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Overview of ISO 13485 Quality Management System

ISO 13485: Quality Management System for Medical Devices

Unscalable and unreliable medical devices can heavily impact work in medical areas, which can affect public health. To mitigate the inherent risks in some medical tools and equipment, there needs to be some sort of quality management system (QMS) in place that’s enforced.

This is where the implementation of customizable and configurable QMS like ISO 13485 comes into play.

What is ISO 13485?

Quality management system ISO 13485 is an international and very commonly used QMS regulatory standard for medical devices. It’s one of the most comprehensive standards for medical device manufacturers to use in order to meet customer and applicable QMS regulatory requirements.

In this case, a medical device is defined as a product (ranging from larger machines to in vitro reagents to individual tools) that is intended for use in the prevention, diagnosis, and treatment of diseases or other medical conditions.

ISO 13485 applies to medical device industries and manufacturers (those involved in the design, production, installation, and servicing of medical devices and any related services). It’s also used by internal and external parties, such as certification bodies, to assist with their auditing processes.

The ISO 13485 standard goes hand-in-hand with ISO 9001, with the main difference being ISO 13485’s added layer of customer satisfaction and continuous improvements.

Improving the Standard (ISO 13485:2016)

All standards are revised every few years to keep them updated according to the changes and demands of the marketplace. So far, two revised editions of the ISO 13485 standard have been introduced after 1996: ISO 13485:2003 and ISO 13485:2016. 

ISO 13485:2016 is the current standard. It focuses more on risk management, risk-based decision making, and changes related to the increased regulatory requirements for organizations in the supply chain industry.

How is ISO 13485 Beneficial?

The implementation of ISO 13485 provides a practical foundation for medical device manufacturers; it allows manufacturers to meet the Medical Device Directives (in EU and UK), regulations, and responsibilities for the safety and quality of medical devices

Some of the other benefits of ISO 13485 standards are mentioned below: 

  • Global recognition and better alignment with the Food and Drug Administration (FDA): ISO 13485 is recognized by the International Medical Device Regulators Forum and is the model QMS standard in major worldwide markets and medical industries. It’s also closely tied to the FDA’s quality system regulations (QSR) standards that hold global acceptance and reputation. 
  • Efficient quality management: All the relevant products and processing steps are analyzed for any faults, defects, and risks, leading to increased product quality. Additionally, it helps staff to achieve optimal performance by facilitating an ideal work environment with improved communication between individuals and clearly assigned roles and responsibilities.
  • Complies with European regulatory standards: ISO 13485 is the first step towards achieving compliance with European regulatory requirements. It provides conformity for the quality of medical devices and in vitro diagnostic medical devices according to European Union Medical Devices Directives (MDD) 93/42/EEC, 90/385/EEC, and 98/79/EEC.

Accreditation bodies assess the implementation of the ISO 13485 standard in organizations and provide a certificate of conformity. This provides CE marking and permission to sell medical devices in the European Union. 

  • Improve customer satisfaction: The standard is designed to assess customer needs and expectations. This scaffolded approach allows manufacturers to meet the demands of customers and build confidence in their products.
  • Improve credibility and image: The ISO 13485 accreditation shows the manufacturer’s commitment to quality and safety. The accreditation bolsters credibility and overall trust in a manufacturer’s processes and end-products.

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How is the ISO 13485 Accreditation Structured?

The implementation of the ISO 13485 standard, while recommended, is not mandatory. (You can also create your own QMS, as long as it meets the legal and regulatory requirements for manufactured and sellable medical devices.)

The ISO 13485 certification process is a multistep approach. A medical device manufacturing lab is accredited only after satisfying the applicable regulatory requirements of ISO standards and demonstrating a commitment to medical device quality and safety. 

While it’s not mandatory, a third-party certification demonstrates your commitment to the safety and quality of medical devices. (If your lab does seek accreditation, it must pass a third-party Medical Device Single Audit Program or “MDSAP” audit.)

Below is an overview of the ISO 13485 requirements:

  1. Scope: Describes the purpose of the standard and its use by organizations and manufacturers.
  2. Normative References: Provides the fundamentals, common vocabulary, and other references for quality management systems.
  3. Terms and Definitions: Provides definitions and frames the terminology used throughout the standard.
  4. Quality Management System: Requirements for the overall quality management system documentation, including document control, requirement procedures, and forms control.
  5. Management Responsibility: Includes the requirements for management’s role in the QMS, including management review, policies, objectives, and customer satisfaction efforts.
  6. Resource Management: Provides requirements for resources such as personnel and training courses.
  7. Product Realization: Covers everything from planning and designing to the process’s quality control. 
  8. Measurement, Analysis, and Improvement: Includes requirements for monitoring processes and improving upon those processes. It includes customer satisfaction metrics, internal audits, control of the non-conforming products, and corrective and preventative action.

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Excedr Helps Labs Procure the Quality Equipment Needed for Accreditations

ISO 13485 is an international standard to assist medical device manufacturers focus on their management system, mitigate risk, and meet regulatory requirements. It assesses the quality of the medical devices throughout their lifecycle, starting from their design, development, storage, servicing to final distributions.

To help you obtain this accreditation, your lab may require high-quality equipment. This is especially true if you are working in the public health sector, where the quality of work cannot be compromised at any level.

Excedr can help your lab procure the high-functioning equipment it needs at an affordable rate. Our custom lease program allows you to fully outfit your lab without the high upfront costs.

Contact us for more information on how we can help your lab reach its milestones. 

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