ISO 13485 Certification

Medical Devices – Quality Management System

ISO 13485 is the globally recognised standard for medical device quality management.

iso 13485 certification
When you think of the most prestigious medical device manufacturers, do you automatically think of big names like GE, Siemens, Philips or Medtronic? If so, then you might also know that they all have one thing in common – they are ISO 13485 certified organizations. ISO 13485 is an internationally recognized quality management system (QMS) standard which describes how medical devices should be designed, manufactured, and tested to ensure the highest possible level of quality throughout the product life cycle from design through disposal.
Overview | Principles | Benefits | Revision | Process | Validity | Cost | Contact

What is ISO 13485 Certification?

ISO 13485 is an internationally recognized and blended Quality Management System (QMS) standard for medical device manufacturers. It is developed for companies involved in one or more stages of the life-cycle of a medical device and categorize a process approach in terms of the design, safety and quality. ISO 13485 certification provides assurance that an organization’s management system complies with the requirements of ISO 13485.

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 Why is ISO 13485 important?

The medical device industry is a competitive and challenging place to be, with many companies competing for the same clients. One way to set yourself apart from the competition is by obtaining ISO 13485 certification in India. This internationally recognized certification will allow you to show your dedication and commitment to delivering a quality product that meets the needs of patients and their healthcare providers.

Is ISO 13485 a legal requirement?

ISO 13485 isn’t a legal requirement, but it’s still a good idea to get certified. Getting ISO certification will demonstrate your commitment to quality and safety, as well as giving you access to the huge international market that is the medical device industry. Plus, you’ll be able to compete with other companies on an even playing field in the global marketplace. 

ISO 13485 certification is not required by any law or regulation in India and the United States, but both countries have made considerations for its implementation.

Which Organization needs ISO 13485 Certification?

ISO 13485 is a quality management standard that applies to any organization involved in the medical device industry. This includes medical device companies, manufacturers, and any organization that handles or distributes medical devices. ISO certification ensures product safety for end-users and provides an auditable system for tracking compliance with regulations. For example, ISO certification helps organizations meet US FDA requirements as well as other country-specific regulations. It also assists organizations with obtaining reimbursement from insurance companies and ensures accurate documentation of the manufacturing process.

Principles of ISO 13485 Certification

ISO 13485 is a quality management system standard that is used by medical device companies worldwide. To be ISO 13485 certified, the company must meet a few principles. For example, the company must have a quality policy that is supported by top-level management and it must have documented procedures for product design, production, installation and servicing.

Requirements for ISO 13485 Certification?

ISO certification is necessary for anyone who wants to produce and sell medical devices, as it ensures that the quality standards are met. ISO 13485 certification in India is the requirement for any business that wants to manufacture medical devices. However, while this may seem like a daunting task, there are several steps you can take to make this process easier on yourself. First of all, you will need to find a certified auditor who can help you assess your organization’s compliance with ISO requirements. 

ISO certification and registration can be obtained through third party certification bodies, who provide this service to ISO members. In India, such certification bodies are accredited with NABL accreditation.

ISO 13485 certification entails that your company has created documented procedures for how you will design products, build them safely and manufacture them to meet quality standards. It also means that your company will have a documented plan for how it will train its employees as well as how it will handle defects or incidents within your company.

Benefits of ISO 13485 Certification

ISO 13485 certification provides the following benefits: 

Benefits of ISO 13485 Certification to Company: 

ISO 13485 Certification is the certification which ensures that you are following a standardized process to create your medical devices. This means your employees will be better protected from harm and your devices will be safer for patients. It’s important to note that ISO 13485 certification is an expensive process and it may take up to three years before you see results, but it’s worth it for the benefits that come with it.

Benefits of ISO 13485 Certification to Employees: 

The most obvious benefit is that ISO certification helps to protect the company’s data. Since a single breach can result in significant financial loss, it’s important to be prepared for any eventuality. 

Reducing the risk of a data breach also benefits employees by keeping their personal information safe. For example, if an employee leaves the company and takes sensitive information with them they could threaten your company’s confidentiality agreements or even sell this information illegally.

Benefits of ISO 13485 Certification to Customers: 

Increased customer satisfaction – Organizations that are ISO 13485 certified will likely have satisfied customers who know that the organization is serious about doing everything to create a safe, quality product. In contrast, having a certification such as ISO 13485 demonstrates an organization’s commitment to quality and safety in their products.

An ability to increase competitiveness – One of the top benefits of obtaining ISO 13485 certification for medical device organizations is increased competitiveness.

Can an individual person be ISO 13485 certified?

ISO 13485 certification is not just for organizations, it’s for individual people as well. ISO is an internationally recognized and harmonized Quality Management System (QMS) standard. It is developed for organizations involved in one or more stages of the life-cycle of a medical device and describes a process approach in terms of the design, safety and quality.

Simple Process to ISO 13485 Certification

Organizations seeking ISO certification are required to undergo a gap analysis process. This is a comparison between the organization’s current quality management system and the requirements of ISO 13485. The results of this analysis will outline where improvements need to be made in order to achieve ISO certification. There are many benefits for an organization that has been ISO certified including increased customer satisfaction, increased employee morale, reduced risk exposure, etc. The cost of obtaining an ISO certification varies depending on your location or the scope of the project.

Choosing an ISO 13485 Certification Body

While ISO does not offer any certification services of its own, the organization does approve other certifying bodies to issue certification.  Choosing a certification body is a difficult decision. You want to choose one that will meet your needs, but not break the bank.  The best way to find out which certification body is the best for you is to ask yourself a few questions: Here are some factors to keep in mind when making your choice:

  1. Does the certification body have an established reputation?
  2. Is the body accredited by a reputable accreditation organization?
  3. What is the certification process? – What are the costs involved?
  4. How will my company be certified (online or onsite)?
  5. How long does it take to become ISO 13485 certified after completing the process?

How to Check ISO Certificate Validity Online?

IAF CertSearch international verification portal website will show you a list of ISO certificates issued by IAF accredited certification bodies. The certification body will provide you with a certificate number that you can use to search the listing to verify its authenticity. You just need to type in the code or name of the entity on the search bar and a list of valid certificates matching your code or name should be displayed along with their validity dates.

What is the Cost of an ISO 13485 Certificate?

The cost of an ISO 13485 certificate varies based on different parameters of a company. ISO Certifier offers ISO certificates at an affordable price to its customers. To know more about the rates, kindly get in touch with a representative from ISO Certifier.


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