Recognize Recommendations To Comply With The Iso 13485 Requirements

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Implementing the ISO 13485 standard is essential for medical device companies for a variety of reasons. The standard was developed to support medical device manufacturers in developing a Quality Management System that develops and maintains the efficacy of their operations. Maintaining compliance with this standard, which is focused on safety and quality, can help the organization avoid regulatory fines. It can also help to streamline the operation, raise client satisfaction, and improve the quality of the products.

So, ISO 13485 is a universal standard established by the International Organization for Standardization (ISO) for organizations that design, manufacture, implement, and distribute medical devices and other associated services. ISO 13485, perhaps the most widely recognized worldwide quality management standard in the medical device industry, provides a framework for manufacturers to demonstrate a dedication to medical device quality and safety criteria. Here are eight suggestions that will help organizations achieve the ISO 13485 standard requirements.
Maintain thorough audit trails: It is important ...
... to set up detailed audit tracks at your clearance to make an ISO 13495 audit easier. It means that any record creation, modification, or deletion should be recorded in an audit history file or else maintained in the ISO 13485 Documents, along with the documents should be kept for a set amount of time and should be available for ISO auditors to inspect and copy as needed. Keep a close eye on CAPA, risk, and supplier records because they are included in ISO 13495 regulatory requirements.

Complete a comprehensive internal audit: Internal auditing aims to analyze the operations more intensely and identify opportunities for improvement before bringing in a verified auditor. In terms of ISO 13495, an internal audit can support the organization in identifying gaps in its quality procedures and correcting high-risk parts of its operations rather than wasting time on areas that are already totally compliant. Just make sure to follow up after the internal audit is finished to address any potential issues that could lead to a gap in compliance.
Educate the team on the guidelines of ISO 13495: Without a clear strategy, it is simple to go with the ISO standard rules. Take the time to carefully read the regulations to make sure fully know what's required of you to become certified, and then pass that information on to the rest of the team. Everybody must be on the same page and understand how ISO 13485 certification may change organizational processes to achieve its requirements.

Build a single source of truth: To achieve ISO 13485 certification and remain compliant, the organization must create a single source of truth for its processes, systems, and policies that will withstand any future growth, merger, or acquisition. If company data and documentation are scattered and not organized, information will eventually slide through the gaps, making it impossible to pass audits or refer to earlier information.

Meet CAPA standards: In the medical device business, failure to achieve CAPA requirements is the most common cause of ISO citations. As a result, it is critical to prioritize the CAPA process. Refer to ISO 13485 8.5.3 (prevention) and ISO 13485 8.5.2 (correction) and develop the CAPA standards around their recommendations to ensure your organization satisfies CAPA requirements. You can find them here.

Accurately track employee training: One of the most crucial aspects of ISO certification is demonstrating employee training. ISO defines training standards as "Everyone in the team should have thorough ISO 13485 auditor training and have an experience in their given work." This training must be documented and auditable.

Develop Medical Device Reporting (MDR) procedures: MDR is a post-market surveillance method used by the FDA to monitor device performance, discover potential device-related safety concerns, and contribute to benefit-risk analyses of these products. Medical device businesses must also follow MDR criteria, including filing events and yearly reports, under ISO13485:2016. Keep this in mind when you build detailed MDR procedures to avoid potential compliance difficulties.

Use a digital QMS: The ISO 13485 framework is used to develop digital quality management systems for life sciences organizations for quality control, operational efficiency, regulatory compliance, and the safe manufacture of medical devices. Quality management software automates all of the quality activities and allows you to link documents from various quality processes together for game-changing visibility, traceability, and control. It can also assist in ensuring that the highest quality business processes are followed to fulfill the expectations of consumers, stakeholders, and ISO regulations.

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