QUESTION: What is 21 CFR 820 and what is ISO 13485:2003

ANSWER: Title 21 of the Code of Federal Regulations (CFR) covers the broad area of food and drugs, but Part 820 pertains to quality systems for medical devices. It outlines Current Good Manufacturing Practice (CGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. These requirements are meant to ensure that medical devices are safe, effective, and in compliance with the Federal Food, Drug, and Cosmetic Act.


ISO 13485:2003 is an international standard that specifies requirements for regulatory purposes for medical device manufacturers. It provides a framework for companies to meet their customer and regulatory requirements. The main goal is to provide a harmonized model for quality management system requirements in the international market since different countries might have different standards. ISO (derived from the Greek word ‘isos’, meaning equal) refers to the International Organization for Standardization, a non-governmental organization based in Geneva.

QUESTION: Who is covered by 21 CFR 820 and who is covered by ISO 13485?

ANSWER: 21 CFR 820 is applicable to manufacturers of finished medical devices sold in the United States, including foreign manufacturers who import devices. Some manufacturers might be subject only to certain requirements, depending on the operations they are engaged in Medical device manufacturers that sell their products in the global market find it advantageous to get ISO 13485 certification because ISO standards are recognized worldwide. Certain countries require such certification. Many customers also prefer medical devices that are ISO 13485 Certified.

QUESTION: What’s the relationship between 21 CFR 820 and ISO 13485?

ANSWER: Although the two are similar, they have significant differences. For example, complaint handling and reporting requirements are integral to the FDA’s quality systems regulation (QSR), but the FDA thinks they are not adequately addressed in ISO 13485. In this case, conformity to the ISO standard would not suffice to demonstrate conformity with the QSR and the FDA’s Center for Devices and Radiological Health will not recognize the standard for this particular purpose.

QUESTION: Who enforces 21 CFR 820 and ISO 13485?

ANSWER: The Food and Drug Administration enforces 21 CFR 820.

Third parties usually conduct assessment of a manufacturer’s system and processes to make sure they are in accordance with the requirements of ISO 13485.

QUESTION: What’s the connection between 21 CFR 820, ISO 13485, and QMSCAPA?

ANSWER: Developed more than five years ago, the QMSCAPA™ quality management software solution was designed to help companies adhere to ISO standards for tracking customer feed-back and corrective actions. Many QMSCAPA™ users compelled with FDA regulations found the software to be a cost effective and efficient tool for assisting with quality management. Today hundreds of companies worldwide rely on ABCI to help them analyze, document, control, interconnect, log and manage their quality processes, customer feed-back and corrective actions.

QUESTION: What are some of QMSCAPA™ features and how can they help medical device manufacturers comply with 21 CFR 820 and ISO 13485?



Audit Management

Corrective & Preventive Actions

Customer Feed-back

Document Control Index

Management for Monitoring & Measuring Devices

Records Control Index

Risk Management

Supplier Management

Training management



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