ISO 13485 A Complete Guide - Couverture souple

The Art Of Service - ISO 13485 Publishing

Couverture souple

ISBN 10 : 1867423669 ISBN 13 : 9781867423669

Editeur : 5STARCooks, 2020

Synopsis

ISO 13485 compliance is the gateway to market access and patient safety, yet many organizations stumble on the complex documentation, process controls, and audit requirements. This guide cuts through the confusion with a clear, actionable roadmap that lets you measure, improve, and sustain a certified quality management system without endless guesswork.

The book delivers a structured Self-Assessment based on the RDMAICS framework (Recognize, Define, Measure, Analyze, Improve, Control, Sustain). Hundreds of ISO 13485-specific questions are grouped under the seven criteria. You score each item from 1 to 5, and the results generate a radar-chart Scorecard that instantly highlights the exact areas, design control, risk management, supplier evaluation, post-market surveillance, and more, that need attention. Even readers with limited ISO experience can quickly gauge their organization's maturity and prioritize actions.

Included Professional Toolkit (40-48 Practitioner Tools): A fresh, up-to-date digital toolkit is emailed to you at purchase. 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 toolkit contains more than 30 deliverables in Excel, PDF, and markdown formats, all tailored to ISO 13485. Highlights include maturity assessments with scored improvement paths, gap-analysis worksheets, decision-framework matrices, implementation roadmaps, stakeholder-mapping templates, process runbooks, KPI dashboard templates, risk-matrix sheets, audit checklists, quick-reference cards, and detailed guidance notes. Each Excel file offers three sheets (Instructions, Template, Pro Tips & Common Mistakes); each PDF provides Pro Tips, Common Mistakes, and a Quick Reference section. The collection is ready to download, fill out, and apply immediately.

Every purchase grants Lifetime Updates. As ISO 13485 evolves, you receive revised content and refreshed toolkit materials at no extra cost, ensuring that your quality system guidance stays current and compliant.

This guide is designed for Compliance Managers, Quality Engineers, and Regulatory Affairs Specialists who need a practical, hands-on method to assess and improve their ISO 13485 system, whether preparing for a certification audit, responding to a supplier request, or launching a new medical device.

Developed by The Art of Service, business process architects serving over 100,000 professionals across 160 countries since 2000. Every book 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: 1867423669
• ISBN 13: 9781867423669
• Reliure: Broché
• Nombre de pages: 314
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible