Here is one interesting article that can help you: Infographic: ISO 9001:2015 vs. If you have only ISO 9001:2008, then you only need to make transition to ISO 9001:2015. The deadline for the transition is September 2018. A focus is placed on complying with laws. However, customer requirement is of immense importance both in these two ISO standards. ISO 13485 has some features that are congruent with those of other management systems, especially ISO 9001.
> we are manufacturer of medical devices product i.e syringes etc, what type of update need our quality manual as per iso 9001-2008? iso 13485-2016 or ISO 9001-2015?īot ISO 9001 and ISO 13485 have new versions, so if you implemented old versions of these standards, you need to make transition to the new versions in order to maintain the certificates. ISO 9001:2008 emphasizes the assessment of customer requirements and satisfaction while ISO 13485 insists on monitoring the data to show that customer requirement is met. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. (Have a look at our infographics for more details about the differences existing between the two systems). In a nutshell, ISO 9001 is more customer oriented whereas ISO 13485 is more product oriented.
Strahinja Stojanovic Fri, 21:09:02 GMT I've received this question: There are many similarities and differences between ISO 9001 2015 & ISO 13485, and many organizations want to know what they are. ISO 13485 was developed to ensure reliability, quality, trust and strong commitment to human safety.