Is this Quality Policy acceptable in the context of ISO 13485?

T

treesei

#21
May I ask you to elaborate the kind of dangers are hiding for the bastards focusing on customer satisfaction and improvements?
Many thanks.
Ronen E. earlier made an excellent explanation of being conservative and being innovative in the medical industries which also shows why an ISO 9001 mind-setting of "improvements" might be dangerous if our engineers and others go overboard in "being the first in the world" which is exactly regulatory tries to avoid in many cases.

"Customer satisfaction": In many cases, the supplier is the technical expert of the parts it makes. Unfortunately, sometimes, often driven by cost, customer will propose some requests/requirements which from the technical view/analysis may have an impact on the safety and effectiveness of the final product. In controlled industries, if a supplier/technical expert always says YES to a customer, possible consequences of non-compliance may occur in the future. Alternatively, always refer the regulators as your biggest customers and their satisfaction must be ensured.

Footnote: After all, continuous improvement and customer satisfaction are all "word play"s. Those vague and broad phrases can be interpreted and implemented in many ways to satisfy all industries. However, I think ISO 13485 purposely avoided those phrases to bring people out of the ISO 9001 mind-setting as a preventive action when a company evolves from 9001 to 13485. Welcome to the regulated world.
 
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Ronen E

Problem Solver
Staff member
Moderator
#22
Interesting indeed :)

Alternatively, always refer the regulators as your biggest customers and their satisfaction must be ensured.
As enticing as this view it may be, it's a bit risky. I like the definition that says "the Customer is the one who pays". Satisfying regulators is a noble cause ;) however, one could have perfectly satisfied regulators and be out of business. This is not to say that regulation compliance is not mandatory or not important; all I'm saying is that the right balance needs to be sought continuously.

After all, continuous improvement and customer satisfaction are all "word play"s.
I believe that in the medical industry context these 2 can be interpreted in a way that could still work alongside regulatory compliance:

Continuous improvement = Stay vigilant, active if need be; if you see a problem, don't ignore it. Before fixing something, make sure you got it right.

Customer satisfaction = Make sure you understand who your customers are and what are their needs. Capture those needs, make informed decisions which ones to pursue, measure their fulfilment and revisit as necessary.

Cheers,
Ronen.
 
J

Julie O

#24
Speaking as someone with nearly three decades of experience in Regulatory, dealing mostly with high-risk Class III devices, I do not think regulators are a customer of any kind. I think it is unfortunate that ISO 13485 uses the term "customer," since this sets up the option of treating the purchaser as the customer, when the intent (much more clearly expressed by the FDA) is that quality is to be determined by the USERS, not the purchasers. Regulatory is not risk averse. Lawyers are risk averse, so is Compliance. Regulatory strives to manage risk, rather than avoid it. I agree that the medical device industry tends to be risk averse. which is why it tends to realize limited rewards. I do not think that continuous quality improvement clashes with ISO 13485 in any way. A standard is a baseline, not a straight jacket. Any quality-driven company is going to strive to perform continuously above and beyond the standard. I do not think ISO 13485 is all about meeting regulatory requirements. I think it is all about establishing a system for managing the quality of medical devices. I think it is sad but true that a good number of medical device companies would not have a quality management system if the regulators didn't make them, but that doesn't mean ISO 13485 is aimed at regulatory compliance. Regulatory compliance is just a side effect of ISO 13485, and only in jurisdictions where it is a recognized standard.
 
J

Julie O

#25
The continuous improvement concept was not removed from ISO 13485 because it "clashes" with a controlled regulatory environment. It was removed because it sets up a possible scenario where a company is allowed to have poor quality as long it is continuously trying to improve it. Under ISO 13485, the requirements are established as a baseline below which no company is allowed to go. This is not a clash. Improving beyond the standard is not only quite acceptable from a regulatory perspective, it is wise on many levels, including from a regulatory perspective.
 
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