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#Iso 13485 checklist iso
Lastly, the ISO 13485 has got more requirements for the management of risk. In terms of documentation, based on our experiences in setting up the Quality Manual, Procedures, Form templates and Work Instructions, the amount of ISO 13485 documentation is on average more than twice of those needed for ISO 9001, though the number of documents may differ between different companies and should not be a definitive gauge towards actual compliance. Challenges of the ISO 13485 certification In addition, ISO 9001 now requires the product manufacturers to focus on continuous improvement, while ISO 13485 requires the company to demonstrate implementation and consistent maintenance of the quality management system. Looking deeper into their differences, the ISO 9001 requirements are set towards ensuring that your organisation put more focus on achieving customer satisfaction, while ISO 13485 puts a lot more emphasis on patient safety during the usage of the medical devices, and greater efficacy in the results of diagnosis for example. This greatly impacts the impression that the ISO 13485 standard is very similar in nature, which is far from the truth due to the differences in structure and framework of the standard. Being the number 1 most popular standard being certified to, anyone in this industry would be familiar with the ISO 9001 standard or have worked with an organisation with the ISO 9001 certification. To add to the challenge, the most commonly adopted ISO standard - the ISO 9001 standard is also known as a Quality Management System, though the ISO 9001 standard applies to many other industries, including construction, engineering, manufacturing, hotels & hospitality, just to name a few. Difference between ISO 13485 and ISO 9001 What this means is that a large majority group of consultants, experts and certification body auditors familiar with the Annex SL standards, would still find ISO 13485 hard to implement, to correct gaps and to audit. Some of the famous standards following the Annex SL framework includes ISO 9001, ISO 14001, ISO 45001, ISO 22000 and ISO 27001. When a standard follows the Annex SL framework, the terminology, the way it is written and defined are mostly similar to one another. The Annex SL framework refers to the way a standard is being written. Besides the stringency of the medical device industry, since it relates to the healthcare and medical sectors, the ISO 13485 does not follow the Annex SL framework. Comparing ISO 13485 to other Annex SL ISO standardĭespite being one of the Top 10 ISO standards being adopted by companies all over the world, ISO 13485 remains one of the hardest standards to conform with. As such, your notified body may require you to conform to both standards, especially if you need to meet regulatory compliance in the EU.
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Comparatively, there are no major differences with ISO 13485:2016, except for the Z-Annexes.
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In 2012, as part of the harmonisation process with the European Union directives for the medical sector (93/42/EEC, 98/79/EC and 90/385/EEC), the EN ISO 13485: 2012 was released. Since then, it was revised twice in 20 respectively - with the latest being the 3rd edition ISO 13485:2016. The standard states the requirements of comprehensive quality management systems for the design and manufacture of medical devices products. The standard, officially known as the ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes, was first published by International Organization for Standardization (ISO) in 1996. Stendard Solution™ -generated documents include details that meet all the ISO 13485, US FDA 21 CFR Part 820, ISO 14971 and IEC 62304 requirements.
#Iso 13485 checklist software
In addition, medical device software (both standalone and embedded ones) are to comply with IEC 62304. The framework of this quality management system focuses on the need to handle risk management, in line with ISO 14971. Besides ISO 13485, US FDA 21 CFR Part 820 compliance is also mandatory for companies entering the United States market. This covers processes spanning the entire product life-cycle, including design and development, production, warehousing, distribution, installation and servicing activities. The ISO 13485: Quality Management System for Medical Devices is an international standard that was specifically published to define the requirements of a quality management system for organisations within the medical device industry.