ISO 13485

ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices. ISO 13485:2003 provides a harmonized set of quality management system requirements for medical device manufacturers. ISO 13485 certificate can help you in entering almost any market in the world. It is currently recognized in most major markets (Europe, USA, Canada etc).

While it is based on ISO 9001:2000, ISO 13485 does not include the customer satisfaction and continual improvement clauses - so an organization certified to ISO 13485 does not automatically meet the requirements of ISO 9001 unless it is assessed against that standard separately. Compliance with ISO 13485 also does not guarantee compliance with regulatory requirements, but it can facilitate the audit process for those requirements. The ISO 13485 accomplishes a harmonization by writing specific medical device requirements in a generic framework that allows any specific or unique needs of local regulation to be addressed



Why to implement ISO 13485 ?

ISO 13485 will help you reap the benefits of

Expanded market access Many national regulatory authorities require, or strongly prefer, that manufacturers marketing medical products in their countries have a third-party audited and certified quality system in place. Obtaining such a system speeds access into those countries that require it, and expedites market entry into the others.

Reduced cost of sales ISO 13485 certification shows your commitment to quality from the day one. This standard emphasizes on requirements of medical instruments, hence your product will gain faith of consumers without making much sales effort.

Improved overall performance Based on a uniform and widely accepted system of process control, your certified QMS helps you improve your products and processes. This can foster improved relationships with your suppliers, business partners and customers, and give your business a real advantage in the marketplace.

Enhanced product safety By implementing this standard you improve safety of your product.

Proactive error detection and prevention This standard can be used as a tool to detect error in your product and you can also decide a preventive action plan.

How to proceed for ISO 13485 ?

1. Identify the basic ISO 13485 requirements and how they apply to your business.

2. Establish quality goals and understand how they can best be incorporated into your business operations.

3. Identify the quality management system’s parameters and develop and implement a fully documented plan.

4. Contact us for certification.

ISO 13485 differs from 9001 in:

From QMS Continuous Improvement to maintaining the effectiveness (since it must meet certain requirements as a medical device)

Focus on meeting regulatory requirements versus increasing customer satisfaction.

Additional documentation requirements (depending on product) including

Regulatory requirements

Health, cleanliness, sterilization

Risk management system

Traceability of purchased material

Labeling and packaging



SIGNIFICANCE OF ISO 13485

The medical device industry is affected by a complex array of regulatory systems, national and international standards and other requirements. We provide ISO 13485 certification which is globally recognized standard & helps a product in meeting compliance (national & worldwide). ISO 13485:2003 is the latest version of ISO 13485 which was published in July 2003. This standard is similar to ISO 9001:2008 and is based on process model approach. Our certificate is formally recognized worldwide. Being a medical device manufacturer, it is your responsibility to deliver a device which is effective & safe for everyone. By implementing ISo 13485 in your organization you can achieve this goal.



BENEFITS OF ISO 13485

Improved legal and regulatory or contractual requirements compliance

Risk identification and management

Improved brand image.

Safe & effective end product

Increased customer satisfaction

Increased process efficiency.