QMS Procedure Elaborator

Overview

Guided elaboration of QMS procedures, process maps, and quality objectives aligned to ISO 9001 clauses and context of the organization. Verifies required clause topics are addressed and objectives are measurable.

Getting Started

Add your source materials to the project workspace, then activate the QMS Procedure Elaborator skill. The agent will guide you through the process step by step.

Example Conversation

You: We’re updating our production control procedure to align with ISO 9001. Can you map it to clauses 8.5.1, 8.5.2 and 8.5.6 and check that our quality objectives are measurable?

Agent: I’ll review the procedure document and run check_procedure_clause_coverage to see which clause topics are referenced and whether objectives mention metrics or targets.

Agent: The tool found references to clauses 8.5.1 and 8.7 but no explicit mention of 8.5.2 (identification and traceability) or 8.5.6 (control of changes). It also flagged that your objectives section doesn’t include specific targets or measurement methods. I’ll add a subsection for 8.5.2 and 8.5.6 and suggest measurable objective wording (e.g. defect rate %, on-time delivery %).

You: Add the subsections and one example objective.

Agent: Done. Re-run check_procedure_clause_coverage to confirm all key clauses are now addressed.

Sample Output Excerpt

Excerpt from a QMS procedure showing clause mapping and a measurable objective.

Control of production and service provision (8.5.1)

Activities are planned and controlled per this procedure. Equipment and work environment are maintained per maintenance schedule.

Identification and traceability (8.5.2)

Where traceability is required, batch/lot and product identification are applied per work instruction WI-12. Records are retained for the defined retention period.

Control of changes (8.5.6)

Changes to production parameters, materials, or equipment that affect product conformity are reviewed and approved per change control form QF-08. Validation is documented before release.

Quality objectives (6.2) — excerpt

Built-in Validation Tools

The skill includes an extension tool that checks procedure and QMS documents for clause coverage and measurable objectives.

What the tool checks

Example validation output

======================================================================
QMS PROCEDURE CLAUSE COVERAGE REPORT
ISO 9001:2015
======================================================================
Document: procedures/production-control.md
Clause references found: 5 distinct clause(s)

--- FINDINGS ---
  [WARNING] Clause 8.5.2 (ISO 9001) is not referenced. Ensure procedures or objectives address this requirement where applicable to scope.
  [WARNING] Quality objectives (6.2) should be measurable. Add specific targets, metrics, or timeframes where applicable.

--- SUMMARY ---
  Errors: 0
  Warnings: 2
======================================================================

Run the tool on procedure documents or the QMS manual before internal or certification audits.