What is ISO9001? Is it important?

ISO 9001 – The Documentation System, The Legend

If you’ve been looking into manufacturing, you’ve probably heard some things about ISO9001.  If you don’t dig too deep, it may seem like the perfect solution to all your quality problems, but, let’s dig a little deeper, shall we?

At it’s heart, ISO9001 is truly a great system.  The basic idea was to provide a set of rules and management guidelines that could be used to control and improve the quality output of an organization.  Mapwright has created a nice summary of the main sections (4-8) here. Any factory manager or quality control supervisor could learn a lot and probably improve their quality output significantly if they applied all of the lessons and structure that are provided in ISO9001.  The problem lies in the fact that this is also generally true for all of those factories that are already ISO9001 certified!

The Difficulty

The problem is, as with any sufficiently powerful system, there are a lot of details that need to be attended to in intelligent ways to effectively carry-out the intentions of the system.  As you can see, section 4.2.2 states that you should have a quality manual.  There are some guidelines in that section that help define what makes a good or bad quality manual, but even within the guidelines there is a LOT of room for error.  It is still possible to have a quality manual and fit the requirements of the system, but not have a very good quality manual, or perhaps a poorly written one, that could confuse workers and lead to even more defects.

The other difficulty is that all of the required documentation really takes a lot of time and resources.  I believe these resources are generally well spent, but if a factory has good management and has already achieved a good level of quality through intelligent decisions and good leadership, they will be spending a lot of unnecessary resources  that will increase their costs and potentially even cause new problems.  The first rule of quality should be, “if it ain’t broke, don’t fix it”!

The Audit

To be ISO certified, the company needs to go through an auditing process with an official registrar.  You can see a list of registrars here. But, in China, there are different registrars.  A true thorough audit with a company like TUV or SGS will cost at least $10k and take two years with their support and detailed guidance of how to improve and diligent, concerted effort by everybody in the participating company. Using registrars like these does give at least some guarantee that at least the system of quality control is solid (though there is still room in the details for plenty of quality problems in the products themselves).

The other option, is for the participating factory to use a local Chinese registrar that can get them certified for as low as $500-2000 in a matter of months with almost no changes to their existing system.  So, if you are a Chinese factory that doesn’t really believe in document control with hundreds of workers who have no experience with a rigorous systems approach but you’d like your US clients to feel comfortable with working with you because you are ISO9001 certified, guess which option they are going to choose.

The Result

So, at the end of the day, factories that really care about quality and are willing to use the high level, international registrars for their ISO9001 audit because they actually want to get better are the same factories that are probably already doing a pretty decent job controlling quality in their own way (because caring about it is the most fundamental aspect to producing good quality),and won’t actually get a whole lot out of getting the certificate.  The factories that don’t really care, go forward with the cheap alternative, don’t make any major changes, and still have the same problems that they started with (basically that they don’t really care that much). As a potential customer, if you are concerned about ISO9001, make sure to check who the factory used as a registrar (and confirm with the registering company), but know that systems are only going to be as good as the people implementing them.  The devil is still hanging out in the details.




Photo Credit: Yshr

Photo Credit: Neal Rabogliatti


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