ISO 13485

 

What is ISO 13485 and why is it required?

 What is ISO 13485

ISO 13485 is an international Quality Management System standard for the medical device industries. This standard serves to be an effective solution to meet the comprehensive needs and requirements to have a QMS in place in the medical device sector and governs the designing and manufacturing of medical devices. It is a standalone standard published by the ISO and provides requirements for QMS for the companies in the medical device industry. The standard helps the manufacturers in the medical device industry to set up a QMS and exhibits design, development, storage, production, distribution, servicing and disposal of medical devices or components along with the design and development of the associated activities.

Objectives of ISO 13485

Companies that want to certify for ISO 13485 should have their company’s QMS to carry out a third party MDSAP (Medical Device Single Audit Program) Audit. This standard which is globally accepted is made as a mandatory standard in few countries and in the US. The latest revision to ISO 13485 was in the year 2016 that includes additions to its original criteria like focusing on risk, clarifying the responsibilities of the management, clarifying on the responsibilities of the training, facility requirement improvement, better design and developmental requirements, etc. 

What is the purpose of ISO 13485?

Adopting the ISO 13485 provides manufacturers a practical foundation that helps to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, in addition to bringing a commitment to the safety and quality of medical devices. Medical Device industries benefit immensely by being in alignment with the designing and manufactured with ISO 13485 standard’s practices. This international standard is in fact the world’s most widely used to measure the effectiveness of QMS of the medical device manufacturers. The standard can be used by suppliers, manufacturers, or distributors who furnish products or services to medical device companies. Certifying to this standard ensures the safety and quality of the finished products. The standard outlines a framework for creating QMS and helps in identifying gaps in your organization's current system and processes.

Benefits of ISO 13485

·         The standard protects the health of consumers by minimizing the risk of defective devices.

·         Gain access to a larger client base

·         Exhibit compliance with the regulatory requirements

·         Reduction in quality costs due to improved efficiency

·         Enhanced efficiency in the company’s operations and more

How do you execute ISO 13485 in your organization?

For your organization to certify to ISO 13485, you must first gain support from the management and identify the requirements of the customers for the Quality Management System. Your company should start working on documents like the quality objectives, quality manual, quality policy. These documents describe the scope and implementation of the QMS. Additional documents for processes and procedures are also required to prepare to develop and deliver your products or services. The certification process involves implementing QMS based on the requirements of ISO 13485 for your company and auditing & approving the QMS by hiring a reputed certification body.

 

 

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