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CAPA Requirements in ISO 13485
Quality issues in medical devices often point to underlying weaknesses in the system, and ISO 13485-compliant CAPA is essential for correctly identifying cause and preventing the problem from recurring.
Here’s an overview of CAPA requirements in ISO 13485 for medical device manufacturers.
Effective CAPA is a key requirement for businesses operating in the medical device manufacturing space. It offers a methodical approach to managing and resolving quality issues, and preventing similar problems from arising again.
By addressing quality failures, manufacturers comply with globally recognised safety, performance and quality standards.
Proper CAPA management preserves organizational reputation, streamlines manufacturing processes, and reduces rework costs. It maintains regulatory compliance, reduces risk and boosts customer satisfaction.
Globally recognised as the QMS standard for the medical device sector, ISO 13485 mandates the use of CAPA processes to resolve quality issues.
It refers to corrective action and preventive action in two separate clauses:
8.5.2 Corrective Action (CA) – requires manufacturers to rapidly eliminate the root cause of nonconformities, prevent recurrence, and document the implemented CAPA process, including:
- the review of quality issues and complaints
- identifying root cause
- tracking the impact and effectiveness of CA
- root cause analysis and the action taken.
8.5.3 Preventive Action (PA) – requires manufacturers to avoid the recurrence of nonconformities by prioritizing the identification and correction of root causes with the greatest potential impact.
The process must be properly documented to include:
- the cause and potential impact of quality issues
- an assessment of the recommended action and its implementation
- ensuring compliance of the action
- tracking and monitoring the effectiveness of PA
- root cause analysis and the actions taken.
CAPA requirements in ISO 13485 focus on establishing a proactive, risk-based approached to QM.
The EMA (European Medicines Agency) and FDA (Food and Drug Administration), along with other regulatory bodies, require the mandatory use of CAPA.
These agencies are responsible for regulating the safety and effectiveness of medical devices in Europe and the USA, respectively.
Manufacturers that do not have effective CAPA processes are in violation of regulatory CAPA requirements, and may incur financial penalties or face criminal prosecution.
Correctly determining the underlying cause of quality issues is a major challenge. Without identifying root cause, there’s a high probability of recurrence. Any corrective measures are likely to fail.
Even with effective CAPA processes, the lack of inter-departmental communication and collaboration, inadequate documentation, unrealistic timelines and ineffective resource management are inherent problems that can delay or impede compliance.
CAPA software provides a centralized approach to CAPA. It enables the automated management of core processes, from comprehensive multi-methodology root cause analysis and the identification of quality issues, to the implementation, monitoring and verification of CAs and PAs.
By standardizing and automating CAPA, businesses can more easily meet regulatory requirements, avoid non-compliance, and consistently enhance the quality, performance and safety of medical devices.
isoTracker offers modular, cloud-based quality management software that includes CAPA capabilities to facilitate ISO 13485 compliance.
Contact us to find out more or sign up for a free 60-day trial of isoTracker’s quality management software to see how it can help your organization be compliant with CAPA requirements in ISO 13485.