Kendall Malenfant performs a fixture changeover at the CSS manufacturing facility in Farmington, CT.
to give customers immediate assurance that we understand the medical business and all the required protocols,” said Steve Dicke, vice president of sales and marketing at CSS. “It makes sense for us—we will not need a team of auditors from pro- spective customers to review our processes before even being able to quote on a product.” Aſter making the decision, Gerry Godburn, quality
systems manager for CSS, launched a step-by-step process to achieve certification. Te company began by commissioning an ISO13485 gap
assessment from CONNSTEP, a Connecticut fee-for-service 501(c) (3) nonprofit organization that assists small and midsize manufacturing companies with critical business assistance. CONNSTEP connected CSS with a consultant skilled at assess- ing quality management systems. Te two-day analysis com- pared all the procedures required in ISO 13485 with those of CSS, documenting any potential weaknesses, and listing actions that would have to be taken to meet the particular requirement. “Te gap assessment shows where we are currently and what
needs to be done, and has become our roadmap for change,” said Godburn. He adds that CSS is now working internally to close the gaps before the pre-audit, scheduled for April 2013, and the full audit, scheduled for May 2013. Because CSS already has the aerospace quality management certification, it had already incorporated quite a bit of the requirements found in the ISO 13485, but the medical standard adds a lot more detail to the risk analysis and validation procedures.
“Everyone, from senior management to our 21 self-direct-
ed work teams, is focused on doing what it takes to implement the recommendations found in the gap assessment,” said Godburn. “Our training process will make it clear to everyone in the building that there can be no shortcomings in any of these procedures.” He reiterates that CSS has always staked its reputation on
its firm process control, and already had complete traceability throughout the plant, but ISO 13485’s very precise documen- tation requirements means that some items require a lot more record-keeping. With ISO 13485, there can be absolutely no change to any part of the process without prior authorization. Tis covers everything, from raw materials, to production steps, to exactly which machine is used. For example, ISO13485:2003, sec 4.2.4, Records, stipu-
lates that records are retained for at least the lifetime of the device. CSS’ records procedure must now be updated to specify exactly how that process works. Another example is ISO13485:2003, sec 6.4, Work Environment, stating that control of contaminated or potentially contaminated product must be established and documented. CSS was required to update its quality manual with a statement regarding handling of potentially contaminated product. How does this translate to real parts on the floor? “Each
customer is different,” Godburn said. “For example, one surgical tool customer for whom CSS has worked for more than 40 years used to use a standard one-piece first-article