This article aims at pointing out the key mistakes that medical device businesses should not make while implementing their quality management system (QMS) standard, i.e. ISO 13485.

ISO 13485 standard was specifically developed for companies that deal with producing, selling, installing and servicing of medical devices. It requires them to meet with certain requirements of the highly regulated medical industry to ensure a supply of safe and reliable medical devices. In other words, any company that wants to ensure quality treatment and wellness services with their products need to consider this explicit ISO 13485 medical devices standard of quality management.

However, nothing comes without pitfalls or challenges! The same goes for implementation of a stringent quality management standard in the vast medical device field. As a manufacturer or provider of medical devices, you need to avoid falling for these common mistakes while getting your quality assurance system established.

Not Conducting Any Management Reviews

If you have achieved the ISO standard for quality management and think that was the only work to be completed, then you are wrong. Persistent compliance of your QMS with ISO 13485 requirements is required to ensure that your quality assurance is strong. To do that, conducting management reviews regularly is necessary! Conducting it on an infrequent basis or just once a year is never enough. It is not only a formality—you need to check your QMS, assess its documented procedures and ensure that everything is still followed in the most effective way.

Also, regular management reviews and keeping reports of them will be proof to show auditors that your company is truly dedicated to quality management instead of just doing the least to ensure compliance. Quality auditors ask for management review reports while conducting an external certification audit, which is needed for renewal of the ISO certification.

Lack of a Risk-based Approach

A quality management standard always put emphasis on risk-based processes to ensure that every product produced and supplied is absolutely safe. With varying levels of risks associated with medical device uses influencing the lives of people, manufacturers or suppliers need to have a stringent risk assessment approach in their QMS. They should document every error identified or risk assessed in manufacturing processes and report them immediately to the management team for corrective actions. Thus, to maintain their QMS effectiveness as well as its ISO compliance, manufacturers need to have a comprehensive risk management approach. It should cover risks at levels of production as well as should risks related to the supply chain items or materials.

Absence of CAPA Plan

Many manufacturers of medical devices do not have a CAPA plan, which refers to Corrective Actions and Preventive Actions. Most companies go with a contingency plan of actions in case of risks or abrupt events. However, CAPA plans are needed for addressing any systematic issue, quality problems, anticipated risks as well as unpredictable events. Having a CAPA plan ensures that your company has concrete understanding and enough preparedness for all types of quality concerns. With corrective actions, you will be able to eliminate the cause of any risk or error or nonconformity and prevent it from occurring again. With preventive actions, you will be able to eliminate the root cause of a problem and prevent any potential risk or issue.

Not Valuing Customer Feedback

This is the worst mistake your company can make while striving to have strong quality management system. With a vast customer base, many companies find it difficult to keep track of their customer experiences and solicit their feedback. However, that is crucially important if you want your QMS to further improve the quality of your medical devices. When you know what your customers want, what they liked, what they disliked, or what caused a problem in any treatment/care, you will be able to modify your product offerings. You can change its attributes, introduce new features, and eliminate the issues reported by customers. Thus, valuing feedback of your end users and considering them in your product development will only help to better your product quality and customer satisfaction.

While obtaining ISO 13485 medical devices standard is a huge undertaking for your medical products company, any of these mistakes can become a major hurdle in obtaining it. If you want QMS as a powerful solution for your business and to help ensure safe and quality-oriented devices, keep these mistakes in mind and avoid these basic pitfalls. Implementing an ISO 13485 QMS correctly can not only help in maintaining product quality but also can add value to your business.

Author's Bio: 

Damon Anderson is the owner and managing director of an ISO consultancy which offers customized services for quality assurance certifications, including ISO 13485 for medical devices. He blogs in his free time and mainly talks about challenges, myths and tips to comply with ISO 13485 requirements to help medical device manufacturers.

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