Archive for June, 2007

ISO9001:2000 Section 4.1 General Requirements Part 2

Tuesday, June 26th, 2007

This is the second part of an occasional series on ISO9001:2000 Section 4.1, General Requirements.

Keep in mind that when the ISO9001:2000 quality standard uses the word “shall”, then whatever they’re referring to is a requirement, not a suggestion.

We’ve already written about how your company must identify and document all the processes that affect your quality management system. In addition to identifying and documenting them, you must also document how they interrelate with each other, and in what sequence. You’re basically writing an operational manual for how your company works. After all, you want all your people to be “rowing the boat” in the same direction, so its very helpful if they’re all looking at the same map.

You must also determine the criteria and methods needed to make sure that the operation and control of your processes are effective. If you’re turning out small, large, and medium widgets, what is your criteria for determining if they are good widgets? What size constitutes small, medium and large? How do you ensure that your criteria are being met? Who’s responsible for determining what is acceptable and unacceptable?

Another requirement in ISO is that you have available sufficient resources and information needed to support the operation and monitoring of your processes. Do you have adequate machinery? A sufficient quantity of adequately trained personnel? A sufficient quantity and quality of measuring devices?

More on this later.

Your comments are encouraged.

ISO9001:2000 Section 4.1 General Requirements Part 1

Thursday, June 21st, 2007

This is part one of a primer on the general requirements of the ISO9001:2000 quality management system. You can find these in section 4.1 of the standard.

1. Your organization or company must identify the processes needed for your quality management system, and you must also decide how these processes will be applied in your company.

What processes do you use (or will you use) in your quality management system? Do you have a procedure for handling sales orders? Purchase orders? You’ll probably need a written procedure on how to choose vendors, and a system of recording which vendors are approved. You might have an inspection at time of receiving, another in-process, and yet another at final shipment.

You must identify ALL of the processes used in your quality management system. It’s likely that you’ll have to create one or two processes to meet the requirements of the ISO9001:2000 quality standard. You might have no existing system for approving vendors, for example. Under ISO, you’ll not only have to develop a procedure for approving vendors, but you’ll also have to keep records of which vendors are approved, which have been disapproved, and you’ll also have to keep records of your vendors’ performance. There are a lot of records needed in an ISO9001:2000 quality system, get used to it!

Can you have defined objectives that are not measurable?

Tuesday, June 19th, 2007

One company owner I worked with took a while to understand what ISO9001:2000 is all about. At one point he wanted to include quality objectives that were not measurable. They were subjective evaluations.

He asked me if every objective needed to be measurable. Couldn’t they just have as an objective something to the effect of “better quality”, or “more satisfied customers”? The short answer is “no”. I suspect that while he was excited about getting the nice certificate on the wall, he wasn’t too keen on actually following the requirements if ISO9001:2000.

ISO9001:2000 is all about continual improvement. In order to steer a ship you need to know where you are, and where you want to go. It’s the same with a quality management system. Without concrete numbers, its difficult to know where you are, and how you are progressing.

How would you implement an ISO9001:2000 quality system for your website?

Friday, June 15th, 2007

Let’s say you’ve got a website that is a forum with news and reviews on a particular topic, such as motorcycles. You intend to have advertising on your site, so it is a profit making venture. How would you implement an ISO9001:2000 quality management system for such a business?

Your “product” would be your website. Your customers are the good people who will hopefully send you checks to advertise on your site. Would the ISO requirement for Design and Development apply? Probably. You are, after all, continually designing and developing your website. I think it would be fairly easy to document a process of how your website is designed and written. Maybe there could be a process whereby any new content is reviewed and must be approved by the company owner, or some person other than the writer. You could have an electronic signature on the document to provide proof that the process was followed.

How would you measure customer satisfaction? Since you don’t have a physical product, you can’t count the number of returns. There are a myriad of other ways you can measure customer satisfaction here.

You could always ask your customer how you’re doing and document the results. Hopefully you would format your questions so they’re in the form of objective numbers, which would be easy to quantity and track. Over time, hopefully, your customer satisfaction numbers should increase.

You could also count the number of clicks from your readers to the advertisers’ websites. I guarantee your advertisers are keeping track of this, you should too.

In a weird way it’s kind of interesting to think about esoteric little businesses and how ISO9001:2000 may or may not work out. I’ve yet to find a business where ISO doesn’t apply.

Customer Related Processes

Thursday, June 14th, 2007

Your ISO9001:2000 quality management system (QMS) should be tailored to your organization. The Customer Related Process discussed here is one process that may be used by quite a few companies, but may not necessarily relate to your situation. You have to decide for yourself.

The Cycle Guys is a company that sells motorcycle parts. Orders are called in, or sent via a website. Occasionally a customer might call back to add something, change an item, or cancel their order. Obviously if the customer has waited too long, and the order has shipped, then there’s not too much Cycle Guys can do about it.

However there are times when the customer calls with changes before the order has shipped. The Cycle Guys must devise a way to control their order process so that the correct order is shipped to the customer. How to do this?

At The Cycle Guys, when a sales order is entered into their computer, a copy of the order is printed out for shipping.

The Cycle Guys quality procedure states that the salesperson taking the customer call must immediately walk out to the warehouse to find the physical copy of the order. If the order has already been picked, the salesperson must notify the shipping person that the order will be changed. Whether or not the order has already been picked, the salesperson must find the physical copy of the order and destroy it. Only after the physical sales order is destroyed is the salesperson to then enter the new sales order.

This system depends on the salesperson doing his job and following the procedure. There might be a better way to do this depending on software capabilities of the company, how many people work there, and a variety of other issues. But for a small, 4 person company such as The Cycle Guys, this procedure seems to be working fine.

Alchohol and the Audit

Wednesday, June 13th, 2007

I swear this is true…I am not making it up … although I have left out names of the guilty.

A small, highly disorganized company hired me to consult on their ISO quality system 4 weeks before their upcoming audit. This company was really only interested in getting a pretty certificate to show their customers, they never really intended to follow ISO, that much was obvious from the start. The place was a shambles, both physically and organizationally.

Fortunately for the company owner, the auditor loved to talk about himself, which the owner used to his advantage. They even went out at lunch and drank. Back at the office, bottles of wine were opened and the auditor and owner continued drinking. By 5:00 the auditor was pretty tipsy, and the company passed their certification. So many things were overlooked. Personally, if I had been the auditor this company would never have passed. If I hadn’t witnessed this episode in person, I’d never have believed it.

I Learned a Lot from this Guy

Monday, June 4th, 2007

For several years it was my pleasure to work with an ISO consultant and auditor by the name of Dale Baldwin, in the Southern California area. Dale understood our business and didn’t try to be preachy when helping clients implement ISO9000 — both the 1994 version and later ISO9001:2000. I don’t know if Dale is still in the ISO business, but he knew his stuff and was a great help.