We’re working with a client in the Medical Equipment Industry who need Quality Management in their solution. However with Control Plans, this requires us to define in the Acceptance Sampling Parameters which ISO Standards are to be used.
There are 3 predefined as values within the system:
ISO 2859-3:2005, ISO 2859-1:1999, ISO 3951-2:2013
However the client insists that they also use ISO 13485:2016, but we can find no way of including this can anyone suggest a way in which we can get this added?
I´m not sure I understand the question here.
In IFS Cloud three different standards are supported for Acceptance Sampling. If, and only if, you are using acceptance sampling you need to select what acceptance sampling standard(s) to use.
ISO 13485:2016 is a standard for quality management systems (QMS) specific for medical device industry, and is not an Acceptance Sampling standard. So it cannot be added in the Acceptance Sampling Parameters group.
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