(ISO) Quality Manual Chat

You’re a quality person, working for a company, doing your job. The company doesn’t really have any serious problems, but one day someone gets a bug in their ear that the company should have an ISO9001:2000 quality management system. Or, even worse, your company’s biggest and best customer has decided that you need to implement ISO. And you’re handed a due date. Yikes!

Whether you’re a quality professional working on ISO9001:2000 for the first time, or a quality consultant hired to get a company certified, you can’t do it alone. You will need help.

I recently started working with a customer who wants to get ISO9001:2000 mostly due to customers’ mandating it. The company isn’t perfect, they have a few organizational issues, but they don’t have any serious problems, and they produce high quality products with very few returns. They are recognized as the leader in their industry, and the people working there are mostly long term, dedicated employees. It’s obvious that top management has fostered an atmosphere of teamwork and cooperation.

The company has been trying to get ISO9001:2000 certification for a few years. Fortunately they have not had a customer deadline….yet. The main reason, in my opinion, why they haven’t been able to get registered is because they did not have the right person driving the quality program.

The last person charged with driving the ISO program was apparently an older curmudgeon who rubbed people the wrong way. Instead of listening to the people who already do a good job, he alienated people with his insistence that it was his way or the highway.

The employees already working at the company don’t really know much about ISO, and they don’t really care. They know the company needs it and wants it, but they are already very busy trying to do the best job they can at their position. For someone to come in and tell them they’re doing things the wrong way, and they have to change to satisfy ISO, well, this is not a great way to get people on your side.

While you certainly may need to implement some new records, maybe change around a few procedures, I am a huge proponent of avoiding large-scale changes at any organization just for ISO’s sake. Chances are that if a company is successful and well-established, they’re already doing a lot of very good things. Why mess with that?

ISO9001:2000 is somewhat malleable, and has some gray areas, as we all know. The ISO9001:2000 quality standard was intentionally written this way so it can apply to all sorts of different organizations.

I’ve run into many people who only know a little bit about ISO9001:2000, and they’re a little intimidated by it. They believe ISO will dictate exactly how their company must be run, and they’re afraid that with all the forms, procedures and records that they won’t be able to get any actual work done.

I think one sign of a successful ISO quality consultant, or a good quality professional of any kind just coming into a new company, is that he/she is a good listener. It’s amazing how much you can learn about a company just by listening to people. And by listening at first, you will probably find that people are much more receptive to what you have to offer later.

You will need help from others to implement a new ISO9001:2000 quality management system. No one can do it alone, unless its just a one person company.

The first two things I’d recommend to any person trying to implement ISO are:
1. Realize that you can tailor ISO to the company. If the company is already doing well, try to change company procedures as little as possible.
2. Listen to the people who work there. This will pay you huge dividends in the future.

We all joke about needing a whip to get people in line, but the reality is that you want people on your side in order to have an effective quality system. If you make a bunch of enemies at first, you’ll never be successful.

It’s clear that without solid management commitment, you will not have a successful ISO9001:2000 quality management system.

Some of the items that are required under section 5 of the ISO9001:2000 standard include:

Your top management must be able to provide evidence of its commitment to your quality system, and its continual improvement.

Top management must communicate to the organization that it is of the utmost importance that the company meet customer requirements, as well as any applicable government regulatory requirements.

Top management must establish a quality policy. This is usually a few sentences at the beginning of your quality manual. Think of it as a high level direction. If you were commanding an ocean liner, the equivalent would be to say “we’re going to New York”. The rest of your quality manual and procedures will give everyone detailed instructions on how you’re going to get there.

Top management must see that quality objectives are created, and that quality measurements are taken and recorded and compared against those objectives. One of the driving goals of ISO9001:2000 is “continual improvement”. You must be able to demonstrate continual improvement. This is done by establishing quality objectives (or goals) that are just slightly above where you are at now. A year from now, after a year’s worth of measurements, you should have evidence of improvement. If you don’t, you’re doing something wrong. Having your quality measurements (records) compared against where you were, and where you want to be, is a really good place to start figuring out how to improve your system.

Top management must conduct periodic management reviews. That is, management must review the quality system and make changes if necessary. And, of course, you have to be able to show evidence of your management reviews, so records are necessary.

Top management is also charged with the responsibility of ensuring that adequate resources are available to people within your organization. This means all resources, from adequate personnel (both quality and quantity of those personnel) an adequate environment to accomplish the work, the necessary tools, computers, paper clips…..everything needed to run the company, accomplish your goals, and continually improve.