What is the ISO Standard for Medical Devices: Here’s what you should know

Medical device manufacturers need to focus on the quality of their products in the first place to assure safety and effectiveness of the treatment services provided to customers. While the only way to ensure quality medical devices is a Quality Management System (QMS), what is an ISO standard for medical devices quality management system?

ISO 13485 is the standard which is specifically designed for the medical industry. It ensures that most medical manufacturers meet the regulatory compliance requirements and customer expectations/health service needs. The standard, when achieved by a medical devices manufacturer, works as a valuable credential which ensures that the medical professionals, customers, hospitals, clinics and others are supplied with quality medical devices.

Here is how ISO 13485 is beneficial to medical devices manufacturers in establishing their compliance with the highest quality regulations. Take a look.

How ISO 13485 Helps Medical Devices Manufacturers in Quality Management

ISO 13485 is primarily based on the general standard for quality management, ISO 9001. It is hence again a process-based approach and the QMS is required to meet additional requirements that are specific to the medical devices. The requirements cover the process of manufacturing, storage, packaging, distribution, installation and post-sales servicing of medical devices.

The key requirements of the ISO 13485 medical device standard are summed up into the following points.

• Implementation of a strong QMS with specific enhancements above general quality regulations
• An approach to risk assessment and management from the process of product development to product realization
• Consistent reviewing and validation of the processes of manufacturing
• Compliance with the legislative and regulatory regulations imposed by local as well as international medical authorities
• Effective procedures for product traceability, recall, and revision systems

The most important benefit of this standard is that it enables medical device manufacturers to eliminate safety risks as much as possible by promoting best practices across the production cycle or supply chain.

In the business front, ISO 13485 helps a company or manufacturer to earn recognition in the market as a credible provider of medical devices. Big hospitals, medical research institutes, healthcare professionals and physicians, clinics, diagnostic centers, etc., look for trustworthy providers whose products can assure effective treatment as well as the safety of their patients. Therefore, when your medical device company is earmarked with this valuable ISO certification, it raises your potential for winning more sales contracts especially from large, reputed health care organizations and professionals. With higher sales and revenue, you can even invest in R&D (Research and Development) to further improve the quality and reliability of your products.

Other potential business benefits of ISO 13485 for the medical device manufacturers are:

• Higher customer satisfaction
• Reduced costs for operations due to consistently efficient operations
• Better and more sustainable long-term relationship with the stakeholders
• Ability to win business contracts in highly regulated sectors

Who is Eligible to Get ISO 13485?

ISO 13485 is applicable to every organization that deals with production, designing, deployment, servicing, storage, and distribution of medical devices, regardless of their size or type. To put it simply, the certification is achievable to any company operating at any level in the medical device or pharmaceutical industry chain.

Even if it is not mandatory, companies that wish to demonstrate their compliance with regulatory quality requirements and establish confidence in their customers needs this certification.

Steps to Get the Certification

Here is a simple outline of the steps that can get your medical device manufacturing company certified with ISO 13485.

1. With the help of a consulting partner, learn about the specific requirements of the standard
2. Perform a thorough gap analysis and find out where your current quality management approach fails to meet the standard’s requirements
3. Based on findings of the gap analysis, plan the steps for implementing a QMS which would align completely with the requirements of ISO 13485
4. Train the staff and help them learn about their responsibilities regarding the QMS
5. Document the QMS processes/functions as they are intended to be executed in the manufacturing cycle
6. Implement the QMS conforming to the requirements of the standard and matching with the documentation
7. Perform an internal audit of your QMS to ensure its compliance with every requirement of the standard
8. Register for the certification with an accredited body
9. Get the external certification audit done and achieve the ISO 13485 certificate

Key Improvements Realized by Medical Device Sector with ISO 13485

Certification with ISO 13485 reflects compliance of medical device organizations with advanced regulatory requirements. Overall, it results in many serious improvements in the medical device supply chain.

• Greater emphasis on production infrastructure, especially for the manufacturing of sterile medical devices
• Heightened focus on the post-market activities which include complaint-handling and reporting of non-conformity issues
• Application of the standard’s regulations to related organizations that repair/maintain medical devices, supply raw materials, assemblies or components, perform sterilization, installation or calibration of the devices, import or distribute devices
• Additional requirements related to product validation or verification processes

Key Takeaway!

A higher level of quality management is required for a demanding sector like medical device manufacturing. While many manufacturers are still not aware of what the standard for medical devices is, quality control, ISO 13485 is the most relevant standard for their quality control. It helps them to implement a QMS that has a specific focus and greater control on the processes of manufacturing. The standard emphasizes tougher requirements that ensure the safety, consistency, and reliability of medical devices. Therefore, a company that achieves this benchmark certification gets a competitive edge in the market and earns more possibilities of sales/business contracts.

Are you the owner of a medical device business and haven’t been certified with ISO 13485? We can help you! We, at Compliancehelp Consulting LLC, are a team of dedicated ISO consultants who can assist you to understand the requirements of the standard, implement a QMS conforming to them, and get certified in one go. Feel free to contact us!