{"id":729,"date":"2020-02-11T05:05:04","date_gmt":"2020-02-11T05:05:04","guid":{"rendered":"https:\/\/www.ddismart.com\/?post_type=blog&p=729"},"modified":"2024-05-31T04:52:12","modified_gmt":"2024-05-31T04:52:12","slug":"most-common-and-avoidable-mistakes-while-adopting-iso-13485","status":"publish","type":"post","link":"https:\/\/www.ddismart.com\/blog\/most-common-and-avoidable-mistakes-while-adopting-iso-13485\/","title":{"rendered":"Most Common and Avoidable Mistakes While Adopting ISO 13485"},"content":{"rendered":"\n

In the process of implementation of QMS standard ISO 13485,<\/strong> 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.<\/p>\n\n\n\n

1. Treating the ISO 13485 Requirements as a \u201cCHECKBOX\u201d Activities<\/strong><\/h2>\n\n\n\n

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.<\/p>\n\n\n\n

Implementation of ISO 13485 should be a holistic approach, where the culture of \u201cQUALITY\u201d 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.<\/p>\n\n\n\n

2. Limited CAPA Understanding ->Overload on CAPA ->Hide CAPAs ->cause Audit Failure<\/strong><\/h2>\n\n\n\n

Due to company\u2019s 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 \u201chow the root causes are identified& how efficient are the QMS processes\u201d. The more you understand the CAPA, you can judge where CAPA required or not and can eliminate and prevent the cause(s).<\/p>\n\n\n\n

3. Failure to Perform Internal Audits<\/strong><\/h2>\n\n\n\n

If you don\u2019t conduct internal audits, you\u2019re missing out on the opportunity to stay at the pulse of what\u2019s 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.<\/p>\n\n\n\n

Other important avoidable mistakes from the medical device manufacturing companies:<\/strong><\/p>\n\n\n\n