21 CFR 820 vs. ISO 9001

Attribute	21 CFR 820	ISO 9001
Scope	Medical devices	Quality management systems
Documentation	Extensive documentation required	Documentation required but less prescriptive
Management Responsibility	Emphasis on management commitment	Management commitment required
Design Control	Specific requirements for design control	Design control included but less detailed
Corrective and Preventive Action	Specific requirements for CAPA	Requirements for corrective action and preventive action

Introduction

Both 21 CFR 820 and ISO 9001 are quality management systems that are widely used in the medical device industry. While they have similar goals of ensuring product quality and customer satisfaction, there are some key differences between the two standards that companies need to be aware of when implementing them.

Scope

21 CFR 820, also known as the Quality System Regulation (QSR), is a set of regulations established by the U.S. Food and Drug Administration (FDA) that govern the manufacturing of medical devices sold in the United States. It covers all aspects of the manufacturing process, from design and development to production and distribution. On the other hand, ISO 9001 is an international standard that focuses on quality management systems in general, not just in the medical device industry. It can be applied to any organization, regardless of its size or industry.

Documentation Requirements

One of the key differences between 21 CFR 820 and ISO 9001 is the documentation requirements. 21 CFR 820 has more stringent documentation requirements compared to ISO 9001. For example, 21 CFR 820 requires companies to maintain records of design changes, device history records, and validation activities. ISO 9001, on the other hand, does not have specific requirements for these types of documentation, but it does require companies to maintain documented procedures for key processes.

Management Responsibility

Both 21 CFR 820 and ISO 9001 place a strong emphasis on management responsibility for quality. However, there are some differences in how this is addressed in each standard. 21 CFR 820 requires companies to establish a quality system and designate a management representative who is responsible for ensuring compliance with the regulations. ISO 9001, on the other hand, requires top management to demonstrate leadership and commitment to the quality management system, but does not specify the need for a designated management representative.

Risk Management

Risk management is another area where 21 CFR 820 and ISO 9001 differ. 21 CFR 820 requires companies to establish and maintain a risk management process that is appropriate for the complexity of the device and the manufacturing process. This includes identifying and assessing risks, implementing risk controls, and monitoring the effectiveness of those controls. ISO 9001, on the other hand, does not have specific requirements for risk management, but it does require companies to identify and address risks and opportunities that could affect the quality management system.

Supplier Management

Supplier management is an important aspect of both 21 CFR 820 and ISO 9001. Both standards require companies to evaluate and select suppliers based on their ability to meet quality requirements. However, there are some differences in how this is addressed in each standard. 21 CFR 820 requires companies to establish and maintain procedures for evaluating and selecting suppliers, while ISO 9001 requires companies to ensure that purchased products and services meet specified requirements.

Continuous Improvement

Continuous improvement is a key principle of both 21 CFR 820 and ISO 9001. Both standards require companies to establish processes for monitoring and measuring quality performance, and to take corrective and preventive actions when necessary. However, there are some differences in how this is addressed in each standard. 21 CFR 820 requires companies to establish procedures for implementing corrective and preventive actions, while ISO 9001 requires companies to continually improve the effectiveness of the quality management system.

Conclusion

While 21 CFR 820 and ISO 9001 have similar goals of ensuring product quality and customer satisfaction, there are some key differences between the two standards that companies need to be aware of when implementing them. Understanding these differences can help companies ensure compliance with both standards and improve their overall quality management systems.