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#ISO 13485:2016 FREE DOWNLOAD ISO#
It has been developed by and is also being used by our ISO 13485 consultants while conducting corporate training sessions and implementing ISO 13485 system in many pharma and medical device manufacturing companies. A user can use this ready-to-use tool while preparing for ISO 13485 Certification. The entire set of ISO 13485 documents are designed in the editable. Our ISO 13485 documents include iso 13485 Quality Manual, iso 13485 procedures, SOPs, formats, and ISO 13485 audit checklist. Global Manager Group has designed ready-to-use ISO 13485 2016 documents kit to comply with Medical Devices manufacturing QMS. The ISO 13485 certification ensures a very safe use of medical devices as per quality system guidelines. The ISO 13485 Certification is based on the quality management system, which helps to implement the medical device preventive system.
#ISO 13485:2016 FREE DOWNLOAD MANUAL#
These iso 13485 2016 manual requirements are becoming popular among the medical devices' manufacturers Medical devices - Quality management systems - Requirements for regulatory purposes represent the requirements that the medical device manufacturers must incorporate into their management systems.
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Regarding ISO 27001, this means including in the organizational process the activities related to information security risk assessment and treatment processes.
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These will require lesser adjustments to refer to systems coveredĢ – Integration of the specific parts of each system. After that, you can make the link with ISO 27001 clauses.įor example, ISO 13485:2016 clause 4.2 (Documentation requirements) corresponds to ISO 9001:2015 clause 7.5 (Documented information), which is the same clause for ISO 27001.Īfter this mapping the integration process should consider two phases:ġ – Integration of the common requirements of ISO 13485 and ISO 27001 management systems, e.g., control of documents, internal audit, management review, etc. First, you have to map the relations between ISO 13485:2016 clauses and ISO 9001:2015 clauses (you can do that consulting ISO 13485 Annex B). Before I answer this question is important to note that besides the 2016 version of ISO 13485, all ISO management systems published after 2012 have the same general structure.Ĭonsidering that, integrating ISO 27001 with ISO 13485 is possible, but requires a bit more effort than required regarding integration with other management systems, like ISO 9001, and ISO 14001.