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MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS


ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization
ISO 13485 certification

HOW TO USE ISO 13485 2016: certification

ISO 13485:2016 develops a quality management system for medical devices and related services and then use this system to:-
  • Show that your organization is consistently capable of providing medical device products and services that meet customer requirements and fulfill with all relevant & regulatory requirements.
  • Assess your organization ability to consistently provide medical device products and services that meet customer requirements and comply with all relevant & regulatory requirements.

HISTORY OF ISO 13485:2016 Certification

ISO 13485 Medical devices Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016.  

BENEFITS OF ISO 13485:2016

  • Guarantees high quality of provided services and products
  • Reduces production loss rate
  • Reduces operational costs and reduces risk
  • Increases effectiveness across the whole organization
  • Increases your customers trust in you as a safe supplier or producer
  • Identify and develop a quality management system for medical devices
  • Utilize the quality systems and control processes for medical devices
  • Monitor and maintain quality management system for medical devices
  • Increase efficiency, cut costs and monitor supply chain performance
  • Meet regulatory requirements and customer expectations
  • Demonstrate that you produce safer and more effective medical devices 
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