Corrective and Preventive Actions (CAPA)

Certification Experts can help provide new insights into a process.

CAPA is an integral part of your standard processes. The challenge lies in completing them correctly, comprehensively, and on time. At Certification Experts, we can assist you in achieving compliance.

Outsource the CAPA Process
Summary

A quick overview of this page

Corrective and Preventive Actions (CAPA)

CAPA (Corrective Action / Preventive Action) is a process used to identify issues (non-conformities), determine their root causes, and implement corrective measures to prevent recurrence.

Challenges with CAPA

The challenges in the CAPA process lie in identifying the various causes. There is very likely never just one reason, but often a combination of events that lead to the non-conformity.

Guidance from start to finish

The consultants at Certification Experts leverage their extensive experience and expertise in quality management and regulatory standards, enabling them to play an essential role in overseeing and guiding the CAPA process.

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CAPA

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CAPA Assessment by Certification Experts

The CAPA process can be complex, but following a structured format can help effectively tackle it.

Our methodology is as follows:

  • Identify and document the problem
  • Analyse the root cause
  • Determine immediate corrective action
  • Propose corrective measures
  • Assist in implementing the corrective action
  • Aid in monitoring and measuring effectiveness through performance indicators and measurable objectives
  • Report evaluation results to relevant stakeholders

Difference between corrective action and preventive action

A corrective measure is aimed at correcting or resolving an existing problem or non-conformity that has occurred. The main objective is to address the root cause of an issue and ensure it does not recur.

A preventive measure is aimed at preventing future problems or non-conformities before they occur. The main objective is to identify potential causes of problems and take proactive action to eliminate or reduce them.

Let us handle your CAPA’s!

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+31 (0)85 007 3210
ISO 9001 Certified
ISO 27001 Certified
ISO27001 & ISO9001 certified – Trusted by 300+ Clients

CAPA format

Timely completion of Corrective and Preventive Actions (CAPA’s) requires a structured approach and clear responsibilities.

When initiating a CAPA, establish clear deadlines for each phase of the process, including identifying the root cause, developing corrective actions, implementing measures, and evaluating effectiveness. Ensure these deadlines are realistic and account for the complexity of the issue.
Designate specific individuals or teams responsible for each phase of the CAPA. Ensure these individuals have the necessary authority and resources to carry out the tasks and meet the deadlines.
Regularly monitor the progress of each CAPA to ensure it stays on track. Establish periodic status updates and keep communication lines open to identify and address any obstacles in a timely manner.
Maintain clear communication about expectations, deadlines, and responsibilities with all involved parties. Encourage open communication and provide support and resources as needed.
If multiple CAPA’s are being conducted simultaneously, prioritise them based on risk and impact on the organisation. Allocate more resources to CAPA’s with higher priority to ensure they are completed on time.

Benefits of outsourcing CAPA Process

Outsourcing the CAPA process can offer several benefits:

Our experts specializing in quality management and CAPA processes bring a high level of expertise and experience. They can leverage in-depth knowledge of industry standards, regulatory requirements, and best practices, leading to more effective CAPA implementations.
Outsourcing CAPA processes to our experts can result in improved efficiency and time savings within your organization. Our experts can handle the implementation of CAPA’s more quickly, freeing up internal resources for other important tasks.
Our experts can provide an objective and independent assessment of CAPA’s, helping to avoid any bias or conflicts of interest within your organization. This can lead to more accurate problem analysis and more effective solutions.
Outsourcing CAPA processes provides your organization with flexibility and scalability, as you can leverage the resources and expertise of our experts on an as-needed basis.
By outsourcing CAPA processes, you can focus on core activities and strategic objectives while leaving the execution of CAPAs to our experts. This can lead to improved overall business performance and competitive advantage.

How can Certification Experts help?

In the pursuit of enhancing quality and compliance with regulations, implementing an effective Corrective and Preventive Actions (CAPA) process is essential. The consultants at Certification Experts bring valuable experience and expertise in quality management and regulatory requirements, enabling them to play a crucial role in taking over the CAPA process. Their profound knowledge allows organizations to precisely align CAPA processes with sectoral and regulatory standards, such as ISO 13485. By engaging our experts in the design, implementation, and evaluation of CAPA procedures, organizations can ensure a robust and compliant process that not only addresses problems reactively but also takes proactive measures to prevent future non-conformities. Their insights aid in identifying best practices and optimizing CAPA workflows, resulting in improved operational efficiency, risk management, and customer satisfaction.

Let us handle your CAPA’s!

Contact Us
+31 (0)85 007 3210
ISO 9001 Certified
ISO 27001 Certified
ISO27001 & ISO9001 certified – Trusted by 300+ Clients
Portfolio

Check out our CAPA services

CAPA

To enhance quality and regulatory compliance, implementing an effective Corrective and Preventive Actions (CAPA) process is vital. Certification Experts’ consultants, with their expertise in quality management and regulations, play a crucial role in managing CAPA. Their knowledge aligns CAPA processes with standards like ISO 13485, ensuring compliance and proactive problem-solving. Engaging our experts streamlines CAPA procedures, optimizing workflows, and enhancing operational efficiency and customer satisfaction.

  • Identify and document the problem
  • Analyse the root cause
  • Determine immediate corrective action
  • Propose corrective measures
  • Assist in implementing the corrective action
  • Aid in monitoring and measuring effectiveness through performance indicators and measurable objectives
  • Report evaluation results to relevant stakeholders

Capa Training

Our service offers customised CAPA training for medical devices, led by expert instructors. We focus on regulatory aspects such as ISO 13485, share best practices, and provide interactive sessions with practical scenarios.

  • CAPA Training
  • CAPA discussion

Non-Conformance Procedure

A Non-Conformance Procedure within a Quality Management System (QMS) is a structured and documented process that outlines the steps to be taken when a non-conformance is identified within the organization’s quality processes. A non-conformance refers to any instance where a product, process, or activity does not meet the specified requirements, standards, or expectations.

  • Identifying and documenting the non conformity (With evidence/proof in the form of photos)
  • Root Cause analysis of the con conformity (by applying the 5 way method or the Ishikawa method (fishbone)
  • Corrective and preventive actions  (CAPA’s)
  • Preventative actions which will stop the non conformance from occurring again
  • Effectiveness check on the taken actions
  • Close out signatures once both or all parties have  rectified and closed the non conformance

QMS

CE Medical can set up, implement, review and maintain a Quality Management System (QMS) for your organisation. We provide an appropriate QMS based on your situation and wishes.

  • ISO 13485
  • vISO 9001
  • Article 10 Quality Management System MDR

QMS Maintenance 

The basis of a quality management system is the continuous improvement and optimisation of the organisation. Once the certificate has been obtained, the quality must be continuously maintained. By engaging with our Medical Team, you can enhance the effectiveness of your QMS, maintain compliance with regulatory standards, and ensure the continued safety and quality of your medical devices in the market.

  • Maintenance QMS

Internal Audit

Our team of experts can provide aid via the Testing of your management system against standards, the law and your own requirements. The internal audit is also the preparation for the certification audit.

  • Internal Audit

Certification Audit

Certification experts will support with certification audit. During the on-site audit our experts will provide on-site support to assist with any queries that arise during the audit. With our guidance, companies can approach the QMS certification audit with confidence, knowing that they are well-prepared and supported every step of the way.

  • Advise and support during certification audit

Management Review

Certification Experts will support the management in assessing the effective operation of the quality management system and help identify opportunities for improvement and risks.

  • Management Review
Frequently asked questions

All the answers you might need!

It is part of the QMS. There should be a procedure in place for the CAPA process, described in chapter 8.5 of the ISO13485

During an external audit, this can be seen as a non-conformity. Especially, if this is a repeated issue.

 A corrective measure is aimed at correcting or resolving an existing problem or non-conformity that has occurred. The main objective is to address the root cause of an issue and ensure it does not recur. Corrective measures are taken after a problem or non-conformity has occurred and been identified.

 A preventive measure is aimed at preventing future problems or non-conformities before they occur. The main objective is to identify potential causes of problems and take proactive action to eliminate or reduce them. Preventive measures are taken before a problem or non-conformity occurs, based on risk analysis, trend analysis, or other predictive methods.

Testimonials

What our clients are saying about us

New Compliance

Carolina Koster Operations Manager
Your expert conducted an internal audit for ISO 13485 at our company. The pre-audit communication was clear and brought valuable expertise. Despite some challenges, your expert was understanding and fostered a relaxed atmosphere. The audit was thorough and effectively pinpointed our areas for improvement. We are grateful and will be working on the feedback.

Van Heek Medical

Wilma Peereboom Quality Coordinator
The cooperation with Certification Experts is satisfactory. They are decisive from the start and one of their main strengths is their excellent problem-solving skills.

Let us handle your CAPA’s!

Contact Us
+31 (0)85 007 3210
ISO 9001 Certified
ISO 27001 Certified
ISO27001 & ISO9001 certified – Trusted by 300+ Clients