ISO 13485 - Implementation Toolkit (Excel XLSX)

BENEFITS OF DOCUMENT

1. Diagnose ISO 13485 projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices.
2. Implement evidence-based best practice strategies aligned with overall goals.
3. Integrate recent advances in ISO 13485 and put process design strategies into practice according to best practice guidelines.

DESCRIPTION

This product (ISO 13485 - Implementation Toolkit) is an Excel template (XLSX) with a supplemental Zip archive file document, which you can download immediately upon purchase.

ISO 13485 is an international standard that specifies the requirements for a quality management system (QMS) specifically for the medical devices industry. It is essential because it ensures that organizations involved in the design, production, installation, and servicing of medical devices consistently meet both customer and regulatory requirements. By implementing ISO 13485, companies can enhance product safety, minimize risks, and ensure that their medical devices meet the necessary standards for quality and performance, which is critical for patient safety and compliance with global regulations.

This ISO 13485 Implementation Toolkit includes a set of best practice templates, step-by-step workplans, and maturity diagnostics for any ISO 13485 implementation related project. Please note the above partial preview is ONLY of the Self Assessment Excel Dashboard, referenced in steps 1 and 2 (see below for more details).

Through a 3-step process, this toolkit will guide you from idea to implementation. Please find a below a summary of the 3 steps.

STEP 1: Get your bearings

Start with the latest quick edition of the ISO 13485 Self Assessment book in PDF containing 49 requirements to perform a quickscan, get an overview and share with stakeholders.

Organized in a data driven improvement cycle RDMAICS (Recognize, Define, Measure, Analyze, Improve, Control and Sustain), check the example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation.

STEP 2: Set concrete goals, tasks, dates and numbers you can track

Featuring 993 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which ISO 13485 improvements can be made.

The Self-Assessment Excel Dashboard; with the ISO 13485 Self-Assessment and Scorecard you will develop a clear picture of which ISO 13485 areas need attention, which requirements you should focus on and who will be responsible for them:

•  Shows your organization instant insight in areas for improvement: Auto generates reports, radar chart for maturity assessment, insights per process and participant and bespoke, ready to use, RACI Matrix
•  Gives you a professional Dashboard to guide and perform a thorough ISO 13485 Self-Assessment
•  Is secure: Ensures offline data protection of your Self-Assessment results
•  Dynamically prioritized projects-ready RACI Matrix shows your organization exactly what to do next

STEP 3: Implement, Track, follow up and revise strategy

The outcomes of STEP 2, the self assessment, are the inputs for STEP 3; Start and manage ISO 13485 projects with the 62 implementation resources. There are 62 step-by-step ISO 13485 Project Management Form Templates covering over 1500 ISO 13485 project requirements and success criteria.

Source: Best Practices in Healthcare, ISO 13485 Excel: ISO 13485 - Implementation Toolkit Excel (XLSX) Spreadsheet, Gerard Blokdijk