ISO 13485 is a quality management standard that is designed specifically for the manufacturing of medical devices.

The standard is based on ISO 9001 but contains additional requirements that relate specifically to manufacturing, installing, and servicing medical devices.

ISO 13485 calls for:

• Implementing a quality management system
• Taking a risk management approach to product development
• Validating processes
• Complying with regulatory and statutory requirements
• Establishing effective methods for product traceability and recall

ISO 13485 also helps companies that manufacture, install and service medical devices with process improvement, operational efficiency, and product improvement.

Although ISO 13485 is based on ISO 9001, achieving certification does not mean you are automatically compliant with the other, and both require auditing. ISO 9001 and ISO 13485 have many similarities, but ISO 13485 contains requirements and terms that are unique to the medical device industry. For example, ISO 13485 has a stronger role for a quality representative to top management than ISO 9001 does.

Complying with ISO 13485 and achieving certification to it can provide numerous benefits to medical device companies. Some of the benefits of ISO 13485 certification include:

• Legal Compliance: ISO 13485 certification requires compliance with all legal and regulatory requirements. It also helps you to improve your understanding of how these requirements impact your organization and your customers.
• Enhanced Risk Management: Certification to ISO 13485 also helps you to manage risks by increasing the traceability and consistency of your products and services.
• Reduced Operating Costs: ISO 13485 helps you to continually improve your processes and make them more efficient over time, saving your organization money.
• Improved Customer Satisfaction: A medical device QMS helps you to provide more consistent quality in your products and services, making your products more reliable and better able to meet customers' needs. This enhanced quality increases customer satisfaction.
• Better Access to Information: The documentation that ISO 13485 requires can assist your organization in creating a consolidated knowledge base, which can help you to identify issues and improve your products and processes. Documentation also helps you to ensure that team members have access to accurate information whenever they need it.
• Improved Business Reputation: Certification to ISO 13485 is recognized internationally as a sign of a reputable business and high-quality products, so it can improve your business's reputation among current and potential customers, investors, partners, suppliers and other stakeholders.
• Ability To Win More Business: Many businesses prefer to work with medical device organizations that have ISO 13485 certification, and some require that all the companies they partner with have it. This is due in part to the fact that, under the latest version of ISO 13485, companies are responsible for ensuring any subcontractors they work with conform to ISO 13485 requirements. Because of these preferences and requirements, ISO 13485 certification enables you to win more business.
• International Expansion Opportunities: ISO 13485 is internationally recognized as a sign of product quality and is the first step to regulatory approval in many major markets. These qualities mean ISO 13485 certification can help you to expand your business into new markets.
• Assistance With ISO 9001 Certification: Achieving ISO 13485 certification can make it easier to earn certification to ISO 9001, as the two standards share many requirements. Keep in mind that there are some differences in requirements that you will need to account for.