“If you can’t beat them, join them!”
If your company has decided to enter the medical device market, and you are in charge of making this transition, one of the things you will have to implement sooner or later is a compliant quality system.
It is not going to be an easy job, but on top of that you will have to find a way to sell it to the rest of the company and this could be even harder.
People will tend to be at best dubious about it, if not rejecting it altogether. In most cases eventually everyone will accept it, but there is another way to tackle this problem.
The purpose of a medical device quality system is to ensure the product you develop is safe and effective. And this is what a manufacturer wants too, with the addition of making it a profitable business. How can the two things go together, when the regulatory requirements seem to add overhead everywhere?
Regulations, in particular ISO 13485, are a collation of best practices, principles and processes aimed to achieve a predefined purpose. But aside specific requirements solely applicable to medical devices, many clauses have a broader application. You may have rolled your eyes when you heard that a quality system can reduce costs and improve efficiency, but this is exactly what you can achieve if you use your quality system to your advantage.
How can a company grow if management did not have a clear idea of where they want the business to go? If they did not set some sort of measurable objectives for the year and did not check them periodically? If they did not review the results and performance of different areas? If they did not have an idea of the required resources? [Management Responsibility]
Don’t you think it is a good idea to have some standardized methods to perform tasks, so people can understand each other’s work? Procedures that new hires can use to learn their job without having to rely on word of mouth information? That these procedures were somehow controlled and approved by someone that has the authority and knowledge to manage them? That they are easy to find and everyone is using the same one and not a different revision? [Document Control]
If you work on customer’s project, having a well defined contract, statement of work, measurable requirements you are required to achieve, would definitely help prevent scope creep and unpleasant discussions with the client due to a critical misunderstanding. Of course it would also be good to ensure the company has the ability and capacity to provide a certain service or product, before accepting a project, wouldn’t it? [Planning, Design Inputs]
Tailor your quality system to suit your business and your product; it doesn’t matter how you achieve compliance, as long as you do. Apply the regulations to improve how you develop products – look beyond the boring rules.
Don’t be a ”victim” of your Quality System, but instead use it to achieve your objectives!
To kick-start the development of your Quality System, we provide you a set of SOPs and technical templates with Quality Manual and Quality Policy with embedded guidance on how to customize them for your organization in SoftCopmly eQMS for Atlassian Confluence.