Showing posts tagged with: ISO 13485

Preparation of the QMS documentation is based on the organizational needs, and it is crucial for an efficient QMS. Besides, correctly organized documentation will make operations much easier.   The purpose of QMS documentation is to provide a clear framework for the company’s operations and a better understanding of the QMS, and finally to show the evidence...

When an eQMS is implemented in a medical device company, such software must be validated.  It should be ensured that the system is working and that it meets the requirements of ISO 13485. Validating the software decreases risk and legal liability, and provides evidence that the system fits for purpose.   Software validation process Validation for intended use...

Perfect, now when you have learned about the ISO 13485 standard with the help of 20 lessons explained on this website, now you are ready to implement it. The first step is to perform a GAP analysis. We won't leave you hanging at this part now, so we explained it to you as well.   You might wonder how can...

ISO 13485:2016 has set out requirements for a quality management system where you need to demonstrate your company’s ability to provide safe medical devices and related services that consistently meet customer and regulatory requirements. Learn more about the certification flow to certificate through this infographic. It’s more eye-catching than texts, or in other words, more attention-drawing. ...

The ISO 13485 standard in this lesson wants to suggest you a few explanatory perspectives that may serve as inputs for improvement. It also expects you to define which inputs, and sources of information may indicate the need for improvement. From your medical device company is required to initiate the link between quality activities such as...

The ISO 13485 Standard requires collecting data from processes and activities and analyzing them to identify trends and patterns in your processes to verify the continuing suitability and control of the effectiveness of your QMS by maintaining improvement. It’s advisable to ask a lot of “how” based questions when analyzing your quality management system. The data analysis...

The ISO 13485 covers all phases of the medical device lifecycle and one that must be covered is also the control of nonconforming products. It’s a product or a medical device that does not fulfill its specified requirements like customer or regulatory requirements. It’s important to be identified as soon as possible. Plus, ISO 13485:2016...

What mostly reflects the effectiveness of the Quality Management System is monitoring and measurement focus on the quality of your medical device. The ISO 13485 Standard defines several sections in which monitoring and measurement should be emphasized highly addressed.   Feedback The ISO 13485 Standard requires the evaluation of feedback regarding the use of the medical device. The aim...

Your medical device and its quality process must be measured, monitored, analyzed, reported, and reviewed. It's done by using a system of measurement-analysis-improvement that is designed to strategically manage the ‘quality’ of the Quality Management System (QMS). The processes that ensure the effectiveness of the measurement, analysis, and improvement requirements are: Performing improvement processes; Monitoring and measuring quality; Controlling...

The ISO 13485 standard treats monitoring and measuring devices very seriously. Every medical device company must have had plenty of various equipment for measuring and monitoring. According to the ISO 13485 Standard, they are considered as an important element of the realization process. Therefore, the requirements are quite specific and logical. If you want your data...

ISO 13485 standard intends to cover a wide range of manufacturing, therefore, it’s a bit generalized when it comes to defining applicable requirements and service provision processes. This section of the standard might be confusing for many, but we will try to divide it down into simple and understandable pieces. Exactly 11 sections.   Control of production and...

In the medical device industry, it’s not just purchasing. ISO 13485 standard has some strict rules when it comes down to purchase from suppliers. The main factors that influence this process should be addressed, and the main suppliers. ISO 13485 requires you to document your purchasing procedure to ensure purchased products adheres to stated purchasing information....

The design and development of the medical device are one of the most crucial parts of the ISO 13485 standard due to its complexity compared to other industries. The design and development process for medical devices has to deal with product safety, risk controls, relevant regulations, and customer needs. On one hand, it’s a continuation...

Depending on the medical device type you can assume who are potential users of the same. After you define that, you will easier understand this chapter of ISO 13485.   Determination of the requirements related to the product There is a standardized method to identify the inputs that supposed to form and determine the device. As a medical...

Naturally, planning goes ahead of realization. And this part of the standard explains how important is for you to be consistent in planning throughout all parts of your quality management system. Plus, it refers to all phases of the life-cycle of your medical device.   Quality Plan This requirement of the ISO 13485 is fulfilled by defining the...

Work environment and contamination control are important and critical for effective and compliant medical device business run.   Definition of the Working Environment Work conditions and environments must be under effective control. And by the ISO 13485 standard, it undoubtedly means, it must be documented as well. It’s expected that the working environment will be in the proper conditions...

As a requirement within ISO 13485, the management must ensure that adequate resources are available to perform continuous work by the organization. Providing resources can refer to personnel, infrastructure, consumables, equipment, etc.   Human resources In this part, the standard focuses on the improvement of human resources by making sure they can provide quality work. It’s very important...

The main goal to conduct a management review is to allow top management from time to time to examine the quality management system. That is done usually not less than once in a year. Commonly, it’s done through the meetings. Various topics can be covered and Top management will check if there is any need for...

Responsibility and Authority Top management is in charge of appointing responsibilities to other staff and management to ensure that the QMS is being met. They also need to be responsible for communicating internally. One of the musts for them is to establish the pyramid of decision making to accomplish the quality objectives. ISO 13485 emphasizes the fact...

This part of the standard explains why is planning so influential. Because without planning it's impossible to build quality into your medical device and company since the start. It's necessary to plan in such a way to ensure your QMS will be and remain effective. One of the ways you can assure that is through...

Management has an absolute responsibility to foster the quality policy, confirm its alignment, and communicates the mission to employees. They have a responsibility to plan, delegate authority, and communicate effectively. They are also in charge of a periodic review of operations and improvement within the organization, known as the Management review.   Management Commitment Some of the management...

You will see in the end, it’s all about documentation. If not in this part then by the end you will perceive the importance of documenting practically everything. Everything has to be documented, so it can be tracked. In this QMS world, there is an already known saying that says: “…if it isn’t documented like...

Every ISO standard has the system of requirements and each one of them is described in segments. In general requirements, it’s established what is meant by: Developing and documenting QMS – Establish QMS Defining your QMS processes – Clarify the structure Supporting them – Support processes Managing QMS process changes – Manage changes Controlling your QMS outsourcing – Control outsourcing Validating your...

Let’s say you have an idea of placing an innovative medical device on the market. That’s great, but you already know that going from idea to actual realization is not the whole picture, just the tip of the iceberg. Yes, there is a much larger part below the surface to know about, and it has...

1. What is an ISO 13485? ISO 13485 is an international standard for establishing quality management in the medical device industry. It is an effective explanation to meet the comprehensive requirements for a QMS in the medical device industry. The other well-known QMS requirements to follow come from the US, as the FDA requires that the medical...