Comparing 1994 to 2000: Key Revisions to the ISO 9001 Standard.
The impact of the changes to the ISO 9001 standard depends largely on the interpretation of ISO 9001:1994 standard. It could be argued that if the intent, and not simply the requirements, of the 1994 standard are considered, the changes are relatively minimal. In this light, the revisions are an attempt to clarify and strengthen some key concepts.
Certainly the most noticeable change is structure. Gone are the 20 somewhat arbitrary sections, replaced by 5 key systems:
Although the 1994 standard contained twenty separate sections, for most individuals, working with the standard meant grouping the elements into sub-systems. For example:
This concept is key to making a smooth transition to the revised standard. It is less about the number of each section, and more about the intent of each section and how they are combined to provide functionality to the quality system (i.e. the top level bullet points above). In fact for many years, I have advocated that clients name, number and group elements of their quality system in a manner that is pertinent to the organization instead of mirroring the standard. A cross-reference list is more than adequate to ensure that an external auditor can navigate the system.
Several key quality management, and for that matter business management, concepts are prominently featured in the ISO 9000 standards. These same concepts were embedded in the 1994 standard, however, the latest revisions have further clarified and emphasized their role. It should be stressed that these are not the only foundation principles nor does the following discussion attempt to encompass all revisions. The following is an attempt to identify the most significant changes.
It can certainly be argued that elements of a high-level or “strategic” planning cycle were part of the 1994 standard, however, the 2000 standard defines a general model and clarifies the constituent elements.
The addition of 5.4 Planning (including Quality objectives and Quality management system planning) ensures that the focus of planning activities extends beyond purely operational or product level planning. Key quality objectives (or by extension, business objectives) must be identified, documented and implemented. This combined with Quality Policy, defining the overall relevant direction and context for the objectives, and Management Review, providing a forum to evaluate performance against objectives, creates a cycle the parallels a typical Business Planning Cycle.
Though again an undercurrent of the 1994 standard, for 2000 the voice of the customer is front and centre.
The addition of 5.2 Customer focus ensures that customer requirements are considered as part of the very foundation of the system. Though much of 7.2 Customer-related processes was included in the previous 4.3 Contract Review section, the addition of 7.2.3 Customer communication ensures “soft” requirements such as “ease of dealing” and “responsiveness” are considered.
One of the most discussed changes, is the requirement to “monitor information relating to customer perception” (8.2.1 Customer satisfaction). The key distinction is “customer perception”, meaning the viewpoint of the customer and not solely that of the organization. Customer satisfaction is also one of the key information streams identified in 8.4 Analysis of data.
In the 1994 standard the issue of resources was largely confined to people (4.18 Training), with some brief and fragmented references to additional process resources. The revised standard consolidates and expands the concept of resources. This allows connection to other key systems within the organization.
That is not to say that all of these systems are part of the quality system, however, the revised standard presents a much more explicit interface.
Apart from the more comprehensive view of resources, the depth of requirements for individual resource streams has also been expanded. For example, 6.2 Human resources covers not only the requirement of assessing and providing training to ensure competence but the need to evaluate the effectiveness of the training (i.e. ensure the training has created the right behaviours). Additionally, the acknowledgement that employees require an understanding of context to make good decisions and contribute to the overall objectives of the organization.
All activities within an organization are the result of systematic steps that must be understood and improved. Understanding the interrelation of processes allows the management of the parts for the benefit of the whole. These are the underlying principles of process and system control.
The 1994 standard segregated elements of a business process model into independent functions such as Purchasing, Process Control, Servicing, etc. It relied far more on the users ability to connect these functions to control the business process. The 2000 standard has made this connection far more explicit. Beginning with the introduction (0.2 Process approach) and throughout the standard the focus on identifying and controlling processes is clear.
Section 7.0 Product realization groups all elements related to the business process including:
It is important to mention that the actual content changes within these elements have been relatively minor, however, the grouping makes the concept more accessible.
Similar to the Planning Cycle discussed above, the 2000 standard has clarified the proposed model of the improvement cycle. This process began with the 1994 revisions. At that time, the distinction between corrective and preventive action (reactive or proactive problem solving) was made. The new revisions continue to flesh out this model.
The addition of 8.4 Analysis of data provides the missing link between measurement (data collection) and improvement (resolving problems or potential problems). Though it is intuitive that collected data must be analyzed to identify key issues requiring resolution, the revisions have made this connection explicit. Section 8.5.1 Continual improvement connects the planning cycle to the improvement elements (i.e. macro and micro improvement).
Key Opportunity for Improvement
Although undoubtedly disconcerting for those organizations familiar with the 1994 standard, the revisions introduced to the 2000 standard clarify and more explicitly deal with key quality principles. Whereas the 1994 standard required the user to understand the intent of each element and develop a model for key functional systems by effectively grouping elements, the 2000 standard identifies a systems approach much more directly. This provides a great opportunity for organizations transitioning to ISO 9001:2000 to critically evaluate and enhance the key sub-systems discussed above.
Exploring some of these opportunities will be the subject of future articles.
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Check back for February’s article:
Implementing ISO 9001: How to plan and manage organizational change