I've wondered about this as well, especially because in academic research I've needed to look at ISO standards and I wasn't going to pay for them. I found this information given by ANSI: https://ansi.org/help/charge_standards.aspx. It seems it is really just about the costs associated for the organizations to write, administer, and supply the standards. It may be worthwhile if document databases offer access to such standards through the subscriptions that companies pay for regularly. Another possibility is for the standard organizations to offer subscriptions that allow access to all documents. It might make things more cost effective for companies while still allowing the organizations to function.

I have to agree with your suggestion of subscribing to a database rather than buying documents one off. This creates a much more sustainable business model for these organizations by ensuring that subscribers will always have access to these articles and the subscriber will continue to pay an annual fee. In theory this should fund future work on these standards but the reality is they run the risk of an individual or company signing up, taking the information needed and then cancelling the subscription. It may be something worth discovering but I for one, would most likely be in the latter camp which might be an indicator as to why the don't offer these services.
-Tarek

I think the major reason that these Regulatory Agencies make companies pay for the regulations is simply a matter of business. They spend a huge number of man hours to develop all of these regulations that are essentially only to be used by other companies, not themselves. If you want to be compliant with a certain agency, it is a smart business choice by the agency to make you pay for their material that is really only helping you to meet the guidelines. I also think, from personal experience, that the cost to purchase regulations is very minimal and isn't something a major company really spends much time worrying about. That is of course different for academic institutions where money is very limited. These cases could definitely benefit from subscription style reading or reduced rates.

Kaitlin Connell

Wow, that is very interesting. I didn't know that you had to pay to view standards but it makes sense. As Kaitlin said they are essentially doing you a service by helping you stay in compliance. It is comparable to hiring a consultant for something (really expensive as well) or doing hours of research on your own? I am not sure how expensive they are but maybe they can have a subscription service for academia since money is limited there, I think that is fair.

These costs have a bigger impact in those companies that are just starting and don't have a big budget. Big company have no problem with paying a lot of money for it because they have a big budget. The FDA (I'm gonna use it as an example) uses these expensive standards as a barrier for companies to enter the medical devices field (Which makes sense to me because they would prefer dealing with 10 companies that produce medical devices in the New Jersey region rather than dealing with 25). I am sure there are more barriers to enter this market but this one is not present in all the markets of the United States. So from a FDA point of view it makes sense to have these expensive tags.

I understand that having to pay may just be the cost of doing business, but I do agree having a database would be helpful to those smaller companies. Some smaller companies may have such innovative ideas and be able to really back that up with a product, but the cost of the purchasing these could really hinder that. If it were available in something similar to PubMed that could really contribute to some great ideas moving forward. Even having access to these before a project starts could really help those projects move forward faster and more efficiently.

Regulation and standards should be abided by regardless of cost. Calibrations/maintenance are costly, but must be done. Safety inspections - also costly but must be done. Subscribing to these databases are simply a necessity just like all the tasks above. Each company (ISO, FDA, USP, etc.) needs to hire regulation specialists to verify that these standards are up to date. If there is no cost attached to these regulations, corners would be cut. For standards of this magnitude, cutting corners can't be a possibility.

80 to 90 percent of startups fail. Maybe making these standards so highly priced contributes to a filtering of only startups and large companies that are guaranteed to prosper.

I would have to disagree with most people on here. These regulations should not cost any money. There should be a standard set of rules that all companies should follow, similar to the way the FDA has guidelines for medical devices and holds certain standards for them before they are put in the market. These rules are important for safety, and money should not hinder a company or organization from finding information on how to provide this safety to their consumers. In my opinion, a company should pay when the safety guidelines are not met, as sort of a fee and their products should not be allowed to be marketed if found that the product has too many risks. The company's quality engineers should be well trained in being familiar with these guidelines and be able to enforce them properly.

I agree with other students in regards to offering the company a subscription where they can access a database that supplies access to all of the necessary documents. Employees will continually have access to articles while the company as a whole pays an annual fee. However, I believe that there would be a risk associated with this plan. Companies may subscribe, but once they do, they have the opportunity to cancel the subscription after taking the information they need from the database. Thus, the regulatory agencies risk losing an immense amount of money and hours that were taken to develop all of the regulations. These regulations cost money because it helps the user meet the necessary guidelines. Preventative maintenance, calibrations, safety inspections, and hiring auditors are necessary and cost money. Business is business. Overall, these expenses should definitely not stop a company from obtaining information on how to offer safety to customers.

I think that it worth buying this standards from regulatory department because if they are the one who are gonna finally approve our product for sales if the device specs are not withing the device specs as they have suggested that might lead to more scrutiny of the device approval.

Different ISO standards are charged differently when it comes to medical devices there are ISO like 17664,1160,11135 etc
The cost ISO 2626 for electrical safety is USD 2000 its the cost off all the document combined which leads to high charges and not the individual once.
I think if they would sell this as bundle package than it would cost bit less but for a reason they know all company would buy there document even if they sell separately.
ISO itself needs buildings, and all the costs associated with those.Basically, there is a large overhead in running a standards organization which is not attributable to any single standard. Which leads them to charge this much.

It seems like a fair trade-off, especially for more established companies that know what their goals and needs are. However, for new companies like start ups, it would make sense to have some way to rent the material before purchasing it to see how it would align with their needs. Overall, it is important to have this documentation in order to to ensure that the risks are maintained and proper regulations followed, for every company big and small.

The regulations are highly important in ensuring that the product follows the correct standards and is safe to use in the medical device market. It does seem a little unfair that the company has to pay for the regulations, but don’t even get the full document, only a viewing. Sometimes they do not need document but they already paid for it and it seems like waste. The preview of the document should be given for free or rented, as someone else said, and if it is the necessary document then they should pay for it. The full document should be paid for to account for the work that went into creating the documents and continuously updating them as the regulations change. As difficult as it may be for startups to afford the documents, it will make them stay up to date with the regulations and create a good image for themselves.

Regulations are very important to any company because the products have to follow a certain standard for safety. Some people may argue that it is unfair but the FDA does a really good job to ensure the standards are followed and they should be paid to make sure this is done properly. All documentation should be paid if not, anyone can access it also. If it goes into the wrong hands, it would liable for the company because all of their work is now accessible to the public. But the document should be paid once but every time a revision is made, the company should not need to pay for it.

I think that its only fair that getting a hold of these standards for regulations because these standards are what can possibly save a company from a lawsuit. However, sometimes regulatory standards are not enough measure to prevent injuries. I remember from one of my classes where the issues with the design on the Ford Pinto had caused the car to catch fire causing serious injuries and even death to users. There was a lawsuit filed against; However at that time, Ford's defense was that the car design passed regulations and they were not held fully responsible for the accidents. There's a whole lot of discussion regarding this but that's for another topic (ethics) but this just shows how powerful regulatory standards are. It can save you or go against you in a lawsuit.