In the B2B world, quality assurance is paramount. Quality doesn’t only impact product performance; it affects relationships, contracts, and long-term collaborations. One such renowned standard-bearer is the International Standards Organization (ISO). At Estes, we are both ISO 13485 and ISO 9001 certified.
But what do these certifications truly mean for our customers? Let’s dive in.
ISO 13485 primarily focuses on medical device manufacturing. This certification ensures that companies have a management system in place to meet the stringent requirements of medical device regulations and quality.
ISO 9001, on the other hand, is a universal certification that speaks to the quality management systems of any organization, ensuring they meet customer and other stakeholder needs within statutory and regulatory requirements.
How ISO Benefits Estes
ISO doesn’t just provide a badge for companies to wear with pride; it lays out a comprehensive framework that companies must adhere to.
Some of the ISO standards integrated with the Estes Quality Management System (QMS) include:
- Understanding external and internal issues that are relevant to our customers’ purpose and strategic direction.
- Management taking an integral role and placing high priority on the QMS.
- Identification of risks and opportunities, along with a strategy to address them.
- Standards and processes for support resources: the people, equipment, environment, metrology, and traceability.
- Document control, ensuring all processes and procedures are recorded.
- Continuous monitoring of supplier performance.
- Production and service plans for goods sold.
- Control procedures for non-conforming products.
- Demonstration of continuous improvement.
Benefits to Estes’ Customers
The real winners here are the customers. “Being certified gives our customers confidence that Estes is always striving to improve by monitoring quality,” Estes Quality Manager Rich Kleiman says. “These certifications demonstrate that Estes takes customer satisfaction very seriously, and they can expect Estes to work toward zero defects.”
The Power of ISO Certification
With these certifications in hand, Estes can confidently do business with customers who require such certifications as a prerequisite. It validates Estes’s commitment to adhering to international standards and ensuring quality at every step.