ISO 13485 A Complete Guide - 2020 Edition
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About this ebook
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.
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ISO 13485 A Complete Guide - 2020 Edition - Gerardus Blokdyk
ISO 13485
Complete Self-Assessment Guide
The guidance in this Self-Assessment is based on ISO 13485 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 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.
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.
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 13485 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 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 with limited background knowledge of ISO 13485, 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 13485 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 13485 Scorecard on the second next page of the Self-Assessment.
Your completed ISO 13485 Scorecard will give you a clear presentation of which ISO 13485 areas need attention.
ISO 13485
Scorecard Example
Example of how the finalized Scorecard can look like:
ISO 13485
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 13485
Scorecard Example12
ISO 13485
Scorecard13
BEGINNING OF THE
SELF-ASSESSMENT:14
CRITERION #1: RECOGNIZE15
CRITERION #2: DEFINE:24
CRITERION #3: MEASURE:41
CRITERION #4: ANALYZE:50
CRITERION #5: IMPROVE:66
CRITERION #6: CONTROL:82
CRITERION #7: SUSTAIN:99
ISO 13485 and Managing Projects, Criteria for Project Managers:137
1.0 Initiating Process Group: ISO 13485138
1.1 Project Charter: ISO 13485140
1.2 Stakeholder Register: ISO 13485142
1.3 Stakeholder Analysis Matrix: ISO 13485143
2.0 Planning Process Group: ISO 13485145
2.1 Project Management Plan: ISO 13485147
2.2 Scope Management Plan: ISO 13485149
2.3 Requirements Management Plan: ISO 13485151
2.4 Requirements Documentation: ISO 13485153
2.5 Requirements Traceability Matrix: ISO 13485155
2.6 Project Scope Statement: ISO 13485157
2.7 Assumption and Constraint Log: ISO 13485159
2.8 Work Breakdown Structure: ISO 13485161
2.9 WBS Dictionary: ISO 13485163
2.10 Schedule Management Plan: ISO 13485165
2.11 Activity List: ISO 13485167
2.12 Activity Attributes: ISO 13485169
2.13 Milestone List: ISO 13485171
2.14 Network Diagram: ISO 13485173
2.15 Activity Resource Requirements: ISO 13485175
2.16 Resource Breakdown Structure: ISO 13485176
2.17 Activity Duration Estimates: ISO 13485178
2.18 Duration Estimating Worksheet: ISO 13485180
2.19 Project Schedule: ISO 13485182
2.20 Cost Management Plan: ISO 13485184
2.21 Activity Cost Estimates: ISO 13485186
2.22 Cost Estimating Worksheet: ISO 13485188
2.23 Cost Baseline: ISO 13485190
2.24 Quality Management Plan: ISO 13485192
2.25 Quality Metrics: ISO 13485194
2.26 Process Improvement Plan: ISO 13485196
2.27 Responsibility Assignment Matrix: ISO 13485198
2.28 Roles and Responsibilities: ISO 13485200
2.29 Human Resource Management Plan: ISO 13485202
2.30 Communications Management Plan: ISO 13485204
2.31 Risk Management Plan: ISO 13485206