ISO 14971 Fundamentals: Risk management plan

A detailed look at the 7 essential elements of a risk management plan and how they link to the requirements in ISO 14971.

If you fail to plan, you are planning to fail!

This quote, often attributed to Benjamin Franklin, reflects the essence of the requirement for a risk management plan according to ISO 14971, the International Standard for application of risk management to medical devices.

Clause 4.4¹ requires risk management activities to be planned. The rationale for this requirement is described in Annex A. According to A.2.4.4:

A risk management plan is required because:

• an organized approach is essential for good risk management;

• the plan provides the roadmap for risk management;

• the plan encourages objectivity and helps prevent essential elements being forgotten.

At a minimum, Clause 4.4 requires the following 7 elements to be included in a risk management plan:

1. Scope of planned activities

2. Responsibilities and authorities

3. Review of activities

4. Criteria for risk acceptability

5. Method and criteria for evaluating overall residual risk

6. Verification activities (implementation + effectiveness)

7. Production and post-production activities

Creating a risk management plan should not be treated as a check-the-box activity, especially when you are trying to remediate your documentation to conform to ISO 14971 requirements. As an example, it is useful to consider the lifecycle aspects of your plan to ensure that risk management activities continue to be adequate throughout the device lifecycle.

Consider the following guidance from ISO/TR 24971²:

The risk management plan is a “living document” that will be reviewed and updated throughout the lifecycle of the medical device as new information becomes available.

This is the main reason why we include an optional 8th element to manage the lifecycle aspects of a risk management plan in our template. Go deeper into the requirements for a risk management plan in a video lesson from our ISO 14971 certification training course on ACHIEVE, and download a free template below.