What is ISO 13485 ?

iso13485_certificate

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.

13485 dictates that risk management must be thoroughly documented and conducted throughout a product’s entire lifecycle, from initial concept to delivery and post-delivery. However, the standard leaves the specifics to a related standard, ISO 14971: 2001, Application of Risk Management for Medical Devices. While 13485 states that a manufacturer’s management team is charged with the management of device-related risks and the development of risk management plans, 14971 defines a list of steps to be taken by management in order to fulfill risk-related requirements. While it is not mandatory that a manufacturer be 14971 certified in order to attain 13485 certification, being certified to the former standard can ease the attainment of certification to the latter.

Medical device manufacturers also should realize the importance that risk management bears in a 13485 management system. A lot of places typically look at risk management only at the design and development function and they don’t carry it through the entire lifecycle of the product or process


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
     o Regulatory requirements
     o Health, cleanliness, sterilization
     o Risk management system
     o Traceability of purchased material
     o 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.