(ISO) Quality Manual Chat

The ISO9001:2000 quality standard says that you must review product requirements prior to your organization commiting to supply the product to your customer. Different companies handle this in wildly different ways, it all depends on what kind of company you are, and what your product is.

For some companies this is easy. You get a request for quote (RFQ) from your customer, which specifies their requirements. You prepare a bid or tender that states what you will supply. Your bid can simply reiterate your customer’s requirements, or you can state you own product specifications and how they might be different from your customer’s RFQ. Either way, you’ve got to let them know what you intend to supply.

Or it might be a lot more simple. If your organization sells consumer products such as, let’s say motorcycle brake levers, then life is a little easier. You make your product specifications known to your customers by way of advertising, catalogs, web sites, etc. Its a standard, well known product that is the same for every customer. The customer merely lets you know the part number they want to order.

Even in a case like the above mentioned brake lever company, you want to have procedures in place to make sure your sales people get the customer requirements right. Since many orders are placed verbally over the phone, you’ve got a couple of options to consider.

You could require all your customers to fax or email a copy of their PO to you. Of course, you would not be able to ship their order until they do so, as you’d need a confirming copy of their order on file. This is not practical for many companies.

Another thing you might consider is having your sales people follow a procedure to confirm the customer’s verbal order. You could require your people to repeat the complete order to the customer as confirmation. And as a record of this this confirmation you can have the salesperson sign the sales order. Maybe you could include some verbage on the sales order form that states “confirmed entire order with customer”, with the salesperson’s signature next to it. This way you are holding the salesperson responsible for making sure the order is correct. If problems arise due to alleged “communication errors”, you should be able to narrow down the problem to one person in your organization, and take appropriate corrective actions.

In chapter 7 of the ISO9001:2000 quality standard there is a requirement that you control devices you use for monitoring or measuring your product. Like so many parts of the ISO quality standard, you have a fair amount of flexibility in how you accomplish this.

First of all you should determine if you actually have monitoring and measuring devices. You might not. If, for example, you are a distributor of automotive distributor caps, and all you do is receive and ship boxes of distributor caps, this section of ISO probably does not apply to you. It is perfectly fine to claim you are exempt from this section of the ISO9001:2000 standard, as long as it’s true. If all you’re doing is visually verifying part numbers, and counting quantities, then you should make a note in your ISO quality manual that this section does not apply to you. However, be warned that if an auditor finds a calipers or a micrometer in your facility, you could have some explaining to do. If you’re going to exclude the “control of monitoring and measuring devices” section of ISO, then it would be best to make sure such devices are not to be found on your premises.

You may also be able to exclude individual devices, but again you’d better have a really good reason for doing so. One company I worked with has a company owner who rarely participates in the business, leaving the company operation to his partner. This owner still comes into the office each day, but works on personal projects that have nothing to do with the company. He’s a gadget freak, too, and has lots of cool little tools laying around. Again, his personal tools have nothing to do with the company, but they are on the premises and would certainly arouse the curiosity of an auditor.

What we did in this case was specifically exclude the owner’s personal tools and devices. We also had to label the devices as “uncontrolled” and instruct everyone in the company not to use those devices. It was an unusual situation, but it worked out fine.

The ISO standard states that “where necessary” your measuring and monitoring equipment must be periodically checked and calibrated to verify accuracy of your measurements. ISO gives you the flexibility to decide for yourself what kind of calibration is necessary, and how often. On one end of the spectrum, a yardstick is a measuring device that most likely does not need periodic calibrating. On the other end, a micrometer should probably be calibrated at least annually.

Calibration of measuring devices should be done by qualified technicians, and records must be kept. If a measuring device is found to be out of calibration, you should take steps to ensure that products measured with that device are rechecked. In extreme cases you may wish to consider a recall of products that already shipped.

ISO wants you to calibrate your measuring devices against measurement standards traceable to national or international measurement standards. If, however, there are no such standards for what you’re measuring, you must have records of what basis you use for calibrating your devices.

You should be able to quickly identify the calibration status of all measuring devices in your organization. A label on each device is usually sufficient.

More on this later.

ISO9001:2000 section 4.2 states the requirement to have a documented quality policy. Cynical people might look at the quality policy as a bunch of horse dung. And lord knows I’ve seen quite a few companies that don’t take any part of their quality system seriously. So its not surprising that some folks might not take their quality policy to heart.

Unfortunately, in many companies the quality policy is effectively meaningless. Empty words written just to be in compliance with the standard.

Part of the reason why you need a wll written quality policy is to make your employees understand that their job affects product quality, and therefore the success or failure of the company. Your people must be made aware that their individual contribution is vitally important to the company’s overall success.

If your quality policy is simply written to satisfy the requirements of ISO9001:2000, then it might be worthless. You should keep it simple and keep it relevant to your organization. Make it meaningful to the people in your organization.

Your quality policy can also be thought of as making a commitment to quality. If management doesn’t take it seriously, then employees won’t either. However if management demonstrates an actual willingness to improve product quality without throwing people under a bus, then maybe the employees will also get on board.

In many cases the quality policy is just a bunch of words that management agonizes over to get the wording just right. It gets printed in your quality manual, posted on some walls, and then it is promptly forgotten about. Until the next audit, that is.

Your people don’t need a bunch of fancy hogwash to know what good quality is. Everyone knows when your quality policy isn’t worth the paper its printed on. It is up to management to show everyone the way by their actions, not merely by their words.