Who is ISO, and what is ISO 9001?

ISO is the International Organisation for Standardization, and is an international standard-setting body composed of representatives from 164 national standards organisations (with the British Standards Institute, or BSI, being the British organisation represented).  Founded in 1947, it’s aims were to create international standards to help countries and companies work together effectively. 

Their very first standard related to a standard temperature of an object when measuring it’s dimensions (which sounds a little boring, but if you think about it … the hotter a solid object is, the larger it becomes … so without a standard temperature the same object would have different dimensions at different temperatures despite being the same object, causing inconsistent measurements on different days).

Today, they publish over 22,000 different standards, ranging from documents like ISO 4217 that specifies international Currency Codes (like GBP for Pound Sterling, USD for United States Dollar, etc.) to documents like ISO 24113 that specifies how any object headed for space should mitigate the risk of damage from Space Debris.  Without such standards like these, and many others, international collaboration on projects like the International Space Station would be significantly harder and more expensive.

ISO 9001

The standard we’ve discussed earlier is ISO 9001, which documents the requirements for Quality Management Systems.  For a QMS to be ISO 9001-compliant, it must meet or exceed all the requirements in the standard.

ISO 9001 lists its requirements in many areas, including:

• How the Leadership of the organisation focuses on customers and the effectiveness of the QMS
• The Planning steps taken to design an effective QMS
• How the key Resources are identified and provided (resources such as people, infrastructure, environment, knowledge, monitoring, etc.)
• How competence of staff is defined and monitored, including how gaps are addressed
• How the aims and effectiveness of the QMS are communicated to stakeholders
• How the Design and Development stages are planned to focus on quality delivery
• How the goods/services are Produced and Provided to customers
• How the organisation evaluates the Performance of the QMS and the components within it
• The scheduled Audits that take place to ensure people are complying with the stages within the QMS
• How Management review the QMS performance, including identifying any changes necessary to maintain its relevance within the organisation
• How the organisation used the data it gathers to drive Continuous Improvement within the QMS

As you can now see, the QMS is a significantly larger piece of work to produce and, unlike a Quality Plan, has a heavy focus on actual performance and effectiveness of the QMS in action.