When will ISO 13485 be updated? Will it be harmonized with ISO 9001?

[TNHunter]

Does anyone know if 13485 is being revised to harmonize with 9000L:2008? Is so, what is the assumed time frame, thanks.

[Marcelo Antunes]

Hello

A technical corrigendum for ISO 13485 was published last year, alignment the standard with the 2000 version of ISO 9001.

The next revision of the standards will begin next year and will alingn it with the next version of ISO 9001 (2014 or 2015).

ISO TC 210 WG 1 (which is the working group responsible for ISO 13485) is acompanying the work of the WGs of TC 176 which will develop the new version of ISO 9001).

At the time what is being done in TC 176 is a research on possible topics to be included or better required in ISO 9001 (for example, one of the areas being studied for inclusion is risk management).

This will reflect on the new version of ISO 13485.

[Ajit Basrur]

In addition to Marcelo's great response, refer Has ISO 13485: 2003 been Updated?


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[arios]

If it were to be revised I would propose greater emphasis of Risk Management along section 7, and even in some sections like 8.3

The reference to batch record (DHR) at the end of section 7.5.1.1. seems to me not the best place. I would move it to section 4.2.4.

I would also suggest further requirements or further clarity for the training needs for internal auditors, e.g. knowledge/competence on the ISO 13485 itself and in other applicable or applicable regulations.

[arios]

....BTW, please share your opinion on what would you like changed on ISO 13485. It will be nice to hear opinions.