What is ISO 13485 ?
ISO 13485:2016 is the common medical device QMS which specifies the requirements for a quality management system where an organization needs to establish its ability to provide medical devices and related services that constantly meet customer requirements and regulatory requirements. Main Objective of the standard is basically to simplify to coordinate with medical device regulatory requirement system. Therefore, It is necessary to includes the specific requirements for Medical devices and eliminate the requirement of ISO 9001 (QMS) which is not required as a regulatory requirement.
Why ISO 13485 is Important?
ISO 13485 is the system implementation process in the area of medical devices sector. It is important for Designer, Manufacture, developer even supplier of medical devices which ensures the quality, safety, risk management. Globally, it was the most accepted model for any medical device organization that supports in the establishment of compliance to law and regulations of the medical device industry. ISO 13485:2016 is specific based on ISO 9001:2008. A QMS only helps to an organization to improve its efficiency and effectiveness on a continuous basis. But MDQMS marking the credibility of medical devices being produced in any facility.
Why do we need ISO 13485?
It is a kind of evidence from a third party that you are fulfill the basic requirement of ISO management standard. This shows that you are running your organization accordingly with standards. That help in maintaining your business structure with stable growth and more profits.
Implementation of ISO 13485 provide a support to the manufacturers for conveying the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as signifies assurance to the safety and quality of medical devices. Initiate with management support and recognizing the customer requirements for the QMS, you will need to start developing documentation that including the Quality Policy, Quality Objectives, and Quality Manual. All these define the overall scope and implementation of the Quality Management System. Along with these, organization need to create the mandatory and additional processes and procedures that are necessary. An outline of ISO 13485-certified organizations reveals that the number of organization implemented an ISO 13485 Medical devices Quality Management System still active a general supportive system globally.
Benefits of ISO 13485?
- Helping in increased Efficiency
- Help in improvement of organization by enhancing the credibility and image
- Reduce risk
- Identify risk and further better opportunity
- Determining the customer satisfaction
- To improve the quality of products, processes, operations etc.
- Improve the consistency of your company
Is ISO 13485 Complex to Implement?
It is not that much complex to implement ISO standard. A proper guidance and a proper training can help in organization to implement. ISO 13485 implementation shows company follow the proper regulation and norms according to the standard that eventually meets the basic requirement of customer satisfaction. It helps to ensure the quality output maintenance of medical devices, Risk Management etc.
Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.
Starting with management support and identifying the customer requirements for the QMS, you will need to start developing documentation including the Quality Policy, Quality Objectives, and Quality Manual. Together, these define the overall scope and implementation of the Quality Management System. Along with these, you will need to create the mandatory and additional processes and procedures necessary for your organization to properly create and deliver your product or service. For a good explanation on this, take a look at the article List of mandatory documents required by ISO 13485:2016. A survey of ISO 13485-certified companies shows that the number of companies that have implemented an ISO 13485 Quality Management System still shows a general positive trend worldwide (the drop in 2018 was mainly due to a different measurement methodology).
