Quality Management Iso9001:2015 Changes: A Guide to Implementation
By David Hewitt
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About this ebook
So I invite you to have a look through this handbook and use the templates and models offered to build or enhance your quality management system.
These ideas are my interpretation only and do not constitute a compliant system. That can only happen by the individuals use and customization of the tools described in this handbook.
David Hewitt
David Hewitt is a writer and a lawyer, and he lives by the sea, half-way between a Dominion and an Orion.
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Quality Management Iso9001:2015 Changes - David Hewitt
Copyright © 2016 by David Hewitt. 748988
ISBN: Softcover 978-1-5245-9447-3
EBook 978-1-5245-9448-0
All rights reserved. No part of this book may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system, without permission in writing from the copyright owner.
Rev. date: 09/19/2016
Xlibris
0800-056-3182
www.xlibrispublishing.co.uk
QUALITY
MANAGEMENT ISO9001:2015
CHANGES
A GUIDE TO IMPLEMENTATION
DAVID HEWITT
Contents
Forward and Structure
Quality management system requirements
Interested parties and scope
Quality management system and processes
Leadership
Communication and Customer focus
Contract review
Policy and planning
Objectives
Support
Monitoring and measuring resources
Organisational knowledge and Awareness
Documented information
Operation
Customer communication and feedback
Customer survey
Design and development of products and services
Control of externally provided products and services
Production and service provision
Identification and traceability
Customer property, preservation and post delivery
Change control, release of product and service
Non-conforming outputs
Performance evaluation
Analysis and evaluation, Internal Audit
Management review
Improvement, corrective action
Quality tools and techniques
Continual improvement
Appendix 1 Quality Manual option 1
Appendix 2 Quality Manual option 2
Appendix 3 Practical guide to flow diagrams
Forward
The recent issue of the revised International Standard has introduced new thinking into the text of the document. Companies who are embarking on accreditation for the first time should embrace these requirements as they design their Quality Management Systems but companies who have already achieved the 2008 version have until 2018 to convert their systems to the 2015 version of ISO9001.
New companies coming on board
after this date would use this document to assist in their application of systems and documents.
This handbook will guide you through the various paragraphs of the standard and offer my interpretation of models and templates to work with and to embed into your new Quality Management System. If you have an integrated system with the Environmental Standard (ISO14001) there is some read-across to interpretation but this handbook does not address all the Environmental considerations.
So I invite you to have a look through this handbook and use the templates and models offered to build or enhance your Quality Management System.
These ideas are my interpretation only and do not constitute a compliant system. That can only happen by the individuals use and customisation of these tools described in this handbook.
Aragon Consulting Services can therefore take no responsibility for any user failing to achieve the requisite standards for accreditation.
Structure
The structure and benefits of a strong Quality Management System are well documented within the ISO9001:2015 standard itself so I don’t want to repeat these words. Just to say that the interpretation of International Standards, in my experience, is both varied and detailed especially for the small to medium companies. Sometimes it creates more problems and opens up more issues that the external auditor can examine and may decide to dig down
into process areas that are not yet ready for that sort of examination.
So the structure of this handbook will take the reader through each section of the standard and offer my thoughts and interpretations together with some ideas, processes, templates etc. to help navigate through the structure of the standard and to use in their design of a documented Quality Management System.
Aragon Consulting Services has always offered a simple, pragmatic, common sense approach to the implementation and maintenance of a Quality Management System and as the author of this handbook, I see no reason to change my thought pattern.
ISO9001:2015 employs a process approach incorporating the Plan/Do/Check /Act cycle (PDCA). It also tells us to adopt more of a risk-based thinking
attitude to how our processes interface and react with each other.
We should also be knowledgeable of drawing out our business process flowchart at maybe level 1 and