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  2. Standardisation Testing and Quality Certification - Wikipedia

    en.wikipedia.org/wiki/Standardisation_Testing...

    Management Representative: A designated representative communicates with top management and ensures the quality management system is effectively implemented. Certification Operations Personnel : Individuals directly involved in the day-to-day operations of the certification process.

  3. ISO 13485 - Wikipedia

    en.wikipedia.org/wiki/ISO_13485

    ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.

  4. Certified Quality Engineer - Wikipedia

    en.wikipedia.org/wiki/Certified_Quality_Engineer

    The American Society for Quality (ASQ) is a professional institute that examines the professional competency of candidates and, if found to be acceptable, awards them with official certification. This process helps to establish and maintain a minimum body of knowledge and skill level among certified engineers.

  5. ISO 9000 family - Wikipedia

    en.wikipedia.org/wiki/ISO_9000_family

    The ISO 9000 family is a set of international standards for quality management systems.It was developed in March 1987 by International Organization for Standardization.The goal of these standards is to help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service.

  6. Quality management system - Wikipedia

    en.wikipedia.org/wiki/Quality_management_system

    Quality management software centralizes the storage of these documents. Regulatory compliance: To decrease compliance risks, quality management software is used within companies to make sure they comply with ISO, OSHA, FDA, and other industry norms and requirements. The software makes closed-loop corrective and preventive action procedures ...

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