ISO 13485 Quality Management System - Medical Device

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What is ISO 13485?

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

 

Benefits of ISO 13485

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

ISO 13485 offers benefits such as:

  • Raise awareness of regulatory requirements for liability, such as meeting statutory requirements of the US market (FDA) or the European Union, etc.

  • Outline how to review and improve processes, professionally and with high accuracy

  • Increase efficiency, cut costs and monitor performance

  • Create a competitive advantage, demonstrating that you produce safer and more efficient medical devices. Companies with this certification communicate a commitment to quality to both customers and regulators.

 

Start applying ISO 13485

This standard is open to all organizations, whether your organization is: a small business, a global corporation, a not-for-profit organization, a charity, a training organization, or a government organization,...

As long as your organization carries out the production and business of medical equipment, medical services in general (for example: medical masks, medical protective equipment, disinfectant solutions, sterilization equipment for medical products, endoscopes, infusions, ...)

The standard can be used by organizations with low-risk activities. As well as large and complex organizations there is a high degree of risk.This is a voluntary standard that focuses on the safety management of medical products.

Compliance with ISO 13485 is often seen as the first step in complying with EU regulatory requirements; or meet medical device quality system regulations in the United States enforced by the FDA (U.S. Food and Drug Administration).

Training courses to help you start with ISO 13485 >>

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Deployment, implementation ISO 13485

The ISO 13485 structure is split into eight sections, with the first three being introductory, and the last five containing the mandatory requirements for the Quality Management System.

  • Section 4: Quality Management System – This section talks about general QMS requirements. It includes the requirements for the Quality Manual, Control of Documents, and Control of Records, all of which are required documents in the QMS.

  • Section 5: Management Responsibility – The management responsibility requirements cover the need for top management to be instrumental in the implementation and maintenance of the QMS.

  • Section 6: Resource Management

  • Section 7: Product Realization – This section includes requirements on planning, product requirements review, design, purchasing, creating the product or service, and controlling the equipment used to monitor and measure the product or service.

  • Section 8: Measurement, Analysis and Improvement – It includes assessing customer satisfaction, internal audits, monitoring products and processes, dealing with non-conforming product, and corrective and preventive actions.

These sections are based on a Plan-Do-Check-Act cycle, which uses these elements to implement change within the processes of the organization in order to drive and maintain improvements within the processes.

Are you ready to apply ISO 13485:2016?

Every business is separate and unique. Each business is a different stage in implementing the roadmap of ISO 13485 certification.

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Certification ISO 13485

Maintain regulatory compliance by being ISO 13485 certified. ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities.

Once all of the processes and procedures are in place, you will need to operate the QMS for a period of time. By doing this, you will be able to collect the records necessary to go to the next steps: to audit and review your system and get certified.

ISO 13485 certification for your company involves implementing a QMS based on the ISO 13485 requirements; The audit will be conducted by a third-party certification body that you hire, which is accredited to evaluate and approve your QMS as meeting the requirements of the ISO 13485 standard.

Certification procedure ISO 13485 >>

 

Why choose certification ISO 13485:2016 at Won-Med

Reasons for you to choose Won-Med's international standard certification services:

  1. Reasonable cost: For the benefit of the interested parties

  2. As soon as possible: Always on time for delivery

  3. Experience experts, improvement opportunities for production process and products  

  4. Enhance added value for the benefit of customers. Improve operations, eliminate waste in the production process

  5. Perfect service: Exceeded customer expectations

  6. Global brand

  7. Quality of Service No.1 for Everywhere.

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