ISO 9001 Traceability: Clauses 7.1.5.2 and 8.5.2 for Gauges and Products

What does ISO 9001 traceability require?

ISO 9001:2015 asks for traceability in three clauses. Clause 8.5.2 covers outputs, the products and services you deliver. Clause 7.1.5.2 covers measuring equipment, calibrated against standards traceable to international or national measurement standards. Clause 8.6 asks that release records trace to the person who authorized the release.

Two of the three are conditional. Clause 8.5.2 asks for unique identification "when traceability is a requirement". Clause 7.1.5.2 applies "when measurement traceability is a requirement", or when you judge it essential for confidence in your results. The 8.6 release record has no such condition.

Location is part of the definition. ISO 9000:2015 holds the vocabulary behind ISO 9001. It defines traceability as the "ability to trace the history, application or location of an object" (clause 3.6.13). For measurement, it defers to ISO/IEC Guide 99, where traceability means a documented, unbroken chain of calibrations back to a reference. NIST quotes that definition in its policy on metrological traceability.

A customer, a regulation or your own judgment usually sets where traceability applies. The ISO 9001 Auditing Practices Group notes that traceability "requires an established calibration hierarchy for measuring equipment". Its guidance on measurement traceability points auditors to certificates from accredited calibration labs or national metrology institutes.

ISO 9001 identification and traceability (clause 8.5.2)

Clause 8.5.2 asks you to identify outputs where that is needed to ensure conformity. You also identify their status against monitoring and measurement requirements, through production and service provision. Status shows, for example, whether a part is waiting for inspection, has passed or is on hold.

When traceability is a requirement, you control the unique identification of outputs. You also keep the documented information that makes tracing possible. Common means are lot or batch codes, serial numbers, travelers and route sheets, labels and inspection stamps.

Tracing runs both ways. For a product, ISO 9000 lists the origin of materials and parts, the processing history and the location after delivery. Backward tracing helps find the cause of a defect. Forward tracing shows where affected lots went, which is what a recall needs.

Clauses 8.5.2 and 7.1.5.2 meet at inspection. An inspection record can name the gauge used. If that gauge later fails a check, you can trace from the gauge back to the lots it passed.

ISO 9001 clause 7.1.5.2 measurement traceability, part by part

Clause 7.1.5.2 gives measuring equipment three duties and one follow-up. It sits under clause 7.1.5, monitoring and measuring resources, after 7.1.5.1 asks for resources that suit the measurement and stay fit for purpose. The table puts each duty next to the record that usually shows it. Row b) is the clause behind asset marking, and the last column is what a dated location record adds.

A location record does not make a gauge traceable. Measurement traceability comes from the calibration chain and its certificates. The location record supports the recall and safeguarding work around that chain.

IATF 16949 7.1.5.2.1: what calibration records must hold

IATF 16949 clause 7.1.5.2.1 lists what calibration and verification records must include. IATF 16949 is used together with ISO 9001 and adds automotive requirements. Among other items, the list covers the following (a summary, not the standard's wording):

• Readings found out of specification when a gauge comes in for calibration.
• An assessment of the risk to the product's intended use from that condition.
• The validity of earlier results when a gauge is found out of calibration or defective.
• Statements of conformity to specification after calibration or verification.
• Notice to the customer if suspect product or material has shipped.

A location record can help with the review of earlier results. For a gauge that moved between sites, it shows where the gauge was since its last good check. The inspection records then show which lots it measured at each site.

Adding where each gauge has been to ISO 9001 traceability records

A tag on each gauge records where it has been between checks. Calibration records show when a gauge was checked and what it read. They seldom show where it went in between. You can play back its history for any window.

The record works at site level. It covers cases like these:

• Outside calibration. You get an alert when the gauge reaches the calibration lab and another when it is back in the plant. The dates sit beside the certificate.
• Loans to a sister plant. The record shows when the gauge left, where it stayed and when it came home.
• Overdue recall. The map shows whether a gauge due for calibration is in the plant or at another site.
• Field service tools. Torque wrenches and meters that visit customer sites leave a dated record of each site.
• Customer property. Clause 8.5.3 asks you to take care of property that belongs to customers or external providers. A dated record shows where a customer's checking fixture was while you held it.

How to add location records to a calibration program

Location records fit inside the procedure you already run for monitoring and measuring resources. Four steps cover it.

1. Pick the gauges that travel and tag each one. Start with gauges sent to outside labs, loaned between plants or used on customer sites.
2. Draw a geofence around each site. Add the plant, the outside lab and any sister plant, then turn on arrival and departure alerts.
3. Attach the history when a gauge fails. Export its locations since the last good check and add them to the review of earlier results.
4. Write it into your procedure. Name the location record, who exports it and how long you keep it.

For the geofence step, see how to create a geofence. For the export step, the data export and API guide covers spreadsheets, reports and the API.

What to expect from tags on measuring equipment

A tag adds a location record to each gauge. Here is what that record holds.

• Building-level position. The record tells you the plant, the lab or the customer site a gauge is at, rather than the bench.
• Updates come from phones passing by. Tags report through crowdsourced networks, and any phone that passes relays the position. These networks are large (Apple counts over a billion iPhone, iPad and Mac devices, and Google over a billion Android devices). A busy plant gives frequent updates, and a remote site gives fewer.
• Location rather than calibration data. The tag records where a gauge is. Readings, intervals and certificates stay in your calibration system.
• Where rather than who. The record shows where the gauge went. A sign-out sheet or crib log still records who took it.
• Long battery life. A tag runs up to six years, depending on its size.