Ensuring the Traceability of Measurement Instruments in Compliance with ISO Standards

 

➔ What Does Traceability Actually Mean?

In industrial measurement technology, the term "traceability" is central to quality assurance and compliance with international standards. Traceability means that the result of a measurement can be traced back to national or international standards — through a complete, documented chain of calibrations, each with known measurement uncertainties.

Definition according to ISO/IEC 17025:

"A measurement result is traceable if it can be related to a reference through a documented, unbroken chain of calibrations, each contributing to the measurement uncertainty."

ISO 9001 also states in section 7.1.5.2 that measuring equipment must be calibrated at regular intervals — and traceable to international or national standards.

 

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Why is traceability essential in industrial measurement?

In virtually all industries — from pharmaceuticals and mechanical engineering to the energy sector — measurements serve as the foundation for:

• Product safety

• Process control

• Quality documentation

• Legal compliance

Without traceable calibrations, measurement results may not be legally valid — particularly during audits, liability cases, or certification processes. Therefore, traceability is not just a "nice-to-have" but a fundamental requirement for any quality-controlled production.

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Traceability vs. Factory Calibration – What's the Difference?

Many manufacturers deliver their sensors and measuring devices with a factory calibration certificate. This confirms that the device was tested before shipment — but often without full traceability to national standards or without clearly defined measurement uncertainty.

In contrast, a traceable calibration ensures that:

• Certified reference equipment is used (e.g., with DAkkS or ISO/IEC 17025 certificate),

• All measurements are documented and verifiable,

• The entire measurement chain complies with standards (e.g., ISO/IEC 17025).

Only traceable calibrations meet the requirements for audit readiness, quality assurance, and international comparability.

 

Traceable Pressure Modules with Calibration Certificate

Both DPI610E and PACE devices operate with interchangeable pressure modules that:

• Are factory-calibrated or calibrated by accredited laboratories (e.g., DAkkS)

• Include traceable certificates (with serial number & measurement uncertainty)

• Can be easily swapped and recognized by the device

This ensures that every calibration process is supported by a certified, traceable reference standard—a basic requirement for ISO-compliant quality assurance.

 

➔ Practical Example: How a Traceable Calibration Process Works – Seamlessly Documented with 4Sight2

A traceable calibration process ensures that each measurement result of a device under test can be traced back to a recognized national or international standard—fully documented, with known measurement uncertainty and fully audit-compliant.
Below we show how such a process works in practice—using the example of a pressure transmitter calibrated with the PACE6000E or the DPI610E and seamlessly managed using 4Sight2.

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Step-by-Step Guide: Traceable Calibration of a Pressure Sensor

Integration into a Modern Quality Management System – with 4Sight2 as the Control Center

A professional calibration process doesn't end with the measurement but with the secure and traceable archiving of all data – this is where 4Sight2 excels:

Export Formats:

• PDF: Automatically generated, audit-proof calibration certificates with logo and signature
• CSV: For Excel evaluation or import into existing CAQ systems
• XML/JSON: Machine-readable for automated data import

Interfaces to Third-Party Systems:

• ERP systems such as SAP PM
• CAQ solutions such as Babtec, Böhme & Weihs
• External calibration databases (e.g., WIKA-Cal, Excel/Access)
• REST API for system integration (e.g., into maintenance or test software)

Long-Term Archiving:

4Sight2 enables centralized, secure, and standards-compliant archiving, including full-text search, filtering by serial number, user, or device type – audit-proof and always ready for inspection.

 

A traceable calibration process using devices like DPI610E or PACE6000E meets the highest technical standards.
4Sight2 complements this process as a powerful software platform, intelligently combining documentation, management, and integration.
This creates a closed, digital, and standards-compliant calibration loop – perfectly prepared for internal QA and external audits.

 

➔ Tips for Documentation & Proof with 4Sight2

Calibration is only complete when documentation is gap-free and audit-proof. In audits, undocumented steps are considered not done.
This is where the 4Sight2 by Druck software offers great value to companies wanting to manage their calibration workflows digitally, efficiently, and in compliance.

Proper Archiving of Calibration Certificates

Calibration certificates must be:

• Traceable: Assigned to a specific instrument (serial numbers!)
• Accessible for years: Typically 5–10 years depending on the standard
• Tamper-proof: Stored securely without manipulation

4Sight2 supports this by:

• Central storage of all calibration data and test records
• Linking each certificate to the relevant instrument
• Automatic versioning & change tracking
• Export to PDF or digital archive formats

This eliminates error-prone manual filing of paper or spreadsheets.

 

Digital vs. Paper-Based Management – Why 4Sight2 Wins

Aspect	Paper-Based Management	Digital Management with 4Sight2
Access	Manual, local, often slow	Centralized, multi-user, globally accessible
Search & Filter	Time-consuming, error-prone	Seconds by serial number, date, device type
Archiving & Backup	Needs physical storage space	Built-in backup, long-term archiving
Audit Readiness	Gaps or media breaks possible	Complete history, securely documented
Day-to-Day Efficiency	High administrative effort	Automated workflows and calibration plans

With 4Sight2, not just individual certificates are managed – a complete calibration management system emerges, including schedules, reminders, and responsibilities.

 

Dealing with Audit Deviations

Auditors check:

• Are calibration certificates complete and traceable?
• Are overdue calibrations systematically flagged and addressed?
• Are deviations documented, assessed, and followed up?

4Sight2 actively helps avoid audit risks:

• Traffic light system and auto-notifications for overdue calibrations
• Out-of-tolerance findings are logged, commented, and optionally linked to actions
• Full calibration history with technician, timestamp, and result

This way, audits are not only passed – they are confidently managed, without paper chaos or lost records.

With 4Sight2, documentation becomes a strength in the calibration process:
Instead of isolated spreadsheets or hard-to-find paper certificates, the software enables centralized, audit-proof, and compliant management of all calibration data – ideal for companies with strict quality or compliance demands.

 

➔ In Summary

Traceability in calibration is not optional – it's a requirement for compliant, safe, and quality-conscious operations in all industries dealing with pressure measurement. Only if each result can be traced to a national or international standard – fully documented and with known uncertainty – the calibration process meets standards such as ISO 9001 or ISO/IEC 17025.

Our Recommendation: Standards-Compliant Calibration with DPI610E & PACE

For companies looking to calibrate independently, efficiently, and audit-compliantly, we recommend a combination of:

• DPI610E: Portable field calibrator with integrated pressure generation – ideal for on-site calibration
• PACE5000E / PACE6000E: High-precision pressure controller for lab or test bench use
• Traceable pressure modules: Certified to DAkkS or ISO/IEC 17025, identified directly by the device
• 4Sight2 Software: Central solution for managing, planning, and logging all calibration workflows

This system solution ensures traceability is not only implemented technically, but also transparently documented – ready anytime for internal or external audits.