Put simply, ISO 13485 is a set of guidelines designed to define how you should manage your Quality Management System (QMS). Managing your management system may seem a little redundant, but this regulation exists for a reason.
Many medical device manufacturers use a QMS process that is a combination of paper-based processes and some general-purpose tools. Their quality processes are quite loosely held together by a small group of individuals in their company — usually document control personnel.
This disorganized approach leads to headaches, errors, and unnecessary delays for companies struggling to bring potentially life-changing devices to market. We were the first company to bring a web-based eQMS platform to life to solve this problem for growing life sciences companies, and we’re intimately aware of all aspects of ISO 13485.
We know that one of the biggest hurdles for most people in your position is to understand and implement the product realization requirements of ISO 13485:2016 and specifically, the complicated passages of its Section 7. To help you, below we’re translating Section 7 into layman’s terms.
A Simple Explanation of Product Realization ISO 13485 Section 7
Section 7 is designed to help you maintain control of your ISO 13485 medical device quality management systems along the journey from the initial idea or concept of your device all the way through its realization.
Let’s take a deeper look at each area and their recommendations and requirements. Keep in mind that the right ISO 13485 quality management system software can be a tremendous help as you work your way through Section 7.
7.1 Planning of Product Realization
Proper planning is a step that is often overlooked in the rush to get your product into development as soon as possible.
Section 7.1 requires that you appropriately plan your realization efforts. It states that you should:
- Establish the quality requirements for your product(s).
- Define what your required processes will be and what supporting documentation will be needed for those processes.
- Outline the company infrastructure that will need to be created and what the work environment should be like.
- Define employee qualification and training requirements.
- Establish your processes for verification, validation, measurement, monitoring, handling, inspection, storage, distribution, and traceability.
Finally, you have to organize all of that information in such a way that it can be easily accessed and understood.
7.2 Customer-Related Processes
Before you begin developing your device, you need to have a clear understanding of your target audience. For the purposes of this ISO specification, the term “customer” is used much more loosely than what you’d normally think of.
Your customer is more than just the end patient. It is every person or company that interacts with your product after it has left your control. For example, if your product contains certain types of batteries or other potentially hazardous materials, you may have customer requirements that apply to the shipping or logistics companies that transport it.
Your customer’s needs and requirements will need to be thoroughly defined and clearly documented along with any product requirements along the way — like asking your shipping company to avoid temperatures over or under a certain degree to avoid damaging the device.
7.3 Design and Development
Section 7.3 is a continuation of 7.2. All of the needs and requirements that you defined under 7.2 will feed straight into your design and development process.
By the time you reach this section, you’ll have already thoroughly assessed your customer’s requirements — from packaging to shipping and finally the end patient. You will also have thought through, communicated, and documented your product’s design process from concept to reality and understand how it’s going to come to life.
All of that information will help inform what you do in the design and development phase. This will give you a clear advantage over other similar companies.
Many design and development teams will jump straight into their jobs without having a clear picture of how the customer is going to use it. This leads to costly and time-consuming revisions later when they move from design and theory into practical daily use.
For example, consider patients that require oxygen. Many of these patients are elderly. However, tanks and other oxygen containers and generators are heavy, bulky, and hard to read. Digital and analog displays that indicate how much life-saving oxygen is left are often tiny and hard to read for patients with failing eyesight.
If design teams consider this kind of feedback early on, they can address it in early iterations of the product instead of after the product is already in the hands of consumers.
Take the time to clearly define each stage of your design and development process.
- What planning needs to occur before design and development begin?
- What input should be gathered at each stage and from which resources?
- What are the outputs that should be generated?
- Who is conducting reviews, and what should the reviews include?
- Who will be responsible for conducting verifications?
- Who will validate the results?
- What are the requirements as the progress is transferred between departments/teams?
- How will changes and documentation be managed, and who is responsible for them?
- What files will need to be created, and how will those be managed?
Your supply chain is also a critical component in bringing your device through from concept to reality. You have materials that you will need to purchase, and quality standards that you have to ensure are met on those materials.
You should start by documenting the requirements that you need along your supply chain and how your suppliers will meet your needs, such as:
- List the materials and quantities needed along with your suppliers’ ability to deliver those items in those amounts.
- Detail the risk potential that specific materials can have on your product — such as if a material being a few micrometers too thin would make your product not perform as intended or if that would be an acceptable deviation.
- Also see: An ISO 13485 Risk Management Plan Example You Can Steal and Use
After you start purchasing items, make sure that you document:
- Your supplier’s performance in delivering the quality, quantity, and materials purchased in a timely fashion.
- The impact the individual suppliers are having on your overall device quality and ability to meet your defined deadlines.
Additionally, you need to document your process for identifying suppliers, dealing with substandard suppliers or materials, adjusting to delays, documenting receivables, and tracking performance in the final product.
7.5 Production and Service Provision
The purpose of Section 7.5 is to plan oversight of the manufacturing of your medical device. Your entire production process should be planned, executed, monitored, and controlled so that it meets your specifications.
These steps are crucial to ensure that when you develop a successful batch of devices, you can scale and repeat this process with the same quality produced each time.
Your production controls should include:
- All of the necessary details to produce the device — drawings, specifications, special manufacturing instructions, required labeling and packaging, and inspection procedures.
- All applicable activities that can impact product quality — product testing, monitoring equipment and processes, measuring equipment and processes, and record-keeping that’s needed along the way.
It’s also common to outsource some of these stages to a Contract Manufacturing Organization (CMO). While they will help you meet some of the ISO 13485 requirements, you are still ultimately responsible for any errors, delays, or quality problems. So take the time to put an agreement in place with your CMO for who is responsible for what at each stage and what the requirements are.
7.6 Control of Monitoring and Measuring Equipment
Throughout the process of bringing your device to life, you will undoubtedly use a variety of measuring and monitoring equipment to ensure that your guidelines are followed and a quality product is produced. Section 7.6 addresses the criteria that you need to follow for this equipment and the process of using it.
- All monitoring and measuring equipment must be calibrated or verified to be working accurately. Make sure you document the process for doing this step at regular intervals to maintain quality and accuracy in production.
- You also want to document the results of this calibration. You can do this by labeling the actual equipment with identification, calibration status, and date calibrated. You’ll want to record this information in your logs.
Stop Relying on Outdated Quality Management Technologies
As I’m sure you’ve realized by now, effective medical device manufacturing quality management is a tedious trail of multiple steps, tons of information, and endless pages of documentation.
You don’t have to continue to track all of this data in paper notes, overstuffed file cabinets, and a knowledgeable employee’s brain. There is a better way.
Stop wasting time and start forging ahead with your mission to make the world a better place. Download our guide filled with 7 Things You Can Do Now to Improve Quality in Medical Device Product Development and spend more time building and less time chasing papers.