ISO 13485 certification represents tight control over the manufacturing processes. This matters to our customers because they sell life-critical products. The fear of receiving nonconformities keeps them up at night. We believe so strongly in giving our clients confidence in our delivered product that we continue to improve our quality management system and earned the ISO 13485 certification.
We announced today that we received the ISO 13485 certification for the design and manufacture of applications with custom injection molded plastic parts for use in the medical industry. Achieving the ISO 13485 certification represents a culture of continual improvement of Natech’s people and processes to reduce our customers’ anxieties. We make life better for our customers by developing skills in risk accountability, team learning, and improvement culture.
Risk Accountability
Our customers want to know that we manage their risks, and ISO 13485 places high importance on risk management. Building risk management and accountability skills made for a smooth transition into ISO 13485. Our customers do not want us to just tell them about all the risks we see in their applications and leave all the responsibility on them. This would basically dump the burdens and hassles onto our customers, making their lives more difficult.
Instead, we want to help our customers remove burdens, avoid hassles, and reduce efforts. We train our people to communicate risks in an easy-to-understand way. They then clarify the likelihood and impact and make suggestions to mitigate those risks. They transfer their knowledge by putting the lowest mental load on our customers.
We had originally started this with our external customers and realized we had developed risk management skills and accountability skills that could be used for internal customers. Adopting this approach internally changed the nature of our quality management system and helped us achieve ISO 13485.
Team Learning
ISO 13485 holds employee training as one of the most critical components. A danger with certifications such as ISO 13485 is becoming a slave to the process and allowing that process to become stagnant. Telling people to do it one way and only one way produces a genius-with-a-thousand-followers culture. This creates problems and works against the aim of continual improvement. On the opposite end of the spectrum, telling people to just figure it out can create disconnection and demotivate people.
Most training employs the lecture approach with some demonstration, but these represent only two among a sea of options. We discovered that employing a combination of more engaging activities achieves better learning.
Several years ago, Natech instituted safety training for all employees. During those first sessions, people remained passively quiet. Over time we started asking them questions and got them used to speaking and practicing in front of each other, and they started opening up. These days people speak up, share experiences, and make suggestions even outside of the training.
ISO 13485 does not work as a one-size-fits-all, perfect approach issued as a decree from above. We want to engage the team to continually learn together. This allows us to better tap into the collective wisdom of the group. That collective wisdom far exceeds the knowledge of any one person.
Improvement Culture
Fear is a threat to the aim of ISO 13485 or any quality management system. Some managers assume people will do a better job if they are afraid of doing a bad job. This unfounded and dangerous assumption can actually make things worse. Risks escalate and quality suffers when leaders adopt a Management by Fear approach and treat people disrespectfully.
People do their best learning and improving, not when they feel fear from above, but when they feel they are part of a supportive team continually learning and improving together. Fear will inevitably creep into the organization. Management can combat this by saying: “Let’s design this process together. Let’s implement it together. And let’s improve it together. I’m here to support you, not to scare you. We need you, and we welcome your ideas.”
Conclusion
When things go wrong, we want to fix the process rather than blame the person. By implementing the ISO 13485 standard, we have improved our risk management, employee training, and culture of improvement.
Natech’s ISO 13485 certification applies to both the primary contract manufacturing facility as well as the second contract manufacturing facility in New York. Natech has been ISO 9001 certified since 2003 and will continue to maintain the ISO 9001 certification at both contract manufacturing facilities.
If quality is critical to your product, and your application includes custom injection molded plastics, you can speak to a Natech Engineer at (631) 580-3506.