The 2015 version of ISO 9001 is expected to be released in October of this year (http://bit.ly/ISO9001-revision). We also expect the ISO 13485 Standard to be revised shortly after the release of the 2015 version of 9001. Manufacturers will need to update their quality system to comply with the new version of either Standard. There are two big questions related to the 9001 change: …..
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The requirements for production of medical devices is going to get more stringent and comprehensive due to imminent regulations; as is the case in Europe, Australia and the USA. The cleanliness requirement of the environment and facility will be dependent on the type, stucture and format of the medical device, it’s packaging and manufacturing process. This is where clean room design, layout and validation is becoming more applicable. To quote WHO “– clean area – An area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants within the area.”