedule
- Selecting and training internal auditors
- Developing audit checklists based on ISO IEC 17025
- Conducting process-based and clause-based audits
- Writing clear, objective nonconformity statements
- Documenting evidence and interviews
- Reporting audit findings to management
- Assigning corrective actions and owners
- Verifying effectiveness of corrective actions
- Integrating audits with risk management
- Using audit data for management review
- Tracking audit trends over time
- Preventing recurrence of common findings
- Scheduling department-specific audits
- Conducting audits remotely or in hybrid environments
- Automating audit workflows with digital tools
- Reviewing auditor performance and competency
- Calibrating audit rigor across the organization
- Using internal audits to support external readiness
- Creating a feedback loop for continual improvement
Module 15: Management Review and Strategic Oversight - Scheduling and planning management review meetings
- Required inputs: audit results, customer feedback, PT data
- Performance metrics and KPIs for lab operations
- Resource adequacy and staffing levels
- Reviewing corrective and preventive actions
- Assessing changes in external and internal issues
- Evaluating risks and opportunities
- Reviewing quality objectives and progress
- Reporting on accreditation status and compliance
- Updating the quality policy and strategic direction
- Ensuring decision traceability and documentation
- Assigning action items from management review
- Tracking implementation of decisions
- Communicating outcomes to staff
- Balancing operational and strategic focus
- Using data dashboards for efficient review
- Involving cross-functional leadership
- Archiving management review records
- Frequency of reviews based on lab size and risk
- Linking management review to continual improvement
Module 16: Certification, Next Steps, and Sustaining Excellence - Final review before accreditation application
- Compiling the accreditation dossier
- Selecting an accreditation body
- Submitting the formal application
- Preparing for the document review phase
- Scheduling the on-site assessment
- Assigning roles during the assessment
- Handling the closing meeting and report
- Responding to nonconformities
- Timeline for accreditation decision
- Receiving the scope of accreditation
- Using the accreditation mark correctly
- Surveillance audit preparation
- Handling scope extensions and method additions
- Reassessment and renewal cycles
- Withdrawing or reducing scope
- Transitioning between accreditation bodies
- Marketing your accreditation to clients
- Leveraging the Certificate of Completion for career growth
- Continuing professional development in quality
- Understanding the concept of measurement uncertainty
- Why uncertainty is required for every accredited result
- Differentiating between error and uncertainty
- Top-down vs bottom-up approaches to uncertainty estimation
- Identifying uncertainty components: equipment, environment, operator
- Using control charts and historical data
- Applying GUM (Guide to the Expression of Uncertainty in Measurement)
- Simplified uncertainty models for routine testing
- Uncertainty budgets: structure and documentation
- Reporting uncertainty with test results
- When to update uncertainty calculations
- Tools and templates for uncertainty assessments
- Training staff on uncertainty interpretation
- Linking uncertainty to decision rules and compliance statements
- Uncertainty for qualitative and semi-quantitative methods
- Method-specific uncertainty evaluation examples
- Peer review of uncertainty calculations
- Regulatory expectations for uncertainty reporting
- Handling client questions about uncertainty
- Using uncertainty to improve method performance
Module 11: Quality Assurance and Internal Quality Control - Designing a comprehensive internal quality control program
- Using control samples, blanks, and spike recoveries
- Establishing control limits and trending analysis
- Implementing Levey-Jennings charts and Westgard rules
- Corrective actions for out-of-control signals
- Frequency of QC based on method stability and risk
- Proficiency testing: planning, selection, participation
- Evaluating PT results and addressing underperformance
- Using interlaboratory comparisons as QA tools
- Internal blind testing and sample reanalysis
- Rotating responsibilities to detect bias
- Reviewing QA data during management meetings
- Linking QA findings to process improvement
- Automating QC data collection and analysis
- Documenting QA activities and trends
- Corrective action triggers based on QA failures
- Using QA to support measurement traceability
- QA program review during management review
- Validating QA effectiveness with audit findings
- QA integration with LIMS and reporting systems
Module 12: Proficiency Testing and External Quality Assessment - Role of PT in demonstrating laboratory competence
- Identifying PT providers accredited to ISO IEC 17043
- Selecting appropriate PT schemes by discipline
- Scheduling PT participation based on test volume
- Assigning staff to conduct PT without bias
- Handling PT results: interpretation and reporting
- Corrective actions for unsatisfactory PT outcomes
- Documenting PT performance over time
- Using PT results in management reviews
- Peer comparison and benchmarking with PT data
- PT frequency requirements by accreditation body
- Alternative approaches when PT is not available
- Use of interlaboratory comparisons and round robins
- Customer requirements for PT participation
- Reporting PT status in accreditation applications
- Internal PT programs for self-assessment
- Using PT to validate new methods or equipment
- Training staff on PT best practices
- Archiving PT reports and certificates
- Linking PT to laboratory performance KPIs
Module 13: External Audits and Accreditation Assessments - Preparing for initial and surveillance assessments
- Understanding assessor roles and expectations
- Creating an audit readiness checklist
- Conducting mock audits with internal assessors
- Documenting compliance evidence for each clause
- Handling auditor requests and site tours
- Supporting technical staff during observation
- Document review and record presentation protocols
- Responding to findings and nonconformities
- Corrective action writing and submission timelines
- Pre-audit meetings and documentation walkthroughs
- Using audit preparation templates and timelines
- Training staff on audit communication skills
- Handling difficult questions or challenges
- Post-audit review and action planning
- Follow-up audit preparation
- Tracking resolution of findings to closure
- Using assessor feedback for improvement
- Building a culture of audit readiness
- Continuous improvement after accreditation
Module 14: Internal Audits and Continuous Improvement - Planning the internal audit schedule
- Selecting and training internal auditors
- Developing audit checklists based on ISO IEC 17025
- Conducting process-based and clause-based audits
- Writing clear, objective nonconformity statements
- Documenting evidence and interviews
- Reporting audit findings to management
- Assigning corrective actions and owners
- Verifying effectiveness of corrective actions
- Integrating audits with risk management
- Using audit data for management review
- Tracking audit trends over time
- Preventing recurrence of common findings
- Scheduling department-specific audits
- Conducting audits remotely or in hybrid environments
- Automating audit workflows with digital tools
- Reviewing auditor performance and competency
- Calibrating audit rigor across the organization
- Using internal audits to support external readiness
- Creating a feedback loop for continual improvement
Module 15: Management Review and Strategic Oversight - Scheduling and planning management review meetings
- Required inputs: audit results, customer feedback, PT data
- Performance metrics and KPIs for lab operations
- Resource adequacy and staffing levels
- Reviewing corrective and preventive actions
- Assessing changes in external and internal issues
- Evaluating risks and opportunities
- Reviewing quality objectives and progress
- Reporting on accreditation status and compliance
- Updating the quality policy and strategic direction
- Ensuring decision traceability and documentation
- Assigning action items from management review
- Tracking implementation of decisions
- Communicating outcomes to staff
- Balancing operational and strategic focus
- Using data dashboards for efficient review
- Involving cross-functional leadership
- Archiving management review records
- Frequency of reviews based on lab size and risk
- Linking management review to continual improvement
Module 16: Certification, Next Steps, and Sustaining Excellence - Final review before accreditation application
- Compiling the accreditation dossier
- Selecting an accreditation body
- Submitting the formal application
- Preparing for the document review phase
- Scheduling the on-site assessment
- Assigning roles during the assessment
- Handling the closing meeting and report
- Responding to nonconformities
- Timeline for accreditation decision
- Receiving the scope of accreditation
- Using the accreditation mark correctly
- Surveillance audit preparation
- Handling scope extensions and method additions
- Reassessment and renewal cycles
- Withdrawing or reducing scope
- Transitioning between accreditation bodies
- Marketing your accreditation to clients
- Leveraging the Certificate of Completion for career growth
- Continuing professional development in quality
- Role of PT in demonstrating laboratory competence
- Identifying PT providers accredited to ISO IEC 17043
- Selecting appropriate PT schemes by discipline
- Scheduling PT participation based on test volume
- Assigning staff to conduct PT without bias
- Handling PT results: interpretation and reporting
- Corrective actions for unsatisfactory PT outcomes
- Documenting PT performance over time
- Using PT results in management reviews
- Peer comparison and benchmarking with PT data
- PT frequency requirements by accreditation body
- Alternative approaches when PT is not available
- Use of interlaboratory comparisons and round robins
- Customer requirements for PT participation
- Reporting PT status in accreditation applications
- Internal PT programs for self-assessment
- Using PT to validate new methods or equipment
- Training staff on PT best practices
- Archiving PT reports and certificates
- Linking PT to laboratory performance KPIs
Module 13: External Audits and Accreditation Assessments - Preparing for initial and surveillance assessments
- Understanding assessor roles and expectations
- Creating an audit readiness checklist
- Conducting mock audits with internal assessors
- Documenting compliance evidence for each clause
- Handling auditor requests and site tours
- Supporting technical staff during observation
- Document review and record presentation protocols
- Responding to findings and nonconformities
- Corrective action writing and submission timelines
- Pre-audit meetings and documentation walkthroughs
- Using audit preparation templates and timelines
- Training staff on audit communication skills
- Handling difficult questions or challenges
- Post-audit review and action planning
- Follow-up audit preparation
- Tracking resolution of findings to closure
- Using assessor feedback for improvement
- Building a culture of audit readiness
- Continuous improvement after accreditation
Module 14: Internal Audits and Continuous Improvement - Planning the internal audit schedule
- Selecting and training internal auditors
- Developing audit checklists based on ISO IEC 17025
- Conducting process-based and clause-based audits
- Writing clear, objective nonconformity statements
- Documenting evidence and interviews
- Reporting audit findings to management
- Assigning corrective actions and owners
- Verifying effectiveness of corrective actions
- Integrating audits with risk management
- Using audit data for management review
- Tracking audit trends over time
- Preventing recurrence of common findings
- Scheduling department-specific audits
- Conducting audits remotely or in hybrid environments
- Automating audit workflows with digital tools
- Reviewing auditor performance and competency
- Calibrating audit rigor across the organization
- Using internal audits to support external readiness
- Creating a feedback loop for continual improvement
Module 15: Management Review and Strategic Oversight - Scheduling and planning management review meetings
- Required inputs: audit results, customer feedback, PT data
- Performance metrics and KPIs for lab operations
- Resource adequacy and staffing levels
- Reviewing corrective and preventive actions
- Assessing changes in external and internal issues
- Evaluating risks and opportunities
- Reviewing quality objectives and progress
- Reporting on accreditation status and compliance
- Updating the quality policy and strategic direction
- Ensuring decision traceability and documentation
- Assigning action items from management review
- Tracking implementation of decisions
- Communicating outcomes to staff
- Balancing operational and strategic focus
- Using data dashboards for efficient review
- Involving cross-functional leadership
- Archiving management review records
- Frequency of reviews based on lab size and risk
- Linking management review to continual improvement
Module 16: Certification, Next Steps, and Sustaining Excellence - Final review before accreditation application
- Compiling the accreditation dossier
- Selecting an accreditation body
- Submitting the formal application
- Preparing for the document review phase
- Scheduling the on-site assessment
- Assigning roles during the assessment
- Handling the closing meeting and report
- Responding to nonconformities
- Timeline for accreditation decision
- Receiving the scope of accreditation
- Using the accreditation mark correctly
- Surveillance audit preparation
- Handling scope extensions and method additions
- Reassessment and renewal cycles
- Withdrawing or reducing scope
- Transitioning between accreditation bodies
- Marketing your accreditation to clients
- Leveraging the Certificate of Completion for career growth
- Continuing professional development in quality
- Planning the internal audit schedule
- Selecting and training internal auditors
- Developing audit checklists based on ISO IEC 17025
- Conducting process-based and clause-based audits
- Writing clear, objective nonconformity statements
- Documenting evidence and interviews
- Reporting audit findings to management
- Assigning corrective actions and owners
- Verifying effectiveness of corrective actions
- Integrating audits with risk management
- Using audit data for management review
- Tracking audit trends over time
- Preventing recurrence of common findings
- Scheduling department-specific audits
- Conducting audits remotely or in hybrid environments
- Automating audit workflows with digital tools
- Reviewing auditor performance and competency
- Calibrating audit rigor across the organization
- Using internal audits to support external readiness
- Creating a feedback loop for continual improvement
Module 15: Management Review and Strategic Oversight - Scheduling and planning management review meetings
- Required inputs: audit results, customer feedback, PT data
- Performance metrics and KPIs for lab operations
- Resource adequacy and staffing levels
- Reviewing corrective and preventive actions
- Assessing changes in external and internal issues
- Evaluating risks and opportunities
- Reviewing quality objectives and progress
- Reporting on accreditation status and compliance
- Updating the quality policy and strategic direction
- Ensuring decision traceability and documentation
- Assigning action items from management review
- Tracking implementation of decisions
- Communicating outcomes to staff
- Balancing operational and strategic focus
- Using data dashboards for efficient review
- Involving cross-functional leadership
- Archiving management review records
- Frequency of reviews based on lab size and risk
- Linking management review to continual improvement
Module 16: Certification, Next Steps, and Sustaining Excellence - Final review before accreditation application
- Compiling the accreditation dossier
- Selecting an accreditation body
- Submitting the formal application
- Preparing for the document review phase
- Scheduling the on-site assessment
- Assigning roles during the assessment
- Handling the closing meeting and report
- Responding to nonconformities
- Timeline for accreditation decision
- Receiving the scope of accreditation
- Using the accreditation mark correctly
- Surveillance audit preparation
- Handling scope extensions and method additions
- Reassessment and renewal cycles
- Withdrawing or reducing scope
- Transitioning between accreditation bodies
- Marketing your accreditation to clients
- Leveraging the Certificate of Completion for career growth
- Continuing professional development in quality
- Final review before accreditation application
- Compiling the accreditation dossier
- Selecting an accreditation body
- Submitting the formal application
- Preparing for the document review phase
- Scheduling the on-site assessment
- Assigning roles during the assessment
- Handling the closing meeting and report
- Responding to nonconformities
- Timeline for accreditation decision
- Receiving the scope of accreditation
- Using the accreditation mark correctly
- Surveillance audit preparation
- Handling scope extensions and method additions
- Reassessment and renewal cycles
- Withdrawing or reducing scope
- Transitioning between accreditation bodies
- Marketing your accreditation to clients
- Leveraging the Certificate of Completion for career growth
- Continuing professional development in quality