HTI Plastics ISO Certifications

HTI Plastics ISO Certifications

HTI Plastics is ISO 9001:2015 Certified
HTI is ISO 9001 and 13485 certified

When looking for a new injection molder, your company needs to consider many different factors during your search. These factors might range from plant location, prices, technology, and more. While these factors are essential, you also need to consider the company’s commitment to good quality products, proper documentation, and good service. HTI Plastics has shown this commitment through the various certifications.

What is ISO?

International Organization of Standardization (ISO) is an independent, non-governmental international organization with a membership of 165 national standards bodies. It is a seal of approval from a third-party body.

How to become ISO Certified?

To become ISO certified, an organization needs to successfully implement a quality management system according to all of the requirements detailed in the ISO standard(s).

Part of the ISO certification process is making sure areas for improvement are identified and addressed. As such, organizations with ISO certification can be assumed to provide products and services that meet strict quality management standards.

Why is ISO Certification important?

“Certification can be a useful tool to add credibility by demonstrating that your products or services meet the expectations of your customers. For some industries, certification is a legal or contractual requirement”.

-         Improvement of your credibility and image

-         Improvement of customer satisfaction

-         Better process integration

-         Improve your evidence for decision-making

-         Create a continual improvement culture

-         Engagement of employees

Quality Management Systems Principles

-         Customer focus: Meet and exceed customer expectations

-         Leadership: Provide purpose, direction, and engagement

-         Engagement of People: Recognition, empowerment, and enhancement of skills and knowledge

-         Process Approach: Understand processes to optimize performance

-         Improvement: To maintain current performance and to create new opportunities

-         Evidence-based Decision Making:  Facts, evidence, and data analysis for decision making

-         Relationship Management: Manage relationships with interested parties to optimize performance.


ISO Certification Guidelines and requirements:

It outlines various criteria (or standards) to define quality management principles such as focusing on the customer, optimizing leadership and management within the organization, improving and fine-tuning internal processes, and general methods of continuous improvement.

What is the difference between ISO 9001 and ISO 13485?

The primary difference is the scope of the two quality standards. ISO 9001 is the international standard that provides specifications for a quality management system that can be applied to any organization regardless of industry, product or service, or company size. ISO 13485 is a management system specifically for the manufacture of medical devices. It places a more significant focus on regulatory compliance and offers less flexibility in the organizational process.

What is the difference between being certified and registered?

Where ISO is concerned, you must obtain certification by having the company’s QMS audited by a certified auditor. You cannot just be “registered” to an ISO standard.

What are the documentation requirements for ISO certification?

The documentation required for ISO Certification includes a collection of policies, processes, and documented procedures that define the ideal way you want to be delivering your product or service to your customers. It’s a system of documentation detailing the implementation of your Quality Management System.

ISO Certification Audit

- To get certified, you are required to implement a quality management system according to the most recent ISO standard(s) and then proceed to have that QMS audited by a certified auditor. Annual surveillance audits are required.

- The certification typically lasts for three years, after which the organization will have to be re-certified.

Companies can have more confidence in an ISO-certified injection molder, knowing their facilities and processes have been audited by independent third parties and certified to conform with ISO standards.

We understand it is not easy to decide on a reliable injection molding company for your next project. We also understand there are many factors you need to consider. Choosing HTI Plastics, an ISO-certified company, can give you the peace of mind that you are working with a company committed to good quality parts and services, excellent customer service, and a long-term partnership.