QMS
Skill packages tagged with “QMS”
AS9100 Procedure Author
Guided elaboration of AS9100-aligned procedures and risk-based thinking documentation: quality manual sections, process procedures (design, purchasing, production, NCM), and key objective evidence for AS9100 Rev D.
Controlled Document Export
Render a markdown source into a branded, controlled-document DOCX with cover page, logo header, version/page footer, classification banner, and optional approval table — suited to ISO, QMS, GxP, and other compliance document sets.
IATF 16949 Process & CSR Author
Guided elaboration of IATF 16949 process documentation and customer-specific requirements (CSR) matrix: process maps, turtle diagrams, and evidence of conformity to OEM CSR.
ISO 17025 Quality Manual & Document Control
Draft and validate quality management system documentation per ISO/IEC 17025:2017 Clauses 8.1–8.4. Produces a quality manual with quality policy, document control procedure, record control procedure, and master document list. Quality manual checker validates policy, structure, and clause coverage; document control validator ensures approval, revision, and distribution processes are defined.
Pharmacy QMS (ApBetrO)
Pflege und Erstellung des Qualitaetsmanagementsystems (QMS) fuer oeffentliche Apotheken gemaess Apothekenbetriebsordnung (ApBetrO). Erstellt QMS-Handbuecher, Hygieneplaeane nach RKI-Richtlinien, Rezepturprotokolle nach DAB/Ph.Eur. und prueft die Compliance.
QMS Procedure Elaborator
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.
Quality Metric Validator (COBIT APO11)
Define quality standards for IT services and SDLC aligned to COBIT APO11. Suggest quality gates based on Capability Levels. Includes SLA–quality sync check.