Practical Reasons Behind The ISO 13485/QSR Regulations

Hello Everyone:

I am working with a company who wants to understand the practical reasons behind some of the 13485/QSR regulations.

I have some ideas but I bet with the experience on this forum, I can add to the list.

So in layman's terms, why is the following list important for companies to understand and how will it help employees do their jobs better:

1: Documentation Practices
2: Noncomforming Materials
3: Training
4. Product Labeling
5. Importance of Calibrated Equipment
6. Vendor qualification/use of qualified materials.

All responses are appreciated.

Best Regards,

Mark

Re: Practical Reasons Behind The Reguations

Mark M. Sweeny said:

I am working with a company who wants to understand the practical reasons behind some of the 13485/QSR regulations.

I have some ideas but I bet with the experience on this forum, I can add to the list.

So in layman's terms, why is the following list important for companies to understand and how will it help employees do their jobs better:

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It doesn't have to be a medical devices situation in order for these things to be important, and to be honest, most seem self-evident, but here goes:

Mark M. Sweeny said:

1: Documentation Practices

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Development and control of documentation is important in maintaining configuration control, which is assuring that the product is produced (and performs) in accordance with customer requirements. How can we tell what the requirements are if they're not properly documented, and how can we assess the efficacy of the product? Document control is important in establishing control over changes in products and processes during every phase of "product realization."

Mark M. Sweeny said:

2: Noncomforming Materials

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Nonconforming material (and conditions) must be controlled in order to assure that products and processes meet customer requirements. Control of nonconforming material is also important in the corrective action process and efforts to reduce waste and improve processes.

Mark M. Sweeny said:

3: Training

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This might better be characterized as assuring competence. People need to know how processes are supposed to be operated and should demonstrate the necessary competence in doing so. Training is but one way to establish competence.

Mark M. Sweeny said:

4. Product Labeling

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Because I'm not an expert in medical devices, I'll defer to others here with more experience on this one, except to say that it's important to have uniformity in product labeling so that product users can make logical comparisons between products, and so that products are used in accordance with design intent.

Mark M. Sweeny said:

5. Importance of Calibrated Equipment

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"Calibration" is the act of comparing a measurement device to an accepted standard, which may or may not involve adjustment. If the importance of something is such that it must be measured in order to assure compliance with requirements, it's also important to know that the device in question is capable of performing as intended.

Mark M. Sweeny said:

6. Vendor qualification/use of qualified materials.

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It's important to know that suppliers are capable of providing products that meet specifications, can deliver them when they're needed, and are financially stable. Not all suppliers who claim capability are capable. Some form of standardized method of qualifying suppliers is important in assuring a reliable stream of purchased materials. Insofar as materials are concerned, it must be assumed that particular materials are specified for a reason. It might be that two similar materials will perform completely differently in a given application. Furthermore, proper identification and qualification of materials is important because it should never be assumed that a given material is what its supplier claims it is.

Re: Practical Reasons Behind The Reguations

Well said, Jim. Not even minor quibbles in wording.

Re: Practical Reasons Behind The Regulations

I like to think of things in fairly simple ways so to me this question can be answered something like this....

The finished devices have been tested to show that their safety and efficacy is up to scratch. The results of this testing has been approved by some agency (e.g. FDA) and they have agreed that the finished product was suitable for the proposed function (Indications for use).

If any of the 6 items you mention vary, how can you be sure that the approved test results will be repeated?


Jim has given a much more detailed answer that I thought was excellent, but I guess my answer is more of a precis.

As for point 4 specifically, the labelling is part of the approval process. It must be clear to avoid any confusion by the end user, and must be controlled so that random changes aren't made that may cause confusion.

Hope this helps.

Standardization in labeling is also important as many countries use ISO standards therefore if you comply with the standards you are more confident that your warnings and labels will be correctly interpreted.

Having a quality system is very important, because it is focused to aid in prevention. You may be able to conclude why some recalls of Medical Devices occur, and there could be times when they happen because of an issue directly or indirectly related to a quality system.

You can find examples of product recalls in some websites like: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/default.htm

I particularly remember one product recall which took place because of an incorrect segregation of non-conforming PCB's.

Not having good a quality system in any industry sector represents a risk for making mistakes. In the medical device sector in particular, a mistake can cost lives. That is the importance of establishing good controls at different stages of the process.

I hope this helps
Alberto

I like all the explanations but I would also approach it from a different angle: Just common sense.

Most of the requirements for Quality Systems anywhere are not rocket science, again, just common sense.

Let the people in your company approach it from an individual point of view:

I am a customer/consumer and I

- receive a phone call from my insurance agent that I am going to save money - wouldn't I write down with whom I spoke, when it is going to happen, why it is going to happen etc?
- buy an applicance - wouldn't I like to have a manual which describes how to handle it?
- have a broken coffee maker, wouldn't I set it aside until I decide what to do with it but most certainly take it out of service and make sure that I could not mix it up with another coffee maker I might have?
- hire a plumber, wouldn't I like to know that the person I hire knows what (s)he is doing?
-buy some expensive clothing, wouldn't it be nice to know how to clean it before I ruin it?
-do some measurements. If I need to rely on the measurement, I want to make sure that whatever I use for doing it works as anticipated;
-order tools or equipment, again, who would I chose, a company I find somewhere or would I do my homework and research and make sure that I can rely on their products, customer service if I should need it etc.

I worked for several companies which were certified, some were medical device companies others weren't and therefore I dealt with a lot of people who never heard of Quality Systems. I always tried to compare regulations to just day-to-day situation I would encounter as a consumer/customer - it usually worked.