ISO 13485 Critical Capabilities

person icon Gerard Blokdijk

ISO 13485 Critical Capabilities



This eBook includes

Formats : PDF (Read Only)

Pages : 738

ISBN : AS-00100199

Language : English

About the Book

Book description

Look inside the Kanban:

Monitor key quality system metrics, process indicators, and overall health of the cGMP Quality Management System (QMS) to proactively identify and address quality systems or product issues and ensure its continuing stability, effectiveness, and improvement.    

Benefits of the ISO 13485 Kanban 

2295 Ready to use prioritized ISO 13485 requirements:

  • Does your organization have documented procedures to control design and development changes? 
  • Does the manufacturer have documented procedures for traceability for all Class III and IV devices that meet the ISO definition of implantable medical device or active implantable medical device? 
  • Do manufacturers who use suppliers to provide finished medical devices have documented procedures in place to ensure that the finished medical device is safe and effective? 
  • What will employees need to do for the ISO 13485 Quality Management System? 
  • How many design reviews does your medical device product development project need? 
  • How do you maintain the effectiveness of the Quality Management System in accordance with ISO 13485 requirements? 
  • Does the organization have the documented procedures required by ISO 13485 and 21 CFR 820? 
  • Are procedures in place that define the content, location and retention of quality system records and process control records, and are records of compliance available? 
  • How does your organization control the purchasing processes to ensure that purchased product conforms to specified purchase requirements? 
  • How do you implement MDSAP into an quality management system according to ISO 13485, 21 CFR 820 (QSR) or any other regulatory framework?   


The Art of Service has identified and prioritized 2295 ISO 13485 critical capabilities and use cases to assess and use. Leaders can select those results that best align with their business needs before implementing a solution.

The Art of Service's Critical Capabilities evaluates and prioritizes hundreds of results to help with the outcome selection process.

This Critical Capabilities Kanban will enable leaders to shortlist hundreds of appropriate results fast, because they are uniquely ready-to-use prioritized, starting with the 'Must Have' category; the most urgent and critical priorities.

This Kanban will help you plan and manage your ISO 13485 roadmap:

  • Transform the data into actionable views for your organization: business data changes, so how you view it should be flexible. Create the perfect view that's right for you.
  • Put your workflows on autopilot: Help your team go faster and focus on what matters by automating your processes. Upload and use the Kanban with your favorite apps and services like Asana, Aeratable, Basecamp, Monday.com, Atlassian, Trello etc.
  • Knock down data silos: Align your teams around a single source of truth with real-time data from different sources. Point. Click. Stay in Sync.
  • Use it's flexible reporting for your unique use case: Whether you're "no-code" or you "know-code", the Kanban is the foundational tool to show what you want to who needs to see it.  

Included in your instant download purchase are the following digital products:

As seen in the Kanban above, the complete 2295 ISO 13485 critical capabilities and use cases, their prioritization, workflows, tagging and questions. The download is available as an easy to re-use Excel format, which you can use as is, or import in any management tool of your choice, like Monday.com, Atlassian, Smartsheet, Power BI, Asana, Aeratable etc. Also included is the ISO 13485 critical capabilities Book in PDF format covering all the criteria including ideas for (potential) roles to assign the criteria to. 

Table of contents:

About The Art of Service 

ISO 13485 Critical Capabilities, Meaningful Metrics And Their Prioritization 


Prioritization Of Requirements 

The Prioritization Categories Are: 

  • Must Have 
  • Should Have 
  • Ought to Have 
  • Might Have 
  • Could Have 

Use In New Product/Service/Process Development  


The Critical ISO 13485 Capabilities And Their Priorities: 

  • Priority - Must Have # 
  • Priority - Should Have #
  • Priority - Ought to Have # 
  • Priority - Might Have # 
  • Priority - Could Have #
ISO 13485 Critical Capabilities

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Author Details

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Gerard Blokdijk

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