Progress of interrelated processes
Do you still remember ISO 9001:1994? - the quality standard from not so long ago that plainly outlined what was required of companies in a quality manual. It was simple back then.
A compliant company needed only to produce a policy statement, 20 procedures based on the 20 elements, and where necessary, some work instructions. Sure, there was a need to support quality records as well, but the clear guidelines of what it took to become compliant is what made ISO easy.
Fast-forward to the present and you'll notice the process has changed quite a bit. Every few years, ISO revises the language of its standards to change with the times. In the most recent amendment to ISO, now known as ISO 9001:2000, ISO has changed its approach to documentation.
The 20 elements of the past have been renamed, rewritten and expanded to 50+ elements.
So much for making life easy, right? With so many new elements to the amended standard, it became obvious that an easier way to document procedures and processes was needed. ISO went back to the drawing board and reduced 50+ elements to the essential six...inciting companies everywhere to let out a huge sigh of relief.
Suddenly, becoming compliant became that much easier.
So what happened to all the other elements of the standard? Nothing. They are all still important and still need to be addressed, but the focus has changed.
Instead of requiring an abundance of procedures, the focus is on process, which contains a set of interrelated activities.
With the revised ISO 9001:2000 standard, the only procedures required are:
4.2.3 - Control of documents
4.2.4 - Control of quality records
8.2.2 - Internal audit
8.3 - Control of nonconforming product
8.5.2 - Corrective action
8.5.3 - Preventive action
All other elements of the standard can now be addressed in process documents. This allows companies to use processes relevant to their operations while including the necessary aspects of the standard.
Remember, quality is not defined by your documentation alone; the path you take to get there and how you do it is just as important.