ISO 13485 : 2016 Certification


Pyramid Plastics is a thermoplastic injection molding facility serving the medical, automotive, industrial equipment, and other OEMs. Manufacturing plastic parts and components for OEMs comes with rules and regulations that guide our quality standards and processes. This is especially true in relation to producing medical device parts.

One of the most commonly adopted international standards for quality in the medical industry is the ISO 13485 standard. Pyramid Plastics’ quality standards allow for us to manufacture and assemble custom thermoplastic injection molded components related to general medical, dental, and industrial products.


We have been in operating under the ISO 9001:2015 standard for some time. Most recently we have been certified under the ISO 13485:2016 standard for catering our Quality Management System for medical and dental customers. Going forward we can operate under the ISO 13485 QMS standard to better serve our medical OEMs while covering the blanked requirements for ISO 9001-based customers under the same umbrella. The ISO 9001 standard has required Pyramid Plastics as an organization to demonstrate continual improvements in terms of Quality, Production, and general operational efficiency. Now with the ISO 13485 standard, we additionally intend to layout our capability to demonstrate that our quality system is effectively implemented and maintained for each of its beneficiaries.


So what does this mean for our customers? Dealing with us as an organization with a QMS that complies with both ISO 9001:2015 and ISO 13485:2016 enables us to:
• Produce thermoplastics-injection molded products consistently to meet the customer and regulatory requirements.
• Enhance customer satisfaction through the effective application of this QMS, in conjunction with customer-specific requirements of automotive-related products.
• Include continuous improvement processes related to the assurance and conformity to the customer requirements and applicable regulatory requirements.
• Implement requirements that are specific to the medical device industry.

Pyramid Plastics can follow the statutory and regulatory requirements passed down from our medical device customers. This includes any documentation specified by national or other regulations such as the FDA. We will provide files and traceability documents defining product specifications that cover the complete manufacturing process along with other records required by both ISO certifications – including maintaining a device history record.


Our management team and quality engineers are committed to upholding Pyramid Plastics’ quality management system to the highest possible standards to stay in compliance and maintain the effectiveness of the ISO QMS requirements.

Therefore, as a result, becoming certified adds new opportunities for Pyramid to expand into markets that have more regulations than general consumer goods. The added requirements in our QMS system allows us to take on more automotive jobs as well. The enhanced traceability establishes Pyramid as a highly accountable manufacturer that can certify production for any parts that we supply.