Risk manager wikipedia5/15/2023 (9.8.3) Strength of Patient or Operator support or suspension systems.(8.4.4.1) Mechanical strength and resistance to heat.In most cases the requirements overlap with ISO 14971, but there are some additions: Remember also that IEC 60601-1 is a good contributor to the Risk Management File. The PMS process itself should then be able to trigger the risk analysis process, as required. A pointer to the PMS plan and procedures will be sufficient. Items 19 and 20 are part of the PMS process.Items 14, 16, 17 can be merged (end generally are) in the Risk Management Review and Report 18.Alternatively, if each mitigation has a corresponding (traceable) requirement, the trace is taken care of by the requirement → verification traces. Item 3 provides links for items 12 and can be built into the risk analysis documents.Items 6 and 9 can be built into the Risk Management Plan 2.Items 4, 5, 7, 8, 10, 11, 13, 15 are generally contained in each single risk analysis document.Items 1 and 5 are typically contained in separate documents in the DHF.This seems a lot, but let’s look into the details of these items: (10.4) Decision arising from the review of post-production information.(10.3) Results of the review of the post-production information.(9) Risk Management Report, including Risk Management Review.(8) Evaluation of Overall Residual Risk.(7.6) Review of completeness of risk controls.(7.5) Risks arising from implemented risk control measures.(7.4) the results of the Benefit-Risk Analysis.(7.2) Verification of Implementation of the Risk Control Measures.(5.5) The system used for qualitative or quantitative categorization of probability of occurrence of harm and severity of harm.(5.4) Hazards, the reasonably foreseeable sequences or combinations of events that can result in a Hazardous Situation, and the resulting hazardous situation(s).Where appropriate, the manufacturer shall define limits of those characteristics. (5.3) Qualitative and quantitative characteristics that could affect the safety of the medical device.(5.2) Intended Use and Reasonably Foreseeable Misuse.(4.5) Traceability for each identified hazard to the risk analysis, the risk evaluation, the implementation and verification of the risk control measures and the results of the evaluation of the residual risks.(4.2, Note 3) The policy for establishing criteria for risk acceptability.In practice, the risk management file must contain, or have reference to, the following documents: Responding to suggestions from participants during the recent CSF 2.0 workshop, NIST has improved its CSF web page by elevating attention to Examples of Framework Profiles The page, which now is easier to find, features links to more than a dozen profiles produced by NIST or others.ISO 14971:2019 defines the Risk Management file as a “set of records and other documents that are produced by risk management”. This report continues an in-depth discussion of the concepts introduced in NISTIR 8286, Integrating Cybersecurity and Enterprise Risk Management, and provides additional detail regarding the enterprise application of cybersecurity risk information. NISTIR 8286C, Staging Cybersecurity Risks for Enterprise Risk Management and Governance Oversight, has now been released as final. of Treasury OCCIP on September 12, 2022 is now available.ĭraft NIST IR 8406, Cybersecurity Framework Profile for Liquefied Natural Gas - is now open for public comment through November 17th.
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