What is ISO 9001?

Klavs Henriksen, Lead Auditor at Alcumus ISOQAR, considers some of the basics of the international standard for Quality Management Systems.

3rd Sep 2018

Don’t make the mistake of thinking that ISO 9001 is a Quality Management System (QMS). It’s not.
 
As with all other ISO standards, ISO 9001 is just that - a ‘standard’. It’s an internationally agreed document that sets out the criteria against which a QMS is judged.
 
The standard allows organisations to be evaluated - and certified for conformance to it - by an independent certification body. It demonstrates to the organisation itself and its stakeholders the state of the system.
 

What it is not

As we’ve established, ISO 9001 is not a management system. It does not give users detailed instructions on how to do specific tasks. It will not in itself produce a product or deliver a service, but by implementing a management system based on the requirements, the organisation itself finds out how to ensure production or service delivery.
 

What does it contain?

The clauses in ISO 9001 set out the requirements for the organisation. The requirements describe the expectations of a system that is attuned to meeting customer requirements and to strive to exceed customer expectations. And after all, isn’t that a goal of every business?
 
The standard sets out to ensure that the organisation:
 

  • gives thought to what it wants to deliver
  • clearly defines the processes that ensure delivery 
  • learns from mistakes
 

We'll be looking at the detail of the requirements in future blogs.
 

Integration of standards

Such a system will also work well hand in hand with other systems implemented in the organisation such as Lean, Six Sigma, Balanced Score Card, EFQM.
 
More recently, several ISO standards have been introduced or updated to ensure that they integrate more neatly, eliminating duplication of effort in the maintenance of the standards, for example ISO 14001 (Environmental Management Systems) and ISO 27001 (Information Management) and ISO 45001, the replacement for OHSAS 18001 (Occupational Health and Safety).
 

World-wide recognition

As with all other standards from the International Organization for Standards (ISO), ISO 9001 is recognised all over the world. According to ISO, there are now over one million organisations in over 170 countries certified to ISO 9001.
 

Five reasons for working to ISO 9001

It’s not hard to make a case for implementing a Quality Management System that conforms to ISO 9001.
 

  • It provides tools for optimisation of processes, making them more effective and efficient
  • It’s a tool for continuous improvement
  • It enables a common language and approach to quality management across organisations and borders
  • It’s an effective tool in global trade
  • It can set you apart from the competition - in fact, it’s often a customer requirement: you may not be able to tender for contracts unless you are certified

 

Finally

There are many ways of setting up a QMS that conforms to ISO 9001. The nature of the organisation, as well as the challenges it faces, will naturally determine what system the organisation develops and how it implements it.
 
Many organisations choose to appoint an external consultant to help them develop their Quality Management System. You can search the ISOQAR Associate Network of consultants for a consultant near to you and with experience of implementing a QMS in other organisations in your sector.