ISO 13485:2016

ISO 13485 is for Medical Devices Quality Management Systems. It 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.

ISO 13485:2016 is applicable to organizations involved in the design, production, installation and servicing of medical devices and related services 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. The structure is split into eight sections, with the first three being introductory, and the last five containing the mandatory requirements.

Benefits of ISO 13485:2016

  • Demonstrate that you produce safer and more effective medical devices.

  • Increase access to more markets opportunities worldwide with certification.

  • Commitment to continual improvement and customer satisfaction.

  • Capable to review and improve processes across your organization.

  • Increase efficiency, cut costs and monitor supply chain performance.

  • Meet regulatory requirements and customer expectations.

  • Reducing the likelihood of longstanding issues.

  • Improve the organization’s credibility and image.

  • A standardized process to ensure consistent results.

  • Defined process for effective risk analysis.

ISO 13485:2016 Clauses

  1. Scope
  2. Normative References
  3. Terms and Definitions
  4. Quality management system
  5. Management responsibility
  6. Resource management
  7. Product realization
  8. Measurement, analysis and improvement

History of ISO 13485:2016

ISO 13485 Medical devices quality management systems is a quality management standard for medical device companies based on ISO 9001 which first published in 1996. it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).

While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A final revision to ISO-13485 was released in 2016, just in advance of the new European Union Medical Devices Regulations (EU MDR). An organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard.

Why is ISO 13485:2016 Important

Being an ISO 13485 certified organization demonstrate the organization determination to offer qualitative products and services to your organization and/or customers. In the United States, medical devices are regulated by the FDA and organizations must receive ISO 13485 certification prior to their design or assembly. It is importance for:

  • Detailed and clear understanding to avoid errors in design and manufacturing on products related to medical devices.

  • Means the organization has people, equipment, and technology needed to produce high quality medical devices.

  • Demonstrates commitment on continuous improvement and better work processes.

  • Well-defined and effective risk management and analysis methods to avoid safety problems in the manufacturing.

  • Indicates understanding the importance of safety and performance of medical devices.

  • Gain access to the knowledge and experience of highly qualified.

  • Consequently leading to customer satisfaction and gain competitive advantage.

  • Periodic audits to make all involved parties fully accountable for product quality and safety.

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