ISO Quality Standards

Last week we discussed a little about AS9100. You may have seen other ISO standards too. In fact, ISO standards are in use today by over 600,000 companies, worldwide. So what are they for and what is the real difference between them?

With quality you get what you focus on. In other words, the standards try to focus your organization on saying what you do and then doing what you say, while at the same time keeping the customer in mind. The idea is to eliminate variation within your organization. Top Seven Quality Standards

Let’s see what each standard is and how they relate to each other. There are a number of quality standards you could seek ISO registration for, but lets look at the top seven:

1. ISO 9001 Quality 2. ISO 14001 Environmental 3. SAE AS9100 Aerospace 4. ISO/TS 16949 Automotive 5. ISO 13485 Medical Device 6. ISO 22000 Food Safety 7. ISO 27000 Computer Security

ISO 9001 Quality

First there was the ISO 9000 Quality Standard. It was based on the US military standards (MIL-STD) and the British BS5750, both of which evolved from work done during Word War II to ensure safe and reliable creation of weapon systems. Eventually, as the efforts to unify industrial standards gained momentum under the watch of the International Organization of Standardization (ISO), a new ISO quality standard was born.

The latest ISO 9001:2000 standard defines guidelines for establishing a management system that provides confidence in the conformance of your product to customer and applicable statutory & regulatory requirements . This is similar to Philip Crosby’s definition that quality is conformance to customer requirements. ISO 9001:2000 also seek s to enhance customer satisfaction through continuous improvement using the Plan-Do-Check-Act scientific model.

Yes, this is easier said then done. Most people think that conformance to ISO 9000 is quality. The reality is that conformance to ISO 9000 says your company is ready to deliver quality. Now you have to improve and actually do it. You have to strive for continuous improvement. ISO 14001 Environmental

Next came ISO 14001:2004 Environmental Quality. This was really a response to the environmental movement, which lead to rising environmental regulatory compliance. I do not know why we had to force corporations to be good corporate citizens. But the idea is to completely understand how your manufacturing process interacts with the environment and then eliminate harmful effects to produce sustainable development. All ISO 14001:1996 certificates will expire on May 14, 2006.

The Environmental Standard ISO 14001:1996 was revised effective November 15, 2004. All organizations currently certified to ISO 14001:1996 have until May 15, 2006 to upgrade their Environmental Management System (EMS) to the 2004 revision level. ISO/TS 16949 Automotive

But wait, now we have the latest ISO/TS 16949 automotive standard designed to integrate the old QS9000 with the latest ISO 9001:2000. Why does it use the “ISO/TS” designator? Because it is a Technical Specification (TS) and as such it was developed by a working group from the automotive industry.

ISO/TS 16949 is still an option for some. It does not replace the old QS9000, yet. Although, most of the automotive companies have set deadlines including the last of the big ones (Ford and GM) for Dec 14, 2006. SAE AS9100 Aerospace

Well, these quality standards were not enough so the aerospace industry decided it needed its own standard to address specific sector requirements such as safety. It was developed by the International Aerospace Quality Group (IAQG) and is technically equivalent to AECMA prEN 9100 for European aerospace suppliers. It was developed in the United States as AS 9000 in 1997 and later updated to AS9100 in 2001.

The aerospace quality standard has about 80 additional requirements plus 18 clarifications for the aerospace industry. Mostly the changes reflect issues for safety and manufacturability so although it is an aerospace standard it does not contain specific language for aerospace. Think of it as a more detailed, safety conscious manufacturing standard. ISO 13485 Medical Device

The ISO 13485:2003 standard is based on the ISO 9001:2000 quality standard like all the rest (and includes the old ISO 13488). But, Unlike ISO 9001:2000 Continuous Improvement and Customer Satisfaction are not as stressed in ISO 13485 instead the emphasis is on regulatory requirements and device safety. I guess the idea is that if the device is safe then the customer should be satisfied -- not exactly my definition of quality. All ISO 13485:1996 users must transition to the new release by July 15, 2006.

Note: with the introduction of the new 2003 update, anyone using the older 1996 version has until July 15, 2006 to make the transition to the new release. ISO 22000 Food Safety

ISO 22000:2005 is for organizations that operate within any part of the food chain. It is based on the HACCP (Hazard Analysis and Critical Control Point System) principles of food safety risk management and includes the use of prerequisite programs to make a safe food supply.

The standard does not address corrective and preventive action because the use of HACCP and prerequisite programs address this within the food industry. Nor does the standard stress product design and realization. Otherwise it is aligned with ISO 9001:2000 and Plan, Do, Check, Act (PDCA). ISO 27000 Information Security

Today information security is an ever increasing and growing problem. ISO 27001:2005 is the specification for an Information Security Management System (ISMS). The standard replaces the long standing BS7799 standard first published in the nineties.

Some may be familiar with ISO/IEC 17799:2005 and wonder what’s the difference? Well, ISO/IEC 17799 is an advisory information security standard and not an auditable standard like ISO 27001. If you want to certify your organization’s information security system then you will need to pursue ISO 27001. Other Standards?

Have we left some out? Maybe, ISO has over 16,000 standards ranging from electrical specifications to road signs and the weather. But, we have covered some of the main standards in the quality area. And there are more coming.

Soon we will have separate standards for schools, hospitals, and other industries. Is this a good thing? I am not so sure. Increasing the market’s fragmentation of standards only increases complexity. But for now, you have probably learned more about ISO standards than most people in quality.

To learn more about implementing continuous process improvement within your organization, attend the next improvement class How to Align a System of People and Processes for Results . Or, Learn How to Create Well-Defined Processes and to document processes.

ISO 9000 Quality Auditor classes are forming now for Internal Auditor or Lead Auditor. Call for information on having your own private in-house classes today.

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