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    ISO 13485 Second Edition
    ISO 13485 Second Edition
    ISO 13485 Second Edition
    Ebook87 pages1 hour

    ISO 13485 Second Edition

    By Gerardus Blokdyk

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    About this ebook

    in other words, can we track that any ISO 13485 project is implemented as planned, and is it working? Which individuals, teams or departments will be involved in ISO 13485? How do you assess your ISO 13485 workforce capability and capacity needs, including skills, competencies, and staffing levels? How can we incorporate support to ensure safe and effective use of ISO 13485 into the services that we provide? How can you measure ISO 13485 in a systematic way?

    This premium ISO 13485 self-assessment will make you the credible ISO 13485 domain veteran by revealing just what you need to know to be fluent and ready for any ISO 13485 challenge.

    How do I reduce the effort in the ISO 13485 work to be done to get problems solved? How can I ensure that plans of action include every ISO 13485 task and that every ISO 13485 outcome is in place? How will I save time investigating strategic and tactical options and ensuring ISO 13485 costs are low? How can I deliver tailored ISO 13485 advice instantly with structured going-forward plans?

    There’s no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all ISO 13485 essentials are covered, from every angle: the ISO 13485 self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that ISO 13485 outcomes are achieved.

    Contains extensive criteria grounded in past and current successful projects and activities by experienced ISO 13485 practitioners. Their mastery, combined with the easy elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in ISO 13485 are maximized with professional results.

    Your purchase includes access details to the ISO 13485 self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows you exactly what to do next. Your exclusive instant access details can be found in your book.

    LanguageEnglish
    Publisher5STARCooks
    Release dateApr 13, 2018
    ISBN9780655128748
    ISO 13485 Second Edition

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    • 4/5
      Interesting! Seems relevant even if some of the questions might feel redundant.

    Book preview

    ISO 13485 Second Edition - Gerardus Blokdyk

    About The Art of Service

    The Art of Service, Business Process Architects since 2000, is dedicated to helping stakeholders achieve excellence.

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

    Unless you’re 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?’

    With The Art of Service’s Standard Requirements Self-Assessments, we empower people who can do just that — whether their title is marketer, entrepreneur, manager, salesperson, consultant, Business Process Manager, executive assistant, IT Manager, CIO etc... —they are the people who rule the future. They are people who watch the process as it happens, and ask the right questions to make the process work better.

    Contact us when you need any support with this Self-Assessment and any help with templates, blue-prints and examples of standard documents you might need:

    http://theartofservice.com

    service@theartofservice.com

    Acknowledgments

    This checklist was developed under the auspices of The Art of Service, chaired by Gerardus Blokdyk.

    Representatives from several client companies participated in the preparation of this Self-Assessment.

    Our deepest gratitude goes out to Matt Champagne, Ph.D. Surveys Expert, for his invaluable help and advise in structuring the Self Assessment.

    Mr Champagne can be contacted at

    http://matthewchampagne.com/

    In addition, we are thankful for the design and printing services provided.

    Included Resources - how to access

    Included with your purchase of the book is the ISO 13485 Self-Assessment Spreadsheet Dashboard which contains all questions and Self-Assessment areas and auto-generates insights, graphs, and project RACI planning - all with examples to get you started right away.

    Get it now- you will be glad you did - do it now, before you forget.

    How? Simply send an email to access@theartofservice.com with this books’ title in the subject to get the ISO 13485 Self Assessment Tool right away.

    Your feedback is invaluable to us

    If you recently bought this book, we would love to hear from you!

    You can do this by writing a review on amazon (or the online store where you purchased this book) about your last purchase! As part of our continual service improvement process, we love to hear real client experiences and feedback.

    How does it work?

    To post a review on Amazon, just log in to your account and click on the Create Your Own Review button (under Customer Reviews) of the relevant product page. You can find examples of product reviews in Amazon. If you purchased from another online store, simply follow their procedures.

    What happens when I submit my review?

    Once you have submitted your review, send us an email at

    review@theartofservice.com with the link to your review so we can properly thank you for your feedback.

    Purpose of this Self-Assessment

    This Self-Assessment has been developed to improve understanding of the requirements and elements of ISO 13485, based on best practices and standards in business process architecture, design and quality management.

    It is designed to allow for a rapid Self-Assessment to determine how closely existing management practices and procedures correspond to the elements of the Self-Assessment.

    The criteria of requirements and elements of ISO 13485 have been rephrased in the format of a Self-Assessment questionnaire, with a seven-criterion scoring system, as explained in this document.

    In this format, even

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