Implementation of ISO 13485:2016 and CAPA

Implementation of ISO 13485:2016
Monitors of modern medical devices

Proper Implementation of ISO 13485:2016 is Essential

Implementation of ISO 13485:2016 Quality Management System (QMS) is a requirement for manufacturers of products used for the diagnosis, prevention, and treatment of medical conditions in the U.S. market.  This requirement is established by the Food and Drug Administration (FDA).  To ensure compliance, the FDA conducts inspections of medical device manufacturers.  Violations found in these inspections can result in penalties and warnings.

Corrective Action and Preventative Action (CAPA)

A major stumbling block for many medical device manufacturers is establishing effective CAPA processes.  These processes are defined in Section 820.100 of Title 21 of the Food and Drug Administration Department of Human Services Sub-chapter H – Medical Devices.  This section defines seven Corrective and Preventive Actions:

(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:

  1. Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;
  2. Investigating the cause of non-conformities relating to product, processes, and the quality system;
  3. Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
  4. Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
  5. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
  6. Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and
  7. Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

(b) All activities required under this section, and their results, shall be documented.

Continual Improvement

The procedures identified in Section 820.100 comprise a system of of continual improvement.  They are dynamic processes that ultimately involve participation of design, manufacture, and quality assurance teams.  Cooperation between these various sectors must be instilled and encouraged to reap the rewards of any QMS.  Ultimately this can be accomplished though continual education of all team members.  This education should include emphasis of the over all goals of ISO 13485:2016 and the specific processes in place for the execution of those goals.

CVG Strategy Can Help in the Implementation of ISO 13485:2016

Our quality experts understand the importance in processes and process improvement.  We offer a variety of Quality Management service to assist in the implementation and continual improvement of effective systems that save money and ensure customer satisfaction.  We can also have expertise in ISO9001:2015, AS9100D, ISO 27001:2013 and (AAR) M-1003 and can readily deliver compliant procedures and work instructions.  Contact us today to see how we can help.



Kevin Gholston

Kevin Gholston

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