Imagine you have three documents open on your screen. They all concern the same product. The first one says, “This product shall meet the dimensions and perform in accordance with the test methods.” The second one states, “For a product to be sold in this jurisdiction, it must comply with these essential product requirements.” And the third says, “This particular material, dimension, tolerance, labelling, and performance must all conform to this particular design.” The documents could easily be mistaken for one another; they all use technical language, yet they are each performing a completely different function. Being able to distinguish these documents is one of the first and most important lessons of product standardization.
A product standard is a document which usually contains requirements, definitions, classification, test methods or guidelines for a product and its class. It defines the scope and the extent of applicability of the document. It may describe how to measure a characteristic, how to take sample, or what content to include in the documentation. But the existence of a standard does not mean that all its contents apply in all cases. The requirements may or may not apply based on the market, the regulation, the contract and the product.
A technical regulation is related to legal requirements for a certain market or jurisdiction issued by an authority. A regulation establishes legal requirements on certain characteristics of a product, for instance safety or labeling, performance, or conformity assessment. Regulations can refer to standards to prove compliance with the requirements but the regulation and the standard are two separate documents. When evaluating the regulatory obligations of a document, record the jurisdiction and the version, the products and classes covered, and any exceptions before determining if you can apply the requirement.
A product specification sets out the particular requirements for one particular product, product model, material, production batch or configuration. It can define nominal values, tolerances, material grades, dimensions, packaging information, test methods and acceptance criteria. Unlike a general product standard, a product specification should be specific enough for a single item to either pass or fail. Terms like ‘durable construction’ or ‘suitable material’ will not be good unless they are translated into quantifiable limits, specified materials, defined conditions or evidence.
One way to practice distinguishing these documents is to take a sample from each of them. For each sentence in each document, mark the intent as one of these three: a regulatory obligation, a standardised process, or a product requirement. Next, identify the scope statement and the references to norms, the tolerance, the test method and the acceptance limits. This will help you see whether there are terms that have been included in the document for which you have not recorded the source, and whether the document that you are reading is the current version.
This will also help to structure the requirements of a product, as they usually appear in a requirements matrix. You can record the regulation, the standard or the test method to demonstrate conformity, and the product requirement to check compliance. Additional columns might contain information to check that the evidence is correct, the date of the last review, and the revision of the document. This prevents requirements and requests from customers, internal quality targets and regulatory obligations from being lumped together into one document. It will help you understand if you are doing the same work twice and to keep your records up to date.
Before declaring a requirement compliant, identify the source of this requirement, confirm that it does apply to the product and check that you have evidence to satisfy yourself that this is the case. A test report may show compliance for one single item for a single characteristic but the report will not replace a product specification and it cannot be used to show that all regulatory obligations have been satisfied. To have a reliable review, it is necessary to know when and where to use the right standard: a product regulation defines your regulatory requirements, a standard is a shared method for testing products and demonstrating their compliance and a product specification states the measurable requirements for your product.