Defined scope, documented assessment and traceable records

1. Quality principles

2. Condition and service classification

Descriptions are used according to the actual item and the supporting records available. The applicable quotation or delivery document states the condition relevant to the transaction.

3. General working process

4. Controls by service area

5. Testing, inspection and release

There is no single universal test for all medical imaging components, X-ray tubes, equipment systems or manufactured parts. The applicable method is selected according to the item, failure mode, available compatible equipment and the agreed acceptance purpose.

Depending on the item and written scope, controls may include:

• visual inspection, identification and photographic recording;
• connector, cable, contact or mechanical-condition review;
• dimensional checks against agreed drawings or critical dimensions;
• electrical, insulation, continuity or functional checks where suitable equipment is available;
• bench testing, compatible-system testing or simulated testing where technically feasible;
• review of fault codes, service logs, operating data or customer-provided evidence;
• final inspection of labelling, included items, protective packaging and dispatch readiness.

6. Identification, traceability and records

Depending on the item and agreed documentation scope, records may include:

• customer, quotation, order, invoice or RMA reference;
• manufacturer, equipment model, part number, serial number and revision;
• incoming condition, label photographs and relevant visible findings;
• agreed work scope, material changes or replaced components where applicable;
• test method, test date, observed result and known limitations;
• release, packing and dispatch information;
• installation, commissioning or customer feedback where required for the service case.

Availability, format and retention of individual records depend on the contract, the service type, legal requirements and the technical systems used for the project. Where a specific inspection record, service report or photographic record is required, this should be stated before the order is placed.

7. Product and project compliance responsibilities

• Regulatory status, CE documentation, original manufacturer declarations, software licences and market-specific requirements are reviewed only to the extent included in the written scope and supported by available documents.
• Medifern does not recreate, extend or replace an original manufacturer's declaration of conformity unless Medifern has the legal role and documented basis to do so for the specific product.
• Suitability for a destination country is not assumed. Import, registration, radiation-protection, electrical, building, installation and clinical-use requirements may differ by jurisdiction.
• Final installation, radiation-protection approval, safety acceptance and clinical commissioning must be carried out by appropriately qualified parties and competent authorities where required.
• Export controls, customs classification, sanctions screening and transport restrictions are handled according to the contract and the parties' respective legal responsibilities.
• Customers must not send patient-identifiable information, DICOM files or personal health data unless a lawful and expressly agreed process has been established in advance.

8. Independent service provider and certification statements

Manufacturer and product names are used solely to identify equipment, parts and compatibility. Unless expressly confirmed in writing, Medifern GmbH is not an authorised distributor, official service partner or representative of the respective manufacturer.

References to standards, methods, equipment capabilities or customer requirements do not by themselves mean that Medifern holds an accreditation or certification for that activity. Any claim relating to ISO certification, TÜV approval, notified-body involvement, laboratory accreditation, authorised-partner status or manufacturer approval must be supported by a current document covering the stated entity, location and scope.

Where customer, supplier or subcontractor certificates are relevant, their issuing entity and scope remain separate from Medifern's own status.

9. Non-conformity, warranty claims and complaints

Suspected defects, incorrect deliveries, transport damage or deviations from the agreed scope should be reported promptly with the order reference, item identification, photographs and a clear description of the issue.

Do not return equipment, X-ray tubes or spare parts before receiving written return instructions. An RMA reference authorises the agreed return for assessment but does not by itself confirm warranty coverage.

10. Requesting quality documentation

Tell us before ordering which documents are required for your internal approval, receiving inspection, installation or audit process. Depending on the item and agreed scope, available documentation may include identification photographs, an inspection summary, a service report, agreed dimensional results, a packing list or dispatch records.

No document should be assumed to be included unless it is identified in the quotation, order confirmation or project specification.