ISO 14155 A Complete Guide - Couverture souple

The Art Of Service - ISO 14155 Publishing

Couverture souple

ISBN 10 : 1867422409 ISBN 13 : 9781867422402

Editeur : 5STARCooks, 2020

Synopsis

ISO 14155 compliance is a decisive factor for any organization conducting clinical investigations of medical devices, and the 2021 revision introduced tighter data-integrity and patient-safety requirements that many companies still fail to meet. Without a clear, repeatable method, teams waste months navigating ambiguous clauses, miss critical documentation steps, and expose trials to regulatory delays.

The book delivers a structured Self-Assessment based on the RDMAICS framework - Recognize, Define, Measure, Analyze, Improve, Control, Sustain. Across the seven criteria you will find hundreds of targeted ISO 14155 questions. You rate each item on a 1-to-5 scale; the answers are automatically plotted onto a radar-chart Scorecard that instantly highlights the strongest and weakest compliance zones. Even professionals new to ISO 14155 can complete the assessment in a single workshop and obtain a visual roadmap for remediation.

Included Professional Toolkit (30+ Deliverables): A fresh, purchase-triggered toolkit is emailed to you and reflects the latest ISO 14155 guidance. It is organized into ten sections - Getting Started, Assessment and Planning, Models and Frameworks, Processes and Handoffs, Operations and Execution, Performance and KPIs, Quality and Compliance, Sustainment and Support, Advanced Topics, and Reference. The package contains Excel spreadsheets for scoring, risk-matrix templates, PDF process guides, and markdown runbooks that walk you through each RDMAICS step. All materials are crafted specifically for ISO 14155; there are no generic project-management forms.

Every purchase includes Lifetime Updates. As the ISO 14155 standard evolves, you will receive revised questionnaires, updated scorecard formulas, and refreshed toolkit files at no additional cost, ensuring your compliance program stays current without re-purchasing.

This guide is intended for Compliance Managers, Clinical Research Coordinators, and Regulatory Affairs Directors who must demonstrate ISO 14155 readiness to auditors, senior leadership, or health-authority reviewers. For example, a Compliance Manager can run the assessment before a pre-market audit, identify gaps, and assign corrective actions using the provided templates.

Developed by The Art of Service, business process architects serving over 100,000 professionals across 160 countries since 2000. Every assessment and toolkit draws on 25 years of operational-excellence research and a continuously updated knowledge base spanning hundreds of industry frameworks.

Détails de l'édition

• Éditeur: 5STARCooks
• Date d'édition: 2020
• Langue: anglais
• ISBN 10: 1867422409
• ISBN 13: 9781867422402
• Reliure: Broché
• Nombre de pages: 315
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible