Minimum requirements for the certification according to ISO 13485

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 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