To comply with the ISO 9001 standard, businesses need a quality management system (QMS) that includes corrective and preventive action.
Dedicated CAPA software can help businesses understand and meet the requirements of ISO 9001:2015 to ensure compliance.
What is CAPA?
CAPA stands for corrective and preventive action. CAPA processes help businesses identify and address quality issues or non-conformities.
Corrective action tackles existing problems. To prevent those problems from recurring, it must identify and eliminate the root causes.
Preventive action is designed to avoid problems before they happen. In other words, it involves identifying potential non-conformities and taking steps to prevent them.
Simply put, corrective action is reactive and preventive action is proactive.
CAPA in quality management systems
CAPA is a key part of any quality management system even when ISO standards are not involved. All businesses that want a robust QMS should introduce CAPA processes and a system to measure and record them.
At isoTracker, we have a dedicated CAPA software module that can stand alone or work in conjunction with our other quality management software modules.
Centralized, cloud-based software with automated processes and top-notch security makes it much easier to comply with the CAPA requirement in ISO 9001:2015.
Our software allows you to:
- Record and track non-conformances, root causes, and corrective actions.
- Include general non-conformances, non-conforming audit items and complaints.
- Automate workflows and set notifications and task reminders to ensure that corrective actions are fully implemented.
- Access real-time data and analytics help in identifying trends, effectiveness, and areas for improvement.
- Encourage better teamwork on non-conformances, root causes, and CAPA processes.
- Use affordable CAPA software that is effective and affordable for small to medium-sized businesses.
- Get free ongoing support before and after you subscribe.
Sign up for a free 60-day trial and get full access to our software modules with support.
CAPA requirements in ISO 9001:2015
ISO 9001:2015 encourages a proactive, risk-based approach to quality management.
Clause 10.2: preventing non-conformity recurrence
This clause focuses on preventing non-conformity recurrences. It requires the results of corrective actions to be well documented and understood to prevent non-conformities from happening again.
It also requires management and team leaders to be actively involved in identifying, recording, removing, and mitigating risk.
Employees down the chain of command should also provide feedback on risk to managers and team leaders.
CAPA documentation requirements in ISO 9001:2015
Under ISO 9001:2015, the following records are mandatory (among others):
- record of non-conforming outputs (clause 8.7.2)
- monitoring and measurement results (clause 9.1.1)
- internal audit program (clause 9.2)
- results of internal audits (clause 9.2)
- results of the management review (clause 9.3).
CAPA reports are an integral part of internal audits. Typically, a business will compile separate reports for corrective action and preventive action.
Documenting CAPA processes
All corrective action processes should be properly documented, and the outcomes should be recorded and evaluated.
The current standard doesn’t require separately documented, predefined procedures for preventive actions (which were required by earlier editions of ISO 9001).
This doesn’t mean preventive action is any less important just that documentation requirements have been streamlined.
Future changes to ISO 9001
In December 2023, revision of ISO 9001:2015 was started by a working group of more than 150 country representatives from almost all standards organizations.
The broad strokes of the standard are expected to stay largely the same, with a few exceptions. The standard will be tweaked to better align with ISO 9000.
The risks and opportunities topics in chapter 6.1 are also likely to be split into two separate sections. This is so companies won’t get bogged down focusing on risks and end up overlooking potential opportunities.
If all goes according to plan, the expected revision of ISO 9001 will be released in September 2026.
Key steps in a compliant CAPA process
There’s no single template for a CAPA process that can be applied to every business or industry.
However, an effective and compliant CAPA process will include the following key steps:
1. Identification
When a non-conformance, quality issue or defect is noticed by a staff member or customer, the nature of the issue is recorded.
2. Evaluation
The issue is then evaluated to assess severity and to decide if it warrants a CAPA plan.
3. Investigation
A thorough and in-depth investigation is launched to find the root cause/s of the issue.
4. Implementation
Either corrective or preventive action (or both) is implemented – corrective action to resolve the issue immediately and preventive action to ensure it doesn’t reoccur.
5. Monitoring
The CAPA is monitored to document its effectiveness and do an internal audit if appropriate.
6. Modification
Modifications are implemented to address any weaknesses in the CAPA process.
What to include in a CAPA report
All CAPA processes should be reported on. Multiple people might contribute to the report, including whoever initiated the CAPA, the person responsible for implementing it and whoever needs to sign it off.
The report should typically include:
- the nature of the non-conformity
- its severity
- immediate actions that were taken
- suspected causes
- the plan for corrective and/or preventive actions
- verification that action was taken and was effective
- sign-off from a quality manager once the process is complete.
How isoTracker’s CAPA software can help
isoTracker offers modular, cloud-based quality management software, including a dedicated CAPA module to facilitate ISO 9001:2015 compliance.
The benefits of our QMS software include:
- centralized on a cloud-based system
- automated workflows and reminders
- subscription-based and priced flexibly
- facilitates better teamwork for CAPA processes
- real-time data for analytics and reporting
- free after-sales support from isoTracker.
Contact us to find out more or sign up for a free 60-day trial of isoTracker’s CAPA software to see how it can help your organization be compliant with ISO 9001:2015.
