Risk management can, but must not be compliant with ISO 14971.Ĭhapter 7.3's structure has been revised in ISO 13485:2016. Output: suitability and adequacy of the QM-system.Input: complaint handling, notifications to authorities and measurement of products and processes.
This requirement is no longer limited to production and service provision.įrom now on, the management review (chapter 5.6) must additionally consider:
#EN ISO 13485:2016 SOFTWARE#
An example would be software to manage customer feedback. Software validation: What used to be rather ensconced in Chapter 8 is now explicitly expressed in Chapter 4.1 of ISO 13485:2016: Software used in a quality management systems must be validated. For example, risk management could be carried out only once for very similar devices belonging to one family instead of carrying it out redundantly for each individual family member. This no longer exclusively applies to development.Ī new term, namely the medical device family, allows for providing evidence not only on the level of a product, but also on the level of a medical device family. The demand of meeting regulatory requirements was already existent in Chapter 7.1. It is also explicitly included that regulatory requirements shall additionally be regarded as well as risk management. There must not be a black hole within the value-added chain. The new standard specifies that it explicitly also applies to outsourced processes. However, a variety of small changes even affecting chapter structure makes it necessary to deal with this latest version of the standard intensely. First off: ISO 13485:2016 is an evolution of the previous versions having barely been altered since ISO13485:2003 – not a revolution.
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