Revisiting the ISO 9001 Software Standard

Chris Nahil
By Chris Nahil on July 1, 2021

Revisiting the ISO 9001:2015 standard

It’s now been over five years since introducing the ISO 9001:2015 standard—what’s changed? The 2015 update to ISO 9001 set out a requirement for organizations to approach quality management through what’s now known as the PDCA (plan, do, check act) protocol. By systematizing how organizations manage quality and assess risk, the update paved the way for the widespread adoption of ISO 9001 software and other quality management systems.

Year-on-year revenue within the QMS market sector grew 12% in 2019, rising to 16% in 2020. We can extrapolate that QMS adoption is also growing and that more manufacturers are adopting newer versions of ISO 9001 software designed to bring companies into compliance with the 2015 update. Now that the 2018 deadline has passed, any companies wishing to become ISO 9001 certified (or re-certified) must comply with the 2015 revision by default, which also drives the adoption of ISO 9001 software within the manufacturing industry and its associated verticals.

Why is ISO 9001:2015 so Closely Linked to ISO 9001 Software Solutions?

Several factors drove the 2015 update to ISO 9001:

  • Customers are demanding a higher level of quality from manufacturers. In an industry survey from 2018, 53% of consumers now rank quality as more important than price when shopping for new products.
  • Second, supply chains have vastly increased in complexity. Before 2015, the most recent update to the ISO 9000 standard was in 2008, and this, in turn, relitigated parts of ISO 9001:2000. Meanwhile, the supply chain became vastly more complex in this interval. One measurement for this is the manufacturing employment share within the US. It went from around 15% in 2000 to below 10% in 2010 as supply chains migrated overseas.
  • New technologies are emerging. The years since 2000 have been marked by the rise of AI, automation, the cloud, and the Internet of Things. These technologies provide both opportunity and risk for manufacturers.
  • Lastly, the externalities of manufacturing have become too pronounced to ignore. Customers now demand sustainable products, which means that manufacturers (and by extension, the ISO 9000 standard) need to adopt systems of accountability that bring sustainability to the fore.

All these new developments have in common is that they all bring new elements of risk to manufacturing at large. There’s a risk that quality won’t be good enough to meet customer demands, increased risk of failure in complex supply chains, the risk that advancing technologies could leave manufacturers behind, and the risk of environmental crisis due to manufacturing externalities.

As such, ISO 9001:2015 introduced many elements designed to help manufacturers control risk. It starts by defining risk-based thinking. In short, the risk is the effect of uncertainty, a circumstance where the expected outcome fails to result (for good or ill). Risk-based thinking explores the ramifications of this unexpected outcome and considers whether unexpected outcomes are likely to occur.

So, where does this emphasis on risk intersect with ISO 9001 software? The fact of the matter is that humans are bad at calculating risks on their own. People tend to overestimate the odds of unlikely events while underestimating the likelihood of more probable events. They also tend to think those good things can happen to them due to their choices, even when others experience bad outcomes based on the same set of choices. An example of this is playing the lottery. People overestimate the likelihood of winning the lottery, and they tend to think that winning the lottery won’t ruin their lives, even as they see other lottery winners exhaust their winnings with lifestyles of outrageous excess.

Hence, software. ISO 9001 software helps manufacturers and quality managers make more accurate risk assessments.

How Does ISO 9001 Software Improve Risk Assessment?

Software can make significant improvements when it comes to ISO 9001:2015 compliance—and the most significant improvements come from how software helps companies manage risk.

ISO 9001 software helps quality managers both formalize and standardize the risk assessments necessary for ISO 9001 compliance. For example, much of the QMS software currently available contains modules for failure modes and effects analysis or SWOT analysis.

This has led to some follow-on effects. For example, previous iterations of ISO 9001 didn’t encourage quality managers to change their objectives year over year. Six years after the new iteration, we’re now seeing quality managers pursue a renewed commitment to quality, changing quality objectives based on continuous risk assessments.

We’re also seeing some cross-pollination of risk assessment practices between industries, most notably with companies outside the auto manufacturing industry adopting the production part approval process. With software, adopting quality processes from other industries can be as simple as drag and drop.

Lastly, ISO 9001:205 has led to a more encompassing way of examining risk—and software certainly helps with that. Software makes risk assessment easy, repeatable, and in some cases automated—which means that it’s easy to scale risk assessment to other parts of the organization. This dovetails with some updated aspects of ISO 9001:2015, which stresses the importance of understanding risk within the organization’s context at large.

Six years since the debut of ISO 9001:2015, we see that companies have turned their quality initiatives from line items into major strategic initiatives with the help of increasingly advanced EQMS applications. Because of this, the manufacturing industry is getting closer to its overwhelming objective—of ensuring that quality is fundamentally embedded into the organization.

Want to learn how advanced QMS software can help you meet your ISO 9001:2015 obligations?  Contact us for a free demo today!