Define
Translate component requirements into controlled instructions.
QUALITY AND TRACEABILITY
Precision you can trace.
The environment, work instruction, inspection result and lot record must describe the same component and the same agreed method.
Follow the evidenceQuality management approachAligned to ISO 13485
THE EVIDENCE CHAIN
Define, make, inspect and record.
Quality does not begin at final inspection. It starts when component requirements become controlled instructions and continues through every recorded step.
Evidence chain around one medical textile component
Environment, work instruction, inspection and records connect around a central conceptual component.
Controlled entry, filtered air, gowning and cleaning routines support the assembly environment.
THE CONTROLLED METHOD
Four stages that stay connected.
Assemble
Follow the agreed material, preparation and sewing sequence.
Inspect
Check the component against visual and dimensional criteria.
Record
Connect materials, work and inspection results at lot level.
DEFINING THE CHECKS
Make the requirement clear enough to inspect.
AJSM’s process-development work includes defining quality checks around the actual component. The drawing, materials and agreed assembly method determine what needs to be inspected.
- Textile coverageIdentify the areas that must be covered and any surfaces that must remain exposed.
- Seam and stitchAgree the seam position and the appearance of acceptable sewing, with reference samples or images where useful.
- DimensionsDefine the feature, measurement method and allowed limits. Decide whether magnification or a dedicated checking tool is needed.
- Material and batch recordsLink the textile, thread and supporting parts to the work instruction used, the inspection results and the release decision.
These are review topics, not universal pass/fail limits. The device manufacturer and AJSM agree the checks, handling and packaging requirements before the programme moves forward.
Read the guide to connected recordsPARTNER QUALIFICATION
Agree the evidence before the pilot.
Customer audits, pilot lots and acceptance criteria form a proposed qualification route. The exact sequence is agreed for the component programme.
This page describes AJSM’s current approach. It does not claim completed customer qualification or ISO 13485 certification.
THE DETAIL THAT MATTERS
A defined part. A documented method.
Material, coverage and seam placement need agreed acceptance criteria. The inspection record connects those requirements to the component.