ISO 13485 Certification

ISO 13485:2016 CertificationThe International Organization for Standardization (ISO) has created a quality management system for medical devices that are listed under 13485 ISO 2016. The ISO 13485 certification represents the requirements for a comprehensive quality management system for the design and manufacturing of medical devices. ISO 13485 standard certification ultimately allows medical device manufacturers to display their quality management practices in a practical way, while also protecting the consumer from medical devices that do not qualify for ISO 13485 standardization.

Tempco Manufacturing is an ISO 13485 certified company. Contact us for more information regarding quality management systems for medical devices, or call us at 651-452-1441 with any questions that you may have.

ISO 13485 Standardization Benefits

The ISO 13485 quality management system for medical devices is designed to be used as a guide throughout the life cycle of the medical device that is being manufactured. ISO 13485:2016 also helps to form established supply chain specifications and production methods for third party companies that produce medical device parts. Some of the other benefits related to the ISO 13485 standard, include:

  • Work environment controls to ensure product safety.
  • Inspection and traceability requirements
  • Demonstrate compliance with regulatory and legal requirements
  • Sterile medical device documentation and validation
  • Corrective and preventive action verification requirements
  • Proper quality management systems (QMS) practices produce safe and effective medical devices

Who Utilizes ISO 13485 2016 Standardization?

ISO 13485:2016 certification is available to all companies that seek it, no matter the company’s size or type. However, certain requirements may differ depending on the type of part or complete medical device that is being produced. Additionally, ISO 13485 can be used by other internal and external parties, such as certification bodies, to help them with their certification processes, or by supply chain organizations that are required by contract to conform.

ISO 13485:2016 for Medical Devices

A medical device is classified as a machine, implant, instrument, apparatus or something of a similar nature that is designed for the diagnosis, prevention and treatment of disease or other medical conditions. ISO 13485 certified companies provide an effective quality management system (QMS) that provides a specific set of policies, processes and procedures that help an organization meet the specific standardization requirements. ISO 13485 empowers an organization to reliably provide effective and innocuous medical devices that fulfil customer and regulatory requirements. It is also supple enough to meet the individual needs of different types of organizations that produce medical devices or medical device parts.

ISO 13485:2016 for Medical Stamping & Fabrication

Tempco’s stamped metal parts and sheet metal fabrications are completely certified to all ISO 13485 standards. All our medical device stampings and fabricated parts comply with the ISO 13485 quality management system guidelines, which provides increased assurance and reliability. Even though ISO 13485:2016 is not a mandatory requirement, Tempco chooses to be certified under ISO medical device specifications due to the umbrella of increased quality and reliability that it provides to the industry.

Contact Tempco for ISO 13845:2016 Certified Medical Device Fabrications & Stampings Today

Contact us for more information regarding quality management systems for medical devices and what it means to be an ISO 13485 certified company. You can also request a quote for an in-depth price analysis today.