Preparation of Custom Working Instructions

Custom working instructions transform complex additive manufacturing processes into clear, standardized, and audit-ready execution steps. By combining Qualified AM expertise with QamX, operational know-how is translated into repeatable, traceable, and standards-aligned workflows, reducing variability and enabling consistent production quality at scale.

Generic production

Generic Production Line

Part specific production line

Part-specific Production Line

The Preparation of Custom Working Instructions service focuses on the development of clear, structured, and process-specific work instructions tailored to your additive manufacturing environment.

Qualified AM develops step-by-step operational guidelines for all relevant AM process steps, fully aligned with your existing Quality Management System and applicable standards, including ISO/ASTM 52920 and the ISO/ASTM 529xx series, as well as industry-specific quality management frameworks such as ISO 13485, AS/EN 9100, and ISO 9001.

These instructions are not generic templates but are custom-built for your specific machines, materials, processes, and organizational setup, ensuring direct applicability in daily operations.

Using the QamX QMS platform, work instructions are embedded into digital workflows, where they are linked to process steps, validation activities, risk assessments, and documentation requirements, ensuring consistent execution, traceability, and audit readiness.

Purpose

AM processes involve complex, highly variable production steps

Establish clear, repeatable, and controlled execution instructions for all critical operations

Generic SOPs often do not reflect real machine, material, or process behavior

Provide customized, process-specific working instructions tailored to real production conditions

Operator-dependent execution leads to inconsistencies and quality deviations

Ensure consistent process execution independent of individual operators

Missing or unclear instructions increase audit findings and non-conformities

Enable audit-compliant and clearly documented operational procedures

Scaling AM requires standardized execution across teams and sites

Provide harmonized instructions enabling reproducibility and scalability

Key benefits

Process-specific, fully customized working instructions

Tailored step-by-step instructions aligned with your machines, materials, process parameters, and organizational setup

Seamless integration into QMS and operational workflows

Work instructions embedded into the QamX QMS and directly linked to SOPs, checklists, and execution steps

Standards-aligned and audit-ready execution framework

Instructions structured in accordance with ISO/ASTM 52920 and the ISO/ASTM 529xx series, as well as ISO 13485, AS/EN 9100, and ISO 9001

Increased process consistency and repeatability

Reduction of operator variability through clearly defined, controlled execution logic

Integrated linkage of documentation, risk, and validation

Work instructions connected with risk assessments, process controls, and validation activities within the QamX ecosystem

Digital, version-controlled instruction management

Centralized creation, update, and traceability of all working instructions within QamX for scalable, audit-ready operations

Evaluation Criteria

Turn Your AM Processes into Controlled, Repeatable Execution

Establish clear, standards-aligned working instructions tailored to your additive manufacturing processes.
With Qualified AM’s expertise and the QamX platform, transform process know-how into audit-ready, scalable execution rules – reducing variability, improving quality, and enabling reliable production at scale.

Start Structuring Your Working Instructions
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