Quality Management Iso9001:2015 Changes: A Guide to Implementation

Copyright © 2016 by David Hewitt. 748988

ISBN:   Softcover       978-1-5245-9447-3

             EBook           978-1-5245-9448-0

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Rev. date: 09/19/2016

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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