Understanding the Background and New Approaches of ISO 9001

Philosophical Background of ISO 9000

When ISO 9001 started more than 20 years ago, it started as a progression to the guidelines applied to a defined set of institutions, specifically the military, whose functions, products and services were always the same.

The standards where indeed tweaked a few years after so that they could be applied to various kinds of businesses, but the essence of its contents and prescriptions remained the same. In fact, in many ways, the standards would sort of prescribed rather than describe the desired outcome. The ISO 9001 standard was therefore adopted with great skepticism. On the one hand, suppliers were being required and mandated to become ISO 9001 certified, and on the other hand, the tasks that needed to be accomplished as a result of implementing ISO 9001 seemed infinite. There was no emphasis on company goals, customer satisfaction, continual improvement, etc. but rather on documentation. The motto was document, document and document everything. The employees that worked on these companies, which may now be the managers of the companies you work for, may remember this stage of ISO as not a very pleasant one.

The goal of becoming ISO 9001 certified was to remain being a supplier and also to put everything in writing. It wasn’t that the ISO 9001 standard was wrong-although it lack some of the great improvements it now has, but I believe that it was the way it was presented, the way it was written that created confusion, repetition, plagiarism, etc.

Old Practices and Documentation

At that time the standard consisted of 18 to 20 set of guidelines, each of which described in detail what you should do in various areas, such as in Purchasing, Repair, Training, etc. So most companies, rather than look at their own business processes and decide how to apply the standard to their already existing models, they copied the standard in part or as a whole throughout their policies and procedures. Except for replacing the word “organization” with the name of their company, most companies repeated what the standard said, without saying much about the company culture, processes or practices.

To make matters worse, most companies implemented 20 procedures, which you guessed it, where the same exact 20 guidelines or “elements” that the standard contained. Albeit a few more word changes and name references, the procedures did not tell you much about the company. So companies started developing a second tier of documentation where more details regarding the company practices were documented. Even a third tier of documents where developed in many companies, this time going to the other extreme of documenting every little detail of a specific operation, down to exactly how you move a pen or how you move a document from the desk to the file cabinet . So employees thought that ISO was a lot of fluff, because indeed there were tons of documents being generated that were not really of any use or value.

With the internet in its infancy, the concept of electronic documents was nonexistent and binders became the norm. Every office will have its own set of binders, most of which will collect dust and hardly ever be opened. Of course, not everything was bad. Work instructions became the heart of the company and employees often referred to them to conduct their duties. Unfortunately without the electronic document concept, people placed a lot of importance on hard paper and hard signatures.

Unlike today were an email carries a lot of weight and can be used in the court of law, back then, people will look at papers and wonder where the signature was, who the owners were, who the reviewers were, who the approvers were etc. In essence adding more fluff to every document than what was really necessary. Very often you will see real signatures on the documents that were part of the binder, which made updating a procedure or work instruction a very tedious job. Not only the document had to be reviewed and approved by a large group of people, but it also had to be hand signed multiple times by the president so that each copy can be neatly place in the good old binder.

Of course these actions created “permanent” jobs in many companies, with titles such as Document Control Manager, Document Control Clerk, ISO clerk, etc. The mere job of these employees was to keep up with updating documents, updating binders and ensuring that all revisions being used were the latest. No wonder so many employees who experienced that, still think of ISO as the mother of all paperwork.

The ISO Process Approach

Luckily for all of us, that concept has changed a lot. Starting in 2000 with the advent of the ISO 9001:2000 revision, ISO came up with a new concept that pretty much overhauled the way the standard was presented. The standard introduced the Process Approach along with other concepts as the pinnacles of a good implementation and went from basically 20 elements to only 8. The changed was so dramatic, that managers had to be retrained in these new guidelines and companies were given 3 years to upgrade their certificates to the new revision.

Companies could no longer just copy the standard and adopt it as their procedures; they now had to demonstrate that they were process oriented and that their quality management system was based on the company’s own processes and not the ones of their neighbor. The standard also shifted the emphasis from documentation to more important concepts, such as Objectives, Customer Satisfaction, Continual Improvement and Data Analysis. In fact the standard now only requires 6 written documented procedures; anything else is up to the company and depends on the business model and the processes that are part of the company products or services. Certification to the ISO 9001:2000 standard was not only dependant on having the appropriate procedures, but also on making sure that the concepts introduced by the standard were addressed.

The ISO 9001:2008 Standard

The ISO 9001 standard was revised in 2008 but in a much smaller scale. In fact the changes were mostly to wording and footnotes and not to the individual requirements. Among the concepts with added focus by ISO 9001:2000 and continued on the ISO 9001:2008 standard are the requirements for objectives, customer satisfaction and continual improvement.

A company without clear and defined objectives will not be considered as having implemented the standard successfully. Indeed objectives have to be measurable and disseminated or broken down throughout the company so that all employees are working towards the same goal. Likewise a company that is not measuring Customer Satisfaction or finding ways to seek feedback from its customers, is not worthy of ISO 9001:2008 certification even if they claim to seek customer satisfaction on their Quality Policy.

Status Quo is also not accepted, as companies need to demonstrate a sincere effort to continually improve. Basically if you want to demonstrate you are conforming to the ISO 9001:2008 standard, you have to demonstrate that there is a mindset of continual improvement among your employees and that they know what to do if there encounter an opportunity for improvement. Nobody is advocating stopping all work and engage in a search for ways to improve, but periodic efforts should be noticed, systems should be in place to encourage improvement and opportunities should be recognized and follow through.

New Tools and Approaches for Implementing and Maintaining ISO 9001

As personal PCs, information sharing, electronic gizmos and the like have taken over our world, the number of tools available to help implement and maintain conformance to ISO 9001 have also increased. Mireaux Management Solutions for example offers a Web-Based Quality Management which can host a variety of information and requirements needed for ISO, such as procedures, policies, flowcharts, forms, calibration records, etc. Dynamic applications such as the Continual Improvement Program (CIP) make the job of keeping up with corrective and preventive actions a breeze. No longer do papers have to be hand-carried or forms have to be walked to other individuals for filling. Applications fire emails automatically and do the dirty work of reminding people what is expected of them to ensure that tasks get accomplished. Accessibility of information makes the system be “alive” and when the system is alive, it will adapt to the changes in the workplace practices, which in turn results in the employees actually using the system because it is accessible where needed, when needed.

In essence, the ISO standard with its 8 elements is definitely a simple set of guidelines. These are simple guidelines of what is normally seen in world-class quality companies. If done right, the work of implementing ISO 9001 should be simple, enjoyable, eye-opening and welcomed by your employees.