ISO 9001:2015 Handbook for Small and Medium-Sized Businesses

By Denise E. Robitaille

This handbook was developed to help small and medium-sized organizations better understand ISO 9001:2015. It is intended to facilitate implementation and improvement. The establishment, implementation, and maintenance of an ISO 9001–compliant quality management system (QMS) should allow the organization to experience multiple benefits beyond the achievement of certification. Organizations should also see improvements in the quality of products, customer satisfaction, and process effectiveness—all of which ultimately have a positive impact on the bottom line.

It is expected that some readers will have already established a QMS. This handbook will serve to reinforce good practices and will help you better understand the intent and value of some of the requirements of ISO 9001. Since the handbook is especially focused on small and medium-sized organizations, the examples that are provided will have greater applicability and will enhance comprehension, again resulting in increased value.

Implementing a QMS in a small organization is not easier or harder than it is in a large one. Resources are different; each organization has its own unique challenges, constraints, and advantages. The thing to always bear in mind is that this is your organization and these are your processes.

ISO 9001:2015 defines the requirements, but it does not dictate the method of application. Utilizing this handbook should allow you to develop or rejuvenate your QMS so that it is a benefit to both you and your customer.

• Language: English
• Publisher: ASQ Quality Press
• Release date: Sep 17, 2015
• ISBN: 9780873898270

Book preview

ISO 9001:2015 Handbook for Small and Medium-Sized Businesses

Third Edition

Denise E. Robitaille

ASQ Quality Press

Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee 53203

© 2016 by ASQ

All rights reserved.

Library of Congress Cataloging-in-Publication Data

Names: Robitaille, Denise E., author. | Robitaille, Denise E. ISO 9001:2008

for small and medium-sized businesses.

Title: ISO 9001:2015 handbook for small and medium-sized businesses / Denise

E. Robitaille.

Description: Third edition. | Milwaukee, Wisconsin : ASQ Quality Press,

[2016] | Prev. ed. had title: ISO 9001:2008 for small and medium-sized

businesses. | Includes index.

Identifiers: LCCN 2016001424 | ISBN 9780873899055 (hardcover : alk. paper)

Subjects: LCSH: ISO 9001 Standard. | Quality assurance. | Quality control.

Classification: LCC TS156.6 .R64 2016 | DDC 658.4/013—dc23

LC record available at http://lccn.loc.gov/2016001424

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Introduction

This handbook was developed to help small and medium-sized organizations better understand ISO 9001:2015. It is intended to facilitate implementation and improvement. The establishment, implementation, and maintenance of an ISO 9001–compliant quality management system (QMS) should allow the organization to experience multiple benefits beyond the achievement of certification. Organizations should also see improvements in the quality of products, customer satisfaction, and process effectiveness—all of which ultimately have a positive impact on the bottom line.

It is expected that some readers will have already established a QMS. This handbook will serve to reinforce good practices and will help you better understand the intent and value of some of the requirements of ISO 9001. Since the handbook is especially focused on small and medium-sized organizations, the examples that are provided will have greater applicability and will enhance comprehension, again resulting in increased value.

Many organizations have also implemented sector-specific standards that are based on ISO 9001. Examples of QMS standards based on ISO 9001 include AS9100 (for aviation, space, and defense), ISO/TS 16949 (for automotive), ISO 13485 (for medical devices), and ISO 17025 (for laboratory accreditation). This handbook should be equally useful to those organizations in understanding the requirements that are common to all of these standards.

Terminology is discussed in Chapter 2. However, there are three terms that bear particular note and their use should be clarified from the onset.

The words product and service are intended to mean the output of a series of processes that is delivered to a customer. In general, we use product for a tangible product delivered to a customer and service for something that is intangible. Some examples of service might include transportation, training, after-market servicing of a sold product, financial portfolio management, or healthcare. In some cases an organization might provide both products and services. For example, it might manufacture a piece of equipment and then install and maintain it.

There has been an explosion in the number of organizations providing service-type products that are required to conform to international QMS standards. For the sake of efficiency and brevity, in this handbook, an effort is made to standardize the use of the word product to encompass both products and services. However, where it provides greater clarity, the word service is used.

The other word that bears special consideration is organization. ISO 9001’s diversification has resulted in a proliferation of certifications among nonprofit, educational, and governmental entities. Hence, the generic use of organization is universally applicable. At times the term business or enterprise may be substituted.

Finally, one of the great characteristics of organizations is their variety. Products, processes, markets, internal cultures, size, assets, and constraints all contribute to the tableau that is your unique organization. Your QMS must reflect your organization. It should be reflective of your relationship with your customers and your commitment to fulfilling their requirements. There is no cookie-cutter QMS. ISO 9001:2015 defines the requirements, but it does not dictate the method of application. Utilizing this handbook should allow you to develop or rejuvenate your QMS so that it is a benefit to both you and your customer.

Table of Contents

Introduction

Chapter 1

What Is ISO 9001?

Why 9001?

A Few Words about Certification Bodies

Getting Going

Chapter 2

Overview of Your Quality Management System

The Quality Management Principles

Chapter 3

ISO 9001:2015—An Overview

Section 1: Scope

Section 2: Normative References

Section 3: Terms and Definitions

Section 4: Quality Management System

Section 5: Leadership

Section 6: Planning

Section 7: Support

Section 8: Operation

Section 9: Performance Evaluation

Section 10: Improvement

Chapter 4

ISO 9001:2015 Introduction

0.1 General

0.2 Quality Management Principles

0.3 Process Approach

0.4 Relationship with Other Management System Standards

Chapter 5

ISO 9001:2015 Sections 1, 2, and 3

Section 1: Scope

Section 2: Normative Reference

Section 3: Terms and Definitions

Chapter 6

ISO 9001:2015 Section 4

8.3: Design and Development of Products and Services

8.5.2: Identification and Traceability

8.5.3: Property Belonging to Customers or External Providers

Chapter 7

ISO 9001:2015 Section 5

5.1 Leadership and Commitment

5.2 Policy

5.3 Organizational Roles, Responsibilities and Authorities

Chapter 8

ISO 9001:2015 Section 6

6.1 Actions to Address Risks and Opportunities

6.2 Quality Objectives and Planning to Achieve Them

6.3 Planning of Changes

Chapter 9

ISO 9001:2015 Section 7

7.1.2 People

7.1.3 Infrastructure

7.1.4 Environment for the Operation of Processes

7.1.5 Monitoring and Measuring Resources

7.1.6 Organizational Knowledge

7.2 Competence, 7.3 Awareness, 7.4 Communication

7.5 Documented Information

Chapter 10

ISO 9001:2015 Section 8

8.1 Operational Planning and Control

8.2 Requirements for Products and Services

8.3 Design and Development of Products and Services

8.4 Control of Externally Provided Processes, Products and Services

8.5 Production and Service Provision

8.6 Release of Products and Services

8.7 Control of Nonconforming Outputs

Chapter 11

ISO 9001:2015 Section 9

9.1 Monitoring, Measuring, Analysis and Evaluation

Chapter 12

ISO 9001:2015 Section 10

1

What Is ISO 9001?

ISO 9001 is an international standard that defines the requirements for establishing a system to manage your organization and processes to better serve your customers.

This standard does not reinvent your company, nor is the process for implementation difficult. It’s a logical methodology based on how you run your business. It brings consistency and control to everyday practices. The basic philosophy is Do what you say and say what you do. Further, it augments the effectiveness of processes by providing requirements that help you monitor and analyze key performance indicators for maintenance and improvement. Additionally, it provides a framework for identifying and addressing risk and taking appropriate action to mitigate, eliminate, share, or otherwise deal with risk.

Over 1 million organizations around the globe are certified to ISO 9001. The standard has been in place for over 25 years. Companies utilizing this international standard come from varied fields and industries. Over the years the diversity of organizations that have selected ISO 9001 as the model for their QMS has expanded significantly and now encompasses finance, healthcare, service, software development, and governmental agencies—just to name a few.

The title of this book inclines us to think that it is focused only on for-profit enterprises. Although, for convenience, the terms business and company are used interchangeably with organization frequently throughout the book, the intent is that it refers to all organizations. What they all have in common is what we refer to as the business of the organization—the things we do to get things done and bring our products (and services) to our customers. Customer is defined in ISO 9000:2015 as the person or organization that could or does receive a product or a service that is intended for or required by this person or organization. As you can see, profit versus nonprofit is not factored into the definition.

Companies as small as one person have been certified—which leads to our next question: What do we mean by small and medium-sized?

Traditionally, companies with fewer than 50 employees have been considered small, whereas those with up to 500 employees are considered medium-sized. There is no precise definition, no exact number. For example, an organization can have 90 people, but if 80 of them perform the same routine tasks and top management is encompassed by only two individuals, it might be considered a small business. Conversely, with the advent of virtual technology, a medium- to large-sized software company could easily have fewer than 50 employees. The multiplicity and intricacy of processes, assets, tiers of middle management, use of subcontractors, and complexity of the product also contribute to the determination of small versus medium-sized. The determining criteria vary. Some people base their concept of size on head count, while others use annual revenue. Financial institutions and agencies such as the US Small Business Administration (SBA) have specific criteria