An organisation that
wants to be certified has to fully and demonstrably meet all the requirements
of the applicable standards. This means, among other things, that the following
requirements have to be fulfilled:
-
A Quality Management System has to be adopted, recorded and implemeted
and the efficiency of this system has to be maintained. This QM System has to
meet the requirements of the ISO 13485
- Requirements described in the
standards as “appropriate“ are fullfilled, respectively has to submit
comprehensible rationals for any exemptions from the standard’s requirements
- Required processes that are not
carried out by the organisation itself are stated in the QM System
- Specified procedures have to be
implemented and adopted which also means that the employees have to be
consequently trained
- All procedures required by the
standards have to be adopted
- The sequencing and interaction of
procedures have to be specified
- All procedures regarding production and supply of services
considered according to Annex 7.5.2.1 must be validated
- Procedures have to be analysed and
measured
- Measurable quality goals have to
be specified
- Records and documented
requirements required by the standards have to be available
- Risk management has to be included
in the whole process of product development
- The Quality Management System must be reviewed according to ISO 13485 with regard to its applicability and efficiency.
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