ISO 13485:2016 Medical Stamping and Fabrication Certification

国际标准化组织（ISO）为ISO 13485：2016列出的医疗设备创建了质量管理系统。ISO 13485：2016认证表示对医疗设备设计和制造的全面质量管理系统的要求。

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.接触usfor 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.
• 检验和可追溯性的要求
• 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

点击这里to view Tempco’s ISO 13485:2016 registration certificate.

谁利用ISO 13485：2016质量管理标准化？

ISO 13485：2016认证均可提供所有寻求该公司的公司，无论公司的规模或类型如何。但是，某些要求可能会有所不同，具体取决于正在生产的零件或完整的医疗设备的类型。此外，该认证可以由其他内部和外部方（例如认证机构）使用，以帮助他们进行认证流程或合同要求的供应链组织。

ISO 13485：2016年医疗设备

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年医疗冲压和制造

Tempco的盖章金属零件和钣金制造are completely certified to all ISO 13485:2016 standards. All ourmedical device邮票和制造零件符合ISO 13485：2016质量管理系统指南，该指南提供了提高的保证和可靠性。尽管此认证不是强制性的要求，但Tempco由于其为行业提供的质量和可靠性提高而选择根据ISO医疗设备规格进行认证。

ISO 13485Certified Metal Fabrication & Metal Stamping Quality Control Standards

Tempco对优质金属冲压和优质金属制造的持续承诺建立在我们质量管理系统的不断改进的基础上，并致力于符合客户标准和适用的行业要求。我们的金属冲压和钣金质量检查过程可确保我们生产的每一件符合或超过客户期望。

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- 准时运输率至93％或更高

• 维持- 客户返回到0.55％以下

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.

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

接触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 alsorequest a quotefor an in-depth price analysis today.