How ISO 13485 ensures optimal quality in medical equipment?
Over the past few decades, there has been an immense propagation of awareness vis-à-vis health and safety management. The vast research and development in the sphere of medical sciences and the tremendous technological advancements have en masse led to the discovery of complex health problems and remarkable ways to combat them. The International Organization for Standardization or ISO has introduced several benchmarks regarding health safety such as ISO 9001: 2015, ISO 22000, OHSAS 18001, and the recently rolled out ISO 45001 for occupational health & safety.
Here, the significance of ISO 13485 is worth mentioning, as this emphasizes the requirement for a comprehensive quality management system for designing and manufacturing medical equipment.
As usual, the renowned detective Sherlock Holmes was deeply wrapped up in the thought of his recently solved case related to a clinical death of a TB patient who had succumbed to his illness owing to lack of proper medical equipment. He abruptly broke the silence and uttered to his associate Dr. Watson-
“Such inopportune fatalities are a matter of serious infamy for any developed society.... Perhaps the medical practitioners ought to take it upon themselves to figure out a remedy against it….”
Dr. Watson butted in, “Sir, even the most certified practitioners fail to deliver what they propose, for the lack of proper medical equipment.”
To which Holmes replied- “Very importantly, the availability of desired clinical amenities has a crucial role in ensuring optimal health conditions in a particular region. In view of this predicament, International Organization for Standardization has rolled out ISO 13485, the ISO certification one of its kind that commends best quality management practices as regards designing of medical devices.”
Eager to know about this remarkable concept, Watson put forward his question-
#1. What is the significance of ISO 13485?
Holmes: This ISO Benchmark acts as a yardstick for a globally acceptable model for a medical equipment, that an organization in a medical device industry must adapt to. Being a quality management system standard ISO 13485 is harmonised with ISO 9001: 2015.
#2. What are the differences between ISO 13485 and ISO 9001 certification?
Holmes: There are several distinctions between the two types of ISO certification, Watson, though they both function along the same lines.
A broad difference is in the way they both are implemented. While ISO certification 9001 emphasizes continual improvement, ISO 13485 only mandates that a certified entity effectively implements and sustains the desired quality system.
#3. How is ISO 13485 different from ISO 9001 certification with respect to functioning?
Holmes: Apart from the abovementioned aspect, the major difference is that ISO 9001:2015 certification focuses on overall client satisfaction, hence the directives a propos QMS are different in both types of ISO certification. While ISO certification 9001 accentuates on designing of a product as per the customer preferences, ISO 13485 focuses on the conformity of a medical device with the established model approved by global medical agencies.
#4. How much effective is ISO certification 13485?
Holmes: Watson, the effectiveness of this benchmark can be truly justified, as it puts-
• A great emphasis on apt infrastructure, mainly for manufacturing of sterile medical devices.
• Much stress on regulatory requirements and, in particular, authoritative documentation.
• More focus on post-market actions, including complaint redressal.
#5. What are the benefits of ISO 13485?
Holmes: With an ISO certification 13485, an organization can-
• Ensure the fulfilment of QMS practices that consistently yield safe and effective medical devices
• Handle clinical risk efficiently.
• Enhance the processes and efficiency as required.
• Gain a competitive edge over others in the industry.
#6. Which is the latest version of ISO 13485?
Holmes: Currently, ISO 13485:2016 is in practice.
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