Archive for February, 2008

ISO9001:2000 Frequently Asked Questions – FAQ’s part 1

Monday, February 18th, 2008

What is ISO 9001?

ISO 9001 is a Quality Management System standard that helps organizations to get better organized, to produce and ship fewer discrepant products, and to help ensure they are meeting customer requirements. The ISO9001 standard was created to help the organization’s management is to implement systems to better run your business.

When I tell people about ISO9001:2000, many managers will say to me “Oh, that’s like a “best practices” kind of program”. Which is correct.

The ISO9001:2000 standard offers a more structured approach for various processes intended to help your business, such as:
Reviewing and meeting customer requirements;
Realization of your products and/or services;
How employees are hired and their competency determined;
Control of important company documents to make sure only current versions are used;
Periodic review of the quality system by company management;
Correction of unintended results, and prevention of their recurrence;
and other areas of business management.

The ISO9001:2000 standard is a 23 page document, and provides guidance in many areas of business. It does not deal with accounting issues such as A/P and A/R or payroll. The ISO9001:2000 standard can be purchased from ANSI (www.ANSI.org) the American National Standards Institute, or directly from the International Organization for Standardization in Switzerland (www.ISO.org) ISO9001:2000 can be applied to any business – no matter the industry or size.

What does ISO stand for?

The International Organization for Standardization is based in Geneva, Switzerland, and is comprised of standards organizations from 158 countries, including ANSI (the American National Standards Institute) in the United States. Because an acronym for their organization would be different in different languages, they used the word “ISO,” derived from the Greek word “isos” meaning “equal.” Standards of all types are intended to act as an equalizer for companies doing business around the world.

The ISO organization promulgates many different types of standards, from the popular business management system ISO9001:2000, to standards dealing with other issues such as food production, medical device inspection, and pollution emissions.

Why get ISO9001:2000 certification?

There are two primary benefits to implementing an ISO9001:2000 quality management system. The first is the organizational benefits derived from greater efficiencies, fewer discrepant products made, possible reduction of costs, and greater customer satisfaction. The second is that lovely little certificate that you can proudly show to potential customers in the hopes of convincing them you are a good company to do business with. In some industries, major players will not even consider purchasing from you unless you have your ISO9001:2000 certification.

The standard is based on best practices for organizations. It provides management with tools to objectively decide where things are working well and where to apply resources to make improvements. ISO9001:2000 helps to maximize the effectiveness of your business, enhancing growth through increased customer satisfaction, and reducing cost. It can give potential and existing customers confidence that you have an organization that can consistently meet their needs.

What will it cost?

It depends on the size and type of your business, and how much time you have to implement the standard. If you have some time and want to tackle it yourself (which is often feasible), the only real costs will be in the time dedicated to the implementation process by you and/or your staff, doing research, writing documents, and training personnel. If you don’t have much experience with quality systems, or if you don’t have a lot of time available, you might consider hiring some professional help, in the form of a consultant. Consultants range in cost from $300 to $600 per day, and the time needed will totally depend on the size and complexity of your company.

There is also the cost of the registrar, which is the company that will be performing independent audits of your quality system. Most registrars charge a certain rate per day to be on-site at your facility. These days registrars charge about $1,100 – $1,500 per day per auditor. Small companies of 2 to 15 people might expect one auditor on site for 2-3 days; larger companies may require several auditors for an extended site visit. Please note you CAN negotiate with registrars for their days and fees. ISO9001 registars are businesses just like you, and they want your business. They are often flexible in their quotes.

There will be an initial registration audit, and then surveillance audits. You might choose annual surveillance audits, or possibly semi-annual audits. Ask your registrar about your choices and how they’ll work best for you. Surveillance audit costs will be less than the original registration audit, as the time spent will be shorter. Once every three years the registrar’s auditors will return to audit your entire system.

More on this later.

To Calibrate or Not to Calibrate Devices in ISO9001:2000

Monday, February 4th, 2008

One recent consulting gig was done at a company that wanted to have the ISO9001:2000 certificate, but wasn’t too thrilled at the prospect of actually doing everything needed to actually implement an ISO9001 quality management system. Unfortunately there are far too many companies like this out in the world.

One major area of concern was calibrating the company’s measuring equipment. They have about 50 employees, and over 100 various gauges and test equipment that you’d think would need to be calibrated. You’d think so, but the company quality manager didn’t.

About 20 of the measuring devices were used in the inspection department, and the rest used by production people in the course of their job. The quality manager wanted to control and calibrate only the devices in the inspection department, and label the rest “for reference only”. The reason given for this is that only the inspection department devices are actually used to sign off the various processes. The production devices are only used for “monitoring”, and to get the piece “in the ballpark”. No nonconforming material could make it to the customer without a final inspection by the inspection department, so no problem there. The worst thing that could happen is that a small number of products might be made out of tolerance and would have to be reworked, or produced again.

This didn’t fly with me.

It seemed that they had way too many guages in the company, many of which were rarely or never used. The “for reference only” argument doesn’t make sense to me. I see it as a pretty much black-or-white issue. Either the measurement matters, and you calibrate the equipment, or the measurement does not matter, and you should not make it. Why complicate things if the measurement doesn’t matter? What value is added to your process by performing measurements with out-of-calibration instruments? Not much.

My advice- if there’s value added by performing a measurement, then do it right and calibrate your equipment. If you don’t think a particular measurement is important enough to warrant regular calibration of your device, then I’d say you ought to seriously consider deleting that measurement from your process.