Quality Statement

We continuously improve our products, processes, and people to ensure that life, property, and the environment are protected.

Field crews and first responders make safety decisions from the readings our instruments give them. This page sets out how we control that, and what evidence we can put in front of you during evaluation, procurement, or an audit.

A Certified Quality Management System

Our quality management system is built to ISO 9001:2015. Instruments intended for use in explosive atmospheres are additionally manufactured under the relevant standards that apply to Ex product manufacture.

Every Instrument Is Checked Before It Ships

Instruments are inspected for operation and appearance before release to shipping. The record we retain shows conformity against the acceptance criteria and identifies the person who authorized the release.

Instruments are identified by serial number. That serial number links back to the customer order, the operator and inspector, the work instruction used, and significant parts such as serialized sensors.

Traceability and Containment

Traceability between finished instruments and significant parts is maintained by serial number, batch identification, or supplier conformity records. Two methods are used:

• A part serial or batch number is linked directly to the finished instrument serial number
• A part is traced to a defined range of finished instruments using supplier certificates of conformity, receiving records, production records, and shipment records

For Ex instruments, every critical part named in the Ex technical documentation is treated as a significant part.

Traceability exists so we can contain a problem. If a part turns out to be suspect, we can identify which instruments are affected and which customers received them. Records supporting that are retained in order to meet or exceed required record retention periods for ISO 9001:2015 and ISO/IEC 80079-34:2018. This includes inspection and test data, calibration data, manufacturing traceability, supplier evaluations, and delivery data with serial numbers.

Supplier Control

Suppliers are evaluated before selection and reviewed at scheduled intervals. A supplier not used for more than a year is re-evaluated before further work is placed.

Evaluation can be via third-party quality system certification to the appropriate standard and scope from an accredited body, documented objective evidence that the supplier can meet the requirement, or a documented site assessment. 

Incoming material is also checked, with further inspection through manufacturing.

When Something Goes Wrong

We treat a complaint as any written, electronic, or verbal report alleging a deficiency in the quality, durability, reliability, usability, safety, effectiveness, or performance of a SENSIT instrument, or in a service affecting how that instrument performs. Every complaint is logged by our team. 

When we receive a complaint, we will determine whether a return authorization is needed, whether containment applies, and who investigates. Device history and repair history are reviewed first. If the cause is already known and corrected, we tell you that and what the correction was. If it requires further investigation, we tell you that as well, and your instrument is added to a corrective action.

Open complaints are monitored daily, reviewed weekly, and trended monthly.

How We Keep The System Honest

Internal audits are conducted every twelve months, and the interval never exceeds fourteen. Auditors do not audit their own work. Audits of Ex product cover the requirements of EN ISO/IEC 80079-34:2018 and the Ex certificates themselves.

SENSIT's management reviews the quality management system at least once a year, covering customer feedback, progress against quality objectives, process performance and product conformity, nonconformities and corrective actions, audit results, and supplier performance. Each department sets and tracks its own quality objectives against that review.