ISO 13485 201?


These are some conclusions about DIS2 and software statements.


The DIS2 (2nd draft version) of the next ISO 13485 was released in february. It ws rejected by vote in June 2015.

There are not any 'fundamental' changes for software.
Requirements about software are still present in the DIS2 version:
4.1.6 on the validation of the application of computer software used in the quality management system,
the reference to IEC 62304 in 7.1 Planning of product realization,
7.3.9 on Design and development records,
7.6 on Control of monitoring and measuring equipment.
Some notes where the word "software" occurred were withdrawn. Notes are not requirements, so no requirement about software documentation and validation was withdrawn.
A change of wording was made in 7.1:
The reference to IEC 62304 was: See IEC 62304 for guidance related to software life cycle processes. It became: For information related to software life cycle processes see other documents, for example IEC/ISO 62304.
The same change was applied to the wording of the reference to ISO 14971 for risk management.
This new wording leaves the door open to other standards, like standards about the validation of software used in regulated processes.
CONCLUSION: the DIS2 version confirms that ISO 13485 strengthens requirements about software documentation and validation. Whether in a medical device or in a process in the scope of the QMS of a medical device manufacturer.