Quality and Regulatory Standards
ISO 9001 Registered
Manufacturer and Designer
|ISO 13485 Registered||ANAB Accredited|
At HVO we strive to satisfy customer expectations, and we value our ongoing commitment to quality in the healthcare industry. Additionally, HVO’s strong infrastructure has been supported by meeting well-established medical quality and regulatory standards. With over 35 years of excellence in quality medical products, HVO is considered to be an industry leader with its comprehensive, mature, reliable, and reputable Quality Management System (QMS).
HVO has established, documented, implemented, and maintains an advanced Quality Management System to ensure that our products and/or services consistently comply with specified requirements. Additionally, this system monitors and improves the effectiveness of processes throughout the organization. HVO systematically conducts internal audits and has implemented systems and processes within our Quality Management System to maintain medical product quality assurance.
HVO offers medical product quality procedures including: a quality policy and quality objectives, medical device specifications, specialized equipment, standard operating procedures (SOPs), production process qualifications, quality assurance procedures, packaging and labeling provisions, preventative maintenance processes and work instructions. HVO further monitors the air quality of medical production areas as required by industry regulatory bodies; this analysis ensures the highest level of environmental controls for HVO’s medical production facilities.
At HVO the quality of both our medical products and the manufacturing facilities are of chief importance. We apply strict medical product quality and safety standards to all of our processes. HVO also follows well documented and ISO-driven processes to meet all compliance standards and testing requirements. These standards ensure required characteristics of our products including: quality, safety, dependability, & efficiency. The company also undergoes rigorous quality standards by our top customers on an ongoing basis and annual ISO audits.
Additionally, “customer satisfaction” reviews are conducted to ensure that HVO is meeting even the most meticulous customer requirements.
* Over 50,000 square feet of Class 7 and Class 8 controlled environments available
Regulated and Audited by the FDA
Quality & Continuous Improvement
At HVO, product quality in healthcare is our number one priority. Our Quality Manual outlines the general policies and procedures guiding our Quality Management System and illustrates HVO’s ongoing commitment to meeting regulatory requirements as a modern medical device manufacturer. HVO complies with the highest level of medical quality standards both internally and externally. Regulatory bodies monitor & regulate HVO such as the U.S Food and Drug Administration (FDA), ISO 9001, and ISO 13485. This compliance ensures that all medical products and services are first-class and consistent in quality, safety and reliability.
These standards help facilitate HVO in meeting the overall Quality Policy:
"People Centered; Quality Driven; with 100% Customer Satisfaction as our Goal "
HVO continuously seeks opportunities to improve its medical business practices. Our Continuous Improvement Department oversees and advances HVO departmental and medical production efficiency for overall improved performance. This team conducts a periodic review that monitors both advancing industry technologies and market-driven consumer interests, while at the same time evaluating internal practices at HVO. This quality-process-approach ultimately enhances all HVO medical products, services, business procedures & business relationships. Accordingly, HVO assures that it measures up to the ever-changing medical industry standards & customer demands while also maintaining its sophisticated quality system.