When it comes to managing quality within the medical device industry, you have plenty of options available to you, from traditional document control systems to electronic quality management systems that are part of larger enterprise software platforms.
Electronic systems can provide you with real-time data access and analysis, and they can help your organization achieve higher levels of efficiency and compliance. Which system is right for you? In this post, we’ll discuss the benefits of effective document control in the medical device industry and how it fits into an overall quality management system.
What is effective document control?
Effective document control is a key component to ensuring a device manufacturer’s ongoing compliance with international regulatory standards such as ISO13485.
These regulations require that medical device manufacturers maintain accurate records documenting all procedures, processes, and results used to manufacture their devices. In addition, they must prove that these procedures are consistently followed every time a device is made.
Why is it important?
Faulty products ruin lives. Patients, healthcare workers, employees, you are all at risk.
History is full of example of ineffective document control, Standards like ISO13485 were created to help. Written by industry experts form over 157 countries. The standard outlines best practice to help everyone make a high quality product that improve people’s lives while allowing manufacturer to release safe product..
How can you use effective document control improve your processes?
Every product goes through a lifecycle the further along that lifecycle a problem occurs the greater the impact on a business.
Scrapping a lot of raw material may be complicated time consuming and costly but processing a complaint or a field action is exponentially greater.
Good document control will normally prevent the problem occurring in the first place or at the very least allow you to identify the issue early.
How to use A QMS effectively?
Many companies struggle to get their Quality Management System (QMS) up and running.
A QMS can be a costly investment for small-to-medium businesses; getting it wrong can be expensive, time-consuming and damaging to your reputation. The requirement of a QMS often seems daunting and incomprehensible, its probably something you have not done before so you're going to make mistakes.
If you are designing a new mechanical part you recruit a mechanical engineer. However, many companies think they can set up a QMS without recruiting a Quality engineer. As a quality engineer I am admittedly biased but after 20 years working it is required.
However, if you’re looking to use an ISO13485-compliant system as part of your drive towards quality management, there are two key steps you should take before launching:
Implement an effective document control process.
Register with a reputable third party certification body.
These two steps will help ensure that your company is operating to the highest possible standards and that all necessary documentation is available at all times.
One thing worth noting is that many good business owners operate on intuition when it comes to quality management systems, which is not necessarily a bad thing. After all, they’ve spent years building their own set of best practices and feel confident implementing them. However, these kinds of systems need to be updated periodically in order to meet current expectations and reflect changes in standards or regulation.
Common mistakes when implementing a QMS.
The ISO 13845 standard is one of multiple industry standards for maintaining document control. If it’s implemented incorrectly, it could lead to serious quality-control issues that could cost lives. Here are some common mistakes medical device manufacturers make when implementing a QMS and what they can do to correct them
1) Choosing a software system without considering how it would integrate with other systems such as Enterprise Resource Planning (ERP) or Quality Management Systems (QMS). A good example is a company that wants to track customer complaints but their QMS doesn't allow them to do so. They might not realize this until after purchase which means another round of software purchase and training may be necessary.
Make sure you choose an electronic quality management system that will integrate seamlessly with your QMS.
Another common mistake is failing to consider whether the new system will provide access to all appropriate documents in a timely manner.
2) Not understanding ISO 13485 implementation requirements: It's important to read through implementation requirements before purchasing an electronic quality management system because there are certain components that must be included within the toolset - like corrective action requests.
For organizations using paper-based processes, these requests would have been handled by separate teams but now these tasks can be done digitally by anyone within the organization.
One final note on implementation is making sure staff members have adequate training on both the new procedures and on the new software itself. Staff members should receive adequate training prior to going live with any changes.
The future - what’s next?
The medical device industry has long been regulated, but these regulations are only getting more strict as time goes on. In an effort to comply with ISO13485 and 21 CFR 820 it’s becoming necessary to implement a high-quality electronic system for document control within manufacturing environments.
The impact of these increased regulations is being felt across industries, but nowhere so much as in healthcare. Doctors and nurses that work with these devices need to know that they can rely on their safety, which means the highest level of quality assurance throughout production.
One way this can be achieved is through effective document control in your production environment. And one way you can get started today? Get started today by implementing a high-quality electronic system for document control!