What the clause requires
When a company uses measurement to demonstrate that a product or service conforms, the instruments and the methods it uses have to give reliable results. Clause 7.1.5 asks for those resources to be suitable for the type of measurement being made and to be maintained in a condition fit for continued use, and for the company to retain documented information as evidence that they are fit for purpose. That evidence is usually a calibration or verification record, but the standard does not dictate the format.
When measurement traceability is a requirement, whether because a customer demands it, because the law demands it, or because the company itself considers it essential in order to trust the result, the instrument has to be calibrated or verified at defined intervals against measurement standards traceable to national or international standards. Where no such standard exists, the basis used for the calibration has to be recorded. The instrument also has to be identified so that its calibration status is known, and safeguarded against adjustments, damage or deterioration that would invalidate the result.
The part most heavily audited is what happens when an instrument fails its calibration. The company has to determine whether the measurements taken since the last valid calibration are still reliable and, if they are not, take appropriate action on the product already released. Swapping the caliper and carrying on without looking backwards is one of the most common nonconformities raised against clause 7.1.5, and also the most expensive one, because the honest answer often involves contacting customers.
What the auditor asks to see
- A list of instruments showing the identification, where each is used and the calibration interval
- Valid calibration certificates issued by a laboratory with demonstrable traceability, preferably accredited
- An acceptance criterion comparing the error in the certificate with the tolerance of the process
- A label or marking on the instrument showing that it is fit for use and until when
- A record of the analysis made when an instrument failed calibration and of the action taken on the product measured with it
Where companies most often get it wrong
- A certificate filed away with nobody checking whether the error found fits the process tolerance
- An instrument past its calibration date still in use on the production line
- A failed calibration closed with no assessment of the earlier measurements
- Operators using their own personal instruments outside the calibration system
- Intervals set with no criterion at all: everything annual, regardless of how much it is used
Example of a nonconformity
- Requirement
- ISO 9001, 7.1.5.2: when measuring equipment is found to be unfit for its purpose, determine whether the validity of previous measurement results has been adversely affected.
- Evidence
- Micrometer MIC-012 failed the calibration of 12/05/2026 (error of 0.015 mm against a tolerance of 0.010 mm). The instrument was replaced, but there is no record of any assessment of the batches measured between the previous calibration (05/2025) and the current one.
- Finding
- The impact of the unfit instrument on the products released on the basis of its measurements was not assessed.
How to comply using PrismaBiz
Ready-made templates for this clause
Frequently asked questions
Does every instrument have to be calibrated?
No. Calibration with traceability is required when the customer, the law or the company itself considers it necessary in order to trust the result. Instruments used only for reference can have a simpler control, provided that is defined.
Does the laboratory have to be accredited?
ISO 9001 requires traceability, not accreditation. A certificate from a laboratory accredited by the national accreditation body is simply the easiest way to demonstrate traceability. Without accreditation, the company has to be able to prove the chain of traceability some other way.
What is the correct calibration interval?
The standard does not define one. The company decides based on use, criticality, the manufacturer recommendation and the calibration history. An instrument that always passes comfortably can have its interval extended; one that fails should have it shortened.