Quality Policy: ISO 13485 vs. ISO 9001 (or AS9100 or..)

RCW

Quite Involved in Discussions
This is for all of you whose companies have their feet in several different industries.

Regarding quality policy, ISO 13485 wants you to maintain the effectiveness of the quality system. However ISO 9001 and AS9100 and I'm sure several others out there want you to continously improve.

As a company, how do you address this?

I have jokingly told people here we are to continously improve but just not that much.
 

Jim Wynne

Leader
Admin
Re: Quality Policy:ISO 13485 versus ISO 9001 (or AS9100 or..)

This is for all of you whose companies have their feet in several different industries.

Regarding quality policy, ISO 13485 wants you to maintain the effectiveness of the quality system. However ISO 9001 and AS9100 and I'm sure several others out there want you to continously improve.

As a company, how do you address this?

I have jokingly told people here we are to continously improve but just not that much.
ISO 9001 (5.1) says,
Top management shall provide evidence of its commitement to the development and implementation of the quality management system and continually improving its effectiveness... <emphasis added>
And then in 5.3 (regarding the quality policy):
Top management shall ensure that the quality policy...includes a commitment to...continually improve the effectiveness of the quality management system.

I think that maybe the assumption at work with regard to the 13485 language (which I don't have at hand) is that in order to maintain effectiveness, sooner or later improvement will be required. It doesn't say anything different, in other words.
 

ScottK

Not out of the crisis
Leader
Super Moderator
Re: Quality Policy:ISO 13485 versus ISO 9001 (or AS9100 or..)

This is for all of you whose companies have their feet in several different industries.

Regarding quality policy, ISO 13485 wants you to maintain the effectiveness of the quality system. However ISO 9001 and AS9100 and I'm sure several others out there want you to continously improve.

As a company, how do you address this?

I have jokingly told people here we are to continously improve but just not that much.

How do we address it? We don't. It's never come up in any audit.
If it did, I don't think "Maintain" and "Improve" are mutually exclusive in this case.

I suppose one definition of "maintain" is keep something at steady state...
but you are maintaing the effectiveness of the system and in order to maintain the effectiveness you need to continually improve.
 

Doug Tropf

Quite Involved in Discussions
Re: Quality Policy:ISO 13485 versus ISO 9001 (or AS9100 or..)

As a contract sterilizer of medical devices, we are only certified to 13485.
Our Quality Policy states, in part, that we will strive to maintain the effectiveness of the QMS. This stems from the perception that the goal of the regulations is to make safe and effective medical devices and that continual improvement is an unreasonable regulatory goal.

We address "improvement" in our Quality Manual based on
Section 5.6 of 13485, which requires "assessing oppportunities for improvement and the need for changes to the quality management system" during the Management Review process.
 

Jim Wynne

Leader
Admin
Re: Quality Policy:ISO 13485 versus ISO 9001 (or AS9100 or..)

As a contract sterilizer of medical devices, we are only certified to 13485.
Our Quality Policy states, in part, that we will strive to maintain the effectiveness of the QMS. This stems from the perception that the goal of the regulations is to make safe and effective medical devices and that continual improvement is an unreasonable regulatory goal.

Not that I think it really makes much difference, mind you, but who said continualous improvement is a regulatory goal? What happens if your competitors find a way to make their products safer and more effective?
 
V

vanputten

The medical industry does not want to fix things that aren't broken. No reason to improve if it is not needed. Get devices and products approved by the FDA and then don't change a thing.

Is there a clause in ISO 13485 that states you are not allowed to continually improve? Why not maintain and improve your management system? I thought ISO 13845, ISO 9001, and AS9100 were MINIMUM requirements?

I agree with the following: I don't think "Maintain" and "Improve" are mutually exclusive.

Also, if I was the customer, I would want the supplier to do more than *strive* to maintain their management system. I would want them to maintain their management system.

Regards,

Dirk
 

Doug Tropf

Quite Involved in Discussions
Jim,

I meant to convey that we intentionally did not allude to continualous improvement in our Quality Policy because 13485 (and QSR) do not include the explicit requirement for continual improvement - unlike ISO 9001.

I believe one of the reasons the requirement for continual improvement was not included in the general requirements of 13485 was to better harmonize the standard with QSR and other various global regulations.
 

Al Rosen

Leader
Super Moderator
I think that the regulators don't give a rat's *** about product improvement, only safety and efficacy.
 

Jim Wynne

Leader
Admin
I think that the regulators don't give a rat's *** about product improvement, only safety and efficacy.

I'm sure that's the case, and it's as it should be. The regulators are there to help make sure that what's going on today will work as claimed, and won't kill people. But that's no way to build a quality system.
 

RCW

Quite Involved in Discussions
An update to this post....

During my company's recent ISO 13485 initial registration audit, the auditor didn't bring up the improvement aspect but he did question the quality policy as it did not addresss meeting regulatory requirements.

I did some web surfing and found a couple of quality manuals for ISO 13485 certified companies. None of them had anything about meeting regulatory requirements listed in their quality policy.

Guess it depends on who audits you on any given day.
 
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