The ISO 9001:2015 revision has made some key vocabulary changes. While some may appear insignificant or trivial, each difference reveals a little more clearly the intentions of the International Standards Organization and their meanings of quality. Each of the following paragraphs make reference to a specific wording change and how this change better communicates its purpose or clarifies its topic.
The first major word change to address occurs in section 7.5 – the phrase “Documented information” replaces the word “records”. Initially, one might question such a trivial change, but the real significance of the word change involves the resulting structure change. The previous standard referred to documents and records separately, and had different rules for each. Documents generally required rigorous approvals, tedious updates, and extreme protection where its counterpart, records, merely had to be accessible and legible. By combining these two terms into the phrase “documented information” and rendering them subject to the same criteria, they become more consistent and understandable. Furthermore, the ISO observed that quality documentation have shifted towards digital data rather than paper, so the term “documented information”, which makes no specific reference to the means of documentation, allows for a degree of freedom and interpretation. As a result, companies which thrive on paperless, digital documentation and those who have stuck with physical records can both effectively satisfy the ISO requirement.
The single biggest wording change, both in its application and sheer frequency is the change from “preventative action” to “risk and opportunity”. First appearing as early as section 0.1, this change was designed to upgrade the limited scope of preventative actions to pervade all areas of the standard and to become an integral part of every process. The ISO realized that companies could prevent negative consequences yet fail to prepare for potential improvements to their business. For example, consider company A, who realizes their widget will soon break and seeks to minimize the negative consequences. Company A could start a preventative safety training, or put into place certain restrictive measures. And, while adequately satisfying the 2008 revision of the standard, the corporation stops short of its potential. It never asks questions such as, “How can we move forward?” or “What if our widget is inherently flawed and future markets can be penetrated with a new, better widget.” By splitting a solely negative word into both its positive and negative aspects, and requiring a company to consider potentially beneficial consequences with the harmful ones, ISO facilitates a higher quality to its standard.
The next wording change comes in two parts, but ultimately stems from the same reasoning. The 2015 revision has changed the word “product” to the words “goods and services”. As well as “vendors” to “externally provided products and services”. These changes were another attempt by the ISO to better fit the standard to current practices. While the majority of businesses still provide products the worldwide trends show a shift to service based commerce. Businesses including consulting, transport, subscription, or maintenance are becoming more common. These types of companies provide no easily defined product, nor can they be called a vendor, for their services are complex and more involved. This wording change allows them to be specifically referenced and included in a Quality Management System, where they may have fallen through the cracks in previous revisions.
These words merely scratch the surface to the implications and changes in the ISO 9001:2015 standard. The truth is ISO has revamped its standard to be clearer, contextually relevant, and more effective in the long term.