The International Standards Organisation (ISO) can trace its roots back to Word War II. It grew in response to a demand for better safety standards in factories that developed explosive devices – many of which prematurely detonated due to manufacturers not following an approved production process. The introduction of the ISO 9000 standard (or BS5750 as it was then known) meant businesses had to adhere to strict production procedures.
The ISO 9001 standard was formally introduced in 1987, although it takes much of it essence from a previous incarnation of UK quality management standards – the BS5750. As the British services industry grew in the mid 20th century, companies increasingly complained about the BS5750, reasoning that it was geared too specifically to manufacturing businesses and was a poor fit for anything else.
1987 saw the birth of the ISO 9001 which was intended to rectify these issues and provide a universal framework for quality management. Although the ISO 9001 standard is designed to be industry and product-independent, the fast-paced evolution of the business world has inevitably led to the need for updates and revisions.
The 1994 Revision
In 1994, the ISO 9001 standard was reformulated. The intention was to shift the focus of the standard to quality management systems that checked and monitored the product at every stage in the production process, rather than just evaluating the finished product. The main thrust of the revision was to shift quality management from ‘cure’ to ‘prevention’.
More Change in 2000
The ISO 9001 was revised again in 2000. This time, the goal was to streamline the procedures and documentation, so that businesses would be less likely to become bogged down with quality control processes if they didn’t actually create new products. It also aimed to make quality control an integrated goal for the company, connecting it from upper management right down through the company hierarchy.
ISO 9001 in 2008
ISO 9001 received a new revision in 2008. Compared to previous changes, the revisions were minor, and were largely aimed at better explaining existing aspects of the standard, and furthering the consistency with other ISO standards especially with regard to legal compliance.
The latest change – to 2015
The most recent change has seen some dramatic changes in the requirements of this standard. Gone are the requirements for the mandatory written procedures, with a new requirement for processes now bought into effect. These are now also dependent on risks, opportunities and the scope and context of an organisation, so in simple terms no one system is the same with every organisation requiring more or less depending on the size and complexity of the work activities.
Communication is now also key, with the requirement for a quality representative removed the emphasis is now on everyone having a role to play in developing and maintaining the quality management system.
The standard is thought of as a continuous work-in-progress, and it’s continually updated and edited with input from various trade organisations and committees with quality management expertise from around the world. Businesses with ISO 9001 certification are also encouraged to give feedback to the International Standardization Organization, so that the standard can be incrementally improved and stay relevant as global business marches on.
ISO 9001 – What It Does and Does Not Do
ISO 9001 was designed, in part, to help businesses:
1. Understand the needs of their customers
2. Conduct competent root cause analysis
3. Prevent poor products from being used
4. Dispose of/deal with faulty products
5. Regularly audit its quality assurance processes