(ISO) Quality Manual Chat

Documents required by your ISO9001:2000 quality management system must be controlled. This is a requirement of ISO9001. See Section 4 of the quality standard. No ifs, ands or buts about it. But like most elements of ISO9001:2000, you have tremendous leeway in how you accomplish it.

By quality system documents, I mean your quality manual, quality procedures, and any work orders and forms you may have that are part of your quality system.

As you can tell from my previous posts, I’m a big fan of electronic document control where possible. With computers so reliable and prevalent, most companies should be able to control their documents electronically. This will save you lots of paper and avoid some headaches too.

Some old-school companies are still around, not fully computerized. Paper hard-copy quality documents might be the only option for such companies.

There must be a method of approving documents prior to issue. And, of course, you have to be able to prove that your documents were approved by the appropriate person in your organization.

There must be a method of updating your documents and re-approving them. Yes, you have to have a way to prove they were re-approved.

You must have a way to ensure that any document changes are identified, and a way to know the current revision status.

Your controlled, updated, current quality documents must be available to people who need them. You must have a way to ensure that obsolete documents are not used. If you have some reason to retain obsolete documents, they must be identified as such to prevent accidental use.

Your quality system documents must be legible, and easily identifiable.

Any documents from external origin (drawings from a customer, for example) must be identified and their distribution controlled.

An electronic document control system has several advantages. You can easily protect an electronic document with a password known only to authorized personnel. As long as the password is secure, it would be quite difficult for an unauthorized person to change a document.
And as long as you can prove you have a secure password system, you can prove that only authorized people have made any changes. And if changes were made only by an authorized person, you’ve also accomplished “approval for adequacy” at the same time.

In an electronic system there are no controlled paper copies of documents. I recommend you state “uncontrolled if printed” on every document, informing any reader that if they’re looking at a paper copy, it may not be the current revision. Every user has immediate access to the latest revision within seconds of the revision being made. No having to wait for copies to be made and distributed. No more going through reams of copy paper every time a small revision is made. No more trying to track down a binder that’s supposed to be in a particular place in your factory, but always gets lost. No more trying to read documents through coffee and jelly-doughnut stains.

You must also have a written procedure for occasional review of your documentation. I suggest you include this during your periodic management review. On your management review agenda (one of your controlled forms) include on your checklist “review quality system documentation and re-approve for adequacy, or identify changes that must be made”. Something to that effect.

If you’ve looked into an ISO9001:2000 quality management system, you’ve probably found dozens of online companies offering to sell you your ISO documentation. What do you think about that? Ever wonder what you get for your money? Would “bought” documents work for you?

I’m going to answer this with a definite “it depends”. I strongly do not believe that you can purchase your quality manual, procedures and forms and implement your quality system quite so easily. It may sound nice, but only to people who are not terribly familiar with the ISO registration process.

However some so called “do-it-yourself” ISO quality systems might be worth looking into.

Here’s the deal: Don’t spend a lot of money on do-it-yourself documentation. You can find perfectly good documentation for less than 50 bucks online. This is far, far cheaper than even one hour of a consultant’s time, and might be worth your time. Keep in mind, tho, that just like a free lunch, there is no such thing as a turn-key ISO quality management system.

You can purchase ISO documentation online for several hundred dollars, and the sellers may lead you to believe that all you have to do is plug in your company name and you’re good to go. This is highly unlikely. No matter how much you spend on documentation, in order to get a quality system that works for your company, you’re going to have to do a lot of modifications yourself. No two companies are exactly alike, therefore no two ISO quality systems will be exactly alike.

If you’ve decided you want to have a go at creating your own ISO quality management system, I applaud your decision. For a small to medium sized company, you can definitely do it yourself. Keep in mind this is going to take some time, and quite a bit of effort. And buying some sample ISO documentation for under $50.00 might be a good investment. I wouldn’t spend any more than that, though.

Go ahead and buy the 50.00 documentation, and also buy one or 2 books on the subject of ISO9001:2000 quality systems. With a little reading and writing, and some sample documentation to give you some guidance, you can definitely do this.

But please don’t spend hundreds of dollars “buying” your quality manual. You can get the same information for less than $50.00, and you’ll save enough to buy some books. I also recommend you purchase a copy of the actual ISO9001:2000 quality standard, either from www.iso.ch, or www.ansi.org.

One of the somewhat nebulous and confusing terms in ISO is “product realization”. It took me a while to understand this concept, and I know I’m not alone. The reality is that it is an extremely simple concept.

Product Realization is simply realizing your product. OK, maybe that’s a little too simple.

Here is Webster’s definition:

realization: 1) the action of realizing; the state of being realized

realize: 1a) to bring into concrete existence: ACCOMPLISH – as in “they finally realized their goal”

Product realization means making your product – the activities and processes necessary for you to bring your product into existence.

OK, so let’s say you are a Home Inspector who wants to get ISO certification…hey, it could happen. Your “product” is not a tangible object, it is a service. That’s OK, in the eyes of ISO9001:2000 a service can be considered as your “product”. Whatever processes you use to accomplish your final product or service is your process of product realization.

Chances are your product realization process is actually a series of several processes. I’ve never seen one business that has only one process needed to achieve product realization.

Product realization is simply doing whatever it takes to get your product (or service) to your customer.

According to reliable sources, it looks like ISO9001:2009 will be the next revision. The ISO Quality Standard has been undergoing much debate over how much to change it, and what kind of changes to make. There was a lot of speculation that 2008 would be the year, but it has been delayed until, most likely, 2009.