ISO 13485:2015 Pre-Release News and Discussion

Reg Morrison is right, I would not disclose too much detailed information here (as already mentioned in the pst, I?m just putting some general remarks so as not disclose any particular information that can be viewed as not for a public venue).

Anyway, in the case of voting, there were 32 voting members, and 9 against. So we passes the two-thirds majority, but not the one-quarter one.

Regarding the votes themselves, from the quick look I took at them (there?s 135 pages of comments), some were related to the standard not being aligned to ISO 9001:2015 or Annex SL (which is curious because this was decided in the beginning of the revision process), and the majority of the negative votes were for some particular changes that were made to the standard (and some to particular changes that were made in the last meeting, but it seems that there was really no consensus, although there seems to be at that moment).

So it seems that the main expectation is that we have a new round of comments (another DIS) so we can solve everything.

Please note that this is not uncommon as it may seen, but it does require more time. And yes, the formal time is 48 months (we are using an enlarges development track) but this can be extended once for 9 months if needed). Anyway, the WG (and committee) will need to discuss this in Stockholm, too.

Many thanks,
If we want to get the comments, where can I get?

If we want to get the comments, where can I get?

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In principle, you can?t. The comments are circulated to WG1 members. However, if you are part of your country NC or mirror WG, you could get the document from them.

I?m just changing the year of the title of this thread because, due to the negative vote to the DIS, the revision won?t be published in 2015 anymore.

Marcelo Antunes said:

I?m just changing the year of the title of this thread because, due to the negative vote to the DIS, the revision won?t be published in 2015 anymore.

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just for the reason, which the structure of ISO 13485:201X is different from that of ISO 9001:2015? or other main rationale?

Re: ISO 13485:2016 Pre-Release News and Discussion

just for the reason, which the structure of ISO 13485:201X is different from that of ISO 9001:2015? or other main rationale?]

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They are totally different, ISO 13485 will keep the old 2003 structure, and ISO 9001 changed completely.

Marcelo Antunes said:

I?m just changing the year of the title of this thread because, due to the negative vote to the DIS, the revision won?t be published in 2015 anymore.

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Marcelo, many thanks for keeping us informed of the progress of the ISO 13485 revision.

It is very interesting (in my opinion) that the ISO TC 210 is taking the revision process very seriously, taking time and even not following the HLS for the ISO 13485 revision.

In contrast, it seems to me that the ISO TC 176 is determined to have the ISO 9001 revision completed by the deadline they self imposed of September 2015.

With all the respect that ISO 13485 deserves, in terms of user-organizations, it pales against the 1.2 million ISO 9001 certified organizations around the World. The greed to start selling millions of ISO 9001 copies ASAP might be impacting the ISO TC 176 risk management process and they might deliver a half-baked document.

I find very telling the difference of approaches between the TC 176 and TC 210 when it comes to their flagship standards revision process.

Re: ISO 13485:2016 Pre-Release News and Discussion

Marcelo, many thanks for keeping us informed of the progress of the ISO 13485 revision.

It is very interesting (in my opinion) that the ISO TC 210 is taking the revision process very seriously, taking time and even not following the HLS for the ISO 13485 revision.

In contrast, it seems to me that the ISO TC 176 is determined to have the ISO 9001 revision completed by the deadline they self imposed of September 2015.

With all the respect that ISO 13485 deserves, in terms of user-organizations, it pales against the 1.2 million ISO 9001 certified organizations around the World. The greed to start selling millions of ISO 9001 copies ASAP might be impacting the ISO TC 176 risk management process and they might deliver a half-baked document.

I find very telling the difference of approaches between the TC 176 and TC 210 when it comes to their flagship standards revision process.

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Part of the difference is crucial - ISO 13485 has been created to be used for regulatory purposes and thus need consensus by the regulators that will use it.

Some of the main reasons for the negative vote at the DIS were just this - some disagreements on it?s usefulness in the future by regulators (including it?s use in the MDSAp program).

Hopefully we can solve most or all of the disagreements on September.

Re: ISO 13485:2016 Pre-Release News and Discussion

Marcelo, I just wanted to thank you also for keeping us up to date on the

ISO revisions. This site is where I go to see the most current updates.
We all appreciate you and what you do for us. You're the best!

Re: ISO 13485:2016 Pre-Release News and Discussion

Marcelo Antunes said:

...some disagreements on it?s usefulness in the future by regulators (including it?s use in the MDSAp program).

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FDA recently called to ask me/my employer to participate in MDSAP (Medical Device Single Audit Pilot Program).

Is anyone else here participating in US FDA MDSAP, or signed up to do so?