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ISO13485:2016

NOTE: QEC (Quality Evaluation Center), as a Management Systems Certification Body, does not perform any kind of consulting process.

ISO 13485 is the international standard that defines the requirements of the quality management system for organizations that are or may be involved in one or more phases of the life cycle, including design and development, production, storage and distribution, installation or maintenance of a medical device and designing and developing or providing associated activities such as technical support.


ISO 13485: 2016 may also be used by suppliers or external partners who provide quality management system related services to such organizations.

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BENEFITS

 

The ISO 13485: 2016 certification by QEC provides organizations with a process-based approach to the development, implementation, and improvement of the effectiveness of a quality management system in order to meet global regulatory and customer requirements.
When applied to the manufacturing process, ISO 13485: 2016 helps to ensure strict quality assurance criteria in all aspects of production, resulting in a tightly controlled production system that reduces the likelihood of nonconforming products. This provides consistency in product quality and provides a solid foundation for greater reliability in device safety and performance.
Probably the most critical advantage of ISO 13485: 2016 is the preventive approach to ensure the quality of the medical device as opposed to a reactive approach to inspection and rejection at the end of the production line.

  • It is recognized worldwide as the best quality management practices in the medical device industry.
  • It meets regulatory requirements in many countries, as well as the contractual obligations of many organizations, making it easier to win deals with new customers.
  • Helps create a systematic framework in which organizations monitor, measure, and analyze their processes and customer feedback.
  • Helps provide a framework for implementing actions (when necessary) to ensure that expected results are achieved and to ensure the effectiveness of these processes with applicable customer, quality, and regulatory requirements.
  • Can deliver better performance in areas such as sales, product delivery, and process efficiency.
  • It can reduce costs as a result of minimizing product failure.

 

OBLIGATIONS

 

  • Commitment to top management
  • Food Security Policy
  • System Planning
  • Definition of responsibilities
  • Document Control
  • Internal and external communication processes
  • Emergency Response Procedures
  • System Review
  • System Improvement