The documents behind the guidance.
Every article in the library cites its sources. This index says what each source covers and links to the articles that apply it — so you can go from a clause to a practical explanation and back.
- ISO/IEC 17025:2017
- ISO/IEC
- General requirements for the competence of testing and calibration laboratories: impartiality, personnel, equipment, traceability, methods, uncertainty, reporting, nonconforming work and the management system.
Cited by 67 articles
- What is CMC in calibration?
- ISO/IEC 17025 calibration explained
- As-found vs as-left
- What should a calibration certificate contain?
- Calibration curves: fitting, residuals and the uncertainty they add
- How to set calibration intervals
- Data logger calibration: how temperature loggers are calibrated
- Liquid bath versus dry-block calibrator
- Calibration, adjustment and verification are different things
- Tolerance versus uncertainty
- Choosing calibration points
- Selecting a reference thermometer
- The ice-point check
- Calibrating relative-humidity sensors
- Metrological traceability under ISO/IEC 17025
- Reporting uncertainty: rounding and significant figures
- ISO/IEC 17025:2017 structure: what each clause covers
- Impartiality and confidentiality under ISO/IEC 17025
- Personnel competence records under ISO/IEC 17025
- Equipment requirements in ISO/IEC 17025 (clause 6.4)
- Metrological traceability in ISO/IEC 17025 (clause 6.5)
- Method selection, verification and validation (clause 7.2)
- Evaluation of measurement uncertainty (clause 7.6)
- Reporting results and statements of conformity (clause 7.8)
- Nonconforming work under ISO/IEC 17025 (clause 7.10)
- Technical records: what to keep and for how long (clause 7.5)
- Internal audits and management review (clauses 8.8 and 8.9)
- Qualifying a temperature monitoring system
- How to choose a temperature data logger for mapping and monitoring
- Pt100 tolerance classes explained (IEC 60751)
- Thermistors: high sensitivity over a narrow range
- Choosing a liquid calibration bath and its fluid
- Readouts and bridges for reference thermometers
- Infrared thermometers: what they measure and when to trust them
- Maintaining calibration equipment between calibrations
- How to choose a calibration laboratory
- How to read a scope of accreditation
- On-site vs laboratory calibration: choosing the right one
- Questions to ask before sending equipment for calibration
- Certified reference materials and ISO 17034
- Proficiency testing and interlaboratory comparisons
- Outsourcing a temperature mapping study: what to specify
- Calibration certificate red flags
- Building a calibration management system for measuring equipment
- Pressure gauge calibration: procedure, points and uncertainty
- Balance and scale calibration: eccentricity, repeatability and minimum weight
- Torque wrench calibration under ISO 6789:2017
- Pipette calibration by the gravimetric method, under ISO 8655
- Multimeter calibration: what the specification actually promises
- Dimensional calibration: calipers, micrometers and gauge blocks
- pH meter calibration: buffers, slope and why temperature is not optional
- Conductivity meter calibration and the cell constant
- Force calibration and tensile testing machine verification
- Hardness testing machine calibration: direct and indirect verification
- Particle counter calibration for cleanroom classification
- Flow meter calibration: what the reading depends on besides flow
- F0 and steam sterilisation: what the number means and where it comes from
- Depyrogenation oven qualification and the FD value
- Airflow, air changes and HEPA filter integrity testing
- Timers, stopwatches and rotational speed: the calibrations nobody schedules
- Gas detector calibration: bump tests, span gas and why sensors are consumables
- UV-Vis spectrophotometer calibration: wavelength, absorbance, stray light and resolution
- HPLC qualification and system suitability: what each one actually proves
- Karl Fischer titration: titre, drift and what a water result really means
- Viscometer and rheometer calibration: temperature, shear rate and standards
- Density meter and refractometer calibration: air, water and temperature
- Sound level meter calibration: field check, periodic test and class
- JCGM 100:2008 (GUM)
- BIPM / JCGM
- The Guide to the expression of uncertainty in measurement: Type A and B evaluation, the law of propagation, effective degrees of freedom and expanded uncertainty.
Cited by 43 articles
- How to calibrate a Pt100
- Measurement uncertainty explained
- Calibration curves: fitting, residuals and the uncertainty they add
- How thermocouples are calibrated
- Liquid bath versus dry-block calibrator
- Self-heating in resistance thermometers
- Hysteresis in temperature sensors
- Selecting a reference thermometer
- Calibrating relative-humidity sensors
- Type A vs Type B uncertainty: the difference that matters
- Coverage factor k explained: why k = 2 means about 95 %
- Rectangular, triangular and normal distributions in uncertainty budgets
- Sensitivity coefficients: how input uncertainties reach the result
- Correlated inputs in uncertainty evaluation
- Reporting uncertainty: rounding and significant figures
- Accuracy vs precision in measurement
- Repeatability vs reproducibility
- Drift: how instruments change between calibrations
- Building an uncertainty budget step by step
- The reference thermometer's contribution to uncertainty
- Resolution as an uncertainty component
- Drift as an uncertainty component
- Uncertainty from the calibration bath or dry block
- Effective degrees of freedom and when k = 2 is not enough
- Uncertainty budget for a thermocouple calibration
- Measurement uncertainty in temperature mapping results
- Pressure gauge calibration: procedure, points and uncertainty
- Torque wrench calibration under ISO 6789:2017
- Pipette calibration by the gravimetric method, under ISO 8655
- Multimeter calibration: what the specification actually promises
- Dimensional calibration: calipers, micrometers and gauge blocks
- pH meter calibration: buffers, slope and why temperature is not optional
- Conductivity meter calibration and the cell constant
- Force calibration and tensile testing machine verification
- Hardness testing machine calibration: direct and indirect verification
- Flow meter calibration: what the reading depends on besides flow
- Depyrogenation oven qualification and the FD value
- Timers, stopwatches and rotational speed: the calibrations nobody schedules
- Gas detector calibration: bump tests, span gas and why sensors are consumables
- UV-Vis spectrophotometer calibration: wavelength, absorbance, stray light and resolution
- Karl Fischer titration: titre, drift and what a water result really means
- Viscometer and rheometer calibration: temperature, shear rate and standards
- Sound level meter calibration: field check, periodic test and class
- WHO Technical Supplement 8
- World Health Organization
- Temperature mapping of storage areas: study design, sensor placement, duration, analysis and reporting.
Cited by 24 articles
- What is temperature mapping?
- How many sensors are needed for temperature mapping?
- How to identify hot and cold spots
- Temperature mapping report: a worked example
- What a temperature mapping protocol should contain
- What a temperature mapping report should contain
- Cold room temperature mapping
- Warehouse temperature mapping
- Refrigerator temperature mapping
- Freezer temperature mapping (−20 °C and −80 °C)
- What GDP expects from temperature mapping
- Sensor placement principles for mapping studies
- Setting acceptance criteria for a mapping study
- Common temperature mapping mistakes
- Empty versus loaded mapping studies
- Seasonal mapping: when one study is not enough
- Choosing sampling interval and study duration
- Data-quality checks before analysing mapping data
- Furnace and oven temperature mapping
- Temperature control under EU GDP: what is expected
- Warehouse qualification under GDP: from URS to routine monitoring
- IQ, OQ and PQ explained
- Laboratory refrigerator and freezer validation
- Choosing monitoring locations from mapping results
- EU Good Distribution Practice (2013/C 343/01)
- European Commission
- Wholesale distribution of medicinal products: premises and equipment, temperature mapping and monitoring, transport and excursion handling.
Cited by 17 articles
- What is temperature mapping?
- Temperature mapping report: a worked example
- Cold room temperature mapping
- Warehouse temperature mapping
- What GDP expects from temperature mapping
- Empty versus loaded mapping studies
- Choosing sampling interval and study duration
- Temperature control under EU GDP: what is expected
- Handling temperature excursions in storage and distribution
- Mean kinetic temperature (MKT): what it is and when to use it
- Qualifying temperature-controlled vehicles and shipping containers
- Warehouse qualification under GDP: from URS to routine monitoring
- Deviations and CAPA for environmental control failures
- Choosing monitoring locations from mapping results
- Alarm limits vs acceptance limits: setting them correctly
- Reviewing and retaining monitoring records
- Temperature monitoring during transport
- EU GMP Annex 15
- European Commission (EudraLex Vol. 4)
- Qualification and validation: URS, DQ, IQ, OQ, PQ, requalification and the validation master plan.
Cited by 16 articles
- Furnace and oven temperature mapping
- EU GMP Annex 15: the qualification stages explained
- Warehouse qualification under GDP: from URS to routine monitoring
- Deviations and CAPA for environmental control failures
- Stability chamber qualification
- IQ, OQ and PQ explained
- What a validation master plan should contain
- Writing a user requirements specification for temperature-controlled equipment
- Design qualification: catching problems before installation
- Requalification and periodic review
- Qualifying a stability or climatic chamber
- How to structure a qualification protocol
- Handling deviations during qualification
- Risk-based validation: deciding how much is enough
- Validating the software that analyses your monitoring and mapping data
- Laboratory refrigerator and freezer validation
- JCGM 200:2012 (VIM)
- BIPM / JCGM
- The international vocabulary of metrology: definitions of calibration, traceability, uncertainty, accuracy, precision, resolution and related terms.
Cited by 15 articles
- Measurement uncertainty explained
- Calibration curves: fitting, residuals and the uncertainty they add
- Calibration, adjustment and verification are different things
- Metrological traceability under ISO/IEC 17025
- Type A vs Type B uncertainty: the difference that matters
- Rectangular, triangular and normal distributions in uncertainty budgets
- Ten VIM terms every calibration user should know
- Accuracy vs precision in measurement
- Repeatability vs reproducibility
- Drift: how instruments change between calibrations
- Multimeter calibration: what the specification actually promises
- pH meter calibration: buffers, slope and why temperature is not optional
- Conductivity meter calibration and the cell constant
- Timers, stopwatches and rotational speed: the calibrations nobody schedules
- Gas detector calibration: bump tests, span gas and why sensors are consumables
- ILAC-G8:09/2019
- ILAC
- Guidelines on decision rules and statements of conformity: simple acceptance, guard bands, binary and non-binary statements.
Cited by 9 articles
- ISO/IEC 17025 calibration explained
- What should a calibration certificate contain?
- Temperature mapping report: a worked example
- Setting acceptance criteria for a mapping study
- Tolerance versus uncertainty
- Reporting results and statements of conformity (clause 7.8)
- What is a decision rule and why every certificate needs one
- Guard banding explained with a worked example
- Measurement uncertainty in temperature mapping results
- WHO Technical Supplement 16
- World Health Organization
- Environmental temperature monitoring systems for fixed storage areas: requirements and qualification.
Cited by 9 articles
- Choosing monitoring locations from mapping results
- Alarm limits vs acceptance limits: setting them correctly
- Monitoring ultra-low temperature (−80 °C) freezers
- Humidity monitoring in storage areas: when and how
- What a continuous temperature monitoring system must do
- Sensor response time and why it matters for monitoring
- Wireless vs wired monitoring sensors
- Qualifying a temperature monitoring system
- How to choose a temperature data logger for mapping and monitoring
- IEC 60751
- IEC
- Industrial platinum resistance thermometers: the resistance–temperature relationship and tolerance classes AA, A, B and C.
Cited by 8 articles
- How to calibrate a Pt100
- Self-heating in resistance thermometers
- Hysteresis in temperature sensors
- Selecting a reference thermometer
- Pt100 tolerance classes explained (IEC 60751)
- Thermocouple types and tolerance classes (IEC 60584)
- Readouts and bridges for reference thermometers
- Ice point, triple point of water and other fixed points
- WHO TRS 961, Annex 9
- World Health Organization
- Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products.
Cited by 8 articles
- What is temperature mapping?
- What a temperature mapping protocol should contain
- Choosing sampling interval and study duration
- Handling temperature excursions in storage and distribution
- Mean kinetic temperature (MKT): what it is and when to use it
- Qualifying temperature-controlled vehicles and shipping containers
- Stability chamber qualification
- Laboratory refrigerator and freezer validation
- EURAMET cg-20
- EURAMET
- Calibration of climatic chambers: characterising temperature and humidity uniformity and stability.
Cited by 7 articles
- EA-4/02 M
- European co-operation for Accreditation
- Evaluation of the uncertainty of measurement in calibration, with worked examples across quantities.
Cited by 6 articles
- EURAMET cg-13
- EURAMET
- Calibration of temperature block (dry-block) calibrators: axial/radial homogeneity, stability, loading and stem-conduction characterisation.
Cited by 6 articles
- EU GMP Annex 11
- European Commission (EudraLex Vol. 4)
- Computerised systems: validation, audit trails, access control, data retention and change control.
Cited by 5 articles
- ILAC-P14
- ILAC
- Policy for measurement uncertainty in calibration: CMC definition and the rule that reported uncertainty is never below the CMC.
Cited by 4 articles
- ICH Q1A(R2)
- ICH
- Stability testing of new drug substances and products: storage conditions and the mean kinetic temperature definition.
Cited by 4 articles
- ICH Q9(R1)
- ICH
- Quality risk management: principles and tools for risk-based qualification and validation.
Cited by 4 articles
- ILAC-P10
- ILAC
- Policy on metrological traceability of measurement results: acceptable routes to the SI and the role of accredited calibration.
Cited by 3 articles
- EURAMET cg-8
- EURAMET
- Calibration guide for thermocouples: methods, reference junction, inhomogeneity and uncertainty budgets.
Cited by 3 articles
- IEC 60584-1
- IEC
- Thermocouples: EMF reference functions and tolerance classes for types K, J, T, N, E, R, S and B.
Cited by 3 articles
- PIC/S PI 041-1
- PIC/S
- Good practices for data management and integrity in regulated GMP/GDP environments (ALCOA+).
Cited by 3 articles
- JCGM 106:2012
- BIPM / JCGM
- The role of measurement uncertainty in conformity assessment: specific and global risk, guard bands and decision rules.
Cited by 2 articles
- ILAC-G24 / OIML D 10
- ILAC / OIML
- Guidelines for the determination of calibration intervals of measuring instruments.
Cited by 2 articles
- ILAC Mutual Recognition Arrangement
- ILAC
- The arrangement under which accredited calibration certificates from signatory accreditation bodies are recognised internationally.
Cited by 2 articles
- JCGM 101:2008 (GUM Supplement 1)
- BIPM / JCGM
- Propagation of distributions using a Monte Carlo method — uncertainty evaluation without the linear/normal approximations.
Cited by 1 article
- EURAMET cg-11
- EURAMET
- Calibration of temperature indicators and simulators by electrical simulation.
Cited by 1 article
- ISO 17034:2016
- ISO
- General requirements for the competence of reference material producers.
Cited by 1 article
- ISPE Good Practice Guide: Controlled Temperature Chambers
- ISPE
- Industry practice for mapping and qualifying controlled temperature chambers and areas.
Cited by 1 article
- NPL Report MS 56
- National Physical Laboratory (UK)
- Case study on the generation and use of digital calibration certificates.
Cited by 1 article
Descriptions are ValiTrac's summaries. The documents themselves are published by the organisations named and should be consulted in their current editions; ValiTrac does not distribute them.