I'm trying to add ISO 13485 requirements to my ISO 9001 quality manual and quality procedures. (I'm also adding AS9100 requirements too :mg: but I'll leave that one for another thread.)

While my company manufactures medical devices, we do not manufacture or package sterile devices. As such, could I claim that actions to meet 6.4 a) thru d) of the spec are excluded from the scope of my quality system? Is anybody out there in the same situation? How did you handle it? I'm seeking opinions here.

I can't see coming up with contamination procedures when the quality of my product isn't affected.

You can't take an exclusion, but you can state in your manual that you do it where appropriate.

You can't take an exclusion, but you can state in your manual that you do it where appropriate.

How would I handle 8.2.4.2 (we don't deal with implantable medical devices) and 8.5.1 (we are a contract manufacturer - our customer would be issuing the advisory notices to the end user)? Saying we do it where appropriate doesn't seem to apply here as I don't ever see my company having a requirement to perform these actions.

(Section 7 clauses are the only ones a company can take an exception to, correct?)

RCW - confirmed that you can only exclude requirements from section 7.0 - Product realization - if we're talking ISO 9001, here.

BTW - I have been working in a client situation where the infrastructure was provided by the client's customer, so it should have been excluded, IMHO, and maybe TC 176 hasn't encountered all the potential applications, but it is very rare.

RCW - confirmed that you can only exclude requirements from section 7.0 - Product realization - if we're talking ISO 9001, here.


Nope. Talking ISO 13485 here, hence the reference to implanatable devices and advisory notices.

I'm trying to add ISO 13485 requirements to my ISO 9001 quality manual and quality procedures. (I'm also adding AS9100 requirements too :mg: but I'll leave that one for another thread.)

While my company manufactures medical devices, we do not manufacture or package sterile devices. As such, could I claim that actions to meet 6.4 a) thru d) of the spec are excluded from the scope of my quality system? Is anybody out there in the same situation? How did you handle it? I'm seeking opinions here.

I can't see coming up with contamination procedures when the quality of my product isn't affected.

You can not exclude these requirements. These requirements applies to all types of devices and not only for sterile devices.

You could use clean room / controlled areas for manufacturing your devices and the work environment refers to this area. Section 6.4 (a) thru (d) is very important and you could easily comply to the requirements.

6.4 a-d) should not be a problem. There are a lot of "if's" in there. For example, b) begins with "if work environment conditions can have an adverse effect..." So, if work environment conditions cannot have an adverse effect, then the exclusion is already built in.

As far as 8.2.4.2, the title is "Particular requirements for active...." Once again, because the requirements listed are "particular for active implantable medical devices..." they only apply for those devices. The exclusion is again, built in.

Since I first posted this topic back in November '05, I have found several items here that need to be added to address 6.4 - Work environment. Today I just updated this post to ask a similar question for clauses 8.2.4 and 8.5.1.

Again, I don't deal with implantable medical devices and advisory notices are issued by my customers, as we are only contract manufacturers.

I am taking an exception to 7.5.3.2.2 with regards to not processing implanatable devices.

I just find it curious as to why some big assumptions were made about what a medical devices manufacturers are actually doing and these assumptions were incorporated into several clause 8 sections.

Advisory notices are a funny thing. Several of my clients really shouldn't have to worry about advisory notices. However, the second paragraph of 8.5.1 does not contain a built in exclusion. But here is where it could apply. Advisory notices can come from just about anywhere. Your customer, a supplier, you or even the government. The important thing is to have a process to broadcast any advisory notice, regardless of where it originated. And this process must be readily available for activation at any time.

Advisory notices are a funny thing. Several of my clients really shouldn't have to worry about advisory notices. However, the second paragraph of 8.5.1 does not contain a built in exclusion. But here is where it could apply. Advisory notices can come from just about anywhere. Your customer, a supplier, you or even the government. The important thing is to have a process to broadcast any advisory notice, regardless of where it originated. And this process must be readily available for activation at any time.

In the case of being a contract manufacturer, with no exposure to the end user of the product, would this (advisory notices) constitute notifying my customer when nonconformities were found after shipping? (A plan is already in place for this.) Other than that, I can't think of any other situations where this would apply to my company.

On page 2 (3.3) is the official definition of an advisory notice. As a contract manufacturer, I am assuming your supplier and your customer are the same. So, passing on an advisory notice from your supplier to your customer probably won't happen. I also doubt that you would be advising your customer on uses of the device, or device modifications, or disposal /destruction of the devices (once again, I am assuming they already have that stuff figured out). However, they may send you some sort of advisory notice in regards to the device. In that case you probably want to evaluate the notice, and keep it on file. But, without knowing more, I think you could be correct when you say that the best you can think of is related to shipped product (which is the 3rd bullet in 3.3).

As a contract manufacturer, I am assuming your supplier and your customer are the same. So, passing on an advisory notice from your supplier to your customer probably won't happen.

Not true. We do purchase the components used for manufacture from our own suppliers. Therefore, yes, it could be possible that our supplier might provide us with a component recall notification. Then we would inform our customer.

I'm assuming then that this notification falls into the "advisory notice" category?

I also doubt that you would be advising your customer on uses of the device, or device modifications, or disposal /destruction of the devices (once again, I am assuming they already have that stuff figured out).


Now that this is brought up, there maybe cases where this could happen. Several of the items being manufactured were also designed by us. (contract engineering.)

However, they may send you some sort of advisory notice in regards to the device. In that case you probably want to evaluate the notice, and keep it on file.

Another valid point. I was in the frame of mind of addressing only advisory notices going out of my facility, not ones coming into it.


:thanks: Thanks for your help on this, db. Sometimes it takes poking the problem with a stick a couple times to see what happens.

Iso 13485:2003 Clause 1.2 Application
"If regulatory requirements permit exclusions of design and development controls (see 7.3), this can be used
as a justification for their exclusion from the quality management system. These regulations can provide
alternative arrangements that are to be addressed in the quality management system. It is the responsibility
of the organization to ensure that claims of conformity with this International Standard reflect exclusion of
design and development controls [see 4.2.2 a) and 7.3]."

"If any requirement(s) in Clause 7 of this International Standard is(are) not applicable due to the nature of the
medical device(s) for which the quality management system is applied, the organization does not need to
include such a requirement(s) in its quality management system [see 4.2.2 a)]."

"The processes required by this International Standard, which are applicable to the medical device(s), but
which are not performed by the organization, are the responsibility of the organization and are accounted for
in the organization’s quality management system [see 4.1 a)]."

so Permissible exclusions:
Product design and development (chapter 7.3)
Validation of processes for production and service provision (chapter 7.5.2)
Customer property (chapter 7.5.4)
Preservation of product (incl. delivery) (chapter 7.5.5)
Control of monitoring and measuring devices (chapter 7.6)