ISO 14971 Checklist

Use this ISO14971 Checklist for medical device risk management, ensure compliance with GMP, and enhance safety measures throughout the product lifecycle.

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ISO 14971 Checklist

ISO 14971 Checklist

Risk Management Process

Management Responsibilities

Qualification Of Personnel

Risk Management Plan

Risk Management File

Risk Control Option Analysis

Implementation Of Risk Control Measures

4. Is the effectiveness of the risk control measures verified by various testing methods, such as usability testing (IEC 62366-1), testing according to the test standard, clinical investigation of medical devices (ISO 14155), or clinical performance studies for in vitro diagnostic medical devices (ISO 20916)?

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Residual Risk Evaluation

Benefit-Risk Analysis

Risks Arising From Risk Control Measures

Completeness Of Risk Control

Risk Analysis Process

Intended Use/Reasonably Foreseeable Misuse

Identification Of Characteristics Related To Safety

Identification Of Hazards/Hazardous Situations

Risk Estimation

2. Is a systematic process in place, including qualitative scales, for categorizing the severity levels and the probability of occurrence of harm, with relevant information recorded within the risk management file and relevant personnel trained in the application of these qualitative scales?

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Risk Evaluation

Evaluation Of Overall Risk

Risk Management Review

Information Collection

Information Review

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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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ISO 14971 Checklist

Use this ISO14971 Checklist for medical device risk management, ensure compliance with GMP, and enhance safety measures throughout the product lifecycle.

1. Has the organization ensured the availability of a risk management procedure as part of the design and development of its medical device?

2. Does the risk management process extend into the post-production phase (including sterilization, packaging, and labeling where appropriate)?

3. Are production and post-production information and data collected and reviewed in the risk management process?

4. Does the organization’s quality management system integrate the risk management process?

1. Are top management involved in the overall guidance and effectiveness review of the risk management process?

2. Are adequate resources provided for effective risk management activities?

3. Are competent individuals trained in the risk management techniques with which they are involved?

4. Has top management established a policy for determining acceptable risks and risk levels?

5. Does top management participate in periodic reviews of risk management activities to rectify any weaknesses, implement improvements, and adapt to changes?

1. Are only competent people with the necessary knowledge and experience performing risk management tasks, including construction, production, intended use determination, and application of the medical device?

2. Are representatives from various disciplines or functions involved in risk management activities to ensure balanced input?

3. Are records maintained to provide objective evidence of competence and training?

4. Are personnel records properly maintained with confidentiality and security, and without duplication?

1. Is a properly organized and maintained plan for continual risk management in place?

2. Does the plan encourage objective and comprehensive evaluation of risks?

3. Is there a procedure in place for the continued development of the plan?

4. Does the plan contain a thorough description of the device, including a clear and thorough statement of intended use?

5. Does the plan define a scope to establish the baseline on which risk management activities are built, including identification of the medical device and the phases of its lifecycle?

6. Does the plan allocate responsibilities and authority to the respective individuals to ensure accountability?

7. Are risk management activities carried out under the plan frequently reviewed by management as an essential responsibility?

8. Are the criteria for risk acceptability defined before beginning risk analysis for effective risk management?

9. Are the evaluation methods and criteria for the acceptability of the overall residual risk decided?

10. Is verification activity planned, ensuring that essential resources are available when required?

11. Does the plan align with the device’s design verification and validation activities?

12. Do risk acceptability criteria in the plan derive from your policy of determining acceptable levels of device risk?

13. Are the methods for collection and review of production and post-production information to act as input into the risk management process properly defined?

14. Is a record of changes kept to facilitate audit and review of the risk management process for each particular device?

1. Is the location of all records and other documents applicable to risk management activity properly recorded and maintained, with ready retrieval from a file or file index?

2. Is the traceability of records and other documents maintained to help in auditing activities and completion of risk management activities?

3. Does the risk management file fully demonstrate that the risk management process is applied to each identified hazard?

4. Are identified hazards, or any step in the risk management process such as unspecified or ineffective risk control measures, appropriately controlled?

1. Is the design and manufacture of the medical device determined to be inherently safe, with protective measures such as alarms and barriers as appropriate?

2. Are risk mechanisms from ISO/IEC Guide 63:2019 considered and followed?

3. Is information for safety, such as written warnings or contraindications and/or training to users or intended users, provided?

4. Are procedures in place to ensure no risk originates from contamination of components, residues of hazardous substances used in the manufacturing process, or mix-up of parts?

5. Are protective measures, such as visual inspection steps in the manufacturing process, applied as appropriate?

6. Is a benefit-risk analysis conducted to determine if the benefit of the medical device to the patient outweighs the residual risk?

7. Is the hierarchy of risk control options explicitly considered?

1. Is the first verification conducted to ensure that the risk control measure is implemented in the final design of the medical device or in the manufacturing process?

2. Is second verification conducted to ensure risk control measures as implemented are actually reducing the relevant risks?

3. Is the effectiveness of the risk control measures validated, using a validation study to establish a convincing residual risk evaluation?

5. Are verification activities documented, considering that these activities might happen outside the design stage?

1. Have the implemented risk control measures made the relevant risk acceptable?

2. If the risk exceeds the acceptability criteria established in the risk management plan, are additional risk control measures investigated, planned, and implemented?

3. Are additional risk control measures continually investigated until residual risk does not exceed acceptability criteria?

4. Are risks appropriately re-evaluated after the implementation of risk controls?

1. Has device evaluation proven that the risk does not exceed the criteria for risk acceptability and that the benefit of the device outweighs the risk?

2. Does benefit-risk analysis activity exclude economic or business considerations?

3. Are properly delineated roles and responsibilities in place for conducting the benefit-risk analysis?

1. When implementing new risk control measures, alone or in combination, is it actively considered whether or not they are introducing a new or a different hazard themselves?

2. Are steps taken to ensure any risk control measure introduced to reduce one risk is not increasing another risk?

3. Is the impact of risk control measures evaluated?

1. Are all identified hazards and their consequences dealt with?

2. Are steps taken to ensure that no hazardous situations are left out of risk analysis activities?

1. Is the available information on risk analysis for a similar medical device on the market checked?

2. Has the organization systematically assessed the previous work for applicability to your current risk analysis?

3. Is there a basic minimum data set available for traceability, management reviews, and audits?

4. Is the scope of your risk analysis clarified and verified for completeness?

1. Does the documented intended use include elements like a medical condition, patient population, part of the body or type of tissue interacted with, user profile, use environment, and operating principle?

2. Has the intended user(s) been considered, and whether a lay user or trained professional will use the device?

3. Is the use of the medical device in situations that are not foreseen or intended by the manufacturer considered to a reasonable degree?

4. Are future hazards due to potential uses of the medical device, and also reasonably foreseeable misuse, considered and documented?

1. Are all characteristics that are qualitative or quantitative and can be related to the operating principle of the device, its intended use, and/or reasonably foreseeable misuse that could affect the safety of the medical device documented?

2. Are all characteristics related to the performance of the medical device and to the sterility/measuring function, materials used for parts coming into contact with the patient, usage of radiation for diagnostics or therapeutics, or others?

3. Is it considered whether the limitations of these characteristics, if exceeded, could affect the safety of the device?

1. Are anticipated hazards in both normal and faulty conditions based upon the intended use, reasonably foreseeable misuse, and characteristics related to the safety of the device identified and documented?

2. Are hazardous situations identified, with associated risks assessed?

3. Is the reasonably foreseeable sequence of events that can transform a hazard into a hazardous situation documented?

4. Are typical hazards listed, demonstrating the relationship with hazardous situations, foreseeable sequences of events, and associated possible harm?

5. Is the method of hazard analysis determined, considering whether an expert group, outside sources, and product history are used?

1. Are both components of risk, probability of occurrence, and severity of harm, separately analyzed?

2. Is a systematic process in place, including qualitative scales, for categorizing the severity levels and the probability of occurrence of harm, with relevant information recorded within the risk management file and relevant personnel trained in the application of these qualitative scales?

3. Are systematic faults, or the sequence of events leading to hazardous situations, continually monitored?

4. Are the resulting hazardous situations separately listed, with a focus on reducing the risks due to these situations?

5. Is quantitative data made available where possible for new device development or security risk?

6. Are risks evaluated and estimated in a qualitative way – and quantitative, if the data is available?

7. Is a mechanism in place for managing risks whose probability cannot be reasonably defined?

1. Is the acceptability of the risk of the medical device defined?