Ensuring Compliance With Medical Equipment – ISO Perspective

Ensuring Compliance With Medical Equipment – ISO Perspective

Ensuring Compliance With Medical Equipment – ISO Perspective

Medical Equipment

Every healthcare facility or those associated with medical device manufacturing should adhere to the recommended equipment maintenance schedules, protocols and replacement guidelines to achieve positive patient outcomes, maintain efficient equipment lifecycle, compliance and quality system.

ISO, abbreviated as the International Standardization Organization, is an independent entity which established many international standards for manufacturing and other aspects related to medical devices. These standards are critical to not only build as well as maintain high-quality medical equipments but also ensuring efficient healthcare system. Notably, ISO standards, especially ISO 13485:2016 and ISO 9001:2015, are recognized by many regulatory bodies as essential guides for medical equipment companies or services.

What is ISO 13485:2016?

These ISO standards define the quality management system requirements for healthcare organizations which are involved in various stages of the medical equipment lifecycle from designing and development to distribution, installation and maintenance. The standards mainly revolve around quality management system that takes care of monitoring, maintenance and control of the key processes associated with medical devices; these standards are applicable to organizations irrespective of their type and size. They help with complete quality control, process validation, risk management and traceability aspects associated with medical equipments.

ISO 13485:2016 provides alternative approaches with respect to the quality management system. Every healthcare organization must fulfil or ensure the claims of conformity to the established ISO standards. The ultimate goal is positive patient outcomes. If any clause is not applicable based on the nature of medical device or organization, the later may have to record the justification, as described in the standards. Ensuring compliance with ISO regulatory standards is essential.

What is ISO 9001:2015?

These standards are more general; they are not industry-specific. They can be followed and implemented by any organization which wants to establish a more rigorous system involving consistent improvement. ISO 9001:2015 establishes guidelines with respect to cutting down costs while maintaining an absolute quality control, for medical device manufacturers. It provides guidelines on improving accountability and creating scope for growth. In turn, it simplifies regulatory compliance for entitites that deal with different aspects of medical devices. According to the ISO 9001:2015, organizations should demonstrate their ability to provide services and products that meet regulatory standards, and also make genuine efforts to enhance customer satisfaction with effective system, improvement and adherence to regulatory requirements.

Medinnova is certified with both ISO 9001:2015 and ISO 13485:2016 and adheres to all guidelines and steps involved so as to achieve the end result – positive patient outcomes. Our team of Bio-medical Engineers receives regular training on ISO guidelines; they remain updated, so that they handle every part of their noble profession responsibly and thus help hospitals with their equipment needs.

Medinnova offers the largest inventory of refurbished medical equipments to hospitals and surgical centers, along with well-designed maintenance and service assistance that adheres to all established regulatory guidelines where the key focus is to ensure safety of patients and healthcare professionals and also consistent improvement in the quality management system. To explore more details about Medinnova, your trusted medical equipment company in India, call on +91 95121 06062 or send an email to sales@medinnovasystems.com.

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