ISO 9001, “Best Practice”, and Common Sense
To look at 3D Engineering’s website, you’d be excused for thinking that, with their impressive portfolio of clients, they had held ISO 9001 for many years. Surprisingly, a formal qualification is a new venture for them. Not that they didn’t have their own existing Quality Management System. What was needed was the process for applying their best practice on a consistent basis
Steve. Marshall, Managing Director, seems affable enough, but it’s easy to detect a certain steeliness and rigour in his approach to his work. He’s clearly a man of high standards, which may account for why his business is so successful, listing some major multinationals as long-term customers.
“In looking at the whole ISO 9001 approval process, I could see straight away that this was not something we could do ourselves in-house and purchase the approval off the shelf. I was determined that we would do this properly” says Steve.
I ask him what might have put him off going for ISO 9001 accreditation if the business was doing well anyway. “This stuff does not come cheap” he says. “but we were determined to do it well, and do it right”
Was there anything hard or surprising? Not really, despite the issue of controlling the design process of a product being far harder than controlling the manufacturing process, the main challenge was fitting their existing quality management system into the ISO 9001 framework. Fortunately,Colin Brown of ISO Consultants,with his strong background in both design and manufacturing, made the outwardly challenging surprisingly common-sense and simple.
And, what about the day of The ISO 9001 Audit? “Colin demystified the actual audit interview, as well as intervening at certain points when there was a need to simply shut up and move on!”
For 3D Engineering Ltd, ISO 9001 approval is not an end, but a beginning. Several times in our interview, Steve mentions ISO 13485, the exacting Medical Devices Standard. “We’re already looking at accreditation fairly soon”, he says. There is obviously a large opportunity approaching. It’s clear that, despite strong existing relationships with the quality assurance departments of their major customers, accreditation affirms them as reliable supplier of high standards and integrity. A change in procurement personnel won’t jeopardise their position -their status will be built not only on long-term track record, but on a prestigious international standard.
“And, after all this, ISO 9001 is very good for us” says Steve. “It helps us manage processes through our quality management system, putting a formal and recognised rubber stamp of approval on best practice.”
Written by Colin Brown of ISO Consultants