Consequently, conformity is not entirely achieved by complying only with the requirements specified in EN ISO 13485. It is important to take note that the primary goal of ISO 13485:2016 is not to cover exactly the European quality management system requirements as it is intended to be applicable in jurisdictions all over the world.
#Risk management iso 13485 verification#
Please don’t remove this notice even if you’ve modified contents of this template.EN ISO 13485:2016+A11:2021 amends EN ISO 13485:2016, incorporating corrigenda March 2016, December 20, with a revised European Foreword and European Annexes ZA and ZB.Īnnex ZA addresses the relationship between the EN ISO 13485:2016 and the requirements of Regulation (EU) 2017/745 (MDR) with regards to the general obligations of the manufacturer in Article 10 (covered in Table ZA.1), the quality management system requirements in Annex IX on conformity assessment based on a quality management system and on assessment of technical documentation (covered in Table ZA.2) and quality management system requirements in Annex XI on conformity assessment based on product conformity verification (covered in table ZA.3).Īnnex ZB addresses the relationship between the EN ISO 13485:2016 and the requirements of Regulation (EU) 2017/746 (IVDR) with regards to the general obligations of the manufacturer in Article 10 (covered in Table ZB.1), the quality management system requirements in Annex IX on conformity assessment based on a quality management system and on assessment of technical documentation (covered in Table ZB.2) and quality management system requirements in Annex XI on conformity assessment based on production quality assurance (covered in table ZB.3). Weighing the benefits against the risks, we conclude that. The remaining unacceptable risks are compared to the benefits resulting fromĪdd a conclusion whether the benefits outweigh the risks Only use this whole section (Risk-Benefit Assessment) if you have unacceptable risks. They will be furtherĪssessed in the Benefit-Risk Assessment below. If you still have unacceptable risks, use this section:Īfter Risk Control Measures, unacceptable risks remained. A Benefit-Risk Assessment is not required.
#Risk management iso 13485 software#
The software therefore fulfils the specifications
If you don’t have unacceptable risks (more likely), use this section:Īfter Risk Control Measures, no unacceptable risks remained. Risk MatrixĪfter implementation and verification of all Risk Control Measures, the count of risks in the Risk Acceptanceĥ. “inherent safety by design”, “protective measures” and “information for safety”. Potential categories of Risk Control Measures are The Risk Table, Risk Control Measures were implemented. If a risk was classified as “unacceptable” based on Risks were reduces as low as reasonably possible (ALARP). Including intermediate probabilities (p1 and p2). The hazardous situation(s) and harm(s) which they could lead to were analyzed, 2.3 Failure Mode and Effects Analysis (FMEA)Īll preliminary hazards and potential failure modes of the software were analyzed. failure modes of software systems were identified. They were furtherĪnalyzed in the Risk Table. hazards were identified based on the Intended Use and Usability Tests. The general idea about this section is that you simply summarize the amount of stuff you added to your Risk Mapping of Standard Requirements to Document Sections ISO 14971:2019 Section The process and stages of risk analysis are described in the SOP Integrated Software Development.
The general planningĪnd methods are described in the Risk Management plan, while the actual risks are listed and analyzed in the The Risk Management Report contains the output and summary of risk management activities. Beginning of template Risk Management Report