ISO 13485:2016 Medical Stamping and Fabrication Certification

ISO 13485:2016 Certification

The International Organization for Standardization (ISO) has created a quality management system for medical devices that are listed under ISO 13485:2016. The ISO 13485:2016 certification represents the requirements for a comprehensive quality management system for the design and manufacturing of medical devices.

ISO 13485:2016 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 this standardization.

Tempco Manufacturing's QMS is ISO 13485:2016 certified. 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 13485:2016 Quality Management System Standardization Advantages

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

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

Who Utilizes ISO 13485:2016 Quality Management 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, this certification 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 13485:2016 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. This certification 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 13485:2016 standards. All our medical device stampings and fabricated parts comply with the ISO 13485:2016 quality management system guidelines, which provides increased assurance and reliability. Even though this certification 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.

ISO 13485 Certified Metal Fabrication & Metal Stamping Quality Control Standards

Tempco’s ongoing commitment to quality metal stamping and quality metal fabrication is built on continual improvements to our quality management system and our dedication to conforming to customer standards and applicable industry requirements. Our metal stamping and sheet metal quality inspection processes ensure that every piece we produce meets or exceeds customer expectations.

At Tempco Manufacturing, Inc., we are equipped to tackle the toughest metal stamping and fabrication challenges. We guarantee compliance to our quality manufacturing policy and your quality standards by fulfilling the following objectives:

  • Improve - On-Time Shipping rate to 93% or better
  • Maintain - Customer Returns to below 0.55%

ISO 13485:2016 Advanced Medical Stamping and Fabrication Certification

Receiving and maintaining medical device ISO 13485:2016 certification requires a more in-depth and rigid in nature and requires advanced documentation to maintain the certification status when compared with ISO 9001:2015. ISO 13485:2016 effectively ensures the consistent design, development, production, installation, and delivery of medical devices that are safe and manufactured to set certification standards.

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 have and ISO 13485:2016 certified QMS. You can also request a quote for an in-depth price analysis today.

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