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ISO 13485 puts emphasis on safety of medical devicesĬontinuous advancement focus: ISO 9001 currently requires producers to reveal constant improvement. These differences go beyond simply not sharing the Exact Same arrangement and comprise:Īims and results: ISO 9001 requirements are skewed heavily towards ensuring client satisfaction, whilst ISO 13485 puts more emphasis on the efficacy and safety of medical devices. Though they are alike in a lot of ways, it is important to note that there are important ways that they’re different. QMS needs: To comply with regular, organizations will need effective procedures and resources such as Document Control, Employee Training, Audits and Corrective Action.ĭifferences Between ISO 9001 and ISO 13845.Client focus: The two ISO 9001 and ISO 13485 are constructed around ensuring customer expectations are met.
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Plan-Do-Check-Act: regardless of how the two criteria don’t share exactly the exact same structure, they utilize the Plan-Do-Check-Act procedure strategy.Risk reduction: More in comparison with previous models, the two criteria highlight the need for associations to integrate risk into production and design.ISO 9001 shares similarities for example: When you get right down to brass tacks, ISO 9001 and ISO 13485 are both basically about precisely the exact same thing: helping businesses create always safe, higher quality solutions. Similarities Between ISO 9001 and ISO 13485 Today we are looking at the similarities and differences between the two criteria, and if life sciences firms and associated services require both certificates. Certainly, there are structural differences, but you might be wondering how different are they? While most standard alterations follow ISO 9001’s new high-tech construction, ISO 13485 doesn’t, though it premiered after ISO 9001. ISO 13485 for medical device quality control shares several similarities with ISO 9001, the top worldwide excellent management standard with over 1.1 million certifications globally.