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Category " ISO 13485"





COVID-19 Warning – Maintain ISO 9001 and other Management Certification/s or lose them

Date: 01 Apr 2020
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ISO,ISO 13485,ISO 14001,ISO 27001,ISO 45001,ISO 9001,ISO Standards
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CORVID-19 related lockdowns & restrictions, has created a novel situation. However Certification-related Audits are still required to be conducted in-spite of current restrictions. To enable Certification audits to continue, most Certification Bodies worldwide have or are moving to Remote Auditing. This means that the Auditing is carried out remotely as the default. In the past, they were the exceptions. Note...


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ISO 13485 Medical Device Standard – the exception

Date: 28 Sep 2019
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Achieve Iso,ISO,ISO 13485,ISO Standards
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ISO 13485 Standards was updated on 1st March 2016. With the ongoing reviewing and updating of all the Management Standards, it is interesting to note that ISO 13485 is the exception. In particular ISO 13485 follows the previous Standard (and ISO 9001: 2008) Index layout. This is in-spite of ISO specifying that all new or revised Management Standards in 2013 will comply to the new Annex SL format...


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