John Nolan It is universally recognized that the attainment of an ISO 9001:2008 accreditation is a positive thing for any organization (see Six Key Benefits of ISO 9001 Implementation), but while ISO 9001:2008 is a standard which is applied across a vast range of industries and sectors, the focus can change slightly depending on what industry you work in. A good auditor will quickly understand your business and the needs of your customers, and may place extra emphasis on certain aspects of the standard and how your company deals with them, though it is always preferable that you identify these aspects in advance for yourself.
How I started with ISO 9001
During my fifteen years in the electronics industry in the UK, ISO 9001 accreditation was almost a necessity if other blue chip companies were to do business with you or partner with your organization in any joint venture; therefore, my first venture into the ISO process came as a quality manager within that sector.
Purchasing the standard for the first time, I pedantically followed the sections and set about ensuring that I had processes, documents, and forms in place for all the relevant internal, external, and customer-related processes. We followed the “plan, do, check, act” mantra as best we could, and ensured we had all ensuing evidence to support our processes. All we had to do was wait on the auditor arriving and begin.
Specific items to note where ISO 9001 applies to electronics
The first ISO 9001:2008 auditor I met had a background in the electronics industry similar to mine, but with more experience. As well as understanding the standard fully, he understood how application of the terms of the standard directly affected the product we delivered to the customer, and how the reputation of an organization in our sector could be damaged quickly on the basis of that performance. While we all know that customer feedback, supplier assessments, and all associated factors are important, he declared that he wanted to pay particularly close attention to section 7.6: Control of monitoring and measurement equipment.
Within our organization we had a manufacturing and repair process for computer motherboards. In order to support this, we had a vast amount of machinery we needed calibrated, from multi-meters and oscilloscopes to solder wave and component placement machines, including some very high-specification BGA (Ball grid array) chip placement machinery. The auditor explained that while the people could be well trained and educated and the processes could be as lean and slick as possible, virtually 100% of our accuracy of output depended on this array of finely tuned machinery. No matter how good an engineer’s assessment, if a machine performed at 20 degrees below the temperature it was thought to, it could create a significant long-term problem for the product that is initially undetectable to the human eye. Roll this out across the machinery you have in a normal working environment, and you can see that the risk increases exponentially.
Where ISO 9001, Risk and your product all connect
Thankfully, all our calibration was up to date and our audit was successful, but this incident led me to think about what the auditor said. We performed calibration more out of obedience to the standard than for the benefit of our product and process, which can’t be a good thing. It also caused me to look again at the rest of the standard, and contemplate on why the individual sections exist, which was a valuable lesson. Follow the standard for the sake of compliance, but believe in the actual ethos of it if you want to deliver customer satisfaction and product longevity.
And make sure you have that calibration sorted out before your electronics process is audited!
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