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ISO 9001:2000 is a quality systems standard created by the ISO (International Standards Organization) to help standardize the minimum requirements for a quality system.

The standard is 9001 and the revision level is 2001. The ISO 9001 standard is widely excepted in the EU (European Union) and somewhat accepted in the US. Because ISO certified company are urged to buy from other ISO companies as part of the requirement for purchasing (section 7.4) portion of the standard, the number of companies getting certified continues to grow at a slow rate.


The requirements for ISO certification from a supplier are still very strong in the process and safety industry. It can be very difficult to sell into these markets without a certified quality system. Products such as gas chromatographs, flow meters, process temperature and pressure measurement equipment, and other equipment that helps control a dangerous process are great candidate for manufacturing under the ISO 9001:2000 standard. Many of the these product require safety approvals such as FM, UL, CSA, Cenelec, and ATEX. These safety standards are working with ISO to unify the auditing process by bring ISO and the safely audit requirements together. These safety standard regulate the product design and ISO regulates the manufacturing process to ensure that the final product is consistently build to high quality standards.

The ISO9001:2000 standard requires:

  • Customer centered focus for the company
  • Maintaining CONTROLLED documentation of all processes in the company
  • Extensive record keeping for the purpose of maintaining history and providing evidence during audits
  • Maintaining product quality through the use of good purchasing, trained personnel, process control and product testing
  • Application of some of the companies resources (including top management) to the quality system
  • Continuous improvement of the companies processes and quality system
  • Routine audits (both internal and external) to confirm compliance and for feedback into the preventive and corrective actions system.

Another way to look at the standard is: What are the additional requirement that most companies are not already doing? With this perspective, there are 4 areas that may require additional resources.


1 Document how you operate your business

This is something that most successful companies do even before they hear about ISO 9001:2000. Documenting your process helps make training/cross-training easier and helps eliminate random errors. If they don't already exist, he company must create procedures on how to build your products, communicate with customers, and monitor your processes.

2 Create and maintain documentation to comply with the standard

This includes a some elements like a ISO 9001:2000 quality manual and an all-inclusive document control procedure that the company may not have fully documented. The ISO standard also requires:

Samples of these are available on this web site.

3. Maintain records to allow auditing to the ISO standard.

The quality manual and the company procedures will require the generation and maintenance of quality records for each area. This includes design reviews. production instructions, production records, management quality control meetings, personnel training, internal audits.

4. Show continuous Improvement

The 2000 revision to the ISO 9001 standard place an increased emphasis on continuous improvement. Once again, most successful companies already have some kind of continuous improvement program. The focus in on improving the products and also improving the process

The samples on this web site are designed to fulfill part 2. The ISO standard says you shall do specific things. Each procedure or document that you generate says we do these things and here is how we do it. You must add the detail of how you want to perform the tasks. Then you must generate records that show that you are using your system properly.

If you are just getting started and don't know where to start, try our 10 steps of implementing ISO 9001 that can be found on the articles page.

If you already have started and want a basic understanding of the areas, chose the links to the right of this page or go to the articles page to get more information about ISO 9001:2000.