To help prepare for certification, Composite Resources employed an outside consultant who walked the company through the certification process, trained internal auditors and conducted a gap analysis to identify areas that weren’t up to the standard. Relying on an outside consultant is key, says Amy Autovino, quality technician at Composite Resources. “You’ve got someone who comes in, knows the standard and can explain to you the things that you don’t understand,” she says.

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Machinist Ed Lenhard drills holes in a part for a medical device manufactured by Composite Resources. Photo Credit: Composite Resources

Composite Resources is currently preparing to certify to the newer ISO 9001:2015 standard. To get started, Autovino and the quality manager completed a week-long audit class covering the updated standard at South Carolina Manufacturing Extension Partnership (SCMEP), a non-profit group that offers a range of resources to companies in South Carolina. Then they began revamping processes to adhere to the updated standard.

One of the changes in the ISO 9001:2015 standard is an emphasis on risk-based thinking, which requires companies to consider the consequences – especially negative ones – of any proposed action. While previous standards required “preventative actions,” the 2015 standard calls for a systematic assessment of risks at every step of the quality management process, from planning and operations to analysis and evaluation.

“It’s a mindset that helped everyone think about risks associated with projects and shop floor activities,” explains Autovino. For example, new product/part launch meetings held by engineering staff now include a discussion of the pros and cons of the intended project; potential delays related to materials, machining or layup; and worst-case scenarios.

The new standard also places more emphasis on how the input and output of various business processes interact with each other. For instance, how does the output of the sales team (orders) become input for the engineering department (products to be designed)? Composite Resources created diagrams to analyze and document the input and output of each of their processes.

After a few weeks of internal preparation, a consultant from SCMEP conducted an audit and provided a gap analysis. Autovino says the company was confident in its processes, but was unsure how to implement a few into their ISO quality manual. “We used the gap analysis to make sure we did not miss any important information,” she explains. Next, the company will conduct an internal audit to prepare for July certification.