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    ISO 17025 A Complete Guide - 2020 Edition
    ISO 17025 A Complete Guide - 2020 Edition
    ISO 17025 A Complete Guide - 2020 Edition
    Ebook213 pages1 hour

    ISO 17025 A Complete Guide - 2020 Edition

    By Gerardus Blokdyk

    ()

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    About this ebook

    What about medical device measurement? Have there been any significant changes in regulatory/accreditation requirements in relation to data analysis? Do the quality records include reports from internal audits and management reviews as well as records of corrective and preventive actions? Have you establish a schedule for quality system review? Is the software version controlled?

    This exclusive ISO 17025 self-assessment will make you the entrusted ISO 17025 domain visionary by revealing just what you need to know to be fluent and ready for any ISO 17025 challenge.

    How do I reduce the effort in the ISO 17025 work to be done to get problems solved? How can I ensure that plans of action include every ISO 17025 task and that every ISO 17025 outcome is in place? How will I save time investigating strategic and tactical options and ensuring ISO 17025 costs are low? How can I deliver tailored ISO 17025 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 17025 essentials are covered, from every angle: the ISO 17025 self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that ISO 17025 outcomes are achieved.

    Contains extensive criteria grounded in past and current successful projects and activities by experienced ISO 17025 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 17025 are maximized with professional results.

    Your purchase includes access details to the ISO 17025 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. 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 17025 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.

    LanguageEnglish
    Publisher5STARCooks
    Release dateMar 1, 2020
    ISBN9781867389330
    ISO 17025 A Complete Guide - 2020 Edition

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      Book preview

      ISO 17025 A Complete Guide - 2020 Edition - Gerardus Blokdyk

      ISO 17025

      Complete Self-Assessment Guide

      The guidance in this Self-Assessment is based on ISO 17025 best practices and standards in business process architecture, design and quality management. The guidance is also based on the professional judgment of the individual collaborators listed in the Acknowledgments.

      Notice of rights

      You are licensed to use the Self-Assessment contents in your presentations and materials for internal use and customers without asking us - we are here to help.

      All rights reserved for the book itself: this book may not be reproduced or transmitted in any form by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.

      The information in this book is distributed on an As Is basis without warranty. While every precaution has been taken in the preparation of he book, neither the author nor the publisher shall have any liability to any person or entity with respect to any loss or damage caused or alleged to be caused directly or indirectly by the instructions contained in this book or by the products described in it.

      Trademarks

      Many of the designations used by manufacturers and sellers to distinguish their products are claimed as trademarks. Where those designations appear in this book, and the publisher was aware of a trademark claim, the designations appear as requested by the owner of the trademark. All other product names and services identified throughout this book are used in editorial fashion only and for the benefit of such companies with no intention of infringement of the trademark. No such use, or the use of any trade name, is intended to convey endorsement or other affiliation with this book.

      Copyright © by The Art of Service

      http://theartofservice.com

      service@theartofservice.com

      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

      Included Resources - how to access

      Included with your purchase of the book is the ISO 17025 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.

      How? Simply send an email to

      access@theartofservice.com

      with this books’ title in the subject to get the ISO 17025 Self Assessment Tool right away.

      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, and...

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

      •In-depth specific Checklists covering the topic

      •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.

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

      Send an email to access@theartofservice.com with this books’ title in the subject to get the ISO 17025 Self Assessment Tool right away.

      Purpose of this Self-Assessment

      This Self-Assessment has been developed to improve understanding of the requirements and elements of ISO 17025, 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 17025 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 with limited background knowledge of ISO 17025, a manager can quickly review existing operations to determine how they measure up to the standards. This in turn can serve as the starting point of a ‘gap analysis’ to identify management tools or system elements that might usefully be implemented in the organization to help improve overall performance.

      How to use the Self-Assessment

      On the following pages are a series of questions to identify to what extent your ISO 17025 initiative is complete in comparison to the requirements set in standards.

      To facilitate answering the questions, there is a space in front of each question to enter a score on a scale of ‘1’ to ‘5’.

      1 Strongly Disagree

      2 Disagree

      3 Neutral

      4 Agree

      5 Strongly Agree

      Read the question and rate it with the following in front of mind:

      ‘In my belief,

      the answer to this question is clearly defined’.

      There are two ways in which you can choose to interpret this statement;

      1.how aware are you that the answer to the question is clearly defined

      2.for more in-depth analysis you can choose to gather evidence and confirm the answer to the question. This obviously will take more time, most Self-Assessment users opt for the first way to interpret the question and dig deeper later on based on the outcome of the overall Self-Assessment.

      A score of ‘1’ would mean that the answer is not clear at all, where a ‘5’ would mean the answer is crystal clear and defined. Leave emtpy when the question is not applicable or you don’t want to answer it, you can skip it without affecting your score. Write your score in the space provided.

      After you have responded to all the appropriate statements in each section, compute your average score for that section, using the formula provided, and round to the nearest tenth. Then transfer to the corresponding spoke in the ISO 17025 Scorecard on the second next page of the Self-Assessment.

      Your completed ISO 17025 Scorecard will give you a clear presentation of which ISO 17025 areas need attention.

      ISO 17025

      Scorecard Example

      Example of how the finalized Scorecard can look like:

      ISO 17025

      Scorecard

      Your Scores:

      BEGINNING OF THE

      SELF-ASSESSMENT:

      Table of Contents

      About The Art of Service7

      Included Resources - how to access7

      Purpose of this Self-Assessment9

      How to use the Self-Assessment10

      ISO 17025

      Scorecard Example12

      ISO 17025

      Scorecard13

      BEGINNING OF THE

      SELF-ASSESSMENT:14

      CRITERION #1: RECOGNIZE15

      CRITERION #2: DEFINE:26

      CRITERION #3: MEASURE:41

      CRITERION #4: ANALYZE:55

      CRITERION #5: IMPROVE:71

      CRITERION #6: CONTROL:87

      CRITERION #7: SUSTAIN:101

      ISO 17025 and Managing Projects, Criteria for Project Managers:127

      1.0 Initiating Process Group: ISO 17025128

      1.1 Project Charter: ISO 17025130

      1.2 Stakeholder Register: ISO 17025132

      1.3 Stakeholder Analysis Matrix: ISO 17025133

      2.0 Planning Process Group: ISO 17025135

      2.1 Project Management Plan: ISO 17025137

      2.2 Scope Management Plan: ISO 17025139

      2.3 Requirements Management Plan: ISO 17025141

      2.4 Requirements Documentation: ISO 17025143

      2.5 Requirements Traceability Matrix: ISO 17025145

      2.6 Project Scope Statement: ISO 17025147

      2.7 Assumption and Constraint Log: ISO 17025149

      2.8 Work Breakdown Structure: ISO 17025151

      2.9 WBS Dictionary: ISO 17025153

      2.10 Schedule Management Plan: ISO 17025156

      2.11 Activity List: ISO 17025158

      2.12 Activity Attributes: ISO 17025160

      2.13 Milestone List: ISO 17025162

      2.14 Network Diagram: ISO 17025164

      2.15 Activity Resource Requirements: ISO 17025166

      2.16 Resource Breakdown Structure: ISO 17025167

      2.17 Activity Duration Estimates: ISO 17025169

      2.18 Duration Estimating Worksheet: ISO 17025171

      2.19 Project Schedule: ISO 17025173

      2.20 Cost Management Plan: ISO 17025175

      2.21 Activity Cost Estimates: ISO 17025177

      2.22 Cost Estimating Worksheet: ISO 17025179

      2.23 Cost Baseline: ISO 17025181

      2.24 Quality Management Plan: ISO 17025183

      2.25 Quality Metrics: ISO 17025185

      2.26 Process Improvement Plan: ISO 17025187

      2.27 Responsibility Assignment Matrix: ISO 17025189

      2.28 Roles and Responsibilities: ISO 17025191

      2.29 Human Resource Management

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