Company Certification International | ISO 13485:2016
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ISO 13485:2016

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 13485:2016 – KEY BENEFITS

  • Provides a robust framework for assuring product consistency
  • Creates a competitive advantage
  • Engages top management involvement
  • Ensures a consistent and effective approach to business
  • Reduces risk factors via the use of risk management
  • ISO 13485 regulatory requirements for manufacturers of medical devices on an international scale.
  • A number of countries have incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used in support of regulatory compliance.
  • It incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system.