Flexible Quality Management System (Multiple Standards)

F

Flutar1986

#1
:biglaugh:
Hi, Covers, thank you so much for all the information shared.

I am currently a student carrying out a project of flexible quality management system (ISO 9001 and ISO 13485).

Our client is a design consultancy company with its main focus on medical devices design, and prototype making.

Having gone through both of these standards and completed gap marking process, I still cannot find the way to build a flexible quality management system.

Any ideas, thank you in advance. :agree:
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
Re: Flexible quality management system

Welcome to the Cove! :bigwave:

Many people believe the ISO standards influence regimentation in quality management systems. In his book Stepping up to ISO 9004, Russell Wescott explains that establishing a customer-focused approach and plain sense strategy in building our systems, we can be both compliant and flexible. We remove the focus from "what the standard wants" to "what the customer wants" based on an observation that many stakeholders, including regulators for medical device manufacturing, are asking for the same types of controls to ensure target outcomes are reliably met. We can have a quality management system that is, in fact a business system and not just a series of robot-like processes and requirements toward the end-goal of "compliance."

Flexibility means a responsiveness to the stakeholders and a willingness to apply learnings toward change. Too often, flexibility is confused with looseness or relaxation, but in fact discipline and flexibility are not mutually exclusive terms.

To summarize, a medical device design group needs to have both the discipline to do the appropriate things, and flexibility to notice needs for changes and adopt them without compromising the stakeholders' interests.

I hope that makes sense!
 

somashekar

Staff member
Super Moderator
#4
Re: Flexible quality management system

:biglaugh:
Hi, Covers, thank you so much for all the information shared.

I am currently a student carrying out a project of flexible quality management system (ISO 9001 and ISO 13485).

Our client is a design consultancy company with its main focus on medical devices design, and prototype making.

Having gone through both of these standards and completed gap marking process, I still cannot find the way to build a flexible quality management system.

Any ideas, thank you in advance. :agree:
I wish to understand your word Flexible ?
Both the ISO 9001 and 13485 tells the requirements and further directs you to respect the various other regulatory to which one subscribes. ISO 13485 is ISO 9001 + specific stuff which depends upon the classification of the medical product.
 

cubix rube

Involved In Discussions
#5
We've just been certified to both standards as of this week. :cool: One of the things I had to do was to create separate scope statements for the two standards. Our customer base is divided up between Industrial/Automotive, and Medical. I broke my scope statements out between the two sectors, with Industrial/Automotive meeting 9001, and medical meeting 13485. So we still have ONE integrated QMS that meets both standards. We continually improve the QMS elements related to our industrial customers, and we maintain the effectiveness of the QMS elements related to our medical customers.
All of our reporting, e.g., mgmt. review, goals and objectives, KPI's, etc., are broken out by sector and reported separately. We perform risk mgmt. for our medical customers, but not for our automotive and industrial customers.
I struggled mightily putting it all together, and getting us to this point, but having now gone through the process, it's turned out to be much easier than I thought it would, and if I had to do it again, I'm pretty sure it would be much easier.
I hope this helps a little...
 
F

Flutar1986

#6
We've just been certified to both standards as of this week. :cool: One of the things I had to do was to create separate scope statements for the two standards. Our customer base is divided up between Industrial/Automotive, and Medical. I broke my scope statements out between the two sectors, with Industrial/Automotive meeting 9001, and medical meeting 13485. So we still have ONE integrated QMS that meets both standards. We continually improve the QMS elements related to our industrial customers, and we maintain the effectiveness of the QMS elements related to our medical customers.
All of our reporting, e.g., mgmt. review, goals and objectives, KPI's, etc., are broken out by sector and reported separately. We perform risk mgmt. for our medical customers, but not for our automotive and industrial customers.
I struggled mightily putting it all together, and getting us to this point, but having now gone through the process, it's turned out to be much easier than I thought it would, and if I had to do it again, I'm pretty sure it would be much easier.
I hope this helps a little...
Hi, Cubix, thank you so much for your useful reply which assured me of the possibility of integration. Cheers.
After reading your post, I've got two points on which I really hope you can provide more information.

The first one is: is it necessary to have separate mgmt. review, goals and objectives, KPI's, etc. for two sectors? Can we integrate them into one?
The next one is about risk management in ISO 13485. How did you fulfill this requirement?
Based on the discussions from this forum, risk management should focus on medical devices, is it true? Do we need to conduct risk assessment for key processes?
In addition, every company has various products and processes, should we develop risk management process for all the products or just a generic one which can be used everywhere?

Thank you so much for your time. Appreciate that?
 
F

Flutar1986

#7
;) Thank you all for your informative reply. :applause:

Currently, we are working on process mapping.

It turned out that our client doesn't need certain processes (customer service, installation, delivery etc. which are manufacturers' job) as a design consultancy. It has to be mentioned that they are not legal manufacturer, they just make prototypes to test their design not for finished product.

What we can do given this situation? Should I exclude certain parts?

Any insights, thank you so much.
 

pkost

Trusted Information Resource
#8
With regards to having separate mgmt review, goals, scopes and KPI's etc for the different sectors then it depends on the company. There no reason that they have to be separate, it is up to the company to decide if this is appropriate.

As a company that holds both 9001 & 13485 we don't separate the standards in anyway, both QMS's have the same scope, mgmt reviews etc. But then we only manufacture and sell medical devices, we aren't involved in any other industries.

Risk management in 13485 specifically relates to product realisation. 9001 does not exclude the use of risk management in the same processes. We therefore use 14971 to carry out risk management of our designs and that is all that is required by the standard.

With regards to other processes, there is no requirement to risk manage them. However, neither standard prevents them from being risk managed. Certainly with regards to the manufacturing processes I think it is pertinent to risk manage to reduce the risk of non conforming products but this is not a requirement. It boils down to what is appropriate for the company....will there be some gain/benefit?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#9
;) Thank you all for your informative reply. :applause:

Currently, we are working on process mapping.

It turned out that our client doesn't need certain processes (customer service, installation, delivery etc. which are manufacturers' job) as a design consultancy. It has to be mentioned that they are not legal manufacturer, they just make prototypes to test their design not for finished product.

What we can do given this situation? Should I exclude certain parts?

Any insights, thank you so much.
Some view the standards as being all about a physical product. But delivery of a design service is still delivery. It is an exchange of what brings in revenue, from the provider to the customer. How that is controlled, how effective it is and how it gets customer-focused improvements is what the organization should be talking about. Certainly customer service is a must (how does the design house know the customer is satisfied?) although it does seem as though installation can be exempted.
 
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