jas melonToday, in the medical device industry, quality is a necessity. ISO 13485:2016 standard defines the quality management system (QMS). For pharma & medical device industry professionals, biomedical engineers, consultants, regulatory professionals, and others who are and who are willing to make a career in the medical device industry, it is important to understand this standard.
This article will discuss five steps that are important to build a robust QMS. These steps are as per ISO 13485:2016 for sustained business. Read on to learn more.
Step 1: Understand ISO 13485:2016 Requirements
The first step is to fully understand the requirements of the ISO 13485:2016 standard. This standard guides the elements and structure of the QMS in the medical device industry. It has a broad application area that ranges from product design all through production and delivery.
These areas include risk management, design control and supplier management. In-depth knowledge helps in the development of a compliant and efficient QMS. That is why it is advisable to approach more experienced consultants so that you can learn these requirements.
Step 2: Conduct a Gap Analysis
Your current system requires evaluation before the implementation of changes. Compare it with ISO 13485:2016 requirements. This gap analysis points to the areas that require improvements.
It may be used to specify which procedures, documents, or processes may be missing. This gap analysis then leads to an action plan. It is used to ensure that the implementation of changes that are needed is structured. It supervises the execution of required improvements. This step makes sure a more focused development of the QMS.
Step 3: Develop and Implement Procedures
From the gap analysis, identify or formulate new or revised procedures. These should cover all aspects of the QMS. Some of the areas are related to documentsโ control, records and corrective actions.
Make sure that such procedures are well understood and easy to follow. They should align with ISO 13485:2016 requirements. Share this process with professionals within the team to gain a better understanding and usage of it. Regular training sessions can help employees adjust to new practices.
Step 4: Establish a Risk Management Process
Risk management is central to ISO 13485:2016. So, it is important to establish a risk management process. This embraces the new medical device lifecycle.
In each stage of production, problems that could pose some form of risk should be highlighted. Assess or rate these risks and use some effective control. The assessment of constant risks keeps the product safe and of high quality. Problems are avoided before they start with this proactive approach.
Step 5: Implement Internal Audits and Management Reviews
Internal audits should take place frequently to ensure a robust QMS is in operation. They play significant roles in identifying potential solutions. Update staff to become the organisationโs internal auditors.
This helps to achieve a good understanding of the system. Perform management reviews to evaluate the QMS performance. These reviews should therefore result in productive changes. For continued improvement of the QMS, they assist.
To conclude, building a robust QMS as per ISO 13485:2016 is an ongoing process. It takes effort and continuous improvement. Following these above-mentioned five steps lays a strong foundation. It is of great assistance in formulating a QMS, which can be very useful in producing quality products while at the same time being compliant with the law.
A robust QMS is central to sustained business in medical devices. Consult with an expert concerning the implementation of the plan and its training. Global consultants provide a considerable amount of assistance. They offer education with the help of e-learning technology. This makes quality education available at the convenience of time and space. Investing in a robust QMS today secures business success tomorrow.
Unlock Success in Medical Device Manufacturing!
Visit – www.raajpharmaelearning.com / www.raajgprac.com
Email us – rajashrio@gmail.com, raajgprac@gmail.com, elearning@raajgprac.com, raajacademy2010@raajgprac.com
Or Call us – 9819125208, 098211 44706
