As you certainly know, ISO 9000 is a series of quality-management systems designed to help organizations maintain compliant, productive and, above all, safe business operations. Revisions to the ISO standards are delivered every three to five years or so, and the newest, ISO 9001:2015, is expected to bring new challenges and opportunities to large machining and manufacturing concerns as well as smaller, more regional-focused ones.
Organizations maintaining the previous, ISO 9001:2008 standard have until the transition period ends in September 2018 to update their certifications. No matter how big is the pond you swim in, it’s worth taking a look at what’s changed and how you’re likely to be affected.
How will smaller shops be affected? ... And larger operations?
The mantra associated with ISO 9001:2015 is: “Plan, Do, Check, Act.” Each of the previous versions of ISO 9001 delivered its own unique refinements to the overall formula. If there’s a theme to the 2015 version, it might be “operational mindfulness.”
This most recent update to ISO 9001 is designed to focus on, and further enhance, participating organizations’ quality management and “risk-based thinking.” For machining operations, there are several takeaways:
• ISO 9001:2015 provides new quality-management processes that “loop in” management and streamline communication, from the top of an organization to the bottom.
• ISO 9001:2015 places high-level emphasis on long-term thinking, unlike previous iterations, which had been criticized for their procedural rather than strategic focus.
• In terms of “risk-based thinking,” ISO 9001:2015 provides new guidelines for anticipating and studying the potential adverse effects of new processes. It encourages, in essence, a sort of holistic “mindfulness” of how each moving part in a business impacts the others.
This type of certification doesn’t demand or expect that every company will completely eliminate risk. What it does is prescribe detailed procedures to help participants engage in high-level thinking about how each modified or brand-new operational or business process will impact your likelihood of future success. To put it another way:
ISO 9001:2015 is about quantifying risk in a more specific way than what you do right now. It does not provide any sort of formal “grading” rubric for you to use, but this version does instruct participants to apply some kind of internally consistent scale to each new process and business decision and the risk it represents.
For larger machining operations, risk may take many forms:
• Investing in new manufacturing technologies or techniques without compelling case studies.
• Failing to assemble proactive contingency plans in the event of unforeseen setbacks or business disruptions.
• Shopping around for a more inexpensive vendor of raw materials at the expense of the end-product’s durability and salability.
It might sound like unnecessary bureaucracy at first if you already have a strong, quality-focused culture. But consider the many advantages of having every participant in a supply chain — from product design to management to material procurement — work from the same “rulebook” and set of guidelines. In the global economy, this attempted confluence of values has never been more important.
Should small business owners worry about the effort and expense involved? Is certification to the 9001:2015 standards onerous and unnecessary? In all honesty, it depends on your business. But along with heightened expectations, the new version of ISO 9001 also delivers lots of opportunities to businesses that participate.
If you anticipate applying 9001:2015 certification to your manufacturing processes, here’s a crash course on what’s expected of you (and what’s not):
• If your process works already, don’t change it just for the sake of change.
• If you don’t have one, put together a “quality assurance” manual for internal use that mirrors the official ISO requirements.
• If the work you do requires other forms of certification, including other branches of ISO or OHSAS standards, you’ll find the requirements for ISO 9001:2015 appropriately tailored to help small businesses more affordably pursue multiple certifications at once.
Certification of any kind comes with a certain expense attached — one you can measure in time and money. But when you think about the ISO guidelines as an educational process for you and the rest of your company’s human component — because that’s exactly what it is — it looks less like an obligation and more like an opportunity to become leaner and more competitive in an increasingly crowded global marketplace.
Is ISO 9001:2015 Certification Worth Your Time?
According to official ISO records, there are over one million organizations worldwide with ISO certification. The standard is a familiar presence in commerce, manufacturing and machining in 170 countries. That sounds like overwhelming endorsement — but it also raises the question: Is ISO 9001:2015 certification worth your time and resources? As far back as ISO version 9000:2000, authorities in a number of industries have openly questioned the relevance of the ISO 9000 family of guidelines, at least for certain industries. Here are some real-world numbers to help you decide:
Among the businesses participating in MFG.com — touted as the world’s largest directory for manufacturing buyers and sellers — just 25% carried certification with ISO during its previous incarnation, ISO 9001:2008. That means seeking certification might be a value proposition, and one that helps you stand out from the competition. It also means there are many machining and manufacturing businesses that get along fine without it.
Even if ISO certification is a voluntary process, you can expect more and more businesses to partner with operations that take waste reduction, efficiency, and safety seriously. In construction, engineering, technology services and just about any type of manufacturing, ISO certification isn’t a suggestion — it’s an unspoken requirement. These are industries that are extremely risk-averse when it comes to wasted resources and safety implications, so expect to find some doors closed to you if you don’t pursue certification.
If you manufacture parts for automobiles, certification with ISO 9001:2015 can help ensure you remain aware of, and in compliance with, increasingly stringent safety and environmental regulations. If you provide general engineering and machining services and have a role to play in product design, the consistency of your work is perhaps your greatest and most valuable asset. ISO certification speaks to that.
Not to mention: Hosts of new manufacturing techniques and standards arise on a regular basis, including rapid prototyping, additive manufacturing, 3D printing and more sophisticated diecasting and machining technologies. As prospective customers all over the world discover how much more accessible the manufacturing sector is to them now, they will naturally look for partners with the appropriate certifications and credentials to help guide them through a quickly-changing manufacturing landscape.
The decision to pursue certification according to the 9001:2015 standards (or not) is yours to make. Just remember that taking these extra steps will help you send a message with every bid that you take your work seriously, and that you value the people who lend you their time and talent. And, since you’ll come away with a better understanding of what it takes to deliver world-class products in a timely fashion, how to minimize risks and how to bolster workplace safety and efficiency, you’ll likely find the peace of mind involved here is a two-way street for manufacturer and client alike.
Megan Nichols is an amateur astronomer and environmentalist, and a writer on a wide range of scientific topics. Her recent contributions to AmericanMachinist.com include a guide to troubleshooting metal-forming failures, examined the methods and applications of different metal finishing processes, and the different advantages of electroless plating and traditional plating technologies. Follow Megan on Twitter @nicholsrmegan.
