Contract Manufacturing for Injection Molded Plastic Products in North America
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Contract Manufacturing for Injection Molded Plastic Products in North America | (800) 824.0607
RFQ / CONTACT

ISO Registrar conducted their 2023 Surveillance Audit of HTI Plastics

by | Feb 24, 2023

hti plastics iso audit

In February of 2023, our ISO Registrar conducted their 2023 Surveillance Audit of HTI Plastics with no major or critical findings. The auditor noted in the report HTI’s “excellent use of metrics and analysis” with a “very mature and stable Quality Management System to meet the needs of a growing business”. In addition, the auditor also reviewed the continuous improvement projects at the site and stated in the report that improvement projects “are well managed and executed, providing the needed resources to see them through to successful completion.” The outcome was an overall satisfactory result with a continued ISO certification (9001:2015 & 13485:2016) as the conclusion of the audit. This aligns with HTI’s commitment to continued improvement and maturation of our QMS and dedication to producing high quality products for our customers.

Below is a list of manufacturing certifications HTI Plastics holds. Being certified/registered matters to companies like us.
ISO 9001:2015 certified.
ISO 13485:2016 certified.
FDA compliance 21 CFR 820 registered facility.
HTI Plastics is a USDA approved and registered facility.
Compliant with Good Manufacturing Practices (cGMP).
FFL (Federal Firearms License) registered.
Corrective and Preventive Action (CAPA) system.
Clean assembly environment for FDA/GMP product lines.
Participate in the annual food safety audit by NSF Cook and Thurber.
HACCP (Hazard Analysis & Critical Control Points)

Achieving ISO quality management certifications is important for our manufacturing business in improving efficiency, productivity and customer satisfaction. But the benefits of ISO manufacturing certifications go far beyond your operations to every aspect of the business, including sales and marketing, strategic planning and employee engagement.

Regulators and governments count on ISO standards to help develop better regulation, knowing they have a sound basis thanks to the involvement of globally established experts.

To find out more about how ISO’s 24668 standards touch almost all aspects of daily life, and work for businesses large and small, you can see standards in action. With International Standards on air, water and soil quality, emissions of gases and radiation, and environmental aspects of products, they protect the health of the planet and people, beyond bringing economic benefits.

HTI Plastics, a leader in manufacturing injection molded plastic products, has experienced remarkable growth since 1985, and after being acquired by PCE, Inc. our capabilities expanded significantly in plastics manufacturing. We know there are more innovations to be discovered, and we want to work with our customers to find new solutions for their needs. We are continually striving to make improvements to our proprietary products and are always working with our customers to bring new products to market. As your needs evolve, HTI Plastics is using the latest technology to set the pace for the plastics injection molding and blow molding industries. Our high-speed precision machines are housed in our 100,000+ square foot, state-of-the-art molding facility. We practice continuous process improvement, and HTI Plastics keeps costs low and safety ratings high with our clean assembly environment, FDA and GMP compliance, computerized material distribution system, and on-site resin storage for easy access.