What Is ISO 9001?
It's the international (ISO) Standard for a quality management system.
This Standard sets out requirements for a quality management system. It is intended for use by any organisation, whether a business, nonprofit, government agency or other, that wants to:
- demonstrate that it can consistently provide products/services that meet customer requirements + any applicable statutory or regulatory ones
- enhance the satisfaction of customers.
Note the use of the word demonstrate. Anyone can use this Standard and get value from it, but if you want to get ISO 9001 certification you must satisfy an accredited certifier that you meet all the requirements.
The full title of the document is ISO 9001 Quality Management System - Requirements but it's usually shortened, and most commonly simply known as ISO 9001.
The ISO 9001 Standard is the most widely known and internationally accepted model for a quality management system, used by organisations across the globe for some highly effective quality systems. There are ISO 9001 certified systems in over 175 countries and economies. And the service side has been increasing: now around 40% of those certificates are for organisations that provide services (rather than manufacturing).
What's in 9001?
Basically, it consists of a set of requirements for managing quality. The requirements are neither arcane nor impossible. In general, they are sheer good business sense, as agreed by a group of people drawn from across the world.
In a Standard, a requirement is something you must do or have. Examples of requirements in ISO 9001 include:
- you must know what your customers want; if something's unclear, you must clarify it with them
- you need to have processes to get the results you want
- you must suitably manage and improve your processes
- your people must be competent for the work they do
- you need to regularly review performance of your processes, products and services, using suitable data
- when something goes wrong, you need to consider why, and take appropriate action.
See ISO 9001 in a nutshell for a summary of requirements.
Most Standards are very specific: 9001 isn't. All its requirements are generic, which means they can be applied to any organization, regardless of type, size or whether in a private or public sector.
ISO 9000 documents
ISO 9001 is one of the 'ISO 9000' family of documents. There are three in all.
- ISO 9000 sets out the fundamentals and vocabulary used in quality management (warning: very dry reading!)
- ISO 9001 is the Standard setting out requirements for a quality management system; you can only get certification to this Standard (if you choose certification)
- ISO 9004 goes beyond 9001 with a focus on making your quality management system more efficient and effective; well worth reading once you've got ISO 9001. It is not an auditable Standard, meaning you cannot be audited to it, and thus cannot get certified to it.
Author: Jane Bennett