Most common mistakes when implementing iso 13485 All ISO standards are very well defined about system and documented. People who need to follow also define their procedure in line with standard but miss one item practicality of implementation. They miss one point as describing how, who, when and where when writing procedure this leads to non- compliances. ISO 13485 is for medical devices which are dealing with human and their health hence noncompliance if found major or critical can hamper your business. Documentation is heart of system what you have written is not going to be one time but everchanging affair and control of such system involving change is major and skilful task. Before an audit, we might make sure that any changes made to the work procedures are updated, review the standard Manual and Quality Management System documents, and make sure that each process owner is attentive to their roles and responsibilities he/she understood and got trained self. This is often an ecosystem that forms the basics of excellent documentation control. 1. The “Checkbox Effect� It is common today to treat repeat activities sort of a to-do list; finish employment task, check the box and advance to subsequent task. Unfortunately, this checkbox mindset has become commonplace amongst device manufacturers when implementing ISO 13485 processes to realize compliance. Many contract manufacturers obtain their certification solely to achieve a competitive advantage which will help secure more business, instead of earning a certification for his or her practiced beliefs within the framework for improving quality assurance. Gaining certificate may help business for short time but if system is not implemented properly then end comes fast with stake of reputation. 2. Lack of Internal auditing another process that leads to many mistakes for manufacturers, and just so happens to also be commonly treated as a checkbox activity, is internal auditing. This is one requirement, and it helps organisation control their system and if trained people do this audit as per schedule and address the observations then organisation health improves. 3. Failure to Consider Risk-Based Processes the 2016 version of ISO 13485 places a high emphasis on the thought of utilizing risk-based procedures. The quality pushes manufacturers to think about whether they thoroughly assessed risk after completing any processes or tasks. However, this often turns into a checkthe-box activity, too. Risk assessment of even design and finished device is also essential and risk benefit analysis is compulsory, so this system demands high input from experts like design, manufacture, and quality people.
4. Neglected CAPA Processes CAPA refers to the corrective and preventive actions taken by manufacturers to deal with problematic occurrences, like systemic issues and quality events. it is critical that manufacturers establish a concrete understanding of those terms to make sure proper implementation. However, the unfortunate reality is that a lot of organizations have poorly defined processes in place or misunderstand these terms, which may cause additional mistakes and long-term problems. Often mistaken is understanding the differences between correction and corrective action and corrective action and preventive action. It is like finding faults with self which always becomes difficult, but this is required with everything that goes wrong like complaint, Post market surveillance issue, and internal failures. 5. No Review of Management Management reviews are required under ISO 13485 and FDA 21 CFR Part 820. These reviews are intended to make sure that procedures are executed adequately and followed from the highest down. However, the number of paperwork involved has led many manufacturers to neglect or stumble while implementing this step, though this is done as it is compulsory but just as formality to complete the task or just done for auditor. 6. Failure to Find Value in Customer Feedback many companies struggle to handle and find value in receiving and soliciting customer feedback. This is important in all business and if you failed to understand customer even if he/she may be wrong you are doomed. System must be strong enough to address issues on priority and learn from this to improve. All customer may not give feedback on its own so proactive approach is essential.