Introduction

The intent of this field guide is to assist organizations, step by step, in implementing a QMS in conformance with ISO 9001:2015, whether “from scratch” or by transitioning from ISO 9001:2008. Within the guide each sub-clause containing requirements is the focus of a two-page spread that consistently presents features that fulfill the requirements listed below. This book examines each sub-clause of clauses 4–10 of ISO 9001:2015, which contain the requirements, with a visual representation provided in flowchart format on the facing page.

Purpose and Features

This field guide will:

• Provide a user-friendly guide to ISO 9001:2015’s requirements for implementation purposes
• Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 9001:2015 implementation
• Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists
• Direct management on what it must do and should consider to satisfy ISO 9001:2015’s enhanced requirements and responsibilities for top management
• Depict step by step what must occur to create an effective, conforming QMS

Unique Aspects

What separates this field guide from most other books on ISO 9001:2015 and its implementation are the flowcharts showing the steps to be taken in implementing a QMS to meet a sub-clause’s requirements. As the flowcharts themselves can be overwhelming when you first look at them, a text box appears with each flow chart that explains pertinent facts and/or what the flowchart represents and how it is to be used.