Corrective Actions in ISO 9001:2015: A Quality Manager’s Guide
Strengthen QMS with risk-based corrective actions
Compliance software to help you demonstrate conformance to ISO 9001:2015
What does ISO 9001:2015 say about corrective actions?
Corrective Actions are a specific set of steps used to help improve overall quality management by eliminating process discrepancies and preventing recurrences of root causes. They are implemented to identify, resolve, and prevent issues of quality non-conformity.
In prior ISO 9001 standards, Corrective and Preventive Actions (also known as CAPA) were separate action plans that each had their own requirements. Summarized in a CAPA Report, they outline the plans on how to fix the existing problem immediately and how to prevent it in the future. However, the latest ISO 9001:2015 standards (Clause 10.2) eliminated the need for predefined procedures for preventive actions. Instead, it emphasized the importance of having a risk-based approach throughout the process, rather than “preventive actions” being done and documented separately.
In this simplified guide for quality managers, we present 5 steps on how to implement corrective actions that are compliant with ISO 9001:2015, with the help of a compliance software.
Not every issue warrants a corrective action. The purpose of issuing a corrective action plan is to identify and resolve problems that are systemic, something that endangers a company’s QMS.
Quality managers and their teams can choose an appropriate risk analysis technique to determine the severity of a non-conformity and decide if a corrective action is needed. The most frequently used approaches are FMEA and HAZOP. This is a good way to inculcate risk management right at the start of the process and help qualify the level of risk and impact an issue brings to the organization, product, and/or services.
Once a corrective action is deemed necessary, the quality team and process owners can collaborate and use an ISO 9001:2015 – compliant corrective action report template to document their plan’s progress.
Root-cause analysis (RCA) is a methodical approach in analyzing a problem and identifying the root causes to solve counterproductive issues or events. It is based on the belief that issues are best solved by eliminating the root cause/s, as opposed to merely addressing the apparent symptom. RCA is best used for issues that cannot be resolved quickly, are repetitive, and systemic.
ISO 9001:2015 highly recommends engaging cross-functional team members and leaders throughout the planning of corrective actions. Quality teams can encourage this by using a compliance software to facilitate collaboration, even when they’re in different locations. The 5 Why’s and/or 8 Disciplines of Problem-Solving (8D) approaches are good root-cause analysis techniques that can help them work together on crafting a good problem statement, identifying the root cause/s, and brainstorming on appropriate solutions to address non-conformance.
Identifying the root causes and their effect can help formulate the most appropriate corrective action/s. In a corrective action plan, there are two key actions: a “correction” recommendation to immediately eliminate the detected non-conformity and the corrective action itself. Apart from the details about the non-conformity and the recommended corrective action, specific details should also be provided, such as implementation timeline, key people and signatories, and costs. Once finalized and reviewed, the digital corrective action plan can be shared to key people to standardize information.
Enhance leadership involvement and encourage them to communicate the change and the rationale behind it. Notify key people via the QMS software about their assigned tasks. Provide a communication channel where anyone can give regular feedback while the corrective action is being implemented. These all factor in and determine the success of a corrective action plan’s implementation.
IS0 9001:2015 requires organizations to review the effectiveness of corrective actions and update risk levels and possible opportunities. After the implementation, the process owners and quality team should wait a suitable amount of time and conduct follow-up reviews.
Additional fields in the digital corrective action plan are available so quality managers can input comments during the review. To document results, they can use QMS software features, such as attaching photos and notes, to provide clearer evidence on the effects of the implemented corrective action.
To implement corrective action plans that are compliant with ISO 9001:2015, quality managers can use a collaborative compliance software like iAuditor to manage their implementation — from root-cause analysis to review of effectiveness of corrective action plans.
Here's a collection of templates you can use for planning risk-based corrective actions:
ISO 9001:2015 Corrective Action Report
Use this risk-based Corrective Action Report template to document plans on how to eliminate non-conformities and its root cause/s.
FMEA Risk Assessment Template
Failure Modes and Effects Analysis is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service.
HAZOP Risk Assessment Template
A HAZOP is a sequenced and methodical study of a process that seeks to identify problems that may represent risks to personnel or equipment.
5 Why's Template
Use this 5 whys template to resolve the root cause of a problem so that your business teams can avoid encountering them again.
8D Report Template
This template is used to document a comprehensive root-cause analysis based on the 8 Disciplines of Problem-Solving, previously known as the Team-Oriented Problem-Solving.