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Factory Certification

ISO 9001:2015

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ISO 9001:2015 outlines the criteria for a quality management system when an organization:

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  • Must show its capability to consistently deliver products and services in alignment with customer expectations and relevant legal and regulatory standards.

  • Seeks to elevate customer contentment by proficiently implementing the system, encompassing procedures for system enhancement and ensuring compliance with customer expectations as well as relevant legal and regulatory standards.

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All our partner manufacturers are typically ISO 9001 and/or ISO 14001 and/or IATF 16949 and/or AS9100 and/or ISO 13485 certified.

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IATF 16949:2016

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IATF 16949:2016 is a recent international standard that supersedes ISO/TS 16949:2009. Its primary objective is to establish a quality management system that:

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  • Fosters a culture of ongoing improvement.

  • Places a strong emphasis on preventing defects.

  • Incorporates distinct demands and methodologies specific to the automotive industry.

  • Advocates for the reduction of variability and waste within the supply chain.

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This International Standard, in conjunction with any customer-specific prerequisites, outlines the core quality management system criteria for organizations involved in automotive production, service, and/or accessory parts.

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AS9001

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AS9100 is an aerospace standard that builds upon the ISO 9001 quality system requirements. It extends the ISO 9001 framework by introducing additional quality system requirements defined by the aerospace industry to meet the quality mandates of entities such as the Department of Defense (DOD), NASA, and the Federal Aviation Administration (FAA). Specific regulatory requirements within the aerospace sector encompass:

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  • Configuration Management

  • Verification, Testing, and Validation Criteria for Design

  • Reliability, Maintenance, and Safety of Management Systems

  • Evaluation of Contractor and Subcontractor Performance in Accordance with Agreements

  • Documentation and Identification of Products

  • Control of Changes in Production Processes

  • Management of Plant and Machinery

  • Material/Product Inspection and Testing

  • Resource Management and Documentation

  • Product Recall Protocols

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AS9100 ensures that aerospace organizations comply with these stringent industry-specific quality and safety prerequisites.

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ISO 13485: 2016

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ISO 13485:2016 is a globally acknowledged quality standard that outlines the criteria for a Quality Management System (QMS) applicable to the design and production of Medical Devices worldwide. To obtain certification in compliance with ISO 13485, a company's quality system must successfully undergo a third-party audit conducted under the Medical Device Single Audit Program (MDSAP).

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In essence, ISO 13485 can be thought of as comprising ISO 9001 requirements along with additional stipulations specific to the medical device industry.

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It's worth noting that all of our partner manufacturers typically hold certifications in one or more of the following standards: ISO 9001, ISO 14001, IATF 16949, AS9100, and ISO 13485.

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