ISO 9001 - The ISO bestseller

As systems engineers, we have to deal with standards a lot. But in the hectic day-to-day business, we quickly focus only on what the work requires. Be it ISO 26262 in the automotive environment or ISO 14971 in risk management for medical devices.

Sometimes the basics are neglected. One of these basics is ISO 9001, which can be described as the ISO bestseller.

Key data on ISO 9001

ISO 9001 is part of the ISO 9000 series of standards, which deals with the principles of quality management. This series of standards is generic and is relevant for all organizations, regardless of whether they manufacture products or offer services. The target group of ISO 9000 is therefore correspondingly large.

However, ISO 9001 also has a special position within the series of standards: it is the only standard in this series that can be certified.

Number of valid ISO 9001 certifications: 1,106,356 (2016)

Source: IAF

Certification can also be obtained with relatively little effort and is therefore a simple and inexpensive way of signaling quality. This is particularly interesting for young companies, including those whose home countries have little regulation.

The standard comprises only 29 pages and is to buy for 138 CHF (approx. €128).

Deming circle

ISO 9001 specifies the minimum requirements for a quality management system. In most companies, such a system is likely to consist of a few Word documents (or wiki pages). This system must ensure that customer expectations and legal requirements are met. Furthermore, there must be a continuous improvement process.

For implementation, the standard is based on the deming cycle, also known as the PDCA cycle. This stands for:

• P - Plan: Instead of simply changing processes and procedures, this must be carefully planned. In particular, the potential for improvement should be analyzed.
• D - Thu: After careful planning, the changes are tested. It is important here that the process is not yet rolled out on a broad scale without first testing its effectiveness. In other words, an experiment is carried out first. Another option is to introduce the processes but only automate them after a review.
• C - Check: The results of the experiment must be carefully analyzed to confirm that the desired improvements are manifesting themselves.
• A - Act: Only now that its effectiveness has been proven can the process be rolled out on a broad scale. This must also be checked. What good is the best process if nobody adheres to it?

Derived standards

ISO 9001 is the basis for many other derived standards, which are generally domain-specific. These do not always have to be ISO standards. These include, for example

• IATF 16949 - Series production in the automotive industry
• ISO 13485 - Medical devices
• ISO 50001 - Energy management systems
• ... and many more

A quality manager for medical devices will certainly use ISO 13485 and not ISO 9001, which is correct, but it can't hurt to know the original. Apart from that, ISO 9001 will also be relevant for a manufacturer of medical devices. Only when it comes to products (and not, for example, accounting) is ISO 13485 the right standard.

Conclusion

In the article The four most important systems engineering standards ISO 9001 was not mentioned. This is entirely justified, as it was about systems engineering in particular. Nevertheless, every systems engineer should have held ISO 9001 in their hands at least once.

Image source: From Karn-b - Karn G. Bulsuk CC-BY 4.0 via Wikimedia