Pretty much everybody has heard of ISO 9001 – something to do with quality management – but what’s important is that it’s practiced in reality. As one of the first manufacturers of content management systems, we are now undergoing ISO 9001 certification. This is objective proof that we live and breathe quality management.
ISO 9001 – An Industry Standard
ISO 9001 has been around since the end of the 1980s. Especially industrial companies started to deal with this standard early on, however, often enough they got their noses bloodied in the process. Euphoria was great in the beginning; much more was regulated in the first flush of excitement than was good for seamless operating procedures. Binders full of quality manuals were produced, regulating every last detail; with the consequence that there was no flexibility when something unexpected happened. In the end, the outcome for many companies was that they had quality management sitting on their shelves, but continued on as before.
Many companies have stories to tell from the early days of the norm. In the meantime, though, the situation has greatly improved. Since the revision of ISO 9001 in the year 2000, a process-oriented approach has been implemented. The trend is shifting away from regulating the “what?” (i.e. of individual procedures and details) and towards documenting the “how?” (i.e. of quality measures and underlying quality assurance methods).
ISO 9001 – Room for Quality
ISO 9001 has indeed become the norm in industrial companies. In some areas – such as for our customers in the pharmaceutical sector – nothing is possible without quality management. As a part of Good Manufacturing Practice (GMP), it forms the basis for all essential operating procedures. But many other large companies also require that quality management such as ISO 9001 is followed, not lastly because their own quality management dictates this.
At SCHEMA, quality, customer management, and continuous improvement have been very important for years now. We have proved this time and again in multi-day audits which our pharma customers perform with us onsite. What could be more logical than to establish this quality requirement objectively for our customers from other areas as well? ISO 9001 provides the ideal basis for this.
The revised version of the standard will focus even more strongly on the process-oriented character of quality management: Plan – Do – Check – Act. In addition, it offers greater freedom for the formal design of the documentation and QM manual. As a company that is continuously focused on innovative documentation techniques, we value this freedom.
ISO 9001 – Done Right
It’s important to set the course correctly right from the start. This starts with the choice of a certifying organization. ISO 9001 certifications can be had for a nominal fee; the certification then consists of the documents being approved without much review. This results in the label “ISO 9001,” but doesn’t do much for serious quality management. A good certifier will help and advise you. From his experience, he knows about typical problems and understands how to evaluate the appropriate QM mechanisms for the different companies.
This feedback and expertise is irreplaceable if you’re serious about quality management. In the end, it’s not the ISO 9001 logo on your website that makes the difference. It’s also not just an administrative department that “does quality management.” The difference is if your entire company “lives and breathes quality.” With ISO 9001 we have the ideal basis for that.