ISO Certification

Quality excellence is fundamental to us. This means meeting or exceeding quality requirements and standards for all operational aspects, products and services. Our products are extensively tested and are accepted by major international Classification Societies.

Our ZKJA lithortriptor has been ISO 9001 and ISO 13485 certified since 1995, a record we are very proud of. Our quality system was assessed by CMD, a highly reputable registrar organization specializing quality certification for medical devices.

What is ISO?

ISO is the International Organization for Standardization, headquartered in Geneva, Switzerland. To help support the promotion of free trade between countries, ISO was originally formed to establish an impartial system of quality standards which all countries could recognize and accept. Presently, experts from over 90 countries, including the United States, work cooperatively to establish standards for businesses to follow in their operations.

To qualify for this prestigious certification, ISO first reviews the documentation of a company's quality system. If the documentation meets standards, an onsite, independent third party audit is conducted which can typically take between two and five days to complete. All employees, including all levels of management, are fair game for auditor questions and analysis. To qualify for registration, the auditor must verify first-hand that the company's quality system complies with ISO standards and is known and followed by employees. A company is typically audited for recertification every 12 months. Since the registration process is demanding and expensive, generally only companies which can back up their commitment to quality with effective systems are successful.

What does this mean to me, the customer?

Working with an ISO registered company means you can feel comfortable you are getting goods and services that are manufactured to the highest quality standards. Our standard of quality is more than just a promise or a goal. It is a proven, documented and effective system that achieves results repeatedly, and moreover, is a world recognized symbol of excellence. At ZKJA, it is just one of many ways we achieve total customer satisfaction.