ISO 13485:2015 Pre-Release News and Discussion

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

There are some clauses unclear for me in the DIS2 of ISO 13485.
Could someone answer the following questions?

Related to 6.3.2 in the DIS2, does the testing include not only testing in manufacturing process but also testing in design and development verification?

Related to 7.2.3.2 in the DIS2, what the organization shall communicate with regulatory authorities?
Does it mean the organization shall submit application for medical device licence, application for clearance and etc. in his quality management system?

Related to 7.3.9.1 in the DIS2, what determine the significance of the change to product function?
What the significance determined affects?

Thank you in advance.

Hello Yasuaki and welcome to the Cove!

Related to 6.3.2 in the DIS2, does the testing include not only testing in manufacturing process but also testing in design and development verification?

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It can be beyond manufacture (for example, if you test the device during installation), but not design and development. Note that the requirement is applicable "when such maintenance activities, or lack thereof, can affect product safety or performance". We don?t have a product (medical device) yet during design and development.

Related to 7.2.3.2 in the DIS2, what the organization shall communicate with regulatory authorities?
Does it mean the organization shall submit application for medical device licence, application for clearance and etc. in his quality management system?

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The requirement is for planning, it does not specify what communication there is to be.

The original idea from the requirement came from the discussion that manufacturers have to communicate with regulatory authorities, for example, submitting device documents for registration, but usually they do not have a documented procedure or the like to detail how this is done in the QMS.

The discussion concluded that requiring procedures at this time would be too much, so we ended up requirement that any communication has to be in accordance with "planned arrangements", which in practice means that the organization has to determine what is the communication and how it will be done (and the organization may conclude that they do need documented procedures for some, for example).

Related to 7.3.9.1 in the DIS2, what determine the significance of the change to product function?
What the significance determined affects?

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I?m not sure I understood your questions.

The manufacturer has to determine the significance of the change. This depends on each device, obviously.

Thank you, Marcelo.

Your comment makes me understand those clauses.
Actually, I couldn't understand them clearly.

For instance, clause 7.3.9.1.
On the one hand, this sentence seemed to mean that manufacturer has to establish processes to control design and development changes that determine the significance of the change.
On the other hand, this sentence seemed to mean that manufacturer has to determine the significance of the change.

Hi, I am new to this discussion. Is there any information as to whether ISO 13485 will adopt the new high level structure? Thanks for any information you might have.

For instance, clause 7.3.9.1.
On the one hand, this sentence seemed to mean that manufacturer has to establish processes to control design and development changes that determine the significance of the change.
On the other hand, this sentence seemed to mean that manufacturer has to determine the significance of the change.

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Ah, ok, well, this might be a problem with the wording. The requirement is for establishing processes to control design changes (same as the older one in fact), but then the organization has also to determine the effects.

robinscj said:

Hi, I am new to this discussion. Is there any information as to whether ISO 13485 will adopt the new high level structure? Thanks for any information you might have.

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Hello robinscj and welcome to the Cove!

It won?t adopt the new structure. For more discussion on this, please review older posts in this thread.

Hai everyone
I am new to this group..

Today is the end day for voting the DIS 2,
Do you know the reslut?
Thanks

Today is the end day for voting the DIS 2,
Do you know the reslut?

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The closing date of the voting, in fact, is May 6th.

Marco,

What were the results of the vote?

Bill