Quick answer

A drawing defines the finished component. A controlled method explains how to prepare, position, assemble, inspect and record that component in a repeatable way.

Scope of this guide: This guide explains the planning link between a drawing and a work instruction. The design owner must approve the component requirements, method and evidence before programme use.

Illustrative development bench with a component drawing, textile parts and precision assembly tools

What does the drawing need to tell the team?

Start with the current drawing and every document it references. Mark the geometry, materials, covered areas, exposed areas, attachment points and important dimensions.

List any point that the drawing does not explain. Do not copy a method from a similar-looking component unless the design owner approves it.

How do you build the assembly sequence?

Put the work in a clear order. Identify materials, prepare parts and position the textile. Then attach it, check the result and protect the finished item.

For each step, state the starting condition and expected result. Add the fixture, orientation reference or intermediate check where it is needed.

How do the instruction, training and record connect?

The work instruction tells the operator what to do. Training shows that the operator can follow it. The lot record shows which version and materials were used.

ISO 13485 gives quality-management context for documented medical-device processes. AJSM states that its approach is aligned to ISO 13485. This is not a certification claim.

Sources: ISO — ISO 13485: quality management for medical devices

Check the method before sample work

Walk through the method with the real drawing and planned forms. Close unclear steps before setting the sample plan.

  • Current drawing, specifications and material references are available.
  • Every step has a clear start, action and expected result.
  • Positioning references, fixtures and handling limits are defined.
  • Inspection methods connect to named drawing features.
  • Material, training and inspection records can link to one lot.

Source notes

Sources and further reading