Today the Quality Standard ISO 9001:2008 stating Quality Management System Requirements has become a central focal point for the establishment and expansion of businesses across the entire world, according to management consultants, QA-Z Consulting Specialists .
The Standard has evolved from ISO 9000:1987 which had three models for quality management systems dependant on the scope of the organisation. These were ISO 9001, ISO 9002 and ISO 9003. The emphasis tended to be placed on conformance with procedures rather than the overall process of management.
This was followed by the introduction of ISO 9000:1994 that emphasised quality assurance via preventive actions, instead of checking the final product. The down-side was that companies tended to place large amounts of energy into creating telephone book sized procedures in order to implement their quality systems which meant they became burdened with their weighty compliance to record keeping and following of strict procedures.
This concentration on compliance meant that there was very little focus on customer service and improvement of the quality control management system. Some companies in adapting and improving processes could actually be impeded by their own quality system.
The good news is that in the year 2000 the Quality Standard was revolutionised to combine ISO 9001, ISO 9002 and ISO 9003 into one Standard that was a more user-friendly version using the approach of continuous improvements to the system and focusing on meeting customer requirements. There were only six procedural requirements being: the control of documents, records, conducting of internal audits, control of nonconforming products, and implementation of corrective and preventive action.
Design and development components could then be treated as exclusions to the standard if not undertaken by the organisation. Process management was placed in the front and centre of the organisation’s focus. Expectations of continual process improvement and monitoring customer satisfaction were also made an important factor.
Many organisations have a simple 10-20 page quality manual and then the six procedures or flowcharts plus any additional procedures they wish to have documented. As long as what is stated and referenced in the manual and procedures is fully implemented and recording requirements are undertaken then there is no reason for an organisation not to pass certification.
ISO 9001:2008 which is the newest version released in November 2008 had no major changes to the previous version of ISO 9001:2000. It only introduces clarification of specific requirements. Those currently certified to the previous standard may not have to change anything other than reference to the name of the standard to which they are certified, when they are ready for their next surveillance audit.