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The new CSV version as per ISO 13485-20xx (Medical Device Quality Management Systems)

This international standard specifies requirements for quality management systems for organisations that are to demonstrate their ability to supply medical devices and related services, which constantly meet the needs of customers and the legal requirements on medical devices and related services.

The status quo
Source: EN ISO 13485:2012-11 item
"The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement." This includes any processes where deficiencies become apparent only after the procuct is in use or the service has been delivered". The organization shall establish documented procedures for the validation of the application of computer software (and changes to such software and/or its application), for production and service provision that affect the ability of the product to conform sto pecified requirements. Such software applications shall be validated prior to initial use."

Source: EN ISO 13485:2012-11 item 7.6
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements (see 7.2.1). [...] In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. […] When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.

And now in the new version (draft)
In the new version, which is now available as a Final Draft open for comment until 28.05.2014, the subject of "valid systems" is covered more extensively than in previous editions. While the previous version contained a mere few sentences that were more or less open to interpretation, the requirements for "Computerised System Validation" have now been clarified extensively and expanded in Chapter 4.1.6,

Source: EN ISO 13485:20XX _Draft:

4.1.6 "The organization must determine procedures for the validation of the application of computer software used in the scope of production and service provision, and document them in the quality management system. Such software applications shall be validated in respect of the intended application prior to first use, as well as after changes to the software and/or its application." Records of these activities must be maintained.

For applications of computer software in the quality management system, the organization shall determine and justify the specific approach and the effort of software validation activities on the basis of risk in conjunction with the application of software.

NOTE Computer software can be used to implement, monitor, measure or analyse the quality management system. Computer software can be used for product development, testing, production, labelling, distribution, inventory control, data management, complaints handling, calibration and maintenance of equipment, corrective action, preventive measures, and more.

7.3.9 (Development of software for medical devices), and Appendix A with a direct comparison with ISO 9001:2008. Appendix B shows the differences between the current ISO 13485 edition and the new draft in detail in a highly informative manner. This means that many companies must determine the validation status of the affected systems, and take action, if applicable, to maintain ISO certification.


Click here to see the reference projects "Computerized Systems Validation - IS-validation/CSV in Medical Technology"


For further information please contact Dr. Thomas Karlewski

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