There are some differences between the 2008 and 2015 versions that are merely technical – how it takes the same format as other ISO standards, clarity of language, terminology etc – but what most business people want to know is how will it affect my business? Will there be more paperwork? Will we have to change our systems? And so on.
Overall, the changes are not major but some are underlying ones that appear throughout the standard. Some of the more significant changes are listed below.
Leadership. Top Management are required to demonstrate that they engage in key Quality Management System (QMS) activities, not just to ensure that they happen. Top management need to be actively involved in the operation of the QMS. References to ‘Management Representative’ are removed with the objective that the QMS is viewed as part of routine business operations, not as an independent system.
Context. This is a new aspect of the standard. Businesses are required to identify explicitly any internal and external influences that may impact the QMS’s ability to deliver its intended results. Interested parties must also be identified and their needs and expectations understood. Interested parties are identified as individuals or organisations that can affect or be affected by the business’s decisions or activities.
Scope. Greater emphasis on the definition and content of the Scope is made in this version. The scope sets the boundaries for, and identifies the applicability of a business’s QMS. The scope is to be determined in consideration of the context.
Process Approach. The previous standard promoted the use of a process approach; the new standard goes further in setting out specific essential requirements for the adoption of a process approach
Risk-based Thinking. There are no references to preventive action in the new standard but the core concept of identifying and addressing potential mistakes before they happen is still inherent in the new standard which refers to risks and opportunities. One eminent ISO9001 guru prefers the use of the word ‘uncertainty’ to ‘risks and opportunities’. There must be evidence that uncertainties have been determined, considered, and action taken where necessary if it affects the QMS’s ability to deliver intended results or that impact on customer satisfaction
Services. The term ‘product’ is now replaced by ‘products and services’.
Improvement. Recognising that improvement is sometimes brought about by a breakthrough, or resulting from reorganisation, the words ‘continual improvement’ are replaced by improvement.
External Provision. The words ‘Purchasing’ and ‘outsourcing’ are replaced by ‘externally provided processes, products and services’. This gives greater scope for the control of sub-contracted services to be used; businesses are required to take a risk-based approach to these services and to determine what controls are needed for each external provider or supplier.