ISO 13485:2016 is the quality standard stating the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices.
The organizations that are involved in the manufacturing and handling of medical devices are required to adhere to the norms of ISO 13485 medical devices standard. ISO 13485 is a set of standards that helps in the implementation of the Quality Management System for Medical Devices (MD-QMS).
It demonstrates the competency of the organizations in delivering good quality and safe medical devices and relevant medical services that can fulfill the customer’s requirements as well as ensure compliance with the regulatory norms. The latest version of ISO 13485 Certification was published in 2016 and hence, it is termed ISO 13485:2016.
ISO 13485 certification involves building a quality management system for medical devices by identifying potential risks and documenting them effectively. The threats may arise from contamination of equipment or errors during handling. ISO 13485 provides for analyzing those threats and planning appropriate actions to prevent those risks.
Our vast network of experienced auditors all over the world helps you achieve this certification in a time-bound and hassle-free manner.
ISO 13485 is helpful for organizations in all stages of the product life cycle- starting from its design development, manufacturing, storage, and distribution of the final product. The applicability of ISO 13485 does not stop at that. It can also be applied for relevant services of medical devices along with associated activities that are in the form of technical support- both remote and on-site.
Since ISO 13485 is an internationally recognized standard, building your MDQMS in accordance with it has unfathomable benefits for your organization. It tremendously reduces your costs. Some of the many benefits of ISO 13485 certification are listed below:
An improved process results in reduced costs.
Define the scope – It is very important to understand the purpose and market of the medical device in order to define the scope. It is also important to consider the regional regulations related to the product.
Perform ISO 13485 Audit & analyze the gap – An audit validates the conformities of your management system against the requirements of the management system. Any gaps should be thoroughly examined.
Prepare a project plan – The gap analysis after the audit helps you in developing a corrective action plan that takes into consideration all the non-conformities and ensures that you are compliant with ISO 13485 requirements as well as with other regional regulations.
Maintain documentation – the mandatory documentation, i.e., Quality Manual, procedures, work instructions, and documentation with evidence of proof of implementation should be maintained for the ease of the audit.
Train your workforce – It is very important to educate your workforce involved in the production of medical devices, regarding the requirements of ISO 13485 medical devices certification. This includes both legal and procedural requirements.
Implementation – Once you have established your quality management system for medical devices, you must run it for a period of at least three months and document your processes.
Conduct an internal audit – This is necessary to check for any deviation from the ISO 13485 certification requirements. It can either be conducted by one of your qualified employees or by any third party.
Conduct a management review – A management review is necessary to ensure that your quality management system is functioning as per the requirements.
Apply for ISO certification– This involves inviting a certification body to conduct an audit on your management system. After the successful completion of the audit, you may be awarded ISO 13485 certification.
the certification process goes further. Click here to view the next steps in the ISO certification process
Answer: ISO 13485 certification is globally recognized for the efficiency and effectiveness of the quality management system for medical devices on the basis of ISO 13485 standard. It aims to provide superior medical devices that meet and fulfill the customer’s requirements establishing a better relationship with them.
Answer: ISO 13485:2016 is the latest version of ISO 13485 Certification which was published in March of 2016. It focuses on providing superior medical devices and other related devices that consistently fulfill customers' expectations.
Answer: Your certification body follows certain procedures and checklists to make sure that you have implemented all the necessary requirements.
Answer: Achieving ISO 13485 Certification is not a big deal in today’s upgraded systems. The basic steps to become ISO 13485 Certified are listed below: Firstly, you need to prepare all the relevant information about your company in a systematized way (It is always best and safe to hire a legal consultant.) Secondly, you need to document all the relevant information about your business. Thirdly, you have to implement all the documented information in your organization. Fourthly, get ready for the internal audits which are performed first during the certification process and then periodically after. Lastly, if the certifying body approves your management system then you will be awarded the required ISO standard.
Answer: The cost of ISO 13485 certification varies from one organization to another. Basically, when you approach an internationally accredited certifying body for ISO Certification and they approve your management systems and all your processes, they will then quote an amount for the certificate. Moreover, the cost for achieving ISO certification depends mostly on your organization, such as the no. of employees in your organization, No. of branches your organization has, and many more.
Answer: Basically, an ISO Certificate is valid for three years. And during this time period of three years, a surveillance audit is conducted on an annual basis to ensure that ISO quality standards are being maintained by the organization.
Answer: Just because you received an ISO 13485 certification, your task is not complete. For proper functioning of the management system, you need to maintain the ISO 13485 certification. For that, your company has to continually undergo an annual surveillance audit for the period of three years. After completion of the validity period, you need to get recertified.
Answer: Having an ISO 13485 certification is important for any organization because it helps you to lower your cost amount, maximize your profits ability in the organization. The benefit of a quality management system also helps you to earn new customers and retain those customers for a long period.
© SIS CERTIFICATIONS PVT. LTD. – ALL RIGHTS RESERVED.
