ISO 13485:2016 specifies requirements for a quality management system to ensure compliance with appropriate standards and impacts companies involved in any stage of the medical device life cycle, including:

  • Design
  • Development
  • Production
  • Storage
  • Distribution
  • Installation
  • Servicing

A high-level summary of 5 of the key changes included within ISO 13485:2016 is below:

1. Risk-Based Approach: There will be a much stronger emphasis on a risk-based approach throughout your entire quality management system. Additionally, all processes comprising the quality management system, including any that have been outsourced to third parties, will need to be developed utilizing a documented, risk-based methodology.

2. Documentation of Skills and Training: Any individual involved with your quality management system will need to have their skills and experience levels thoroughly documented. There will also be an enhanced focus on your ongoing training efforts and the assessment of the effectiveness of your training methods.

3. Complaint handling: You will now need to develop and document specific complaint handling procedures for all complaints, not just the ones filed by customers. Additionally, the procedures must also address the need to report complaints to the appropriate regulatory authorities as well as the implementation of appropriate corrective actions.

4. Supplier Monitoring: You must take your evaluation of your suppliers further and continuously monitor their performance levels and conduct appropriate re-evaluations of their performance as well. You must also now document the impact and risk posed to your organization from an underperforming supplier.

5. Design and Development: ISO 13485:2016 now includes specific details on how an organization should control changes in design and development. All personnel must now assess the impact of these new changes and keep all documentation on file. There are also new validation and verification requirements you will need follow for your design and development efforts, including when transferring a medical device from design and development to production.



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