ISO 14971

ISO 14971 Risk Analysis Template

A free risk analysis template built to the structure of ISO 14971:2019. It traces each hazard through a foreseeable sequence of events to a hazardous situation and then to harm, scores risk as severity multiplied by the probability of harm, and records the justification for any risk you don't reduce further. Five tabs, twenty-four columns, and five worked examples, in Excel format.

One file, no sign-up beyond your email. This page describes everything the template contains, so you can decide before you download.

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What is in the template

How to use the file, the legend for which cells you fill in, and a short explanation of the AFAP requirement.

Document control.

Device details, revision history, participants and the review and approval block.

Scales and matrix

Severity and probability definitions, the Clause 7.1 risk control hierarchy, and acceptability bands. Edit these to match your risk management plan before you begin scoring.

Risk Analysis

The main worksheet. Twenty-four columns cover the full path from hazard to residual risk, with dropdowns and calculated risk indices.

Overall residual risk

The Clause 8 judgement on the device as a whole, with counts that update automatically as you complete the analysis.

THE WORKSHEET

Every column, and what it is for

The worksheet follows the order you work in. Six stages, twenty-four columns.

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Stage 1 - Identify what you are analysing

Every row starts with an ID you can trace back to, the item or function the risk belongs to, and the hazard itself. Getting the hazard right matters more than it sounds. A hazard is the potential source of harm, not the failure that causes it, and starting in the wrong place bends everything downstream.

Stage 2 - Trace the chain to harm

This is the part most templates leave out. The foreseeable sequence of events records how a hazard turns into a hazardous situation, including the ways people use the device incorrectly. The hazardous situation is the moment someone is exposed. The harm is what actually happens to them. These three columns are what an auditor follows when they pick one hazard and ask you to show the path.

Stage 3 - Estimate the risk

Score severity and probability from 1 to 5 against definitions you set yourself on the Scales tab. The index and the level calculate automatically, returning acceptable, review required, or unacceptable. There is no detection factor, because a hazard you can detect is still a hazard to the patient.

Stage 4 - Control the risk

Record the risk control measure and which level of the Clause 7.1 hierarchy it sits at in control option, since design controls come before protective measures and information for safety. Then two separate columns: verification of implementation for evidence the control was built, and verification of effectiveness for evidence it works. Most risk files hold the first and quietly skip the second.

Stage 5 - Re-estimate after control

Score severity prime and probability prime as they stand once the control is in place. Index prime and level prime calculate the residual risk. Some risks stay unacceptable after controls, and the file should say so rather than round down.

Stage 6 - Justify and trace

Reduced AFAP and AFAP justification are where you record whether the risk has been reduced as far as possible and, if not, why further reduction is not practicable. New hazard introduced covers Clause 7.4, because controls create problems of their own. Post-production reference links the entry to the complaint or field report that informed it, which is what keeps the file alive after launch. Owner and status close the row

FMEA Worksheet

WHY IT IS NOT AN FMEA WORKSHEET

Most risk templates available for download in medical devices are Failure Mode and Effects Analysis (FMEA) worksheets with an ISO 14971 label on them. They score risk as severity multiplied by occurrence multiplied by detection, producing a Risk Priority Number.

That method comes from automotive manufacturing. ISO 14971 does not use it.

Risk is severity and probability. The standard estimates risk as the probability of occurrence of harm combined with the severity of that harm. Detection does not appear, and there is a reason for that. A hazard the manufacturer is able to detect is still a hazard to the patient. Scoring it as lower risk because you would notice it does not make the device safer.

The chain matters more than the score. FMEA starts at a failure mode. ISO 14971 starts earlier, at the hazard, and asks you to write down the foreseeable sequence of events that turns that hazard into a hazardous situation and then into harm. A worksheet without those columns cannot show that chain, which means it cannot answer the question an auditor asks when they pick one hazard and ask you to trace it.

None of this makes FMEA useless. It is a reasonable design tool and many teams run both. The point is that an FMEA worksheet is not a risk management file, and a template that treats them as the same thing leaves you with a gap you will find during an audit rather than before one.

AFAP

Acceptable is not the same as as far as possible

ISO 14971 lets you define acceptability criteria and stop once a risk meets them. EU Medical Device Regulation 2017/745 does not. Annex I requires manufacturers to reduce risks as far as possible, which is a higher bar than reducing them to a level you have declared acceptable.

This is the known divergence between the two, and it is set out in Annex Z of the harmonised European version of the standard.

In practice it means that meeting your own threshold is not the end of the argument. If you sell into Europe, you also need to show why you did not go further. That reasoning has to live somewhere, and in most risk files it does not live anywhere.

The template carries two columns for it. One records whether the risk has been reduced as far as possible. The other records why further reduction is not practicable, in a sentence you would be willing to show a notified body reviewer.

The worked examples demonstrate both answers, including one risk that is deliberately left open because further reduction is practicable and has not been done yet.

USAGE

How to use it

Set your scales first

Severity and probability definitions and acceptability criteria belong in your risk management plan and should be agreed upon before analysis begins. Criteria written after you have seen the scores make the evaluation circular, and that is a common audit finding.

Delete the worked examples

They are shaded amber. They exist to show the format, not to be adapted.

Work left to right

Complete the hazard chain before you score anything. If you cannot write the sequence of events, you do not yet understand the risk well enough to estimate it.

Verify effectiveness, not just implementation

Clause 7.2 asks for both. Evidence that a control was built is half the requirement.

Keep the post-production column alive

Clause 10 requires you to review production and post-production information against the risk analysis. That column is where the link between a complaint and a hazard is recorded.

Questions? 
We’re glad you asked.

What is an ISO 14971 risk analysis template?

A worksheet structured according to the risk management process in ISO 14971:2019. It records each hazard, the foreseeable sequence of events leading to harm, the estimated risk, the controls applied, and the residual risk after those controls.

Does ISO 14971 use RPN?

No. Risk Priority Number scoring multiplies severity, occurrence and detection, and comes from automotive FMEA. ISO 14971 estimates risk as the probability of occurrence of harm combined with the severity of that harm, with no detection term.

What is the difference between FMEA and ISO 14971 risk analysis?

FMEA starts at a failure mode and asks what it causes. ISO 14971 starts at a hazard and asks for the sequence of events that turns it into harm. The two can coexist, but an FMEA worksheet on its own does not satisfy ISO 14971 because it lacks the hazard-to-harm traceability the standard requires.

What does AFAP mean under EU MDR?

As far as possible. EU Medical Device Regulation 2017/745 Annex I requires manufacturers to reduce risks as far as possible, rather than only to a level the manufacturer has judged acceptable. It is a higher bar than ISO 14971 sets on its own.

Can I download ISO 14971 as a PDF?

Not legitimately. ISO 14971 is a copyrighted standard sold through ISO and national standards bodies. This template reproduces no clause text, no annex table and none of the standard's defined terms, so you will still need a licensed copy to apply it.

Is this template free to use commercially?

Yes. Download it, adapt it, and use it in your risk management file. No attribution required.