Most Common and Avoidable Mistakes While Adopting ISO 13485

February 11, 2020 ViSU

In the process of implementation of QMS standard ISO 13485, many companies face common struggles; however their mistakes can be avoided when you look and analyze these things more closely. The more closer you look at the QMS requirements, you understand the more and can apply your own QMS processes in your organization according to these guidelines.

1. Treating the ISO 13485 Requirements as a “CHECKBOX” Activities

Business market is a series of interrelated processes and functions. Implementation should never be about checking a box; there are many chances to miss the potential benefits of the activities it actually involves.

Implementation of ISO 13485 should be a holistic approach, where the culture of “QUALITY” increases across the entire company by adopting quality-first mindset and doing a lot of value-add exercises and ensure these standards are met in all operations.

2. Limited CAPA Understanding ->Overload on CAPA ->Hide CAPAs ->cause Audit Failure

Due to company’s poor processes, CAPA can quickly be over loaded; unable to eliminate & prevent non-conformities which leads to overburdened with excess CAPA events. Generally as an initial step, auditors check the CAPA procedures to understand “how the root causes are identified& how efficient are the QMS processes”. The more you understand the CAPA, you can judge where CAPA required or not and can eliminate and prevent the cause(s).

3. Failure to Perform Internal Audits

If you don’t conduct internal audits, you’re missing out on the opportunity to stay at the pulse of what’s really happening and make improvements as you go. You are in a big trouble if do not conduct internal audits or follow checkbox activity in the internal audits. Ensure to perform frequent, effective and comprehensive internal audits to meet the compliance.

Other important avoidable mistakes from the medical device manufacturing companies:

  • Ineffective Management Reviews
  • with properly Handling Customer Feedback
  • Failure to manage the Risk-Based Processes
  • Common mistakes when implementing Documentation Control

Manufacturers can avoid common mistakes in implementing the ISO 13485 Quality Management System by dropping the checkbox activities and use a structured QMS to bring safe, effective medical devices to market. This is the overall essential purpose of the standard.