ISO 13485 for Medical Devices Part 1 – What is ISO 13485?

This is our first in a series of Articles on: Branching out – Other Standards based upon ISO 9001.  This is #1 of 2 on ISO 13485 – Medical Standards.

What is ISO 13485 for Medical Devices?

ISO 13485 is an ISO Standard, published in 2003. The ISO 13485 was designed for organizations that provide medical devices or related services. It provides the requirements for a comprehensive management system for the design and manufacture of medical devices.

To learn more we recommend this free tutorial “What is ISO 13485?”

ISO 13485 is generally harmonized with the ISO 9001 standard, though it is a stand-alone document. ISO 13485 removes ISO9001’s emphasis on continual improvement and customer satisfaction though it has been developed based on ISO 9001. It lays emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices.

If you’d like to learn more, here is a comparison of ISO 9001 and ISO 13485

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. To ensure this, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.

Organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 because certain points have been excluded in ISP 13485.

ISO 13485 certification does not fulfill the requirements of either the FDA or foreign regulators. This certification aligns an organization’s management system to the requirements of the FDA’s Quality System Regulation requirements (like CFR 21Part 820) as well as many other regulatory requirements in use throughout the world.

Here is a review of some of the Medical Terms & Definitions, Classes & Regulations

Once you get ISO 13485 certification, it will help your organization do business in this highly regulated sector. It will demonstrate that your organization is committed to quality, customers, and is willing to work towards improving efficiency.

ISO 13485 promotes harmonization of regulatory requirements for manufacturers of medical devices on an international scale. Is it right for you?

Consider this PowerPoint: ISO 13485 executive overview.

Our next issue will focus on Who is requiring ISO 13485 and why should I implement it?


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