People I meet ask me what is happening to the new version of Quality Management Requirements under ISO 9001:2008 for the future. As a committee member of TC 176 which is handling the changes and the new look of the standard I have to say two things:
Quite a lot and
Firstly the High Level Structure [HLS] represents a big change in the numbering of the clauses for all management system standards.
Why? To achieve alignment across these standards [9001; 14001 and 18001] for integrated auditing of the management systems. The structure will look the same but the content will be standard specific.
Secondly, there are changes to the required procedures to allow the organisation to determine what it needs to manage their activities and not prescribe the procedures. This does not mean there won’t be any procedures governing the management system but rather the company will have to demonstrate management and control that confirms the stated objectives and scope of the business as well as achieving customer satisfaction. I don’t see this happening without implementing a structure of management procedures and related control measures.
Thirdly , preventive action has been removed from the principles simply because any management system implemented is preventive in nature.
Not so much!
The basic underlying fundamentals and principles of quality management systems as outlined in ISO 9000, have not changed. The requirements for a certified system rest upon these principles being evident when the QMS is audited. If you were to work outwards from the Management Review inputs it is clear that a structured and logical system is needed to provide the required inputs to determine whether customer requirements have been met or not.
The “New Bones” have the same flesh with a little more freedom to sculpt the body to fit the organisations needs. This may require the auditors [like me] to have a sharper eye and ask more pertinent questions to establish sufficient evidence of an effective management system before awarding certification.