Patrick Ambrose - ISO 9001:2015 Audit Guide and Checklist

Copyright 2016

Patrick Ambrose

Published by SystemsThinking.Works

Distributed by Smashwords

Second Edition

January 2016

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Table of Contents

Forward

Creation of this new guidebook and checklist was a result of many, many discussions with internal auditors, would be internal auditors and those responsible for the outcomes and value of internal audits. A common problem was the conflict between a desire to do process audits that are not driven by meaningless checklist questions, and the needs of auditors who often spend only a very small fraction of their time doing management system audits. It seemed that there was no getting away from some kind of resource that auditors could use to help them through their audits. Yet checklists had proven to be non-value added. The result is this book. The questions listed in this book are by definition a checklist, however the intent is that the questions will be used by the auditor, not asked of the auditee. The questions are those that the auditor must answer through the process of finding evidence. Then, based on the evidence they must determine the effectiveness of the system being audited. Many of the questions listed are ones that can be answered through observation. Many will be answered in conjunction with other information gathered during the audit. Other questions ask the auditor to make a value judgment. In this way it is hoped that auditors will have a guide, while enabling them to use a process approach when auditing. This book could not have been written without help, and I received a great deal of help from some very special people. My wife Patricia was my editor, proof reader, cheerleader and motivator. Without her constant support, I probably would not have finished this book. And, my son Devon reviewed it and did nearly all of the editing and software work. Devon is also knowledgeable and experienced in auditing management systems. He has a very sharp mind and I respect and appreciate his opinions.

And finally I would like to thank you, the user of this book. I sincerely hope you will use this book to provide your management with the information to achieve their goals and objectives, to effectively satisfy their customers expectations, and to provide their employees with a stable, interesting and exciting place to work.

Sincerely

Pat Ambrose

INTRODUCTION

There is an important consideration to make before choosing to use the checklist included in this Guidebook. You should carefully determine your objective with regard to your ISO 9001 Quality Management System. If what you are looking for is the easiest way to get ISO 9001 registered, or if your aim is to do the very minimum needed for conformance, this IS NOT the checklist for you. Every question included in this checklist is designed to promote best practice. The checklist is designed to provide value to organizations that have a desire to get their moneys worth and more out of their systems. The questions strive to provide a value added effective and efficient quality management system. This checklist will help your organization to satisfy your customers, provide added value to your customers and provide value to your stakeholders but at no time does it dwell on the minimum. The interpretations of the requirements and the questions it drives are designed at all times to help create a value added system. Certainly you have the right and I would expect that you will skip questions that you believe, have no value to your organization. I would also expect that you may modify questions or even add additional questions of your own. I welcome your participation in this. In addition to audit questions, this checklist provides guidance for auditors during the process. AP or (Audit Process) notes provide valuable direction as to how and when to take note of specific data that will become important further on in the audit. These notes are the result of many years of best practice audit experience. Also within the checklist are BP (Best Practice) questions which are there to help organizations that want all of the value possible from their systems. As you can see, this is not just an audit checklist. It was designed from the beginning to promote a high value, effective and efficient management system.

1.0 AN INTRODUCTION TO ISO 9001:2015

With this new International Standard, some of the clause structure and terminology in ISO 9001:2008, have been changed to improve alignment with other management systems standards.

Basic Changes

The adoption of the HLS ( standardized High Level Structure)

An explicit requirement for risk-based thinking to support and improve the understanding and application of the process approach.

Fewer prescribed requirements.

Less emphasis on documents.

Improved applicability for services.

A requirement to define the boundaries of the QMS.

Increased emphasis on organizational context. (Link between customer expectations, organizational objectives, the Quality Policy, process objectives and process measurement)

Increased leadership requirements. (Active Participation)

Greater emphasis on achieving desired outcomes to improve customer satisfaction. (Performance Measurement)

Major differences in terminology between ISO 9001:2008 and ISO 9001:2015

Products from 2008 has become Products and services. Exclusions are No longer used in 2015. Documentation, Records is now Documented Information. Work Environment has morphed into Environment for the operation of processes. Purchased Product is now externally provided products or services. Suppliers are now External Providers and Preventive Action is gone.

It is important to recognize that the changes in the structure and terminology do not need to be reflected in the documentation of an organizations quality management system. As in the 2008 version of the ISO 9001 standard, the structure of clauses is intended to provide a coherent presentation of requirements rather than a model for documenting an organizations QMS (Quality Management System). There is no requirement and no intention for the structure of an organization's quality management system documentation to mirror that of this International Standard.

There is also no requirement for the terms used in an organizations QMS to be replaced by the terms used in this International Standard. Organizations can choose to use terms which suit their operations. For example:

ISO 9001; 2015 could be

external providersupplier, 'partner or vendor

Management Review Monthly Operations Meeting

NonconformanceITBF Issue To Be Fixed