AS ISO 14971:2020 pdf download.Medical devices – Application of risk management to medical devices.
4.3 Competence of personnel
Persons performing risk management tasks shall be competent on the basis of education, training, skills and experience appropriate to the tasks assigned to them. Where appropriate, these persons shall have knowledge of and experience with the particular medical device (or similar medical devices) and its use, the technologies involved or the risk management techniques employed. Appropriate records shall be maintained.
NOTE Risk management tasks can be performed by representatives of several functions, each contributing their specialist knowledge.
Compliance is checked by inspection of the appropriate records.
4.4 Risk management plan
Risk management activities shall be planned. For the particular medical device being considered, the manufacturer shall establish and document a risk management plan in accordance with the risk management process. The risk management plan shall be part of the risk managementfile.
This plan shall include at least the following:
a) the scope of the planned risk management activities, identifying and describing the medical device and the life cycle phases for which each element of the plan is applicable;
b) assignment of responsibilities and authorities;
c) requirements for review of risk management activities;
d) criteria for risk acceptability, based on the manufacturer’s policy for determining acceptable risk, including criteria for accepting risks when the probability of occurrence of harm cannot be estimated;
NOTE I The criteria for risk acceptability are essential for the ultimate effectiveness of the risk management process. For each risk management plan the manufacturer needs to establish risk acceptability criteria that are appropriate for the particular medical device.
e) a method to evaluate the overall residual risk, and criteria for acceptability of the overall residual risk based on the manufacturer’s policy for determining acceptable risk;
NOTE 2 The method to evaluate the overall residual risk can include gathering and reviewing data and literature for the medical device being considered and similar medical devices on the market and can involve judgment by a cross-functional team of experts with application knowledge and clinical expertise.
f) activities for verification of the implementation and effectiveness of risk control measures; and
g) activities related to collection and review of relevant production and post-production information.
NOTE 3 See ISO/TR 24971191 for guidance on developing a risk management plan and on establishing criteria for risk acceptability.
NOTE 4 Not all parts of the plan need to be created at the same time. The plan or parts of it can be developed over time.
If the plan changes during the life cycle of the medical device, a record of the changes shall be maintained in the risk management file.
Compliance is checked by inspection of the risk managementfile.AS ISO 14971 pdf download.