International Laboratory

ISO 17025 General Requirements for Testing and Calibration Labs

ISO 17025:2017 establishes general requirements for the competence, impartiality, and consistent operation of laboratories conducting testing and calibration work. It is the primary international standard recognized for laboratory accreditation worldwide. ATEK's environmental monitoring solutions support ISO 17025 compliance by providing precisely calibrated sensors, comprehensive traceability documentation, and management systems that document adherence to all metrological and quality requirements.

Authority: International Organization for Standardization (ISO)

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Why Choose ATEK for ISO 17025:2017 Compliance

Achieve Lab Accreditation

ATEK sensors and documentation support ISO 17025 accreditation by national accrediting bodies, opening doors to new markets and customers.

Ensure Measurement Reliability

NIST-traceable sensors with certified uncertainty specifications guarantee reliable, defensible measurement results.

Simplify Compliance Documentation

Automated record-keeping and calibration tracking reduce administrative burden and provide documentation auditors expect.

Reduce Measurement Risk

Continuous monitoring and regular calibration verification prevent measurement errors and equipment failures that compromise results.

Improve Lab Efficiency

Integrated monitoring eliminates manual data collection and enables preventive equipment maintenance based on real data.

ISO 17025:2017 Requirements

Key compliance requirements and how ATEK addresses each one.

Requirement	Description	ATEK Solution
4.1 Impartiality	The laboratory must be impartial, structured and managed to safeguard impartiality, and identify and manage risks to impartiality on an ongoing basis.	-
4.2 Confidentiality	The laboratory must manage all information obtained or created during laboratory activities through legally enforceable commitments and maintain confidentiality of proprietary information.	Data Integrity and Independence Immutable audit trails and role-based access controls ensure data integrity and maintain laboratory independence.
6.2 Personnel Competence	Personnel must have the necessary qualifications, training, and experience to competently perform their assigned functions.	-
6.3 Facilities and Environmental Conditions	The laboratory must have facilities and environmental conditions suitable for laboratory activities that do not adversely affect the validity of results.	Environmental Monitoring ATEK sensors monitor temperature, humidity, and pressure conditions to validate that laboratory environments meet ISO 17025 requirements.
6.4 Equipment	Equipment must be calibrated, maintained, and operated correctly. Equipment used for measurement must be capable of achieving the required measurement accuracy and uncertainty.	NIST-Traceable Sensors ATEK's temperature and humidity sensors are factory-calibrated with NIST traceability certificates, providing measurement traceability to national standards.
6.5 Metrological Traceability	The laboratory must establish and maintain metrological traceability of measurement results through a documented unbroken chain of calibrations linking to appropriate references.	Calibration Chain Documentation Complete calibration certificates document the metrological traceability chain from international standards through accredited calibration laboratories.
7.5 Technical Records	Complete technical records for each laboratory activity must be maintained, including results, sufficient information to identify factors affecting the measurement result, and enable repetition of the activity.	Complete Technical Records All sensor readings, calibration dates, equipment IDs, and environmental conditions are automatically logged with timestamps for full traceability.
7.6 Evaluation of Measurement Uncertainty	The laboratory must identify contributions to measurement uncertainty and evaluate measurement uncertainty for all calibrations and testing activities.	Measurement Uncertainty Reporting ATEK provides measurement uncertainty specifications and evaluation tools integrated into monitoring and reporting systems.
7.7 Ensuring the Validity of Results	The laboratory must monitor the validity of results through quality assurance activities including internal monitoring techniques and participation in proficiency testing or interlaboratory comparisons.	Quality Assurance Integration Built-in data validation, redundant sensors, and automated quality checks support laboratory quality assurance programs.
7.8.6 Reporting Statements of Conformity	When providing a statement of conformity, the laboratory must document the decision rule employed, taking into account the level of risk and measurement uncertainty.	-
8.4 Control of Records	The laboratory must establish and retain legible records demonstrating fulfilment of requirements, with controls for identification, storage, protection, retrieval, retention, and disposal.	Compliant Record Management Cloud-based secure storage with indefinite retention, audit trails, and export capabilities support ISO 17025 record management requirements.

Understanding ISO 17025

ISO 17025:2017 is the international standard that specifies general requirements for the technical competence of laboratories that perform testing and calibration. It applies to organizations that wish to demonstrate they operate a laboratory competent to produce technically valid results.

Scope and Application

ISO 17025 applies to all laboratories regardless of:

Size or location
Type of testing or calibration performed
Whether the laboratory is first-party, second-party, or third-party
Maturity or sector

The standard is used as the basis for laboratory accreditation by national accrediting bodies and is recognized in mutual recognition agreements worldwide.

Core Requirements

Technical Competence: Personnel must have appropriate qualifications and training. Equipment must be suitable and properly maintained. Measurement uncertainty must be evaluated for all results.

Impartiality and Independence: Laboratories must be free from pressure and conflicts of interest. Confidentiality policies must protect client data.

Management System: Procedures must cover personnel, facilities, documentation, calibration, testing methods, and quality assurance.

Metrological Traceability: Measurements must be traceable to international standards through an unbroken chain of calibrations. Uncertainty must be established at each link in the chain.

Laboratory Accreditation and ISO 17025

Laboratory accreditation to ISO 17025 by a national accrediting body (such as A2LA in the US or ILAC-recognized bodies worldwide) signifies that a laboratory has been independently assessed and found competent to perform specific work within its scope of accreditation.

Benefits of ISO 17025 Accreditation

Market Access: Many industries and regulations require testing or calibration results from ISO 17025 accredited laboratories. Accreditation opens these markets.

Customer Confidence: Accreditation demonstrates that a laboratory has been independently validated against an international standard.

International Recognition: National accrediting bodies participate in mutual recognition arrangements, so accreditation in one country is recognized by accrediting bodies worldwide.

Reduced Liability: Accreditation provides evidence of competence and due diligence, reducing legal and regulatory risk.

The Accreditation Assessment Process

Accreditation bodies assess laboratories against ISO 17025 requirements through:

Documentation Review: Examination of procedures, policies, and management systems
On-site Assessment: Observation of laboratory operations and facilities
Technical Evaluation: Verification that equipment is suitable and properly calibrated
Witness Testing: Performance of actual tests or calibrations under assessment
Records Review: Examination of test reports, calibration certificates, and technical records

How ATEK Supports ISO 17025 Compliance

ATEK’s calibrated sensors and monitoring solutions directly support multiple ISO 17025 requirements.

Metrological Traceability and Calibration

Every ATEK sensor ships with a calibration certificate documenting:

Calibration date and next recommended calibration date
NIST traceability statement
Measurement uncertainty at specified points
Environmental conditions during calibration
Identification of the calibration standard used

This documentation establishes the metrological traceability chain required by ISO 17025, proving that measurements can be traced to international standards.

Measurement Uncertainty

ATEK provides complete measurement uncertainty specifications for all sensors. These specifications include:

Calibration uncertainty
Repeatability
Stability over time
Temperature coefficient
Hysteresis

This allows laboratories to establish measurement uncertainty budgets for any application using ATEK sensors, fulfilling ISO 17025 Clause 7.6 requirements.

Environmental Monitoring and Lab Qualification

Temperature, humidity, and pressure conditions affect measurement validity. ATEK’s environmental sensors can continuously monitor these conditions, documenting that your laboratory environment meets requirements for the tests performed. This environmental data becomes part of your ISO 17025 compliance documentation.

Complete Technical Records

ISO 17025 Clause 7.5 requires complete technical records for each laboratory activity, including:

Date and time of measurement
Equipment identification and calibration status
Environmental conditions
Personnel identification
Results and uncertainty

ATEK’s monitoring systems automatically generate these records, creating an auditable technical record for every measurement with full traceability to sensors and calibration standards.

Quality Assurance Integration

ISO 17025 Clause 7.7 requires laboratories to monitor the validity of results through activities including:

Regular calibration verification
Duplicate measurements
Reference material testing
Comparison with other laboratories
Control charts

ATEK’s integrated quality assurance features support these activities by providing:

Automated alerts when sensors drift beyond expected ranges
Redundant sensors for measurement comparison
Historical data trending to detect equipment degradation
Integration with quality management software

Record Management and Retention

ISO 17025 requires laboratories to maintain technical records for specified periods (typically 3-7 years or longer). ATEK’s cloud-based record management system provides:

Secure, encrypted storage with geographic redundancy
Indefinite retention capability
Complete audit trails showing who accessed records and when
Export capabilities for accreditation audits
Automated backup and disaster recovery

Accreditation Excellence with ATEK

Many laboratories use ATEK’s solutions as core components of their ISO 17025 accreditation scope. Our calibrated sensors and comprehensive documentation allow laboratories to:

Establish defensible measurement traceability
Accurately evaluate measurement uncertainty
Maintain complete, auditable technical records
Demonstrate continuous quality assurance
Support accreditation assessments with objective equipment data

By providing the technical infrastructure that ISO 17025 auditors expect to see, ATEK helps laboratories achieve and maintain accreditation while ensuring measurement reliability that serves clients and regulators alike.

ISO 17025:2017 FAQs

What is ISO 17025?

ISO 17025:2017 is the international standard for general requirements for the competence of testing and calibration laboratories. It establishes criteria for laboratory accreditation, covering technical competence, equipment calibration, measurement uncertainty, quality assurance, and management systems. Laboratories accredited to ISO 17025 by national accrediting bodies are recognized worldwide as competent to perform their scope of work.

Why is NIST traceability important for ISO 17025?

NIST (National Institute of Standards and Technology) traceability ensures an unbroken chain of calibrations from your measurement equipment back to international standards. ISO 17025 requires this traceability to establish the validity and reliability of all measurements. ATEK sensors come with NIST traceability certificates establishing this critical chain.

What is measurement uncertainty and why does ISO 17025 require it?

Measurement uncertainty quantifies the range of doubt around any measurement result. For example, a thermometer might read 25°C with an uncertainty of ±0.5°C, meaning the true value lies between 24.5°C and 25.5°C. ISO 17025 requires laboratories to evaluate and report measurement uncertainty to help users understand the reliability of results and make informed decisions.

How often must equipment be calibrated under ISO 17025?

ISO 17025 does not specify fixed calibration intervals—instead, laboratories must establish appropriate calibration schedules based on equipment type, manufacturers' recommendations, historical data, and the criticality of measurements. ATEK's monitoring systems help track calibration dates and can trigger alerts when recalibration is due.

What records must be kept for ISO 17025 compliance?

Laboratories must maintain complete technical records including equipment calibration certificates, measurement results with uncertainty estimates, environmental conditions, personnel training records, and corrective action documentation. Records must be kept for a period defined in the contract or applicable regulations—typically 3-7 years or longer. ATEK's secure cloud storage and audit trails support comprehensive record retention.

Can ATEK help with environmental monitoring for lab qualification?

Yes, ATEK sensors can monitor temperature, humidity, and pressure conditions to document that your laboratory environment meets ISO 17025 requirements. This environmental monitoring data becomes part of your compliance documentation and helps demonstrate that your facilities are suitable for the work performed.

Does ATEK provide accreditation support?

While ATEK does not provide accreditation itself, our solutions support the technical requirements that accrediting bodies evaluate. Our NIST-traceable sensors, calibration documentation, record management systems, and measurement uncertainty specifications align with ISO 17025 requirements that auditors assess during accreditation assessments.

Need Help with ISO 17025:2017 Compliance?

Our team of compliance experts can help you implement monitoring solutions that meet ISO 17025:2017 requirements. Contact us for a consultation or demo.

Customized compliance assessment for your facility

Validation documentation packages (IQ/OQ/PQ)

Expert support for audits and inspections

Speak with a Compliance Expert

Our team is available to discuss your specific ISO 17025:2017 compliance requirements.

compliance@atek.io

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