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Standards

Calibration management for your standard

Whatever you're audited against, the calibration requirements come down to the same things: traceability, status, records, and acting when something drifts. See how Axiospec maps to the standard you work under.

ISO/IEC 17025

Testing & Calibration Laboratories

ISO/IEC 17025 is the international standard for the competence of testing and calibration laboratories. It puts measurement traceability, equipment control, and defensible records at the center of everything a lab does. Axiospec gives you a single system to manage equipment status, capture the traceability chain, and produce records an assessor can follow from instrument to certificate across the traceability chain.

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ISO 9001

Quality Management Systems

ISO 9001 clause 7.1.5 requires that the equipment you use to verify product conformity is fit for purpose, maintained, and supported by retained evidence. Where measurement traceability is required, clause 7.1.5.2 adds calibration at planned intervals against traceable standards, status identification, safeguarding, and action when equipment is found unfit. The checklist below breaks that into what an auditor looks for. Axiospec gives you a running system to support the workflows behind the clause, whether you are setting up calibration tracking for the first time or replacing software that fights you at audit time.

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AS9100

Aerospace Quality Management

AS9100 builds on ISO 9001 with the additional rigor the aerospace and defense supply chain demands: stronger configuration control, risk management, and an expectation that records are complete and recoverable years later. Calibration is a frequent finding in AS9100 and Nadcap audits. Axiospec keeps your measuring equipment under control and your documentation recall fast.

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ISO 13485

Medical Device Quality Management

ISO 13485 clause 7.6 requires that monitoring and measuring equipment is calibrated or verified at defined intervals against traceable standards, its calibration status identified, the equipment safeguarded and protected, records retained, and the validity of previous results assessed when equipment is found out of calibration. The checklist below breaks that into the obligations an auditor checks. Axiospec gives device manufacturers documented, attributable calibration records and the reverse traceability regulators expect when a measurement is later called into question.

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IATF 16949

Automotive Quality Management

IATF 16949 is the automotive quality management standard built on ISO 9001, and section 7.1.5 is where it tightens the rules on monitoring and measuring resources. It expects measurement systems analysis, calibration and verification against traceable standards, and detailed records on every gauge that supports product conformity. Axiospec gives automotive suppliers one system to keep those resources under control, capture the data behind each calibration, and produce records a customer or third-party auditor can follow from instrument to reference standard.

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API Spec Q1

Oil & Gas Manufacturing Quality

API Spec Q1 is the American Petroleum Institute's quality management system standard for organizations that manufacture products for the oil and gas industry. It puts firm requirements on the control of testing, measuring, and monitoring equipment, from unique identification and traceable calibration through to acting on equipment found out of calibration. Axiospec gives you a single system to identify each instrument, capture its calibration against traceable standards, and produce the equipment records an API Q1 auditor expects to follow.

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ISO 45001

Occupational Health & Safety Management

ISO 45001 is the international standard for occupational health and safety management systems. Most of it is about hazards, risk, and worker participation rather than calibration, but the equipment you use to evaluate OH&S risks and exposures, gas detectors, noise dosimeters, air sampling pumps, and pressure or torque tools, only gives trustworthy readings when it is calibrated and in date. Axiospec keeps that safety-critical monitoring equipment tracked, current, and documented so the measurements behind your OH&S decisions rest on instruments you can stand behind.

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ISO 10012

Measurement Management Systems

ISO 10012 describes the requirements for a measurement management system: the metrological confirmation process and the measurement processes that keep equipment fit for its intended use. It puts traceable calibration, defined confirmation intervals, and clear status front and center. Axiospec gives you one system to record each instrument, capture its calibration against traceable standards, and keep the confirmation records an ISO 10012 reviewer expects to follow.

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ANSI/NCSL Z540.3

Calibration of Measuring & Test Equipment

ANSI/NCSL Z540.3 sets the requirements for the calibration of measuring and test equipment, widely referenced by labs and metrology programs across regulated industries. It emphasizes traceable calibration, documented as-found and as-left readings, and complete records. Axiospec gives your program one place to capture each calibration with its readings and reference standard, and to produce the records a reviewer expects, while measurement uncertainty and decision-rule analysis remain the work of your metrologist.

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ISO/IEC 17020

Inspection Bodies

ISO/IEC 17020 sets the requirements for the competence of bodies performing inspection. The equipment an inspection body relies on to reach a finding must be controlled, calibrated where it affects results, and traceable. Axiospec gives inspection bodies one system to identify each instrument, capture its calibration against traceable standards, and produce the equipment records an assessor expects to follow.

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ISO 15189

Medical Laboratories

ISO 15189 sets the requirements for quality and competence in medical laboratories, where the equipment behind a result must be controlled, calibrated, and traceable. Axiospec gives medical laboratories one system to record each instrument, capture its calibration and verification against traceable references, and keep the equipment records an assessor expects, while interpretation of patient results stays with the laboratory.

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Nadcap

Aerospace Special Process Accreditation

Nadcap accreditation covers the special processes the aerospace supply chain depends on, and the measuring and test equipment behind those processes is a frequent audit focus. Equipment must be controlled, calibrated against traceable standards, and documented in detail. Axiospec keeps your measuring equipment under control and your calibration records, with as-found and as-left readings and full traceability, ready for a Nadcap auditor without a week of archaeology.

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ASME NQA-1

Nuclear Quality Assurance

ASME NQA-1 sets quality assurance requirements for nuclear facilities and applications, with firm expectations on the control of measuring and test equipment. Equipment must be calibrated against traceable standards, identified by status, and acted on when found out of tolerance, all under retained, defensible records. Axiospec gives NQA-1 programs one system to capture each calibration with its readings and reference standard and to keep records an auditor can follow.

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FSSC 22000

Food Safety System Certification

FSSC 22000 is a food safety management certification scheme built on ISO 22000, and the monitoring and measuring devices behind your controls, thermometers, scales, pH meters, and metal detectors among them, only give trustworthy readings when they are calibrated and in date. Axiospec keeps that measuring equipment tracked, current, and documented, so the measurements behind your food safety decisions rest on instruments you can stand behind.

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ISO 14001

Environmental Management Systems

ISO 14001 is the international standard for environmental management systems. Much of it is about aspects, impacts, and compliance obligations rather than calibration, but the equipment you use to monitor emissions, effluent, and other environmental parameters only gives trustworthy readings when it is calibrated and in date. Axiospec keeps that monitoring equipment tracked, current, and documented, so the measurements behind your environmental decisions rest on instruments you can stand behind.

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