ISO 9001:2015 for Small Enterprises What to do? - Advice from ISO/TC 176
Abstract
This handbook gives guidance to small enterprises on developing and implementing a quality management system, based on the International Standard ISO 9001:2015 "Quality management systems - Requirements". The requirements of ISO 9001 are generic and are intended to be applicable to all organizations, regardless of their type, size, or the products and services they provide.
This edition of this handbook refers to "enterprises", which is consistent with the recognized concept of "small and medium enterprises" (SMEs) and is more appropriate for not-for-profit organizations, rather than referring to "businesses" (consistent with the concept of "small businesses") as in previous editions of this handbook.
ISO 9000:2015 "Quality management systems - Fundamentals and vocabulary, defines the term" organization as a "person or group of people that has its own functions with responsibilities, authorities, and relationships to achieve its objectives".
In practice, any small or medium enterprise (or business) is an organization. These types of enterprises do not normally see themselves as an "organization" and often perceive an organization to be something bigger.
The term "enterprises" includes organizations providing products and services, either for profit or not-for-profit, such as manufacturers, distributors, schools, law firms, financial institutions, foundations, public hospitals or local governments.
This handbook is divided up into a number of sections that can be read and used separately, and that can be referred to as the need arises.