Quality
Skill packages tagged with “Quality”
CAPA Report
Corrective and Preventive Action reports for audit non-conformities. Enforces 5 Whys root cause analysis and a future Effectiveness Check date (ISO 9001 / ISO 13485).
HIQA Quality Improvement Plan
Draft or update a quality improvement plan for healthcare services aligned with HIQA NSSBH.
ISO 17025 Gap Assessment
Perform a structured gap assessment against ISO/IEC 17025:2017 clauses 4-8. Clause gap detector ensures all major clause areas are assessed; maturity rating tool validates 0-5 maturity scores for consistency with findings. Produces findings register and remediation roadmap.
ISO 17025 Laboratory Profile
Build and validate a foundational laboratory profile for ISO/IEC 17025:2017 accreditation. Captures lab identity, organizational structure and impartiality basis (Cl.4.1.5), accreditation status, scope of accreditation (disciplines, methods, measurands, ranges, scope type, CMC/uncertainty expressions), authorized signatories, key personnel, facilities, major equipment with calibration intervals, proficiency testing programme (Cl.7.7), subcontracting arrangements (Cl.6.6.3), and management commitment (Cl.8.2.2). Profile completeness checker validates all required sections; scope validator performs per-method field validation and reports failures by method ID.
PMBOK Quality Management
Draft Project Quality Management documents aligned with PMBOK. Covers quality management plans, quality metrics, checklists, test and inspection plans, quality audit reports, and improvement reports with Pareto, Ishikawa, control chart, and cost of quality analysis.
PRINCE2 Managing Product Delivery
Draft Managing Product Delivery (MP) documents aligned with PRINCE2. Covers Team Plans, Product Descriptions, quality review records, Checkpoint Reports, and product handover documentation.
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.