ISO 13485 A Complete Guide - 2020 Edition

Do you report corrections, corrective actions, and verification results? Did management ensure that an adequate and effective Quality System has been established? What sub-systems and components go into your medical device? How do you ensure your OEM suppliers are conforming to standards and regulatory requirements? Are design output content, format and design output approval methods defined in a revision controlled procedure?



Defining, designing, creating, and implementing a process to solve a challenge or meet an objective is the most valuable role… In EVERY group, company, organization and department.



Unless you are talking a one-time, single-use project, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'



This Self-Assessment empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make ISO 13485 investments work better.



This ISO 13485 All-Inclusive Self-Assessment enables You to be that person.



All the tools you need to an in-depth ISO 13485 Self-Assessment. Featuring 2204 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.



In using the questions you will be better able to:



- diagnose ISO 13485 projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices



- implement evidence-based best practice strategies aligned with overall goals



- integrate recent advances in ISO 13485 and process design strategies into practice according to best practice guidelines



Using a Self-Assessment tool known as the ISO 13485 Scorecard, you will develop a clear picture of which ISO 13485 areas need attention.



Your purchase includes access details to the ISO 13485 self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next. You will receive the following contents with New and Updated specific criteria:



- The latest quick edition of the book in PDF



- The latest complete edition of the book in PDF, which criteria correspond to the criteria in...



- The Self-Assessment Excel Dashboard



- Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation



- In-depth and specific ISO 13485 Checklists



- Project management checklists and templates to assist with implementation



INCLUDES LIFETIME SELF ASSESSMENT UPDATES



Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.