ISO 9001 is the international standard for quality management systems.
Why do I need a quality management system? Don’t I already deliver quality products or services?
This is often the first question companies ask themselves when confronted with a customer asking about an ISO 9001 certificate, or when such a certificate is asked for during procurements.
I can offer a short answer to that: of course the company delivers quality products or services. If that were not the case, then the company would not have any customers for their products or services.
However, customers want the certainty that the entire process from request to delivery will take place in a demonstrably controlled manner, thereby also having more certainty that the products or services will comply with what has been agreed upon.
A company can provide customers with that certainty by using a quality management system that complies with the ISO 9001 standard.
What changed in October with the EN ISO 9001:2015?
As an auditor, I have been involved with the quality world for some time now, and I have also seen the entire ISO 9001 series, with all its small—and sometimes big adjustments, come and go.
I have been conducting audits for QMS International for a number of years; many of these audits have included the ISO 9001, and since the beginning of this year, the ISO 9001:2015. In my view, the changes that have been made to the ISO 9001:2015 are relatively big ones, but they certainly have positive aspects for the user.
With the application of the High Level Structure (HLS), it is easier to set up a management system in which for example an environmental management system compliant with the ISO 14001:2015 can also be integrated in addition to the quality management system.
In practice, I have seen a relatively large number of companies take the step to the ISO 14001:2015 after having established or transitioned to the ISO 9001:2015.
Moreover, the ISO 9001:2015 for example no longer requires a Quality Handbook containing the six pre-written procedures, which means that the ‘paper quality management system’ can be minimalised.
Furthermore, there are a few new standard requirements in the ISO 9001:2015, such as “insight into the organisation and its context”, “insight into the needs and expectations of stakeholders”, and “actions to address risks and opportunities”. These are matters that company leadership might see as strange at first glance, but if you read through the standard, they are matters that leadership is actually already addressing. In fact, what it boils down to is that the company leadership’s ‘gut feeling’ needs to be made transparent in a systematic way, and it must then be acted upon in a demonstrably controlled manner.
In short, in my experience I have seen that once companies have delved a bit deeper into the standard or become more informed on the matter, they no longer see the ISO 9001:2015 as yet another new burden, but rather a distinctly beneficial standard.