ISO 9001 or ISO 13485 for a Medical Device QMS?

Both ISO 9001 and ISO 13485 are the standards for Quality Management System (QMS) that help organizations to oversee and manage different processes that assure delivery of quality products/services. However, there is one sharp exception to the ISO 13485 standard which is its specialization for medical devices QMS. Apparently, it is a specified standard designed to accredit the QMS for medical devices organizations and ensures that they provide the best quality and safest products to the customers. Quality and safety are priority concerns for the medical device sector because the products are used for the purposes of healthcare, treatment, or diagnosis and hence, unreliable, or substandard products can adversely affect the lives of people.

However, many medical device manufacturers consider achieving ISO 9001, the general QMS standard which is applicable to all industries. In fact, ISO 13485 is based on the framework of ISO 9001. Therefore, manufacturers think it is comprehensive and would be able to address more quality issues. Also, many seek to achieve ISO 9001 because they consider it to be easier to implement. Whatever their reason, here we are going to explain why implementing it is a wrong decision for medical devices organizations. Here are the sharp differences between the two which tell why you should implement ISO 13485.

Key Differences between ISO 13485 and ISO 9001 Standards

Structural Differences

ISO 9001 provides the framework for QMS which can be applied to any business or organization, regardless of their size, nature of products or services, or industry type. On the other hand, ISO 13485 defines the requirements of a comprehensive QMS for medical devices manufacturing which particularly focus on quality and safety regulatory compliance. This QMS henceforth offers less flexibility in their manufacturing processes. It is thus clear that manufacturers implementing medical devices QMS must to adhere to some additional requirements.

Documentation and Records

The additional requirements for ISO 13485 are mostly in the areas of documentation and record controlling. It exceeds ISO 9001 in the following matters.

• Regulatory documents along with the documentation of QMS 

• Documents for identifying of products’ specifications

• Approval of any changes to QMS documentation by a designated official

• Data retention standards based on the regulations and the lifetime of products

 

Product realization processes

In the aspect of product realization, ISO 9001 focuses on the implementation of effective procedures. As the standard emphasizes meeting customer requirements as a yardstick of quality, it defines operating procedures for the product realization that promote quality.

On the other hand, ISO 13485 emphasizes both meeting customer requirements and ensuring safety. Therefore, it sets forth vast processes of product realization including product validation, cleanliness or sterilization, and risk management. Along with a focus on customer satisfaction and quality, the standard emphasizes these requirements to ensure the safety of products throughout the supply chain:

• Document purchasing information for easy traceability

• Provision of access to the operating procedures, requirements, and inputs/materials for the staff

• Specific processes for packaging and labeling

• Verification of batch records

• Documenting requirements for product cleanliness and sterilization

• Documenting and creating records of processes for installation, servicing activities and verification

• Documenting the procedures related to product conformity

Management involvement

ISO 9001 requires the organization’s top management to assign the responsibilities of the QMS to particular members or a team. On the other hand, ISO 13485 requires them to assign responsibilities as well as identify their respective roles in the QMS.

Also, the standard defines special roles for the managers such as verifying the QMS compliance is verified, regular management reviews, and ensuring the new regulatory updates are incorporated in the QMS.

 

Key Takeaway

The primary differences between the two standards explain why the ISO 13485 standard is essential for medical device enterprises. Apart from these, more focus is also placed on the resources management in ISO 13485 and manufacturers need to manage equipment, IT resources, infrastructure, and environmental regulations for delivering quality devices. Clearly, the comparison between the two clears the doubts for medical devices manufacturers and explains how additional requirements are actually a benefit to them. They promote effective management of procedures, documentation and reviewing that ensure quality and safe medical devices.

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Also Read: What is the ISO Standard for Medical Devices: Here’s what you should know