What are the required elements, or the ingredients, of “successful” conformity assessment? In this three-part blog series, ANAB explores the three-ingredient recipe needed for successful conformity assessment. The concepts apply to any conformity assessment regardless of the activities therein or who performs them.
Defining Conformity Assessment in ISO/IEC 17000
Given the variety of activities and persons or organizations that perform a conformity assessment, it seems reasonable that conformity assessment should be successful and widely practiced as it gives users needed confidence/assurance with justifiable costs/burdens.
ISO/IEC 17000:2020 defines “Conformity Assessment” as “demonstration that specified requirements are fulfilled.” It also states that a “. . . . demonstration can add substance or credibility . . . that specified requirements are fulfilled, giving users greater confidence . . .” or assurance. This statement seems obvious given how broadly conformity assessment is implemented. The special word “can”, however, makes the statement more complex. “Can” is special in the sense of its specific meaning in ISO/IEC Standards. ISO/IEC Directives Part 2 7.5 indicates the word “can” in ISO documents means “there is a possibility of.” So, per ISO/IEC 17000 there “is a possibility” conformity assessment can add substance or credibility and thus give users confidence or assurance. But apparently, there is also the possibility conformity assessment might not add substance or credibility and not give users confidence or assurance.
The First Ingredient in Conformity Assessment
User Confidence and Assurance
The first ingredient in successful conformity assessment is identified by considering in more detail what users really want from conformity assessment. Hopefully, they want confidence (assurance) since ISO/IEC 17000 indicates that is what conformity assessment can deliver but confidence in what? The text from ISO/IEC 17000 above suggests users want confidence that specified requirements are fulfilled. However, common examples of conformity assessment for which almost anyone is a user shows there is more to user confidence and assurance than fulfillment of specified requirements.
Products and services that are commonly used in daily life help show the complete picture of confidence and assurance for users. For many such products and services conformity assessment— a demonstration that specified requirements are fulfilled—has been completed. Our use of these products and services makes us users of the conformity assessment related to them. However, in nearly all cases we are unaware of what specified requirements have been fulfilled let alone the process used to demonstrate fulfillment of them.
For example, adding gas to a car or using a credit card to pay at a store or restaurant may be impacted by multiple instances of conformity assessment. As users, are we actually focused on fulfillment of specified requirements? In fact, do we understand the specified requirements the gasoline fulfills, so that it powers our car exactly as the car manufacturer expected; do we understand the specified requirements the credit card and related equipment meets so that an accurate and secure transaction is completed? That seems unlikely.
But, we certainly notice when we do not get what we expect or get something we want to avoid. And this is what users really want, and the benefits or the avoidance of problems that fulfillment of specified requirements is intended to deliver. Demonstrations of fulfillment give users the confidence/assurance that benefits will be attained and/or problems will be avoided.
Understanding Fulfillment of the Requirements
Of course, users are not always disconnected from underlying specified requirements. Certainly, there are also instances where users do understand the specified requirements and may even participate in their development. Likewise, users may be very knowledgeable about, or even perform, demonstrations that the specified requirements are fulfilled. However, even these “knowledgeable” users are still focused on attaining benefits or avoiding problems and they too need confidence or assurance.
These knowledgeable users are different only in the sense that they understand how fulfillment of the specified requirements delivers what is wanted or avoid what is not wanted. They also may have a detailed understanding, or even perform demonstrations of fulfillment of those requirements. All users, regardless of their underlying knowledge, however, want confidence or assurance of benefits and how to avoid problems. As a result, the specified requirements, for all users, are not the end for users but are rather a means to an end, and the content of the specified requirements is thus critical. Specified requirements must be written so that, when fulfilled, the expected benefits will result, or the expected problems avoided. Otherwise, users will not get what they really want. How can specified requirements be developed so that they are in fact an appropriate means to the desired ends?
Developing the Requirements and Standardization Processes
From a purely logical point of view the answer is that all the users who have the needed knowledge should participate in the development of the requirements. All could contribute to make sure the requirements, when fulfilled, will either deliver benefits or avoid problems. The participation of all users would also assure the costs of fulfilling the requirements are as low as possible and reasonably justified by the benefits delivered or the problems avoided. This approach would work well when there are only a limited number of knowledgeable users. In other cases, the number of users would be too high and developing requirements with all involved could take so long that the need for the requirements might disappear before the requirements are completed.
The latter situation is the reason standards development processes and organizations have evolved generally at the same time and pace as industrial growth over the last 150 years. Standardization processes now in use are focused on achieving the objectives noted above and setting requirements that deliver expected benefits or avoid expected problems with justifiable costs/burdens. Through the rules of participation, representatives of all types of users participate, which accommodates situations with a high number of knowledgeable users. Through such participation the appropriate balance between benefits and problem prevention vs. costs of fulfillment is found and documented. Costs and burdens of fulfillment will also be offset as the use of a standard expands and economies of scale accrue to lower production costs for producers of products and services the requirements impact.
Delivering Benefits and Preventing Problems
The criticality of these characteristics show that effective specified requirements is the first ingredient to successful conformity assessment. The specified requirements, when fulfilled, must deliver the actual benefits desired or prevent the problems to be avoided. Fulfillment of the specified requirements must involve justifiable costs and burdens so that the cure is not worse than the disease. Consensus standards are frequently used as specified requirements since the processes and organizations for developing consensus standards are committed to achieving these goals.
The converse of this conclusion is clear. If specified requirements, when fulfilled, fail to produce benefits or avoid problems, will conformity assessment utilizing those specified requirements succeed? – The answer is clearly not. There is no point to a demonstration of fulfillment of such requirements. Likewise, if fulfillment of specified requirements incurs unacceptable costs or burdens (e.g., an extra $20 per gallon/$5 per liter of gas, or 15 minutes to complete a credit card transaction) will conformity assessment utilizing those specified requirements succeed? Again, no. There is no point to a demonstration of fulfillment such requirements.
So, effective specified requirements are essential for successful conformity assessment and the consensus processes of Standards Setting Organization are often relied on to produce this necessary ingredient. But as with all recipes, an ingredient like this one, while absolutely critical, is alone insufficient. In Part 2, we will see what needs to be added in a recipe for successful conformity assessment. (After all, does anyone want a birthday cake made from only one ingredient?)