Quality assurance and inspection

How is quality managed?

Quality is managed through written procedures that cover purchasing, production, inspection, calibration of measuring equipment, nonconforming product, corrective action and record keeping. The aim is that every instrument shipped can be traced to its components, its inspection record and its test results.

The company's quality management system is intended to align with ISO 9001 requirements. Certification status: {Certification — to be confirmed}. Where an instrument is subject to additional schemes, such as CE marking for the European market or ISO 13485 for medical devices, the relevant status is also shown as {Certification — to be confirmed} until supporting documents are issued.

We do not ask buyers to rely on our statements alone. Documents can be requested at quotation stage, and audits can be arranged.

What inspection stages does an instrument pass through?

Inspection is organized in four stages.

• Incoming inspection: critical components and materials such as optical parts, sensors, heating elements, pumps, pressure parts and electronic boards are checked against drawings or purchase specifications, with supplier records retained.
• In-process inspection: assembly steps are checked at defined points, for example alignment of optical paths, weld and seal quality, wiring, insulation and earthing continuity, and firmware version.
• Final inspection and testing: each unit is powered and operated across its range, and key performance parameters are measured against the specification, for example wavelength accuracy, temperature uniformity, speed accuracy or pressure holding, according to the product type.
• Pre-shipment inspection: visual condition, accessories against the packing list, labeling, and packing strength for international transport.

Electrical safety checks refer to IEC 61010-1 for laboratory equipment. Product-specific standards are cited on each subcategory page. Test results are recorded per serial number, and buyers may request a copy.

How are calibration and traceability handled?

Measuring instruments used in production and testing, such as thermometers, pressure gauges, balances, multimeters and reference standards, are calibrated at defined intervals against references that are traceable to national standards. Calibration records are kept and overdue equipment is not used for acceptance testing.

For instruments that measure, such as spectrophotometers, balances, pH meters and temperature chambers, we can supply a factory calibration or test certificate that states the reference standards, the measured values and the uncertainty where applicable. Whether a certificate is issued by an accredited laboratory, for example one accredited to ISO/IEC 17025, is agreed at quotation and shown on the certificate. Accredited calibration is offered on request and may add lead time.

Calibration at the user's site is the buyer's responsibility after delivery, and our manuals describe recommended intervals.

What qualification documents and support are available?

Regulated laboratories often need evidence that equipment is fit for purpose. We can provide support documents according to the instrument and agreed scope.

• Installation qualification (IQ) templates listing components, utilities, software version and documentation.
• Operational qualification (OQ) protocols with test steps and acceptance criteria drawn from the relevant pharmacopoeia or standard, for example USP <857> for spectrophotometers or USP <711> for dissolution testers.
• Factory acceptance test records and calibration certificates.
• Manuals, wiring and pressure-equipment documents, and declarations of conformity where applicable.
• For software-controlled systems, information on user levels, audit trail and data export, so the buyer can assess data integrity requirements.

Performance qualification, which depends on your samples and methods, is normally carried out by the user, and we can advise on the approach. Any declaration or certificate that depends on a third party, such as CE notified body involvement, is listed as {Certification — to be confirmed} until the document is available.

What happens if a problem is found?

Nonconforming product found in inspection is identified, separated and either reworked and retested or rejected. A unit is not shipped until it meets its specification.

If a buyer reports a problem after delivery, we ask for the serial number, photographs or data and a description, then compare them with the production and test records. Corrective action, where justified, may include repair, replacement parts, replacement of the unit or another remedy agreed in the contract.

For transport damage, please photograph the packaging and instrument before unpacking further and report within the period stated in the sales contract, so that a claim can be raised with the carrier or insurer. Contact sales@labmanufacturerschina.com, or +86 135 9999 9999.