How to Handle Risks Identified as per ISO 9001:2015

How to Handle Risks Identified as per ISO 9001:2015

Every business faces risks — whether it’s losing a customer, a machinery breakdown, data loss, or even employee safety issues. But the real question is: how prepared are you to handle them?

That’s where ISO 9001:2015 makes a big difference. Instead of waiting for problems to occur, the standard encourages you to think ahead — to identify, assess, and control risks before they affect your business.

Risk-based thinking isn’t about creating fear — it’s about building confidence and resilience in your processes.

 What ISO 9001:2015 Says About Risk

ISO 9001:2015 introduced the concept of risk-based thinking throughout its clauses. It doesn’t ask for a formal risk management system like ISO 31000, but it expects every organization to consider risks and opportunities when planning and implementing its Quality Management System (QMS).

The key is to:

1. Identify potential risks in your processes.
2. Evaluate their impact and likelihood.
3. Take appropriate action to reduce or eliminate them.
4. Review the effectiveness of actions during management reviews.

This makes your system proactive, not reactive.

Steps to Handle Risks in ISO 9001:2015

Here’s how you can manage risks effectively — in a practical, real-world way:

1️⃣ Identify the Risks

Start by asking: What could go wrong?
Involve your team — because people who work directly with the processes usually know where the real risks are.

Examples:

• Supplier delays are causing production stoppage.
• Customer complaints due to unclear communication.
• Machine failure during peak production.
• A key employee is leaving suddenly.

You can list these risks in a Risk Register or even use your BIGISO Software dashboard to track them.

2️⃣ Assess the Risk

Not all risks are equally serious. Some are small inconveniences, while others can stop your operations completely.

To assess, use two simple criteria:

• Likelihood: How often could this happen?
• Impact: What would be the consequence if it did?

You can rate them as High, Medium, or Low — and focus first on high-impact, high-likelihood risks.

Example:
If your supplier delay happens frequently and stops production, that’s a high-priority risk.

3️⃣ Plan and Implement Actions

Once you know your key risks, plan how to reduce or control them.
There are four ways to handle a risk:

• Avoid it: Change the plan or process to eliminate the risk.
• Reduce it: Implement controls to minimize its effect.
• Share it: Outsource or ensure to transfer the risk.
• Accept it: If the impact is minimal or the cost of control is too high.

Example:
If late supplier deliveries are a recurring issue, you could:

• Find alternative suppliers.
• Keep a safety stock.
• Set up an automatic reminder system for follow-ups.

These small preventive actions can save you from big headaches later.

4️⃣ Monitor and Review

Handling risk isn’t a one-time task. You need to monitor whether your actions are working.

Review risks:

• During management review meetings
• After major process changes
• When new risks appear (e.g., new customer, new equipment, regulation changes)

5️⃣ Document Everything

ISO 9001 expects you to maintain evidence of how you’re identifying, assessing, and treating risks.
Use a Risk Register, include actions taken, responsible persons, and review dates.

Example:

This record not only helps during audits but also makes your team accountable. OR use our BIGISO Software to manage all your risks. Contact us today for more details or free trial.

🔍 Real-Life Example

A packaging company identified a risk: machine downtime during production.

Earlier, they handled breakdowns only after they happened. After implementing ISO 9001:2015 risk management, they introduced a preventive maintenance schedule and trained operators for early fault detection.

Result?

• 40% fewer breakdowns.
• No missed delivery deadlines.
• Happier customers.

That’s the power of risk-based thinking — fewer surprises, smoother operations.

💪 Benefits of Handling Risks Effectively

• Prevents costly nonconformities.
• Builds customer confidence.
• Improves process stability.
• Encourages a proactive culture.
• Helps meet ISO 9001:2015 requirements.
• Boosts team awareness and accountability.

🌱 Example: Turning Risk into Opportunity

Not all risks are bad — sometimes, identifying risks leads to opportunities.

Example:
During risk review, a company realized that dependence on one big client was risky. So they decided to expand to new markets. Within a year, they gained five new clients — turning risk into growth.

Managing risks the ISO way doesn’t have to be complex.
With BIGISO’s Cloud-based Software, you can easily identify, assess, and track risks using interactive dashboards and automated alerts — ensuring your QMS always stays compliant and effective.

📢 Start building a risk-resilient organization with BIGISO today!